As filed with the Securities and Exchange Commission on May __, 2007.
Registration No. 333-______
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM S-1
Registration Statement
Under
THE SECURITIES ACT OF 1933
CEL-SCI Corporation
---------------- ---------------------
(Exact name of registrant as specified in charter)
Colorado
----------------------------------
(State or other jurisdiction of incorporation)
8229 Boone Blvd. #802
Vienna, Virginia 22182
84-09l6344 (703) 506-9460
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(IRS Employer I.D. (Address, including zip code, and telephone number
Number) including area of principal executive offices)
Geert Kersten
8229 Boone Blvd. #802
Vienna, Virginia 22182
(703) 506-9460
-----------------------------------------
(Name and address, including zip code, and telephone number,
including area code, of agent for service)
Copies of all communications, including all communications sent
to the agent for service, should be sent to:
William T. Hart, Esq.
Hart & Trinen
1624 Washington Street
Denver, Colorado 80203
(303) 839-0061
APPROXIMATE DATE OF COMMENCEMENT OF PROPOSED SALE TO THE PUBLIC:
As soon as practicable after the effective date
of this Registration Statement
If the only securities being registered on this Form are being offered pursuant
to dividend or interest reinvestment plans, please check the following box. [ ]
If any of the securities being registered on this Form are to be offered on a
delayed or continuous basis pursuant to Rule 415 under the Securities Act of
1933, other than securities offered only in connection with dividend or interest
reinvestment plans, check the following box. [X]
If this Form is filed to register additional securities for an offering pursuant
to Rule 462(b) under the Securities Act, please check the following box and list
the Securities Act registration statement number of the earlier effective
registration for the same offering. [ ]
If this Form is a post-effective amendment filed pursuant to Rule 462(c) under
the Securities Act, check the following box and list the Securities Act
registration statement number of the earlier effective registration statement
for the same offering. [ ]
If delivery of the prospectus is expected to be made pursuant to Rule 434,
please check the following box. [ ]
CALCULATION OF REGISTRATION FEE
CALCULATION OF REGISTRATION FEE
Title of each Proposed Proposed
Class of Maximum Maximum
Securities Securities Offering Aggregate Amount of
to be to be Price Per Offering Registration
Registered Registered Share (1) Price Fee
---------- ---------- --------- ---------- ------------
Common stock (2) 42,961,666 $0.88 $37,806,267 $4,046
-------------------------------------------------------------------------------
Total
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(1) Offering price computed in accordance with Rule 457(c).
(2) Represents shares to be sold by selling shareholder.
Pursuant to Rule 416, this Registration Statement includes such
indeterminate number of additional securities as may be required for issuance
upon the exercise of the warrants as a result of any adjustment in the number of
securities issuable by reason of stock splits or similar capital
reorganizations.
The registrant hereby amends this Registration Statement on such date or
dates as may be necessary to delay its effective date until the registrant shall
file a further amendment which specifically states that this Registration
Statement shall thereafter become effective in accordance with Section 8(a) of
the Securities Act of l933 or until the Registration Statement shall become
effective on such date as the Commission, acting pursuant to said Section 8(a),
may determine.
2
PROSPECTUS
CEL-SCI CORPORATION
Common Stock
By means of this prospectus shareholders of CEL-SCI Corporation are
offering to sell up to 42,961,666 shares of CEL-SCI's common stock. The shares
offered by this prospectus consist of shares sold by CEL-SCI in a private
offering for cash, shares issued for consulting services, and shares issuable
upon the exercise of warrants. The selling shareholders may be considered
"underwriters" as that term is defined in the Securities Act of 1933.
CEL-SCI's common stock is quoted on the American Stock Exchange under the
symbol "CVM." On ___________, 2007 the closing price for one share of the
CEL-SCI's common stock was $0.___.
Neither the Securities and Exchange Commission nor any state securities
commission has approved or disapproved of these securities or passed upon the
accuracy or adequacy of this prospectus. Any representation to the contrary is a
criminal offense.
These securities are speculative and involve a high degree of risk. For a
description of certain important factors that should be considered by
prospective investors, see "Risk Factors" beginning on page 6 of this
Prospectus.
The date of this prospectus is ________, 2007
3
PROSPECTUS SUMMARY
THIS SUMMARY IS QUALIFIED BY THE MORE DETAILED INFORMATION APPEARING ELSEWHERE
IN THIS PROSPECTUS.
CEL-SCI
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CEL-SCI is involved in the research and development of drugs for cancer and
infectious diseases
CEL-SCI's lead product, Multikine(R), is being developed for the treatment
of cancer. Multikine is a patented immunotherapeutic agent consisting of a
mixture of naturally occurring cytokines, including interleukins, interferons,
chemokines and colony-stimulating factors, currently being developed for the
treatment of cancer. 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 head & neck cancer (500,000 new 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.
Approximately 800 patients will be enrolled worldwide in the Phase III
trial. The protocol is designed to develop conclusive evidence of the efficacy
of Multikine in the treatment of advanced primary 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 enhance the
local/regional control of the disease, reduce the rate of disease progression
and extend the time of progression free survival in patients with advanced oral
squamous cell carcinoma.
CEL-SCI also owns a pre-clinical technology called L.E.A.P.S. (Ligand
Epitope Antigen Presentation System). The lead product derived from this
technology is the CEL-1000 peptide which has shown protection in animals against
herpes, malaria and cancer. With the help of government grants and US Army and
US Navy collaborations, CEL-1000 is now being tested against avian flu, viral
encephalitis, West Nile Virus, SARS, Vaccinia, Smallpox, herpes, malaria and
other agents. If the bio-terrorism tests are successful, CEL-SCI is likely to
push CEL-1000 for potential bio-terrorism disease indications to gain
accelerated approval.
4
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. 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.
All of CEL-SCI's products are in the development stage. As of April 20,
2007, 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 $(108,000,000) at December 31, 2006 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.
CEL-SCI's common stock is quoted on the American Stock Exchange under the
symbol "CVM".
THE OFFERING
By means of this prospectus shareholders of CEL-SCI Corporation are
offering to sell up to 42,961,666 shares of CEL-SCI's common stock. These shares
consist of shares sold by CEL-SCI in a private offering for cash, shares issued
for consulting services and shares issuable upon the exercise of warrants.
As of April 20, 2007, CEL-SCI had 107,505,621 outstanding shares of common
stock. The number of outstanding shares does not give effect to shares which may
be issued upon the conversion of notes, as payment of interest or principal on
notes, or the exercise of outstanding warrants or options. See "Comparative
Share Data".
CEL-SCI will not receive any proceeds from the sale of the shares by the
selling shareholders.
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.
5
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 the risks described below could adversely
affect the price of CEL-SCI's common stock.
Risks Related to CEL-SCI
------------------------
Since CEL-SCI Has Earned Only Limited Revenues and Has a History of 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, 2006 CEL-SCI incurred net
losses of approximately $(108,000,000). CEL-SCI has relied principally upon the
proceeds of public and private sales of its securities to finance its activities
to date. All of CEL-SCI's potential products, with the exception of Multikine,
are in the early stages of development, and any commercial sale of these
products will be many years away. Even potential product sales from Multikine
are many years away as cancer trials can be lengthy. Accordingly, CEL-SCI
expects to incur substantial losses for the foreseeable future.
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 or force CEL-SCI out of business.
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.
6
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.
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.
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
$1,000,000 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.
7
Risks Related to Government Approvals
-------------------------------------
CEL-SCI's product candidates must undergo rigorous pre-clinical 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.
The clinical trials of CEL-SCI's product candidates may not be completed
on schedule, 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. 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
in the United States, 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 approved for
marketing. 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 will not be able to commercialize Multikine and other product
candidates until it has obtained regulatory approval. 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. 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. 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.
8
Even if CEL-SCI obtains regulatory approval for its product candidates, CEL-SCI
will be subject to stringent, ongoing government regulation.
If CEL-SCI's products receive regulatory approval, either in the United
States or internationally, CEL-SCI will be subject to extensive regulatory
requirements. These regulations are wide-ranging and govern, among other things:
o product design, development and manufacture;
o adverse drug experience;
o product advertising and promotion;
o product manufacturing, including good manufacturing practice
requirements;
o record keeping requirements;
o registration and listing of CEL-SCI's establishments and products
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 contract manufacturers or suppliers, cannot pass a pre-approval plant
inspection, the FDA will not approve the marketing applications 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.
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
license suspension or revocation, criminal prosecution, seizure, injunction,
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. 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
9
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 companies are working on drugs designed to cure or treat cancer and
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 new 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.
10
Risks Related to CEL-SCI's Common Stock
---------------------------------------
Since the market price for CEL-SCI's common stock is volatile, investors 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 year ended September 30, 2006 CEL-SCI's stock
price has ranged from a low of $0.44 per share to a high of $1.78 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 conversion of promissory notes, the payment of interest
or principal on the promissory notes, or the exercise of outstanding options and
warrants 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 had outstanding convertible notes, options and warrants which as of
April 20, 2007 allowed the holders to acquire a substantial amount of additional
shares of its common stock. Until the options and warrants expire, or the
convertible notes are paid, 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 convertible notes, options and warrants may
convert or exercise these securities at a time when CEL-SCI could obtain
additional capital on terms more favorable than those provided by the options.
The conversion of the notes or the exercise of the options and warrants will
dilute the voting interest of the owners of presently outstanding shares by
adding a substantial number of additional shares of CEL-SCI's common stock. See
"Comparative Share Data" for additional information.
CEL-SCI has filed, or plans to file, registration statements with the
Securities and Exchange Commission so that substantially all of the shares of
common stock which are issuable upon the exercise of outstanding options and
warrants may be sold in the public market. The sale of common stock issued or
issuable upon the exercise of CEL-SCI's options or warrants described above, or
the perception that such sales could occur, may adversely affect the market
price of CEL-SCI's common stock.
11
COMPARATIVE SHARE DATA
Number of Note
Shares Reference
--------- ---------
Shares outstanding as of April 20, 2007: 107,505,621
Shares to be sold in this Offering:
Shares purchased by private investors 20,043,333 A
Shares issuable upon exercise of
Series L warrants 10,021,667 A
Shares issuable upon exercise of
Series M warrants 10,021,667 A
Shares issued for consulting services 2,875,000 B
Other Shares Which May Be Issued:
The following table lists additional shares of CEL-SCI's common stock
which may be issued as of April 20, 2007:
Number of Note
Shares Reference
--------- ---------
Shares issuable as payment of interest on
the Series K notes 1,700,000 C
Shares issuable as payment of principal on
the Series K notes 10,480,000 C
Shares issuable upon the exercise of the
Series K warrants 5,211,628 C
Shares issuable upon the exercise of warrants
held by private investors 4,059,159 D
Shares issuable upon exercise of options granted
to CEL-SCI's officers, directors, employees,
consultants, and third parties 11,188,014 E
A. In April 2007, CEL-SCI sold 20,000,000 Units to Korral Partners, an
institutional investor, for $15,000,000. Each Unit was priced at $0.75 and
consisted of one share of CEL-SCI's common stock, one-half of a Series L warrant
and one-half of a Series M warrant. Immediately after this sale Korral Partners
sold the 20,000,000 shares of CEL-SCI's common stock and the 10,000,000 Series M
warrants to 19 foreign investors. Korral Partners retained the 10,000,000 Series
L warrants.
12
Pursuant to a previously granted right of participation two investors in
CEL-SCI's August 2006 financing purchased 43,333 Units, which were identical to
the Units sold to Korral Partners, at a price of $0.75 per Unit.
Each Series L warrant allows the holder to purchase one share of CEL-SCI's
common stock for $0.75. Each Series M warrant allows the holder to purchase one
share of CEL-SCI's common stock for $2.00. The Series L and M warrants expire on
March 31, 2012.
B. CEL-SCI has issued shares of its common stock to the following companies as
payment for consulting services.
Name Date Shares Issued
---- ---- -------------
Riviera Ventures, Inc. 9-29-06 375,000
Ozal Ltd. 4-03-07 2,000,000
Emento S.A. 4-03-07 500,000
C. In August 2006, CEL-SCI sold Series K convertible notes, plus Series K
warrants, to independent private investors for $8,300,000. The notes bear
interest annually at the greater of 8% or 6 month LIBOR plus 3% per year. The
Notes are due and payable on August 4, 2011 and are secured by substantially all
of CEL-SCI's assets.
At the holder's option, the Series K notes are convertible into shares of
CEL-SCI's common stock at a conversion price of $0.75.
The Series K warrants allow the holders to purchase up to 5,211,628 shares
of CEL-SCI's common stock at a price of $0.75 per share at any time between
February 4, 2007 and February 4, 2012.
The number of shares issuable upon the conversion of the Series K
promissory notes or upon the exercise of the Series K warrants may increase as
the result of future sales of CEL-SCI's common stock at prices below either the
note conversion price or warrant exercise price, as the case may be, or the
market price of CEL-SCI's common stock.
At CEL-SCI's election, and under certain conditions, CEL-SCI may use
shares of its common stock to make interest or principal payments on the Series
K notes. The actual number of shares which may be issued as payment of interest
or principal may increase if the price of CEL-SCI's common stock is below the
then applicable conversion price of the Series K notes.
To the extent CEL-SCI uses its shares to make principal payments on the
notes, the number of shares which may be issued upon the conversion of the notes
may be less due to reduction in the outstanding principal balance of the notes.
The actual number of shares which will ultimately be issued upon the
payment or conversion of the Series K notes and the exercise of the Series K
warrants (if any) will vary depending upon a number of factors, including the
price at which CEL-SCI sells any additional shares of its common stock prior to
the date the Series K notes are paid or converted or the date the Series K
13
warrants are exercised or expire. See "Description of Securities" for more
detailed information concerning the Series K notes and warrants.
D. Between August 1, 2001 and May 18, 2006 CEL-SCI sold shares of its common
stock in private transactions. In some cases warrants were issued as part of the
financings. The names of the warrant holders and the terms of the warrants are
shown below:
Shares
Issuable
Upon
Issue Exercise of Exercise Expiration
Warrant Holder Date Warrants Price Date
-------------- ------- ----------- -------- ----------
Lamey Corporation 8/17/2001 272,108 $ 1.75 7/01/2007
Eastern Biotech 5/30/2003 400,000 $ 0.47 5/30/2008
Cher Ami Holdings 12/01/2003 441,176 $ 0.56 12/01/2007
Karen Carson 2/15/2005 15,000 $ 0.73 2/15/2015
Lucci Financial Group 10/14/2005 80,000 $ 1.00 10/14/2010
Lucci Financial Group 10/14/2005 80,000 $ 2.00 10/14/2010
Bristol Capital LLC 9/16/2003 197,863 $ 0.83 9/16/2008
Wachovia Capital 5/4/2004 76,642 $ 1.37 5/04/2009
Cher Ami Holdings 7/18/2005 375,000 $ 0.65 7/18/2009
Jena Holdings LLC 10/31/2005 271,370 $ 0.55 10/24/2010
Cher Ami Holdings 2/9/2006 150,000 $ 0.56 2/09/2011
Lucci Financial Group 4/12/2006 100,000 $ 1.50 4/12/2009
Eastern Biotech 4/17/2006 800,000 $ 1.25 6/30/2008
Cher Ami Holdings 5/18/2006 800,000 $ 0.82 5/17/2011
----------
4,059,159
==========
E. The options are exercisable at prices ranging from $0.16 to $6.25 per share.
CEL-SCI may also grant options to purchase additional shares under its Incentive
Stock Option and Non-Qualified Stock Option Plans.
The shares referred to in Notes C and E are being offered for sale by
means of separate registration statements which have been filed with the
Securities and Exchange Commission.
MARKET FOR CEL-SCI'S COMMON STOCK
As of April 20, 2007 there were approximately 2,500 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.
14
Quarter Ending High Low
-------------- ---- ---
12/31/04 $0.67 $0.46
3/31/05 $1.08 $0.62
6/30/05 $0.73 $0.48
9/30/05 $0.60 $0.46
12/31/05 $0.69 $0.45
3/31/06 $1.06 $0.49
6/30/06 $1.78 $0.71
9/30/06 $0.92 $0.53
12/31/06 $0.81 $0.55
3/31/07 $0.90 $0.56
Holders of common stock are entitled to receive dividends as may be
declared by the Board of Directors out of legally available funds 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.
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.
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. 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 market price of
CEL-SCI's common stock.
MANAGEMENT'S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATION
The following selected financial data should be read in conjunction with
the Consolidated Financial Statements and Notes appearing elsewhere in this
prospectus.
15
For the years ended September 30,
----------------------------------------------------------
Statements of Operations 2006 2005 2004 2003 2002
------------------------ ----------------------------------------------------------
Grant revenue and other $125,457 $269,925 $325,479 $318,304 $384,939
Other expenses:
Research and
development 1,896,976 2,229,729 1,941,630 1,915,501 4,699,909
Depreciation and
amortization 170,902 190,420 198,269 199,117 226,514
General and
administrative 3,406,775 1,930,543 2,310,279 2,287,019 1,754,332
Gain (loss) on
derivative
instruments 2,325,784 363,028 1,174,660 (2,319,005) 5,053,156
Other income - 625,472 - - -
Other costs of
financing (4,791,548) - - (270,664) -
Interest income 92,487 52,660 51,817 52,502 85,322
Interest expense (216,737) - (53,855) (1,365,675) (4,517,716)
------------ ------------ ------------ ------------ ------------
Net loss $(7,939,210) $(3,039,607) $(2,952,077) $(7,986,175) $(5,675,054)
============ ============ ============ ============ ============
Net loss per common share
Basic $(0.10) $(0.04) $(0.04) $(0.16) $(0.20)
Diluted $(0.11) $(0.05) $(0.06) $(0.19) $(0.24)
Weighted average common
shares outstanding
Basic 78,971,290 72,703,395 67,273,133 50,961,457 28,746,341
Diluted 93,834,078 73,581,925 68,924,099 51,127,439 31,788,281
Three Months Ended
December 31,
-------------------
2006 2005
---- ----
(unaudited)
-----------
Grant revenue and other $ 20,793 $ 29,847
Expenses:
Research and development 506,158 434,889
Depreciation and
amortization 41,842 43,790
General and administrative 1,052,704 573,036
Gain on derivative instruments 719,247 13,337
Interest income 95,551 11,404
Interest expense 347,246 --
------------ ------------
Net loss $(1,112,359) $ (997,127)
============ ============
Net loss per common share
Basic $(0.01) $(0.01)
Diluted $(0.01) $(0.01)
Weighted average common
shares outstanding, basic and diluted 82,928,432 74,998,621
16
September 30,
-------------------------------------------------------------
Balance Sheets: 2006 2005 2004 2003 2002
-------------- -------------------------------------------------------------
Working capital (deficit) $ 7,109,879 $ 2,235,297 $ 4,592,332 $ 205,815 $(1,366,925)
Total assets 9,653,277 3,092,352 5,513,810 2,915,206 3,771,258
Convertible debt (1) - - - 194,109 1,673,504
Note payable - Covance (1) - - - 184,330 -
Note payable - Cambrex (1) - - - 664,910 1,135,017
Series E preferred
stock (1) - - - - 2,001,591
Derivative instruments -
current (1) 1,670,234 1,280 - 319,295 4
Derivative instruments -
non-current (1) 8,645,796 811,180 1,175,488 2,517,131 314,844
Total liabilities 10,583,878 987,313 1,391,468 4,694,385 6,115,876
Stockholders' equity
(deficit) (930,601) 2,105,039 4,122,342 (1,779,179) (2,344,618)
Balance Sheets: December 31, 2006
--------------- -----------------
(unaudited)
Working capital $ 5,609,684
Total assets 8,434,224
Convertible Debt - current 1,714,722
Convertible Debt - non-current 8,055,825
Total liabilities 10,242,133
Stockholders' equity (deficit) (1,807,909)
No dividends have been declared on CEL-SCI's common stock.
CEL-SCI's net losses for each fiscal quarter during the two years ended
September 30, 2006 were:
Net income (loss) per share
Net income ----------------------------
Quarter (loss) Basic Diluted
------- ------------ ----- -------
12/31/2004 $ (1,229,443) $ (0.02) $ (0.02)
3/31/2005 $ (1,149,440) $ (0.01) $ (0.02)
6/30/2005 $ (653,786) $ (0.01) $ (0.01)
9/30/2005 $ (6,938) -- --
12/31/2005 $ (997,127) $ (0.01) $ (0.01)
3/31/2006 $ (1,331,071) $ (0.02) $ (0.02)
6/30/2006 $ (1,294,041) $ (0.02) $ (0.02)
9/30/2006 $ (4,391,444) $ (0.05) $ (0.06)
Results of Operations
---------------------
CEL-SCI's most advanced product, Multikine, which has been cleared for a
Phase III clinical trial in the U.S. and in Canada, is being developed for the
treatment of cancer. Multikine is designed to target the tumor micro-metastases
that are mostly responsible for treatment failure. The basic idea of Multikine
17
is to make current cancer treatments 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 head & neck cancer (500,000
new cases per annum). Since Multikine is not tumor specific, it may also be
applicable in many other solid tumors.
CEL-SCI also owns a pre-clinical technology called L.E.A.P.S. (Ligand
Epitope Antigen Presentation System). The lead product derived from this
technology is the CEL-1000 peptide which has shown protection in animals against
herpes, viral encephalitis, malaria and cancer.
Since inception, CEL-SCI has financed its operations through the issuance
of equity securities, convertible notes, loans and certain research grants.
CEL-SCI's expenses will likely exceed its revenues as it continues the
development of Multikine and brings other drug candidates into clinical trials.
Until such time as CEL-SCI becomes profitable, any or all of these financing
vehicles or others may be utilized to assist CEL-SCI's capital requirements.
Three months ended December 31, 2006
------------------------------------
"Grant revenues and other" decreased by $9,895 during the three months
ended December 31, 2006, compared to the same period of the previous year, due
to the winding down of the work funded by the grants. CEL-SCI is continuing to
apply for grants to support its work. During the three-month period ended
December 31, 2006, research and development expenses increased by $71,269
compared to the three-month period ended December 31, 2005. This increase was
due to work on two new CEL-1000 projects and the use of lab supplies in the
preparation for the beginning of the Phase III trials on Multikine.
During the three-month period ended December 31, 2006, general and
administrative expenses increased by $479,668 compared to the three-month period
ended December 31, 2005. This change was primarily due to: 1) additional listing
fees from the American Stock Exchange (approximately $15,000), 2) shares issued
to two stockholders in accordance with their respective agreements
(approximately $110,300), 3) additional accounting fees for the valuation of the
Series K Notes and Warrants (approximately $43,900), 4) an increase in public
relations costs (approximately $305,000) for the cost of common stock issued to
a public relations consulting firm, and 5) annual meeting costs (approximately
$23,000). This was partially offset by lower salary costs as one employee was on
leave for a part of the quarter (approximately $13,600).
Interest income during the three months ended December 31, 2006 increased
by $84,147 compared to the three-month period ended December 31, 2005. The
increase was due to interest earned on the funds received from the Series K
convertible notes.
The increase in the gain on derivative instruments of $705,910 for the
three months ended December 31, 2006, was the result of the change in fair value
of the Series K Notes and Series K Warrants.
Year ended September 30, 2006
"Grant revenues and other" decreased by approximately $144,500 during the
year ended September 30, 2006, compared to fiscal 2005, due to the winding down
18
of the work funded by the grants in 2006 related to grants received in 2003.
CEL-SCI is continuing to apply for grants to support its work.
During the year ended September 30, 2006, general and administrative
expenses increased by approximately $1,476,000. This change was largely due to:
1) costs related to the restatement of the financial statements (approximately
$420,110); 2) an increase in public relations and corporate presentation
expenses (approximately $587,200); 3) an increase in filing and registration
fees (approximately $71,800) and 4) the employee stock option expense required
by SFAS 123R (approximately $180,300).
Interest income during the year ended September 2006 increased by
approximately $39,800. The increase was due to an increase of the cash balances
in the interest bearing accounts from the sale of the Series K convertible debt.
The issuance of the Series K convertible debt in the summer of 2006
resulted in an additional charge of approximately $4,791,500. This charge
included $568,710 paid as fees to the agent, legal fees and $223,907 in
placement warrants issued to the agent. The remaining $3,998,800 (approximate)
represent the immediate charge upon issuance of the convertible debt for the
fair value accounting for the debt and the warrants. This charge is a non-cash
charge. The interest expense of $216,737 is a result of the amortization of the
discount on the convertible debt ($104,351) and actual interest paid in stock
and cash ($112,386) for the interest expense on the Series K convertible debt.
The gain on derivative instruments of approximately $2,325,800 for the
year ended September 30, 2006 was the result of several factors: 1) a decrease
in the value of the stock between the date of the issuance (August 2006) of the
Series K convertible debt and September 30, 2006 resulted in the biggest part of
the gain ($2,311,159), 2) reclassification to equity of all previous derivative
instruments ($13,337), and 3) expiration of the Series E warrants ($1,495).
CEL-SCI's future financial statements are expected to show significant gains and
losses on derivative instruments due to the requirement to mark the value of the
convertible debt to market, as measured by the stock price of CEL-SCI's common
stock.
Year ended September 30, 2005
-----------------------------
"Grant revenues and other" decreased by $55,554 during the year ended
September 30, 2005, compared to 2004. This was due to the winding down of the
work funded by the grants in 2005, related to grants received in 2003. CEL-SCI
is continuing to apply for grants to support its work.
During the year ended September 30, 2005, research and development
expenses increased by $288,099. The increase in research and development expense
was due largely to an increase in work related to CEL-SCI's Phase III
application for Multikine.
During the year ended September 30, 2005, general and administrative
expenses decreased by $379,736. The decrease was mostly due to a decrease in
public relations and corporate presentation expenses, filing fees, travel
expenses, accounting fees and legal fees, as CEL-SCI's efforts were primarily
focused on the submission of the Phase III clinical trial application for
Multikine.
19
CEL-SCI received $625,472 in settlement of a lawsuit in which CEL-SCI was
not a party. The litigation involved a shareholder and three former investors in
CEL-SCI. The lawsuit sought to recover short-swing profits allegedly obtained by
the defendants, their investment advisor and the investment advisor's principal
acting together as a group in trading CEL-SCI securities.
Interest income during the year ended September 30, 2005 increased by $843
as a result of higher balances in interest bearing accounts during the year.
Interest expense decreased to zero as a result of the conversion of the
remaining convertible debt in October 2003. Interest expense for the year ended
September 30, 2004 is primarily for interest related to the convertible debt
payable to Cambrex Biosciences, Inc. and Covance AG.
Gain on derivative instruments for the year ended September 30, 2005
decreased by $811,632 due to a decrease in the number of derivative instruments
outstanding during the year as a result of expiration of certain agreements or
reclassifications of certain instruments to equity.
Year ended September 30, 2004
-----------------------------
Grant revenue and other during fiscal year 2004 remained at approximately
the same level as fiscal year 2003 as work continued on the four grants received
during the fiscal year 2003. Interest income also remained approximately at the
same level.
Research and development expense increased by approximately $26,000 as
CEL-SCI's research and development costs on L.E.A.P.S. increased during fiscal
2004.
General and administrative expenses increased by approximately $23,000
this year. CEL-SCI's cost reduction program continues. This reduction was
substantially offset by an increase in audit and audit-related fees and an
increase in filing and registration fees.
CEL-SCI recognized a gain of $1,174,660 on derivative instruments during
fiscal year 2004 compared to a loss of $2,319,005 for the year ended September
30, 2003. This was due primarily to a decrease in the trading price of CEL-SCI's
common stock which is a significant component of fair value of CEL-SCI's
derivative instruments. Also, during fiscal year 2004, several derivative
instruments met the criteria for equity classification after which they were no
longer marked to market.
Other costs of financing decreased by $270,664 during fiscal year 2004
since CEL-SCI did not enter into an equity line of credit financing arrangement
during the year.
Research and Development Expenses
---------------------------------
The table below shows the research and development expenses associated with
Multikine and L.E.A.P.S. for the periods presented.
20
2006 2005 2004 2003 2002
---- ---- ---- ---- ----
MULTIKINE $1,656,362 $1,911,615 $1,539,454 $1,653,904 $4,405,678
L.E.A.P.S. 240,614 318,114 402,176 261,597 244,769
Other -- -- -- -- 49,462
---------- ---------- ---------- ---------- -----------
TOTAL $1,896,976 $2,229,729 $1,941,630 $1,915,501 $4,699,909
========== ========== ========== ========== ===========
Three Months Ended December 31,
-------------------------------
2006 2005
------- -------
(unaudited)
MULTIKINE $ 428,321 $ 383,897
L.E.A.P.S 77,837 50,992
---------- ----------
TOTAL $ 506,158 $ 434,889
========== ==========
Liquidity and Capital Resources
-------------------------------
CEL-SCI has had only limited revenues from operations since its inception
in March 1983. CEL-SCI has relied primarily upon proceeds realized from the
public and private sale of its common and preferred stock and convertible notes
to meet its funding requirements. Funds raised by CEL-SCI have been expended
primarily in connection with the acquisition of an exclusive worldwide license
to, and later purchase of, certain patented and unpatented proprietary
technology and know-how relating to the human immunological defense system,
patent applications, the repayment of debt, the continuation of research and
development sponsored by CEL-SCI, administrative costs and construction of
laboratory facilities. Inasmuch as CEL-SCI does not anticipate realizing
revenues until such time as it enters into licensing arrangements regarding the
technology and know-how licensed to it (which could take a number of years),
CEL-SCI is mostly dependent upon the proceeds from the sale of its securities to
meet all of its liquidity and capital resource requirements.
As explained in the "Business" section of this prospectus, as of April 20,
2007, CEL-SCI was involved in a number of pre-clinical studies with respect to
its L.E.A.P.S. technology. As with Multikine, CEL-SCI does not know what
obstacles it will encounter in future pre-clinical and clinical studies
involving its L.E.A.P.S. technology. Consequently, CEL-SCI cannot predict with
any certainty the funds required for future research and clinical trials and the
timing of future research and development projects.
21
Clinical and other studies necessary to obtain regulatory approval of a
new drug involve significant costs and require several years to complete. 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. 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. Without regulatory approval, CEL-SCI will be unable to sell any
of its products.
In January 2007, FDA gave the go-ahead for the Phase III clinical trial
which had earlier been cleared by the Canadian regulatory agency, the Biologics
and Genetic Therapies Directorate. CEL-SCI is unable to estimate the future
costs of research and clinical trial involving Multikine since CEL-SCI has not
yet been able to price the Phase III study. CEL-SCI anticipates that the
Multikine needed for its planned Phase III clinical trial will be manufactured
at a cost of $4 to $5 million.
Since all of CEL-SCI's projects are under development, CEL-SCI cannot
predict when it will be able to generate revenue from the sale of any of its
products.
In January 2007, CEL-SCI signed a letter of intent with a privately held
real estate firm specialized in the biomedical sector to acquire and build, to
CEL-SCI's specifications, a turn-key cGMP (current good manufacturing practices)
facility which will be used to manufacture Multikine. This manufacturing
facility is an integral part of moving Multikine into the Phase III clinical
trial and later commercialization. The facility is expected to cost
approximately $15,000,000 and will be financed through a long-term lease
agreement.
As of April 30, 2007, CEL-SCI had approximately $20.4 million in cash and
cash equivalents and approximately $18.2 million in working capital.
Series K Notes and Warrants
---------------------------
On August 4, 2006, CEL-SCI sold Series K convertible notes, plus Series K
warrants, to independent private investors for $8,300,000. The Notes bear
interest annually at the greater of 8% or 6 month LIBOR plus 3% per year. The
Notes are due and payable on August 4, 2011 and are secured and collateralized
by substantially all of CEL-SCI's assets.
Interest is payable quarterly with the first interest payment calculation
due on September 30, 2006. This interest payment was paid on October 2, 2006 and
the second quarterly interest payment was made on January 3, 2007. Beginning
March 4, 2007 CEL-SCI was required and began to make monthly payments of
$207,500 toward the principal amount of the Notes. If CEL-SCI fails to make any
interest or principal payment when due, the Notes will become immediately due
and payable.
At CEL-SCI's election, and under certain conditions, CEL-SCI may use
shares of its common stock to make interest and principal payments.
At the holder's option the Series K notes are convertible into shares of
the Company's common stock at a conversion price of $0.75.
22
If CEL-SCI sells any additional shares of common stock, or any securities
convertible into common stock at a price below the then applicable Conversion
Price, the Conversion 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 CEL-SCI sells any additional shares of common stock, or any
securities convertible into common stock at a price above the Conversion Price,
but below the average closing price of CEL-SCI's common stock over the five
trading days prior to the sale of the shares, the Conversion Price will be
lowered to a price determined by a formula contained in the Notes. The
Conversion Price will also be proportionately adjusted in the event of any stock
splits.
CEL-SCI has filed a registration statement with the Securities and
Exchange Commission so that the shares of common stock issuable upon the
conversion of the Series K notes or the exercise of the Series K warrants may be
resold in the public market. CEL-SCI is required to keep the registration
statement continuously effective until the shares covered by the registration
statement have been sold or can be sold pursuant to Rule 144(k). If CEL-SCI
fails to comply with this provision, CEL-SCI will be required to pay damages to
the holders of the Notes.
At any time after August 4, 2009 any Note holder will have the right to
require CEL-SCI to redeem all or any portion of the outstanding principal amount
of the Notes, plus all accrued but unpaid interest.
The Series K warrants allow the holders to purchase up to 4,825,581 shares
of CEL-SCI's common stock at a price of $0.95 per share at any time between
February 4, 2007 and February 4, 2012.
The exercise price of the Series K warrants, as well as the shares
issuable upon the exercise of the warrants, will be proportionately adjusted in
the event of any stock splits.
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 K 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 CEL-SCI sells any additional shares of common stock, or any securities
convertible into common stock at a price above the exercise price but below the
market price of CEL-SCI's common stock, the exercise price of the Series K
warrants will be lowered to a price determined by a formula contained in the
warrants.
April 2007 Private Financing
----------------------------
In April 2007, CEL-SCI raised approximately $15,000,000 from the sale to a
group of private investors of 20,043,333 shares of common stock, 10,021,667
Series L warrants, and 10,021,667 Series M warrants. The shares and warrants
were sold as Units at a price of $0.75 per Unit. Each Unit consisted of one
share of CEL-SCI's common stock, one-half of a Series L warrant and one-half of
a Series M warrant.
23
Each Series L warrant allows the holder to purchase one share of CEL-SCI's
common stock for $0.75. Each Series M warrant allows the holder to purchase one
share of CEL-SCI's common stock for $2.00. The Series L and M warrants expire on
March 31, 2012.
Contractual Obligation
----------------------
Other than funding operating losses, funding its research and development
program, and paying its liabilities, including the contractual obligations
listed below, CEL-SCI does not have any material capital commitments. Material
future liabilities as of September 30, 2006 are as follows:
Contractual Obligations: Years Ending September 30,
-------------------------------------
Total 2007 2008 2009
----- ---- ---- ----
Operating Leases $244,836 $144,060 $ 71,136 $ 29,640
Employment Contracts $2,291,475 763,825 763,825 763,825
CEL-SCI plans to use its existing financial resources, and any proceeds
received from the exercise of CEL-SCI's outstanding warrants or options to fund
its capital requirements during the year ending September 30, 2007.
Substantial capital is needed for clinical trials which are necessary
before CEL-SCI will be able to apply to the FDA for approval to sell any
products which may be developed on a commercial basis in the United States. In
the absence of revenues, CEL-SCI will be required to raise additional funds
through the sale of securities, debt financing or other arrangements in order to
continue with its research efforts. However, there can be no assurance that such
financing will be available or be available on favorable terms. It is the
opinion of management that sufficient funds are available to meet CEL-SCI's
liabilities and commitments as they come due during fiscal 2007. Ultimately,
CEL-SCI must complete the development of its products, obtain appropriate
regulatory approvals and obtain sufficient revenues to support its cost
structure.
CEL-SCI's cash flow and earnings are subject to fluctuations due to
changes in interest rates on its certificates of deposit, and, to an immaterial
extent, foreign currency exchange rates.
Critical Accounting Policies
----------------------------
CEL-SCI's significant accounting policies are more fully described in the
Notes to its consolidated financial statements. However, certain accounting
policies are particularly important to the portrayal of financial position and
results of operations and require the application of significant judgments by
management. As a result, the consolidated financial statements are subject to an
inherent degree of uncertainty. In applying those policies, management uses its
judgment to determine the appropriate assumptions to be used in the
determination of certain estimates. These estimates are based on CEL-SCI's
historical experience, terms of existing contracts, observance of trends in the
industry and information available from outside sources, as appropriate.
CEL-SCI's significant accounting policies include:
24
Patents - Patent expenditures are capitalized and amortized using the
straight-line method over 17 years. In the event changes in technology or other
circumstances impair the value or life of the patent, appropriate adjustment in
the asset value and period of amortization is made. An impairment loss is
recognized when estimated future undiscounted cash flows expected to result from
the use of the asset, and from disposition, is less than the carrying value of
the asset. The amount of the impairment loss is the difference between the
estimated fair value of the asset and its carrying value.
Derivative Instruments--CEL-SCI enters into financing arrangements that
consist of freestanding derivative instruments or are hybrid instruments that
contain embedded derivative features. CEL-SCI accounts for these arrangement in
accordance with Statement of Financial Accounting Standards No. 133, "Accounting
for Derivative Instruments and Hedging Activities", ("SFAS No. 133") and
Emerging Issues Task Force Issue No. 00-19, "Accounting for Derivative Financial
Instruments Indexed to, and Potentially Settled in, a Company's Own Stock",
("EITF 00-19"), as well as related interpretations of these standards. In
accordance with accounting principles generally accepted in the United States
("GAAP"), derivative instruments and hybrid instruments are recognized as either
assets or liabilities in the statement of financial position and are measured at
fair value with gains or losses recognized in earnings or other comprehensive
income depending on the nature of the derivative or hybrid instruments. Embedded
derivatives that are not clearly and closely related to the host contract are
bifurcated and recognized at fair value with changes in fair value recognized as
either a gain or loss in earnings if they can be reliably measured. When the
fair value of embedded derivative features can not be reliably measured, CEL-SCI
measures and reports the entire hybrid instrument at fair value with changes in
fair value recognized as either a gain or loss in earnings. CEL-SCI determines
the fair value of derivative instruments and hybrid instruments based on
available market data using appropriate valuation models, giving consideration
to all of the rights and obligations of each instrument and precluding the use
of "blockage" discounts or premiums in determining the fair value of a large
block of financial instruments. Fair value under these conditions does not
necessarily represent fair value determined using valuation standards that give
consideration to blockage discounts and other factors that may be considered by
market participants in establishing fair value.
Stock Options and Warrants - In October 1996, the Financial Accounting
Standards Board (FASB) issued Statement of Financial Accounting Standards No.
123, Accounting for Stock-Based Compensation (SFAS No. 123). This statement
encouraged but did not require companies to account for employee stock
compensation awards based on their estimated fair value at the grant date with
the resulting cost charged to operations. CEL-SCI had elected to continue to
account for its employee stock-based compensation using the intrinsic value
method prescribed in Accounting Principles Board Opinion No. 25, Accounting for
Stock Issued to Employees and related Interpretations". In December 2004 the
FASB issued SFAS No. 123R, "Share-Based Payment". SFAS No. 123R requires
companies to recognize expense associated with share based compensation
arrangements, including employee stock options, using a fair value-based option
pricing model. SFAS No. 123R applies to all transactions involving issuance of
equity by a company in exchange for goods and services, including employees.
Using the modified prospective transition method of adoption, CEL-SCI reflects
compensation expense in the financial statements beginning October 1, 2005. The
modified prospective transition method does not require restatement of prior
periods to reflect the impact of SFAS No. 123R. As such, compensation expense
has been recognized for awards that were granted, modified, repurchased or
25
cancelled on or after October 1, 2005 as well as for the portion of awards
previously granted that vested during the year ended September 30, 2006. For the
year ended September 30, 2006, CEL-SCI recorded $180,300 in general and
administrative expense for the cost of employee options. CEL-SCI's options vest
over a three-year period from the date of grant. After one year, the stock is
one-third vested, with an additional one-third vesting after two years and the
final one-third vesting at the end of the three-year period. There were
1,086,000 options granted to employees during the year ended September 30, 2006.
Options are granted with an exercise price equal to the closing bid price of
CEL-SCI's stock on the day before the grant. CEL-SCI determines the fair value
of the employee compensation using the Black Scholes method of valuation. No
corresponding expense was recorded for the year ended September 30, 2005 because
the statement did not require the cost to be recorded in that period. Under SFAS
148, "Accounting for Stock-Based Compensation - Transition and Disclosure",
which was in effect during the year ended September 30, 2005, CEL-SCI's net loss
and net loss per common share would have been increased to the pro forma amounts
indicated below:
Year Ended
September 30, 2005
Net loss: ------------------
As reported $(3,039,607)
Add: Total stock-based employee compensation
expense determined under fair-value-based
method for all awards, net of related tax effects (575,716)
--------------
Pro forma net loss $(3,615,323)
==============
Net loss per share, as reported $ 0.04
==============
Pro forma net loss per share $ 0.05
==============
Options to non-employees are accounted for in accordance with FASB's
Emerging Issues Task Force (EITF) Issue 96-18 Accounting for Equity Instruments
That Are Issued to Other Than Employees for Acquiring, or in Conjunction with
Selling, Goods or Services. Accordingly, compensation is recognized when goods
or services are received and is measured using the Black-Scholes valuation
model. The Black-Scholes model requires CEL-SCI's management to make assumptions
regarding the fair value of the options at the date of grant and the expected
life of the options.
Asset Valuations and Review for Potential Impairments - CEL-SCI reviews
its fixed assets every fiscal quarter. This review requires that CEL-SCI make
assumptions regarding the value of these assets and the changes in circumstances
that would affect the carrying value of these assets. If such analysis indicates
that a possible impairment may exist, CEL-SCI is then required to estimate the
fair value of the asset and, as deemed appropriate, expense all or a portion of
the asset. The determination of fair value includes numerous uncertainties, such
as the impact of competition on future value. CEL-SCI believes that it has made
reasonable estimates and judgments in determining whether its long-lived assets
have been impaired; however, if there is a material change in the assumptions
used in its determination of fair values or if there is a material change in
economic conditions or circumstances influencing fair value, CEL-SCI could be
26
required to recognize certain impairment charges in the future. As a result of
the reviews, no changes in asset values were required.
Prepaid Expenses and Laboratory Supplies--The majority of prepaid expenses
consist of bulk purchases of laboratory supplies used on a daily basis in the
lab and items that will be used for future production. The items in prepaid
expenses are expensed when used in production or daily activity as Research and
Development expenses. These items are disposables and consumables and can be
used for both the manufacturing of Multikine for clinical studies and in the
laboratory for quality control and bioassay use. They can be used in training,
testing and daily laboratory activities. Other prepaid expenses are payments for
services over a long period and are expensed over the time period for which the
service is rendered.
Concentration of Credit Risk--Financial instruments, which potentially
subject CEL-SCI to concentrations of credit risk, consist of cash and cash
equivalents. CEL-SCI maintains its cash and cash equivalents with high quality
financial institutions. At times, these accounts may exceed federally insured
limits. CEL-SCI has not experienced any losses in such bank accounts. CEL-SCI
believes it is not exposed to significant credit risk related to cash and cash
equivalents.
Quantitative and Qualitative Disclosure About Market Risks
----------------------------------------------------------
Market risk is the potential change in an instrument's value caused by,
for example, fluctuations in interest and currency exchange rates. CEL-SCI
enters into financing arrangements that are or include freestanding derivative
instruments or that are or include hybrid instruments that contain embedded
derivative features. CEL-SCI does not enter into derivative instruments for
trading purposes. Additional information is presented in the Notes to
Consolidated Financial Statements. The fair value of these instruments is
affected primarily by volatility of the trading prices of the CEL-SCI's common
stock. For the years ended September 30, 2006, 2005 and 2004, CEL-SCI recognized
a gain of $2,329,091, a gain of $363,028, and a gain of $1,174,660,
respectively, resulting from changes in fair value of derivative instruments.
For the three months ended December 31, 2006, CEL-SCI recognized a gain of
$719,247, resulting from changes in fair value of derivative instruments.
CEL-SCI has no exposure to risks associated with foreign exchange rate changes
because none of the operations of CEL-SCI are transacted in a foreign currency.
(The interest rate risk on investments is considered immaterial due to the
dollar value of investments as of September 30, 2006, 2005 and 2004.)
Recent Accounting Pronouncements
--------------------------------
In February 2006, the FASB issued SFAS No. 155, "Hybrid Instruments". The
statement amends SFAS No. 133 and SFAS No. 140, "Accounting for Transfers and
Servicing of Financial Assets and Extinguishments of Liabilities". The statement
also resolves issues addressed in Statement 133 Implementation Issue No. D1,
"Application of Statement 133 to Beneficial Interests in Securitized Financial
Assets." The statement: a) permits fair value remeasurement for any hybrid
financial instrument that contains an embedded derivative that otherwise would
require bifurcation, b) clarifies which interest-only strips and principal-only
strips are not subject to the requirements of SFAS No. 133, c) establishes a
requirement to evaluate interests in securitized financial assets to identify
interests that are freestanding derivatives or that are hybrid financial
instruments that contain an embedded derivative requiring bifurcation, d)
clarifies that concentrations of credit risk in the form of subordination are
not embedded derivatives, and e) amends Statement 140 to eliminate the
27
prohibition on a qualifying special purpose entity from holding a derivative
financial instrument that pertains to a beneficial interest other than another
derivative financial instrument. CEL-SCI does not believe that SFAS No. 155 will
have a material impact on its results of operations or cash flows.
In July 2006, the Financial Accounting Standards Board issued
Interpretation No. 48, "Accounting for Uncertainty in Income Taxes" ("FIN 48")
which clarifies the accounting for income taxes by prescribing the minimum
recognition threshold a tax position is required to meet before being recognized
in the financial statements. FIN 48 also provides guidance on derecognition,
measurement, classification, interest and penalties, accounting in interim
periods, disclosure and transition. FIN 48 is effective for fiscal years
beginning after December 15, 2006. The Company does not expect the adoption of
this Interpretation to have a material impact on its financial statements.
In September 2006, FASB issued SFAS No. 157, "Fair Value Measurements".
The statement defines fair value, establishes a framework for measuring fair
value in GAAP and expands disclosures about fair value measurements. The
statement is effective for financial statements issued for fiscal years
beginning after November 15, 2007 and interim periods within those fiscal years.
The Company is evaluating whether this statement will affect its current
practice in valuing fair value of its derivatives each quarter.
In September 2006, SAB No. 108 was issued by the Securities and Exchange
Commission. The interpretations in the SAB express the SEC staff's views
regarding the process of quantifying financial statement misstatements.
Beginning with annual financial statements covering fiscal years ending after
November 15, 2006, material misstatements in the current year may result in the
need to correct prior year financial statements, even if the misstatement in the
prior year or years is considered immaterial. SAB 108 does not require
previously filed reports to be amended. Such correction may be made the next
time the company files the prior year financial statements. CEL-SCI believes
that there will be no impact on its results of operations, cash flows or balance
sheet because of this interpretation.
In February 2007, the FASB issued Statement No. 159, The Fair Value Option
for Financial Assets and Financial Liabilities - Including an amendment of FASB
Statement No. 115". This statement permits entities to choose to measure many
financial instruments and certain other items at fair value. Unrealized gains
and losses on items for which the fair value option has been elected is reported
in earnings at each subsequent reporting date. This election is irrevocable once
made by the Company. This statement is effective as of the beginning of an
entity's first fiscal year that begins after November 15, 2007. Early adoption
is permitted as of the beginning of a fiscal year that begins on or before
November 15, 2007, provided the entity also elects to apply the provisions of
FASB Statement No. 157, Fair Value Measurements. The Company has not decided if
it will adopt this statement.
BUSINESS
CEL-SCI Corporation 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
28
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.
OVERVIEW
--------
CEL-SCI's lead product, Multikine(R), is being developed for the treatment
of cancer. Multikine is a patented immunotherapeutic agent consisting of a
mixture of naturally occurring cytokines, including interleukins, interferons,
chemokines and colony-stimulating factors, currently being developed for the
treatment of cancer. 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 head & neck cancer (500,000 new 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 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.
Clinical trials in over 200 patients have been completed with Multikine
with the following results:
1) It has been demonstrated to be safe and non-toxic.
2) It has been shown to render cancer cells much more susceptible to
radiation therapy (The Laryngoscope, December 2003, Vol.113 Issue 12).
3) A publication in the Journal of Clinical Oncology (Timar et al, JCO,
23(15): May 2005), revealed the following:
(i) Multikine induced anti-tumor immune responses through the
combined activity of the different cytokines present in Multikine
following local administration of Multikine for only three weeks.
29
(ii) The combination of the different cytokines caused the induction,
recruitment into the tumor bed, and proliferation of anti-tumor
T-cells and other anti-tumor inflammatory cells, leading to a
massive anti-tumor immune response.
(iii) Multikine induced a reversal of the CD4/CD8 ratio in the tumor
infiltrating cells, leading to a marked increase of CD4 T-cells
in the tumor, which resulted in the prolongation of the
anti-tumor immune response and tumor cell destruction.
(iv) The anti-tumor immune-mediated processes continued long after the
cessation of Multikine administration.
(v) A three-week Multikine treatment of patients with advanced
primary oral squamous cell carcinoma resulted in an overall
response rate of 42% prior to standard therapy, with 12% of the
patients having a complete response.
(vi) A histopathology study showed that the tumor load in Multikine
treated patients was reduced by nearly 50% as compared to tumors
from control patients in the same pathology study.
(vii) The tumors of all of the patients in this Phase II trial who
responded to Multikine treatment were devoid of the cell surface
marker for HLA Class II. This finding, if confirmed in this
global Phase III clinical trial, may lead to the establishment of
a marker for selecting the patient population best suited for
treatment with Multikine.
(viii) In a Phase II study, using the same drug regimen as will be
used in the Phase III study, the addition of Multikine as
first-line treatment prior to the standard of care treatment
resulted in a 33-40% improvement in the median survival at 3 1/2
years post-surgery, when compared to the results of 39 OSCC
clinical trials published in the scientific literature between
1987 and 2004.
CEL-SCI also owns a pre-clinical technology called L.E.A.P.S.TM (Ligand
Epitope Antigen Presentation System). The lead product derived from this
technology is the CEL-1000 peptide which has shown protection in animals against
herpes, malaria, viral encephalitis and cancer.
MULTIKINE
---------
Multikine has been tested in over 200 patients in clinical trials
conducted in the U.S., Canada, Europe and Israel. Most of these patients were
head and neck cancer patients, but some studies were also conducted in prostate
cancer patients, HIV-infected patients and HIV-infected women with Human
Papilloma Virus ("HPV")-induced cervical dysplasia, the precursor stage before
the development of cervical cancer. The safety profile was found to be very good
and CEL-SCI believes that the clinical data suggests that further studies are
warranted.
30
The function of the immunological system is to protect the body against
infectious agents, including viruses, bacteria, parasites and malignant (cancer)
cells. An individual's ability to respond to infectious agents and to other
substances (antigens) recognized as foreign by the body's immune system is
critical to health and survival. When the immune response is adequate, infection
is usually combated effectively and recovery follows. Severe infection can occur
when the immune response is inadequate. Such immune deficiency can be present
from birth but, in adult life, it is frequently acquired as a result of intense
sickness or as a result of the administration of chemotherapeutic drugs and/or
radiation. It is also recognized that, as people reach middle age and
thereafter, the immune system grows weaker.
Two classes of white blood cells, macrophages and lymphocytes, are
believed to be primarily responsible for immunity. Macrophages are large cells
whose principal immune activity is to digest and destroy infectious agents.
Lymphocytes are divided into two sub-classes. One sub-class of lymphocytes,
B-cells, produces antibodies in response to antigens. Antibodies have unique
combining sites (specificities) that recognize the shape of particular antigens
and bind with them. The combination of an antibody with an antigen sets in
motion a chain of events which may neutralize the effects of the foreign
substance. The other sub-class of lymphocytes, T-cells, regulates immune
responses. T-cells, for example, amplify or suppress antibody formation by
B-cells, and can also directly destroy "foreign" cells by activating "killer
cells."
It is generally recognized that the interplay among T-cells, B-cells and
the macrophages determines the strength and breadth of the body's response to
infection. It is believed that the activities of T-cells, B-cells and
macrophages are controlled, to a large extent, by a specific group of hormones
called cytokines. Cytokines regulate and modify the various functions of both
T-cells and B-cells. There are many cytokines, each of which is thought to have
distinctive chemical and functional properties. IL-2 is but one of these
cytokines and it is on IL-2 and its synergy with other cytokines that CEL-SCI
has focused its attention. Scientific and medical investigation has established
that IL-2 enhances immune responses by causing activated T-cells to proliferate.
Without such proliferation no immune response can be mounted. Other cytokines
support T-cell and B-cell proliferation. However, IL-2 is the only known
cytokine which causes the proliferation of T-cells. IL-2 is also known to
activate B-cells in the absence of B-cell growth factors.
Although IL-2 is one of the best characterized cytokines with anticancer
potential, CEL-SCI is of the opinion that to have optimum therapeutic value,
IL-2 should be administered not as a single substance but rather as a mixture of
IL-2 and certain cytokines, i.e. as a "cocktail". This approach, which was
pioneered by CEL-SCI, makes use of the synergism between these cytokines. It
should be noted, however, that neither the Food and Drug Administration (FDA)
nor any other agency has determined that CEL-SCI's Multikine product will be
effective against any form of cancer.
Research and human clinical trials sponsored by CEL-SCI have indicated a
correlation between administration of Multikine to cancer patients and
immunological responses. On the basis of these experimental results, CEL-SCI
believes that Multikine may have application for the treatment of solid tumors
in humans.
31
Between 1985 and 1988 Multikine was tested at St. Thomas Hospital in
London, UK in forty-eight patients with various types of cancers. Multikine was
shown to be safe when used by these patients.
In November 1990, the Florida Department of Health and Rehabilitative
Services ("DHRS") gave the physicians at a southern Florida medical institution
approval to start a clinical cancer trial in Florida using CEL-SCI's Multikine
product. The focus of the trial was unresectable head and neck cancer.
In 1991, four patients with regionally advanced squamous cell cancer of
the head and neck were treated with CEL-SCI's Multikine product. The patients
had previously received radical surgery followed by radiation therapy but
developed recurrent tumors at multiple sites in the neck and were diagnosed with
terminal cancer.
Significant tumor reduction occurred in three of the four patients as a
result of the treatment with Multikine. Negligible side effects, such as
injection site soreness and headaches, were observed and the patients were
treated as outpatients. Notwithstanding the above, it should be noted that these
trials were only preliminary and were only conducted on a small number of
patients. It remains to be seen if Multikine will be effective in treating any
form of cancer.
These results caused CEL-SCI to embark on a major manufacturing program
for Multikine with the goal of being able to produce a drug that would meet the
stringent regulatory requirements for advanced human studies. This program
included building a pilot scale manufacturing facility.
The objective of CEL-SCI scientists is to use Multikine as an adjunct
(additive) therapy to the existing treatment of previously untreated head & neck
cancer patients with the goal of reducing cancer recurrence and ultimately
increasing survival. However, pursuant to FDA regulations, CEL-SCI was required
to test the drug first for safety in locally recurrent, locally metastatic head
and neck cancer patients who had failed other cancer therapies. This dose
escalation study was started in 1995 at several centers in Canada and the US
where 16 patients were enrolled at 4 different dosage levels. The study ended in
1998 and showed Multikine to be safe and well tolerated at all dose levels.
Because CEL-SCI scientists have determined that patients with previously
untreated disease would most likely benefit more from Multikine treatment,
CEL-SCI started a safety trial in Canada in 1997 in advanced primary head & neck
cancer patients who had just recently been diagnosed with head & neck cancer.
This study ultimately enrolled 28 patients, also at 4 different dosage levels,
and ended in late 1999. Halfway through this study, CEL-SCI launched a number of
phase II studies in advanced primary head & neck cancer to determine the best
dosage, best route of administration and best frequency of administration of
Multikine. Those studies involved 19 patients in Israel (1997 - 2000), 30
patients in Poland and the Czech Republic (1999 - 2000), and 94 patients (half
treated with Multikine and the other half disease-matched cancer patients served
as control) in Hungary (1999 - 2003). The Hungarian trial compared the control
group (receiving only conventional cancer therapy) to the Multikine treated
patients (receiving Multikine prior to conventional therapy) by histopathology
and immunohistochemistry. The results of these studies were published in
peer-reviewed scientific journals and/or presented at scientific meetings. The
32
studies that have not yet been published were conducted in support of
Multikine's safety and clinical utility.
The above studies, which are all completed, indicate that Multikine was
safe and well tolerated at all dose levels investigated. The studies also showed
partial and complete tumor responses following Multikine treatment at the best
treatment regimen combinations as well as tumor necrosis (destruction) and
fibrosis (as determined by histopathology).
While CEL-SCI scientists believe partial and complete tumor responses to
be very important, they also believe that other findings with Multikine in these
studies are equally important since they may serve to enhance existing cancer
therapies, thereby affecting the clinical outcome of the cancer patient's
treatment.
The initial results of the Hungarian study were published in December
2003. Data from a Phase I/II clinical trial in fifty-four (54) advanced primary
head and neck cancer patients (half treated, half control), the first part of
the Hungarian study, were published in The Laryngoscope, December 2003, Vol.113
(12). The title of the article is "The Effect of Leukocyte Interleukin Injection
(MULTIKINE) on the Peritumoral and Intratumoral Subpopulation of Mononuclear
Cells and on Tumor Epithelia: A Possible New Approach to Augmenting Sensitivity
to Radiation Therapy and Chemotherapy in Oral Cancer - A Multi Center Phase I/II
Clinical Trial".
The data demonstrates that treatment with Multikine rendered a high
proportion of the tumor cell population highly susceptible to radiation therapy.
This finding represents a major advance in the treatment of cancer since, under
current standard therapy, only about 5%-10% of the cancer cells are thought to
be susceptible to radiation therapy at any one point in time.
The increased sensitivity of the Multikine-treated tumors to radiation was
derived from a dramatic increase in the number of proliferating (those that are
in cell cycle) cancer cells. Following Multikine treatment, the great majority
of the tumor cells were in a proliferative state, as measured by the
well-established cell proliferation marker Ki67. The control patients (not
treated with Multikine) had only low expression (near background) of the same
proliferation marker (Ki67) in this study. These findings were statistically
significant (p<0.05, ANOVA).
This is an important finding because the ability of radiation therapy (and
chemotherapy) to kill tumor cells is dependent, in large part, on the
proliferative state of the tumor cells at the time of radiation (and
chemotherapy) treatment. As seen in the control group in this study, and also in
many other tumor types, the great majority of tumor cells (about 90% or more)
are in a "resting" state (non-proliferating). It is generally accepted that
tumor cells in the "resting" state are by-and-large resistant to radiation and
chemotherapy. However, Multikine treatment induced a reversal of this
non-proliferative state of the tumor cells and caused the great majority of the
tumor cells to enter into the proliferative state, thereby rendering the tumor
highly susceptible to radiation therapy (and chemotherapy).
The results of the Israeli trial have been published in Archives of
Otolaryngology - Head & Neck Surgery, August 2003, Vol.129. This paper on 12
patients treated by Dr. Feinmesser shows positive safety, tumor response and
clinical outcome data, but no firm conclusions can be drawn from a study of only
12 patients.
33
Results from the Multikine Phase II clinical trials were published in June
2004 at the 40th ASCO Annual Meeting. The study involved 39 head & neck cancer
patients, 19 of whom were treated with CEL-SCI's immunotherapy drug Multikine
prior to surgery and radiation. The other 20 patients served as matched
controls, meaning that they did not receive Multikine prior to surgery and
radiation. In a comparison pathology study of the tumors, Multikine treatment
caused a significant shift in the ratio of key immune cells that infiltrate the
tumor. The cancer patients treated with Multikine were shown to have much higher
rate of tumor cell killing, resulting in a 42% overall response rate, including
12% complete responses.
The tumors of the 39 head & neck cancer patients were analyzed by three
independent pathologists, blinded to the study. Of the 19 Multikine treated
patients in this study, 2 patients (12%) had no remaining cancer cells, another
2 patients (12%) had a reduction in the cancer cell mass greater than 50% and an
additional 4 patients (21%) had a reduction in the cancer cell mass of more than
30%. The objective response rate in this trial was 21%, with an overall response
rate of 42%, as determined by pathology.
This study, which used a three-week, non-toxic treatment with Multikine,
caused a shift from a low CD4/CD8 cell ratio (less than one CD4 cell for each
CD8 cell) to a high (over 2.5 - 3) CD4/CD8 cell ratio (2.5 - 3 CD4 cells for
each CD8 cell) in the tumor. This indicates that Multikine treatment shifts the
immune response from a mainly CD8 cell anti-tumor response to a predominately
CD4 anti-tumor response. Both CD4 and CD8 are key cells of the immune system.
The change in the immune response from CD8 to CD4 cells is very important
for the cancer patient because the cancer cells seem to have learned to shut
down the CD8 anti-tumor immune response. This "shut-down" of the CD8 cells was
evident in the tumors of the control (non-Multikine treated) group. The control
group had predominately CD8 cell infiltrate which was inactive against the
tumor. The Multikine treated group, on the other hand, had a predominately CD4
cell infiltrate. The tumor was unable, or less able, to shut down the Multikine
induced CD4 cell immune response and, as a result thereof, the cancer patients
treated with Multikine were shown to have a much higher rate of tumor cell
killing.
A publication in the Journal of Clinical Oncology (Timar et al, JCO,
23(15): May 2005), revealed the following:
(i) Multikine induced anti-tumor immune responses through the
combined activity of the different cytokines present in Multikine
following local administration of Multikine for only three weeks.
(ii) The combination of the different cytokines caused the induction,
recruitment into the tumor bed, and proliferation of anti-tumor
T-cells and other anti-tumor inflammatory cells, leading to a
massive anti-tumor immune response.
(iii) Multikine induced a reversal of the CD4/CD8 ratio in the tumor
infiltrating cells, leading to a marked increase of CD4 T-cells
in the tumor, which resulted in the prolongation of the
anti-tumor immune response and tumor cell destruction.
34
(iv) The anti-tumor immune-mediated processes continued long after the
cessation of Multikine administration.
(v) A three-week Multikine treatment of patients with advanced
primary oral squamous cell carcinoma resulted in an overall
response rate of 42% prior to standard therapy, with 12% of the
patients having a complete response.
(vi) A histopathology study showed that the tumor load in Multikine
treated patients was reduced by nearly 50% as compared to tumors
from control patients in the same pathology study.
(vii) The tumors of all of the patients in this Phase II trial who
responded to Multikine treatment were devoid of the cell surface
marker for HLA Class II. This finding, if confirmed in the global
Phase III clinical trial, may lead to the establishment of a
marker for selecting the patient population best suited for
treatment with Multikine.
In May 2006, CEL-SCI presented long-term survival data from its Phase II
clinical trial in patients with head and neck cancer (oral squamous cell
carcinoma -- OSCC) treated with its anti-cancer drug Multikine(R). The addition
of Multikine as first-line treatment prior to the standard of care treatment
resulted in a 33-40% improvement in the median survival at 3 1/2 years
post-surgery, when compared to the results of 39 OSCC clinical trials published
in the scientific literature between 1987 and 2004. The data were presented at
the "Vaccine Discovery and Commercialization" conference in Philadelphia, PA.
The long-term survival data were collected by the treating physicians in a
follow-up study of 22 patients with advanced untreated primary tumors, who were
enrolled in the Multikine Phase II clinical trial. The Multikine treatment
regimen was administered to these patients prior to the standard of care
treatment (i.e., surgery + radiation or surgery + chemo-radiation). Informed
consent was obtained from all patients in the clinical trial and from 19
patients for the long-term follow-up study. Investigational Review Board /
Ethics Committee approval was provided before the initiation of the clinical
trial and again for the data collection in the follow-up study. The follow-up
study questionnaire assessed the overall survival and the local regional control
of the Multikine treated patients in this Phase II trial.
Documented data were available for 19 of the 22 patients in the follow-up
portion of this clinical trial. Of the three patients who could not be evaluated
in the follow-up study, one patient was known to be alive, but failed to give
informed consent, and the other two were lost to follow-up. One patient died the
day after definitive surgery, unrelated to Multikine therapy.
The median overall survival (calculated by including death from any cause
of patients in the trial, even deaths not related to the disease) of the 19
evaluable patients in the follow-up portion of this clinical trial was 63% at a
median follow-up of 40 months post-surgery. The results of the published
scientific literature (39 OSCC clinical trials published between 1987 and 2004)
document that survival at 3 1/2 years is approximately 47% following standard of
care treatment. The addition of Multikine to the standard of care treatment
resulted in a 33% increase in overall survival over the results published in the
literature.
35
The median survival of patients in this clinical trial was 67% at a median
follow-up of 42 months post-surgery, excluding the one patient with immediate
post-operative death. The same 39 scientific publications indicate that survival
at 3 1/2 years is approximately 47% following standard of care treatment. The
addition of Multikine to the standard of care treatment resulted in an increase
in survival of 40% over the results published in the literature.
Multikine first-line treatment also resulted in a 2-year local regional
control (LRC) rate of 79%, as compared to the median 2-year LRC of 73% reported
in the same 39 scientific publications. Multikine treatment resulted in an
improvement over the published local regional control rate. It is clinically
recognized that recurrence of disease in head & neck cancer is associated with a
very poor prognosis.
Multikine treatment did not result in any severe adverse events (SAE) in
this Phase II clinical trial. No SAEs related to Multikine have been reported in
other trials conducted with Multikine either.
The data from CEL-SCI's Multikine Phase II clinical trial are thought to
be directly applicable to CEL-SCI's planned global Phase III clinical trial, as
the Multikine treatment regimen planned in the Phase III trial is identical to
that of the Multikine treatment in the trial reported here.
In January 2007, CEL-SCI received a no objection letter from the FDA
indicating that it could proceed with the Phase III protocol with Multikine in
head & neck cancer patients. The protocol for the Phase III clinical trial was
designed to develop conclusive evidence of the safety and efficacy of Multikine
in the treatment of advanced primary squamous cell carcinoma of the oral cavity.
CEL-SCI had previously received a "no objection" letter from the Canadian
Biologics and Genetic Therapies Directorate which enabled CEL-SCI to begin its
Phase III clinical trial in Canada.
The Phase III trial will test the hypothesis that Multikine 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. 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.
In May 2005, CEL-SCI was issued a new U.S. patent covering Multikine. The
patent, No. 6,896,879, relates to a new method for pre-sensitizing cancer with
Multikine prior to therapeutic treatment such as chemotherapy, radiation therapy
or immunotherapy.
Multikine has also been tested in 15 HIV-infected patients (1998 - 1999)
in California. This small study found Multikine to be safe in the HIV-infected
population and showed preliminary evidence of improved delayed type
hypersensitivity response to recall antigens. The results of this study were
reported in Antiviral Therapy 5 (Supplement), 2000.
Another study at the Thomas Jefferson Medical Center (1998) used very
small amounts of Multikine to determine the feasibility of injecting Multikine
into the prostate of 5 hormonal therapy refractive prostate cancer patients
36
scheduled for prostatectomy. Although deemed safe by the investigators,
Multikine administration in this trial directly into the prostate (under
ultrasound guidance) resulted in occasional mild dysuria and mild increase in
urinary frequency. Two out of the five treated cases had an inflammatory
response in the prostate and a third case had fibrosis. CEL-SCI believes that
more Multikine injections will need to be given to achieve a potential outcome
as seen in head & neck cancer. None of the prostate cancer patients received
more than half of the amounts given to the head & neck cancer patients. Also, no
testing was done at the time to determine if Multikine would enhance
susceptibility to radiation therapy in the prostate. The results of this trial
were published in Seminars in Oncology Vol. 26 (4) (August) 1999.
In May 2001, CEL-SCI also started a Phase I clinical trial at the
University of Maryland Biotechnology Institute (UMBI). The focus of this study
was HIV-infected women with Human Papilloma Virus (HPV)-induced cervical
dysplasia, the precursor stage before the development of cervical cancer. The
goal of the study was to obtain safety and preliminary efficacy data on
Multikine as a treatment for pre-cancerous lesions of the cervix (dysplasia).
Most cervical dysplasia and cancer is due to infection with HPV. The rationale
for using Multikine in the treatment of cervical dysplasia/cancer is that
Multikine may safely boost the patients' immune systems to the point where their
immune systems can eliminate the virally-induced cancer. Cervical cancer is the
second leading cause of cancer death in women worldwide.
The HIV-infected women with HPV-induced cervical dysplasia were chosen as
a study group because of the high morbidity and low success rate of current
surgical therapies. Since HIV infection results in immune suppression,
HPV-induced cervical dysplasia follows a more malignant and aggressive course of
disease in such women. Co-infection with HPV is common in HIV-positive women
(about 83%) and cervical cancer is considered an AIDS-defining illness.
HPV infection is also a leading health problem in non HIV-infected
American college-age women. A large concern among women who have HPV-induced
cervical dysplasia is that the repeated surgical procedures will lead to a
hysterectomy and the inability to bear children.
At the March 2002 33rd Annual Meeting of the Society of Gynecological
Oncologists in Miami, Florida, scientists from UMBI and CEL-SCI presented data
from this trial in HIV-infected women with HPV induced cervical dysplasia. The
results were as follows: 8 patients had been treated with no major toxicity. The
lower dosage group had 3 out of 5 patients resolved/improved with 2 out of 5
patients with no change in their cervical dysplasia status as compared to the
patient's own baseline disease. The higher dosage group had 2 out of 3 patients
who improved and 1 out of 3 patients with no change. The changes in disease
status were determined by both Colposcopy and Histology.
Subsequent HPV testing during 2001 and 2002 of the first three patients
revealed the elimination of HPV virus types (using in situ PCR) following
treatment with Multikine and ranged from 54% to 84% (Avg = 68%) reduction in HPV
virus in the cervical tissue of Multikine treated HIV/HPV co-infected patients.
The study was closed due to the inability to enroll further patients.
37
CEL-SCI's future studies in the HPV-induced cervical dysplasia area will
only be conducted with grant or government funds as CEL-SCI plans to devote its
resources to head and neck cancer, the area where it has the most data.
In November 2000, CEL-SCI concluded a development, supply and distribution
agreement with Orient Europharma of Taiwan. The agreement gives Orient
Europharma the exclusive marketing rights to Multikine for all cancer
indications in Taiwan, Singapore, Hong Kong and Malaysia. The agreement provides
for Orient Europharma to fund the clinical trials needed to obtain marketing
approvals in the four countries for head and neck cancer, naso-pharyngeal cancer
and potentially cervical cancer, which are very prevalent in Far East Asia.
CEL-SCI may use the clinical data generated in these trials to support
applications for marketing approvals for Multikine in other parts of the world.
Under the agreement, CEL-SCI will manufacture Multikine and Orient
Europharma will purchase the product from CEL-SCI for distribution in the
territory. Both parties will share in the revenue from the sale of Multikine. As
of April 20, 2007, Orient Europharma had not started any clinical trials since
CEL-SCI's plan is for Orient Europharma to begin a Phase III clinical trial when
CEL-SCI begins its Phase III clinical trial or to do one combined Phase III
clinical trial. The above will be finalized in the future.
Pursuant to an agreement dated May 2003, Eastern Biotech will receive a
royalty equal to 2% of CEL-SCI's net sales of Multikine and CEL-1000 prior to
May 30, 2033.
Since 1985, Multikine has been well tolerated in clinical studies
involving over 200 patients. Forty-eight patients were treated in the United
States in accordance with clinical trials authorized by the FDA. The remaining
patients were treated outside of the United States in accordance with protocols
authorized by comparable health regulatory authorities in the countries where
the patients were treated. All the clinical trials were conducted in accordance
with the Declaration of Helsinki (1985), and informed consent was obtained from
each patient volunteer. This process is the standard procedure for the conduct
of human clinical trials.
Proof of efficacy for anti-cancer drugs is a lengthy and complex process.
At this early stage of clinical investigation, it remains to be proven that
Multikine will be effective against any form of cancer. Even if some form of
Multikine is found to be effective in the treatment of cancer, commercial use of
Multikine may be several years away due to extensive safety and effectiveness
tests that would be necessary before required government approvals are obtained.
It should be noted that other companies and research teams are actively involved
in developing treatments and/or cures for cancer, and accordingly, there can be
no assurance that CEL-SCI's research efforts, even if successful from a medical
standpoint, can be completed before those of its competitors.
T-CELL MODULATION PROCESS
-------------------------
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 and cancer, when it
cannot do so on its own. Administered like vaccines, L.E.A.P.S. combines T-cell
38
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 discovered a peptide, named CEL-1000,
which is currently being tested in animals for the prevention/treatment of avian
flu, herpes simplex, malaria, viral encephalitis, smallpox, vaccinia and a
number of other indications.
In the Spring of 2002, CEL-SCI, in conjunction with The Naval Medical
Research Center, announced that CEL-1000 provided 100% protection against
malaria infection in a mouse model. The same peptide also induced protective
effects in mouse models for herpes simplex virus and cancer. In the Fall of
2002, CEL-SCI announced that it had signed a Cooperative Research and
Development Agreement (CRADA) with the U.S. Navy for CEL-1000 in malaria.
CEL-SCI received two grants in April 2003, one grant in May 2003, and one
grant in September 2003, all from the National Institutes of Health (NIH). The
first grant totaling $1,100,000 was awarded to Northeastern Ohio Universities
College of Medicine (NEOUCOM) with CEL-SCI as a subcontractor. The grant is for
a period of three years and is intended to support the development of CEL-SCI's
new compound, CEL-1000, as a possible treatment for viral encephalitis, a
potentially lethal inflammation of the brain. The grant was awarded following a
peer review process and will fund pre-clinical studies leading up to toxicology
studies. The second grant, totaling $134,000 and awarded to CEL-SCI with Johns
Hopkins Medical Institutions as a subcontractor, is a Phase I Small Business
Innovation Research (SBIR) grant for the further development of a potential
treatment for autoimmune myocarditis, a heart disease. The third grant,
announced on May 7, 2003 for $162,000 was awarded to CEL-SCI with NEOUCOM as a
sub-contractor, and is a Phase I SBIR grant for the further development of
CEL-1000 against Herpes Simplex. The fourth grant, totaling $104,000 was awarded
to CEL-SCI with the University of Nebraska as a sub-contractor, and is a Phase I
SBIR grant from the National Institute of Allergy and Infectious Diseases
(NIAID), NIH, for the development of CEL-1000 as a potential therapeutic and
prophylactic agent against vaccinia and smallpox infections as a single agent
and as an adjuvant for vaccinia vaccines. Vaccinia is the virus used in the
smallpox vaccine. The grant funds are disbursed for the necessary expenses
incurred by CEL-SCI for each specific grant. CEL-SCI submits its expenses by
accessing the Division of Payment Management, a Health and Human Services
program support center, when CEL-SCI is the primary contractor, or, when CEL-SCI
is a sub-contractor, by invoicing the primary contractor of the grant, on a
monthly basis, for expenses incurred for the grant.
As of March 31, 2007, the viral encephalitis grant ended and all funds were
reimbursed to CEL-SCI. The other three grants were closed out during fiscal year
2005. As of March 31, 2007 CEL-SCI had received approximately $719,000 from
these grants.
39
In June 2003, CEL-SCI signed a Cooperative Agreement with the NIAID and
the U.S. Army Medical Research Institute of Infectious Disease (USAMRIID) to
test CEL-1000 against various bio-terrorism agents as well as other hard to
treat diseases.
In May 2005, CEL-SCI scientists, in collaboration with scientists from the
laboratory of Dr. Noel Rose at The Johns Hopkins University Department of
Pathology, presented animal data showing that pretreatment and early therapy of
Experimental Autoimmune Myocarditis with a compound developed by CEL-SCI
resulted in significant reduction in heart enlargement and disease associated
histopathological changes. The compound used to achieve these results was
derived from CEL-SCI's patented L.E.AP.S. technology.
The protection observed was statistically significant for both
pretreatment and early therapy. This protective effect was shown to be
antigen-specific and was associated with an increase in IL-13 in both the sera
and heart tissue and of IL-1a in the sera of the protected mice. Other studies
from Dr. Rose's laboratory with IL-13 knockout mice (mice missing the IL-13
gene) demonstrate the importance of IL-13 in this model of Experimental
Autoimmune Myocarditis and corroborated these findings.
In December 2005, CEL-SCI signed an agreement with the National Institute
for Allergy and Infectious Diseases (NIAID), whereby NIAID agreed to test our
CEL-1000 drug against the avian flu virus in animal models.
RESEARCH AND DEVELOPMENT
------------------------
Since 1983, and through December 31, 2006, approximately $53,200,000 has
been expended on CEL-SCI-sponsored research and development, including
approximately $1,897,000, $2,230,000 and $1,942,000 respectively during the
years ended September 30, 2006, 2005 and 2004.
The costs associated with the clinical trials relating to CEL-SCI's
technologies, research expenditures and CEL-SCI's administrative expenses have
been funded with the public and private sales of CEL-SCI's securities and
borrowings from third parties, including affiliates of CEL-SCI. The extent of
CEL-SCI's clinical trials and research programs is 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.
GOVERNMENT REGULATION
---------------------
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
40
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
41
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 several 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 several 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.
42
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.
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.
COMPETITION AND MARKETING
-------------------------
Many companies, nonprofit organizations and governmental institutions are
conducting research on cytokines. Competition in the development of therapeutic
agents incorporating cytokines is intense. Large, well-established
pharmaceutical companies are engaged in cytokine research and development and
have considerably greater resources than CEL-SCI has to develop products. The
establishment by these large companies of in-house research groups and of joint
43
research ventures with other entities is already occurring in these areas and
will probably become even more prevalent. In addition, licensing and other
collaborative arrangements between governmental and other nonprofit institutions
and commercial enterprises, as well as the seeking of patent protection of
inventions by nonprofit institutions and researchers, could result in strong
competition for CEL-SCI. Any new developments made by such organizations may
render CEL-SCI's licensed technology and know-how obsolete.
Several biotechnology companies are producing IL-2-like compounds. CEL-SCI
believes, however, that it is the only producer of a patented IL-2 product using
a patented cell-culture technology with normal human cells. CEL-SCI foresees
that its principle competition will come from producers of
genetically-engineered IL-2-like products. However, it is CEL-SCI's belief,
based upon growing scientific evidence, that its natural IL-2 products have
advantages over the genetically engineered, IL-2-like products. Evidence
indicates that genetically engineered, IL-2-like products, which lack sugar
molecules and typically are not water soluble, may be recognized by the
immunological system as a foreign agent, leading to a measurable antibody
build-up and thereby possibly voiding their therapeutic value. Furthermore,
CEL-SCI's research has established that to have optimum therapeutic value IL-2
should be administered not as a single substance but rather as an IL-2-rich
mixture of certain cytokines and other proteins, i.e. as a "cocktail". If these
differences prove to be of importance, and if the therapeutic value of its
Multikine product is conclusively established, CEL-SCI believes it will be able
to establish a strong competitive position in a future market.
CEL-SCI has not established a definitive plan for marketing nor has it
established a price structure for CEL-SCI's saleable products. However, CEL-SCI
intends, if CEL-SCI is in a position to begin commercialization of its products,
to enter into written marketing agreements with various major pharmaceutical
firms with established sales forces. The sales forces in turn would probably
target CEL-SCI's products to cancer centers, physicians and clinics involved in
head and neck cancer.
CEL-SCI may encounter problems, delays and additional expenses in
developing marketing plans with outside firms. In addition, CEL-SCI may
experience other limitations involving the proposed sale of its products, such
as uncertainty of third-party reimbursement. There is no assurance that CEL-SCI
can successfully market any products which they may develop or market them at
competitive prices.
Some of the clinical trials funded to date by CEL-SCI have not been
approved by the FDA, but rather have been conducted pursuant to approvals
obtained from certain states and foreign countries. Conducting clinical studies
in foreign countries is normal industry practice since these studies can often
be completed in less time and are less expensive than studies conducted in the
U.S. Conducting clinical studies in foreign countries is also beneficial since
CEL-SCI will need the approval from a foreign country prior to the time CEL-SCI
can market any of its drugs in the foreign country. However, since the results
of these clinical trials may not be accepted by the FDA, competitors conducting
clinical trials approved by the FDA may have an advantage in that the products
of such competitors are further advanced in the regulatory process than those of
CEL-SCI. CEL-SCI is conducting its trials in compliance with internationally
recognized standards. By following these standards, CEL-SCI anticipates
obtaining acceptance from world regulatory bodies, including the FDA.
44
EMPLOYEES
---------
As of April 20, 2007 CEL-SCI had 19 employees. Seven employees are
involved in administration, 10 employees are involved in manufacturing and 2
employees are involved in general research and development with respect to
CEL-SCI's products.
MANAGEMENT
Name Age Position
---- --- --------
Maximilian de Clara 76 Director and President
Geert R. Kersten, Esq. 47 Director, Chief Executive Officer and Treasurer
Patricia B. Prichep 55 Senior Vice President of Operations and Secretary
Dr. Eyal Talor 50 Senior Vice President of Research and Manufacturing
Dr. Daniel H. Zimmerman 65 Senior Vice President of Research, Cellular
Immunology
John Cipriano 64 Senior Vice President of Regulatory Affairs
Alexander G. Esterhazy 62 Director
Dr. C. Richard
Kinsolving 69 Director
Dr. Peter R. Young 61 Director
The directors of CEL-SCI serve in such capacity until the next annual
meeting of CEL-SCI's shareholders and until their successors have been duly
elected and qualified. The officers of CEL-SCI serve at the discretion of
CEL-SCI's directors.
Mr. Maximilian de Clara, by virtue of his position as an officer and
director of CEL-SCI, may be deemed to be the "parent" and "founder" of CEL-SCI
as those terms are defined under applicable rules and regulations of the SEC.
The principal occupations of CEL-SCI's officers and directors, during the
past several years, are as follows:
Maximilian de Clara. Mr. de Clara has been a Director of CEL-SCI since its
inception in March l983, and has been President of CEL-SCI since July l983.
Prior to his affiliation with CEL-SCI, and since at least l978, Mr. de Clara was
involved in the management of his personal investments and personally funding
research in the fields of biotechnology and biomedicine. Mr. de Clara attended
the medical school of the University of Munich from l949 to l955, but left
before he received a medical degree. During the summers of l954 and l955, he
worked as a research assistant at the University of Istanbul in the field of
cancer research. For his efforts and dedication to research and development in
the fight against cancer and AIDS, Mr. de Clara was awarded the "Pour le Merit"
honorary medal of the Austrian Military Order "Merito Navale" as well as the
honor cross of the Austrian Albert Schweitzer Society.
Geert R. Kersten, Esq. Mr. Kersten was Director of Corporate and Investment
Relations for CEL-SCI between February 1987 and October 1987. In October of
1987, he was appointed Vice President of Operations. In December 1988, Mr.
Kersten was appointed Director of CEL-SCI. Mr. Kersten also became CEL-SCI's
Treasurer in 1989. In May 1992, Mr. Kersten was appointed Chief Operating
Officer and in February 1995, Mr. Kersten became CEL-SCI's Chief Executive
Officer. In previous years, Mr. Kersten worked as a financial analyst with
45
Source Capital, Ltd., an investment advising firm in McLean, Virginia. Mr.
Kersten is a stepson of Maximilian de Clara, who is the President and a Director
of CEL-SCI. Mr. Kersten attended George Washington University in Washington,
D.C. where he earned a B.A. in Accounting and an M.B.A. with emphasis on
International Finance. He also attended law school at American University in
Washington, D.C. where he received a Juris Doctor degree.
Patricia B. Prichep has been CEL-SCI's Senior Vice President of Operations
since March 1994. Between December 1992 and March 1994, Ms. Prichep was
CEL-SCI's Director of Operations. Ms. Prichep became CEL-SCI's Corporate
Secretary in May 2000. From June 1990 to December 1992, Ms. Prichep was the
Manager of Quality and Productivity for the NASD's Management, Systems and
Support Department. Between 1982 and 1990, Ms. Prichep was Vice President and
Operations Manager for Source Capital, Ltd.
Eyal Talor, Ph.D. has been CEL-SCI's Senior Vice President of Research and
Manufacturing since March 1994. From October 1993 until March 1994, Dr. Talor
was Director of Research, Manufacturing and Quality Control, as well as the
Director of the Clinical Laboratory, for Chesapeake Biological Laboratories,
Inc. From 1991 to 1993, Dr. Talor was a scientist with SRA Technologies, Inc.,
as well as the director of SRA's Flow Cytometry Laboratory (1991-1993) and
Clinical Laboratory (1992-1993). During 1992 and 1993, Dr. Talor was also the
Regulatory Affairs and Safety Officer For SRA. Since 1987, Dr. Talor has held
various positions with the Johns Hopkins University, including course
coordinator for the School of Continuing Studies (1989-Present), research
associate and lecturer in the Department of Immunology and Infectious Diseases
(1987-1991), and associate professor (1991-Present).
Daniel H. Zimmerman, Ph.D. has been CEL-SCI's Senior Vice President of
Cellular Immunology since January 1996. Dr. Zimmerman founded CELL-MED, Inc. and
was its president from 1987-1995. From 1973 to 1987 Dr. Zimmerman served in
various positions at Electronucleonics, Inc. including Scientist, Senior
Scientist, Technical Director and Program Manager. From 1969-1973 Dr. Zimmerman
was a Senior Staff Fellow at NIH.
John Cipriano, has been CEL-SCI's Senior Vice President of Regulatory
Affairs since March 2004. Mr. Cipriano brings to CEL-SCI over 30 years of
experience in both biotech and pharmaceutical companies. In addition, he held
positions at the United States Food and Drug Administration (FDA) as Deputy
Director, Division of Biologics Investigational New Drugs, Office of Biologics
Research and Review and was the Deputy Director, IND Branch, Division of
Biologics Evaluation, Office of Biologics. Mr. Cipriano completed his B.S. in
Pharmacy from the Massachusetts College of Pharmacy in Boston, Massachusetts and
his M.S. in Pharmaceutical Chemistry from Purdue University in West Lafayette,
Indiana.
Alexander G. Esterhazy has been a Director of CEL-SCI since April 1999.
Mr. Esterhazy has been an independent financial advisor since November 1997.
Between July 1991 and October 1997 Mr. Esterhazy was a senior partner of
Corpofina S.A. Geneva, a firm engaged in mergers, acquisitions and portfolio
management. Between January 1988 and July 1991 Mr. Esterhazy was a managing
director of DG Bank in Switzerland. During this period Mr. Esterhazy was in
charge of the Geneva, Switzerland branch of the DG Bank, founded and served as
vice president of DG Finance (Paris) and was the President and Chief Executive
officer of DG-Bourse, a securities brokerage firm.
46
C. Richard Kinsolving, Ph.D. has been a Director of CEL-SCI since April
2001. Since February 1999 Dr. Kinsolving has been the Chief Executive Officer of
BioPharmacon, a pharmaceutical development company. Between December 1992 and
February 1999 Dr. Kinsolving was the President of Immuno-Rx, Inc., a company
engaged in immuno-pharmaceutical development. Between December 1991 and
September 1995 Dr. Kinsolving was President of Bestechnology, Inc. a nonmedical
research and development company producing bacterial preparations for industrial
use. Dr. Kinsolving received his Ph.D. in Pharmacology from Emory University
(1970), his Masters degree in Physiology/Chemistry from Vanderbilt University
(1962), and his Bachelor's degree in Chemistry from Tennessee Tech. University
(1957).
Peter R. Young, Ph.D. has been a Director of CEL-SCI since August 2002.
Dr. Young has been a senior executive within the pharmaceutical industry in the
United States and Canada for most of his career. Over the last 20 years he has
primarily held positions of Chief Executive Officer or Chief Financial Officer
and has extensive experience with acquisitions and equity financings. Since
November 2001 Dr. Young has been the President of Agnus Dei, LLC, which acts as
a partner in an organization managing immune system clinics which treat patients
with diseases such as cancer, multiple sclerosis and hepatitis. Since January
2003 Dr. Young has been the President and Chief Executive Officer of SRL
Technology, Inc., a company involved in the development of pharmaceutical (drug)
delivery systems. Between 1998 and 2001 Dr. Young was the Chief Financial
Officer of Adams Laboratories, Inc. Dr. Young received his Ph.D. in Organic
Chemistry from the University of Bristol, England (1969), and his Bachelor's
degree in Honors Chemistry, Mathematics and Economics also from the University
of Bristol, England (1966).
All of CEL-SCI's officers devote substantially all of their time to
CEL-SCI's business.
Alexander G. Esterhazy, Dr. C. Richard Kinsolving and Dr. Peter R. Young
are independent directors as that term is defined in section 121(a) of the
listing standards of the American stock Exchange.
CEL-SCI has an audit committee and compensation committee. The members of
the audit committee are Alexander G. Esterhazy, C. Richard Kinsolving and Dr.
Peter Young. Dr. Peter Young serves as the audit committee's financial expert.
All members of the audit committee are independent, as that term is defined in
section 121(a) of the listing standards of the American Stock Exchange. The
members of the compensation committee are Maximilian de Clara, Alexander
Esterhazy and C. Richard Kinsolving.
CEL-SCI has adopted a Code of Ethics which is applicable to CEL-SCI'S
principal executive, financial, and accounting officers and persons performing
similar functions. The Code of Ethics is available on CEL-SCI's website, located
at www.cel-sci.com.
If a violation of this code of ethics act is discovered or suspected, the
Senior Officer must (anonymously, if desired) send a detailed note, with
relevant documents, to CEL-SCI's Audit Committee, c/o Dr. Peter Young, 1247
Dodgeton Drive, Frisco, TX 75034-1432.
47
EXECUTIVE COMPENSATION
----------------------
The key components of CEL-SCI's executive compensation program include
annual base salaries and long-term incentive compensation consisting of stock
options. It is CEL-SCI's policy to target compensation (i.e., base salary, stock
option grants and other benefits) at approximately the median of comparable
companies in the biotechnology field. Accordingly, data on compensation
practices followed by other companies in the biotechnology industry is
considered, as well as the officer's performance in his or her area of
responsibility, experience and length of service with CEL-SCI.
Financial or stockholder value performance comparisons are not used to
determine the compensation of CEL-SCI's officers since CEL-SCI's financial
performance and stock value are influenced to a substantial degree by external
factors. As a result, comparing the officer's compensation to CEL-SCI's
financial or stock price performance can be misleading.
CEL-SCI's long-term incentive program consists exclusively of periodic
grants of stock options with an exercise price equal to the fair market value of
CEL-SCI's common stock on the date of grant. To encourage retention, the ability
to exercise options granted under the program is subject to vesting
restrictions. Decisions made regarding the timing and size of option grants take
into account the performance of both CEL-SCI and the employee, "competitive
market" practices, and the size of the option grants made in prior years. The
weighting of these factors varies and is subjective. Current option holdings are
not considered when granting options.
The following table shows in summary form the compensation received by (i)
the Chief Executive Officer of CEL-SCI and (ii) by each other executive officer
of CEL-SCI who received in excess of $100,000 during the fiscal year ended
September 30, 2006.
All
Other
Restric- Annual
ted Stock Options Compen-
Name and Princi- Fiscal Salary Bonus Awards Awards sation
pal Position Year (1) (2) (3) (4) (5) Total
---------------- ------ ------ ----- --------- ------- ------- -----
Maximilian de Clara, 2006 $363,000 $200,000 $ 11,600 $ 58,000 $ 67,164 $699,764
President 2005 $363,000 -- -- $ 24,000 $ 72,041 $459,041
2004 $363,000 -- -- $ 30,500 $ 60,165 $453,665
Geert R. Kersten, 2006 $386,693 -- $ 13,050 $116,000 $ 18,612 $534,355
Chief Executive 2005 $370,585 -- $ 12,700 $ 24,000 $ 18,260 $425,545
Officer and 2004 $366,673 -- $ 11,296 $ 30,500 $ 18,690 $427,159
Treasurer
Patricia B. Prichep 2006 $170,820 -- $ 9,628 $ 52,200 $ 3,050 $235,689
Senior Vice President2005 $159,864 -- $ 9,404 $ 14,400 $ 3,000 $186,668
of Operations and 2004 $148,942 -- $ 7,110 $ 30,500 $ 3,000 $189,552
Secretary
48
Eyal Talor, Ph.D. 2006 $210,568 -- $ 9,600 $ 46,400 $ 3,050 $269,618
Senior Vice President2005 $201,154 -- $ 8,400 $ 14,400 $ 3,000 $226,954
of Research and 2004 $192,373 -- $ 4,797 $ 30,500 $ 3,000 $230,670
Manufacturing
Daniel Zimmerman, 2006 $161,574 -- $ 9,261 $ 34,800 $ 3,050 $208,685
Ph.D, 2005 $154,350 -- $ 9,059 $ 14,400 $ 3,000 $180,809
Senior Vice 2004 $147,613 -- $ 7,176 $ 30,500 $ 3,000 $188,289
President of
Cellular Immunology
John Cipriano 2006 $157,020 -- $ 9,000 $ 34,800 -- $200,820
Senior Vice 2005 $150,000 -- $ 9,000 $ 14,400 -- $173,400
President of
Regulatory Affairs
(1) The dollar value of base salary (cash and non-cash) received. During the
year ended September 30, 2006, $47,220 of the total salaries paid to the
persons shown in the table were paid in restricted shares of CEL-SCI's
common stock.
Information concerning the issuance of these restricted shares is shown in
the following table:
Date Shares Number of Price
Were Issued Shares Issued Per Share
----------- ------------- ---------
09/20/06 81,413 $0.58
On each date the amount of compensation satisfied through the issuance of
shares was determined by multiplying the number of shares issued by the price
per share. The price per share was equal to the closing price of CEL-SCI's
common stock on the date prior to the date the shares were issued.
(2) The dollar value of bonus (cash and non-cash) received. The $200,000 paid
to Mr. de Clara was paid in restricted shares of CEL-SCI's common stock
which cannot be sold in the public market for three years.
(3) During the periods covered by the table, the value of the shares of
restricted stock issued as compensation for services to the persons listed
in the table. In the case of all other persons listed in the table, the
shares were issued as CEL-SCI's contribution on behalf of the named officer
to CEL-SCI's 401(k) retirement plan.
(4) The value of all stock options granted during the periods covered by the
table. Includes certain options issued in connection with CEL-SCI's Salary
Reduction Plan. See "Stock Options" below.
(5) All other compensation received that CEL-SCI could not properly report in
any other column of the table. Amounts in the table represent automobile,
parking and other transportation expenses, plus, in the case of Maximilian
de Clara and Geert Kersten, director's fees of $8,000 each
49
Long Term Incentive Plans - Awards in Last Fiscal Year
------------------------------------------------------
None.
Employee Pension, Profit Sharing or Other Retirement Plans
----------------------------------------------------------
During 1993 CEL-SCI implemented a defined contribution retirement plan,
qualifying under Section 401(k) of the Internal Revenue Code and covering
substantially all CEL-SCI's employees. Prior to January 1, 1998 CEL-SCI's
contribution was equal to the lesser of 3% of each employee's salary, or 50% of
the employee's contribution. Effective January 1, 1998 the plan was amended such
that CEL-SCI's contribution is now made in shares of CEL-SCI's common stock as
opposed to cash. Each participant's contribution is matched by CEL-SCI with
shares of common stock which have a value equal to 100% of the participant's
contribution, not to exceed the lesser of $1,000 or 6% of the participant's
total compensation. CEL-SCI's contribution of common stock is valued each
quarter based upon the closing price of its common stock. The fiscal 2006
expenses for this plan were $88,054. Other than the 401(k) Plan, CEL-SCI does
not have a defined benefit, pension plan, profit sharing or other retirement
plan.
Compensation of Directors During Year Ended September 30, 2006
Name Paid in Cash Stock Awards (1) Option Awards (2)
---- ------------ ---------------- -----------------
Alexander G. Esterhazy $ 8,000 $ 11,600 $ 28,800
Dr. C. Richard Kinsolving $ 8,000 $ 11,600 $ 28,800
Dr. Peter R. Young $ 8,000 $ 11,600 $ 28,800
(1) The fair value of stock issued for services computed in accordance with FAS
123R on the date of grant.
(2) The fair value of options granted computed in accordance with FAS 123R on
the date of grant.
Directors' fees paid to Maximilian de Clara and Geert R Kersten ($8,000
each) are included in the Executive Compensation table.
Employment Contracts.
---------------------
In April 2005 CEL-SCI entered into a three-year employment agreement with
Mr. de Clara which expires April 30, 2008. The employment agreement provides
that CEL-SCI will pay Mr. de Clara an annual salary of $363,000 during the term
of the agreement. In the event that there is a material reduction in Mr. de
Clara's authority, duties or activities, or in the event there is a change in
the control of CEL-SCI, then the agreement allows Mr. de Clara to resign from
his position at CEL-SCI and receive a lump-sum payment from CEL-SCI equal to 18
months salary. For purposes of the employment agreement, a change in the control
of CEL-SCI means the sale of more than 50% of the outstanding shares of
CEL-SCI's Common Stock, or a change in a majority of CEL-SCI's directors.
The Employment Agreement will also terminate upon the death of Mr. de
Clara, Mr. de Clara's physical or mental disability, the conviction of Mr. de
Clara for any crime involving fraud, moral turpitude, or CEL-SCI's property, or
50
a breach of the Employment Agreement by Mr. de Clara. If the Employment
Agreement is terminated for any of these reasons, Mr. de Clara, or his legal
representatives, as the case may be, will be paid the salary provided by the
Employment Agreement through the date of termination.
On September 8, 2006 Mr. de Clara's Employment Agreement was amended and
extended to April 30, 2010. The terms of the amendment to Mr. de Clara's
employment agreement are referenced in a report on Form 8-K filed with the
Securities and Exchange Commission on September 8, 2006.
Effective September 1, 2003, CEL-SCI entered into a three-year employment
agreement with Mr. Kersten. The employment agreement provides that during the
term of the employment agreement CEL-SCI will pay Mr. Kersten an annual salary
of $370,585. In the event there is a change in the control of CEL-SCI, the
agreement allows Mr. Kersten to resign from his position at CEL-SCI and receive
a lump-sum payment from CEL-SCI equal to 24 months salary. For purposes of the
employment agreement a change in the control of CEL-SCI means: (1) the merger of
CEL-SCI with another entity if after such merger the shareholders of CEL-SCI do
not own at least 50% of voting capital stock of the surviving corporation; (2)
the sale of substantially all of the assets of CEL-SCI; (3) the acquisition by
any person of more than 50% of CEL-SCI's common stock; or (4) a change in a
majority of CEL-SCI's directors which has not been approved by the incumbent
directors.
Effective September 1, 2006 Mr. Kersten's employment agreement was
extended to September 1, 2011.
The Employment Agreement will also terminate upon the death of Mr.
Kersten, Mr. Kersten's physical or mental disability, willful misconduct, an act
of fraud against CEL-SCI, or a breach of the Employment Agreement by Mr.
Kersten. If the Employment Agreement is terminated for any of these reasons Mr.
Kersten, or his legal representatives, as the case may be, will be paid the
salary provided by the Employment Agreement through the date of termination.
Compensation Committee Interlocks and Insider Participation
-----------------------------------------------------------
CEL-SCI has a compensation committee comprised of all of CEL-SCI's
directors, with the exception of Mr. Kersten. During the year ended September
30, 2006, Mr. de Clara was the only officer participating in deliberations of
CEL-SCI's compensation committee concerning executive officer compensation. Mr.
de Clara is not an independent member of the compensation committee.
During the year ended September 30, 2006, no director of CEL-SCI was also
an executive officer of another entity, which had an executive officer of
CEL-SCI serving as a director of such entity or as a member of the compensation
committee of such entity.
Stock Options
-------------
The following tables shows the options granted during the fiscal year
ended September 30, 2006, to the persons named below.
51
Options Granted During Fiscal Year Ended September 30, 2006.
Exercise
Grant Options Price Per Expiration
Name Date Granted (#) Share Date
------ ---- ----------- ---------- ------------
Maximilian de Clara 9/12/2006 100,000 $0.62 9/12/16
Geert R. Kersten 9/12/2006 200,000 0.62 9/12/16
Patricia B. Prichep 9/12/2006 90,000 0.62 9/12/16
Eyal Talor, Ph.D. 9/12/2006 80,000 0.62 9/12/16
Daniel Zimmerman, Ph.D. 9/12/2006 60,000 0.62 9/12/16
John Cipriano 9/12/2006 60,000 0.62 9/12/16
Option Exercises
----------------
Shares
Acquired On Value
Name Exercise (1) Realized (2)
---- -------------- ------------
Maximilian de Clara -- --
Geert R. Kersten -- --
Patricia Prichep -- --
Eyal Talor -- --
Daniel Zimmerman -- --
John Cipriano -- --
(1) The number of shares received upon exercise of options during the fiscal
year ended September 30, 2006.
(2) With respect to options exercised during CEL-SCI's fiscal year ended
September 30, 2006, the dollar value of the difference between the option
exercise price and the market value of the option shares purchased on the
date of the exercise of the options.
Shares underlying unexercised
Options which are: Exercise Expiration
Name Exercisable Unexercisable Price Date
---- ----------- ------------- -------- ----------
Maximilian de Clara 1,164,999 149,999 $0.22 - $1.94 5/01/08 - 9/12/16
Geert R. Kersten 3,458,001 249,999 $0.22 - $1.94 5/01/08 - 9/12/16
Patricia B. Prichep 1,104,834 126,666 $0.22 - $1.94 7/31/08 - 9/12/16
Eyal Talor, Ph.D. 764,666 116,666 $0.22 - $1.94 8/03/08 - 9/12/16
Daniel Zimmerman, Ph.D. 768,334 96,666 $0.22 - $1.94 2/19/08 - 9/12/16
John Cipriano 90,001 119,999 $0.48 - $1.13 3/01/14 - 9/12/06
Stock Option, Bonus and Compensation Plans
------------------------------------------
CEL-SCI has Incentive Stock Option Plans, Non-Qualified Stock Option Plans
and Stock Bonus Plans. All Stock Option and Bonus Plans have been approved by
52
the stockholders. A summary description of these Plans follows. In some cases
these Plans are collectively referred to as the "Plans".
Incentive Stock Option Plan. The Incentive Stock Option Plans authorize
the issuance of shares of CEL-SCI's common stock to persons who exercise options
granted pursuant to the Plan. Only CEL-SCI's employees may be granted options
pursuant to the Incentive Stock Option Plan.
To be classified as incentive stock options under the Internal Revenue
Code, options granted pursuant to the Plans must be exercised prior to the
following dates:
(a) The expiration of three months after the date on which an option
holder's employment by CEL-SCI is terminated (except if such
termination is due to death or permanent and total disability);
(b) The expiration of 12 months after the date on which an option
holder's employment by CEL-SCI is terminated, if such termination is
due to the Employee's permanent and total disability;
(c) In the event of an option holder's death while in the employ of
CEL-SCI, his executors or administrators may exercise, within three
months following the date of his death, the option as to any of the
shares not previously exercised;
The total fair market value of the shares of Common Stock (determined at
the time of the grant of the option) for which any employee may be granted
options which are first exercisable in any calendar year may not exceed
$100,000.
Options may not be exercised until one year following the date of grant.
Options granted to an employee then owning more than 10% of the Common Stock of
CEL-SCI may not be exercisable by its terms after five years from the date of
grant. Any other option granted pursuant to the Plan may not be exercisable by
its terms after ten years from the date of grant.
The purchase price per share of Common Stock purchasable under an option
is determined by the Committee but cannot be less than the fair market value of
the Common Stock on the date of the grant of the option (or 110% of the fair
market value in the case of a person owning more than 10% of CEL-SCI's
outstanding shares).
Non-Qualified Stock Option Plans. The Non-Qualified Stock Option Plans
authorize the issuance of shares of CEL-SCI's common stock to persons that
exercise options granted pursuant to the Plans. CEL-SCI's employees, directors,
officers, consultants and advisors are eligible to be granted options pursuant
to the Plans, provided however that bona fide services must be rendered by such
consultants or advisors and such services must not be in connection with the
offer or sale of securities in a capital-raising transaction. The option
exercise price is determined by the Committee but cannot be less than the market
price of CEL-SCI's Common Stock on the date the option is granted.
Stock Bonus Plan. Under the Stock Bonus Plans shares of CEL-SCI's common
stock may be issued to CEL-SCI's employees, directors, officers, consultants and
advisors, provided however that bona fide services must be rendered by
53
consultants or advisors and such services must not be in connection with the
offer or sale of securities in a capital-raising transaction.
Stock Compensation Plan. Under the Stock Compensation Plan shares of
CEL-SCI's common stock may be issued to CEL-SCI's employees, directors,
officers, consultants and advisors, provided however that bona fide services
must be rendered by consultants or advisors and such services must not be in
connection with the offer or sale of securities in a capital-raising
transaction.
Other Information Regarding the Plans. The Plans are administered by
CEL-SCI's Compensation Committee ("the Committee"), each member of which is a
director of CEL-SCI. The members of the Committee were selected by CEL-SCI's
Board of Directors and serve for a one-year tenure and until their successors
are elected. A member of the Committee may be removed at any time by action of
the Board of Directors. Any vacancies which may occur on the Committee will be
filled by the Board of Directors. The Committee is vested with the authority to
interpret the provisions of the Plans and supervise the administration of the
Plans. In addition, the Committee is empowered to select those persons to whom
shares or options are to be granted, to determine the number of shares subject
to each grant of a stock bonus or an option and to determine when, and upon what
conditions, shares or options granted under the Plans will vest or otherwise be
subject to forfeiture and cancellation.
In the discretion of the Committee, any option granted pursuant to the
Plans may include installment exercise terms such that the option becomes fully
exercisable in a series of cumulating portions. The Committee may also
accelerate the date upon which any option (or any part of any options) is first
exercisable. Any shares issued pursuant to the Stock Bonus Plan and any options
granted pursuant to the Incentive Stock Option Plan or the Non-Qualified Stock
Option Plan will be forfeited if the "vesting" schedule established by the
Committee administering the Plan at the time of the grant is not met. For this
purpose, vesting means the period during which the employee must remain an
employee of CEL-SCI or the period of time a non-employee must provide services
to CEL-SCI. At the time an employee ceases working for CEL-SCI (or at the time a
non-employee ceases to perform services for CEL-SCI), any shares or options not
fully vested will be forfeited and cancelled. At the discretion of the Committee
payment for the shares of Common Stock underlying options may be paid through
the delivery of shares of CEL-SCI's Common Stock having an aggregate fair market
value equal to the option price, provided such shares have been owned by the
option holder for at least one year prior to such exercise. A combination of
cash and shares of Common Stock may also be permitted at the discretion of the
Committee.
Options are generally non-transferable except upon death of the option
holder. Shares issued pursuant to the Stock Bonus Plan will generally not be
transferable until the person receiving the shares satisfies the vesting
requirements imposed by the Committee when the shares were issued.
The Board of Directors of CEL-SCI may at any time, and from time to time,
amend, terminate, or suspend one or more of the Plans in any manner they deem
appropriate, provided that such amendment, termination or suspension will not
adversely affect rights or obligations with respect to shares or options
previously granted. The Board of Directors may not, without shareholder
approval: make any amendment which would materially modify the eligibility
54
requirements for the Plans; increase or decrease the total number of shares of
Common Stock which may be issued pursuant to the Plans except in the case of a
reclassification of CEL-SCI's capital stock or a consolidation or merger of
CEL-SCI; reduce the minimum option price per share; extend the period for
granting options; or materially increase in any other way the benefits accruing
to employees who are eligible to participate in the Plans.
Summary. The following shows the stock options and stock bonuses granted
by CEL-SCI as of April 20, 2007. Each option represents the right to purchase
one share of CEL-SCI's common stock.
Total Shares
Shares Reserved for Shares
Remaining Reserved Outstanding Issued as
Name of Plan Under Plans Options Stock Bonus Under Plans
------------ ----------- -------- ------------ -----------
Incentive Stock Option Plans 8,100,000 4,326,933 N/A 3,606,833
Non-Qualified Stock Option Plans 11,760,000 6,861,081 N/A 1,920,667
Stock Bonus Plans 5,940,000 N/A 2,045,247 3,894,669
Stock Compensation Plan 3,500,000 N/A 291,405 3,208,595
Of the shares issued pursuant to CEL-SCI's Stock Bonus Plans 908,131
shares were issued as part of CEL-SCI's contribution to its 401(k) plan.
The following table shows the weighted average exercise price of the
outstanding options granted pursuant to CEL-SCI's Incentive and Non-Qualified
Stock Option Plans as of September 30, 2006, CEL-SCI's most recent fiscal year
end. CEL-SCI's Incentive and Non-Qualified Stock Option Plans have been approved
by CEL-SCI's shareholders.
Number of Securities
Number Remaining Available
of Securities For Future Issuance
to be Issued Weighted-Average Under Equity
Upon Exercise Exercise Price of Compensation Plans,
of Outstanding of Outstanding Excluding Securities
Plan Category Options (a) Options Reflected in Column (a)
------------- -------------- ----------------- -----------------------
Incentive Stock Option Plans 4,326,933 $0.65 3,606,833
Non-Qualified Stock Option Plans 7,511,362 $0.66 2,395,667
PRINCIPAL SHAREHOLDERS
The following table shows, as of April 20, 2007, information with respect
to the only persons owning beneficially 5% or more of the outstanding common
stock and the number and percentage of outstanding shares owned by each director
and officer and by the officers and directors as a group. Unless otherwise
indicated, each owner has sole voting and investment powers over his shares of
common stock.
55
Name and Address Number of Shares (1) Percent of Class (3)
---------------- ---------------- ----------------
Maximilian de Clara 679,006 0.6%
Bergstrasse 79
6078 Lungern,
Obwalden, Switzerland
Geert R. Kersten 6,309,589 (2) 5.7%
8229 Boone Blvd., Suite 802
Vienna, VA 22182
Patricia B. Prichep 1,672,857 1.5%
8229 Boone Blvd., Suite 802
Vienna, VA 22182
Eyal Talor, Ph.D. 1,148,885 1.1%
8229 Boone Blvd., Suite 802
Vienna, VA 22182
Daniel H. Zimmerman, Ph.D. 1,225,397 1.1%
8229 Boone Blvd., Suite 802
Vienna, VA 22182
John Cipriano 151,662 0.1%
8229 Boone Blvd., Suite 802
Vienna, VA 22182
Alexander G. Esterhazy 218,333 0.2%
20 Chemin du Pre-Poiset
CH- 1253 Vandoeuvres
Geneve, Switzerland
C. Richard Kinsolving, Ph.D. 447,424 0.4%
P.O. Box 20193
Bradenton, FL 34204-0193
Peter R. Young, Ph.D. 219,601 0.2%
1247 Dodgeton Drive
Frisco, TX 75034-1432
All Officers and Directors 12,072,754 10.5%
as a Group (9 persons)
(1) Includes shares issuable prior to June 30, 2007 upon the exercise of
options or warrants granted to the following persons:
56
Options or Warrants Exercisable
Name Prior to June 30, 2007
---- -------------------------------
Maximilian de Clara 640,999
Geert R. Kersten 3,458,001
Patricia B. Prichep 1,104,834
Eyal Talor, Ph.D. 764,666
Daniel H. Zimmerman, Ph.D. 768,334
John Cipriano 90,001
Alexander G. Esterhazy 198,333
C. Richard Kinsolving, Ph.D. 358,334
Peter R. Young, Ph.D. 185,000
(2) Amount includes shares held in trust for the benefit of Mr. Kersten's minor
children. Geert R. Kersten is the stepson of Maximilian de Clara.
(3) Amount includes shares referred to in (1) above but excludes shares which
may be issued upon the exercise or conversion of other options, warrants
and other convertible securities previously issued by CEL-SCI.
SELLING SHAREHOLDERS AND PLAN OF DISTRIBUTION
By means of this prospectus shareholders of CEL-SCI Corporation are
offering to sell up to 42,961,666 shares of CEL-SCI's common stock. The shares
offered by the selling shareholders represent shares sold by CEL-SCI in a
private offering for cash, shares issued for consulting services, and shares
issuable upon the exercise of warrants. See "Comparative Share Data" for
information concerning the circumstances surrounding the shares and warrants
acquired by the selling shareholders.
CEL-SCI will not receive any proceeds from the sale of the shares by the
selling shareholders. CEL-SCI will pay all costs of this offering. The selling
shareholders will pay all sales commissions and other costs relating to the sale
of their shares.
Shares
Issuable Shares to Share
Upon Be Sold Ownership
Shares Exercise in this After
Name Owned of Warrants (1) Offering Offering
---- ------ -------------- --------- ------------
APE invest A/S 2,000,000 1,000,000 3,000,000 --
Notabene.net A/S 133,333 66,667 200,000 --
Handelsbanken A/S 1,200,000 600,000 1,800,000 --
Erik Damgaard
Portefoljeinvest A/S 666,667 333,333 1,000,000 --
57
Shares
Issuable Shares to Share
Upon Be Sold Ownership
Shares Exercise in this After
Name Owned of Warrants (1) Offering Offering
---- ------ -------------- --------- ------------
Finn Helmer 1,333,333 666,667 2,000,000 --
KBUS 8, nr. 1,333,333 666,667 2,000,000 --
Ardent Holding 666,667 333,333 1,000,000 --
Fundamental
Fondsmaeglerselskab 1,333,333 666,667 2,000,000 --
Sydbank A/S 2,000,000 1,000,000 3,000,000 --
DKA Consult APS 1,333,333 666,667 2,000,000 --
MCS Holding Aps 792,400 396,200 1,188,600 --
Kgs. Nytorv 21 Aps 2,000,000 1,000,000 3,000,000 --
Ole Trist 100,000 50,000 150,000 --
Forstaedernes Bank A/S 40,933 20,467 61,400 --
Synerco ApS 133,333 66,667 200,000 --
Soren Degn SHD 133,333 66,667 200,000 --
Sparekassen 800,000 400,000 1,200,000 --
UBS Luxembourg SA 1,333,333 666,667 2,000,000 --
Landsbanki Luxembourg SA 2,666,667 1,333,333 33,333 --
Korral Partners -- 10,000,000 10,000,000 --
Iroquois Master Fund Ltd. 33,333 33,333 66,666 --
Otago Partners LLC 10,000 10,000 20,000 --
Ozal Ltd. 2,000,000 -- 2,000,000 --
Emento S.A. 500,000 -- 500,000 --
Riviera Ventures, Inc. 875,000 -- 375,000 500,000
58
(1) All of the warrants, except as noted below, are Series M warrants. The
warrants held by Korral Partners are Series L warrants. Half of the
warrants held by Iroquois Master Fund Ltd. and Otago Partners LLC are
Series L warrants and half are Series M warrants. See "Comparative Share
Data" for more information concerning the Series L and Series M warrants.
The controlling person of each selling shareholder, which is not an
individual, is shown below:
Selling Shareholder Controlling Person
------------------- ------------------
APE invest A/S Aldo Petersen
Notabene.net A/S Brian Mertz
Handelsbanken A/S Claus Gade
Erik Damgaard Portefoljeinvest A/S Erik Damgaard
KBUS 8, nr. 2051 Aps Harry Rosenberg
Ardent Holding Henrik Kejser
Fundamental Fondsmaeglerselskab Michael Voss
Sydbank A/S Jorn Jacobsen
DKA Consult APS Tom Larsen
MCS Holding Aps Mark Szigety
Kgs. Nytorv 21 Aps Ole Abildgaard
Forstaedernes Bank A/S Stefan Rasmussen
Synerco Aps Kenneth Marmetschke
Soren Degn Soren Degn
Sparekassen Kronjylland A/S Tonny Elsberg
UBS Luxembourg SA Palle Lorenzen
Landsbanki Luxembourg SA Torben Bjerregaard
Korral Partners Mark Szigety
59
Selling Shareholder Controlling Person
------------------- ------------------
Selling Shareholder Controlling Person
Iroquois Master Fund Ltd. Joshua Silverman
Otago Partners LLC Lindsay A. Rosenwald, M.D.
Ozal Ltd. Torben Bjerregaard
Emento S.A. Flemming Madsen
Riviera Ventures, Inc. Neil Persh
None of the selling shareholders had or ever had, any material
relationship with CEL-SCI or CEL-SCI's officers or directors. To CEL-SCI's
knowledge, none of the selling shareholders are affiliated with a broker dealer
except for Otago Partners LLC.
Manner of Sale
--------------
The shares of common stock to be sold by the selling shareholders may be
offered and sold by means of this prospectus from time to time as market
conditions permit. These shares may be sold by one or more of the following
methods, without limitation:
o a block trade in which a broker or dealer so engaged will attempt to
sell the shares as agent but may position and resell a portion of the
block as principal to facilitate the transaction;
o purchases by a broker or dealer as principal and resale by such broker
or dealer for its account pursuant to this prospectus;
o ordinary brokerage transactions and transactions in which the broker
solicits purchasers; and
o face-to-face transactions between sellers and purchasers without a
broker/dealer.
In competing sales, brokers or dealers engaged by the selling shareholders
may arrange for other brokers or dealers to participate. Brokers or dealers may
receive commissions or discounts from the selling shareholders in amounts to be
negotiated. As to any particular broker-dealer, this compensation might be in
excess of customary commissions. Neither CEL-SCI nor the selling shareholders
can presently estimate the amount of such compensation. Notwithstanding the
above, no NASD member will charge commissions that exceed 8% of the total
proceeds from the sale.
The selling shareholders and any broker/dealers who act in connection with
the sale of the shares may be deemed to be "underwriters" within the meaning of
ss.2(11) of the Securities Acts of 1933, and any commissions received by them
and any profit on any resale of the shares as principal might be deemed to be
underwriting discounts and commissions under the Securities Act.
60
If any selling shareholder enters into an agreement to sell its shares to
a broker-dealer as principal, and the broker-dealer is acting as an underwriter,
CEL-SCI will file a post-effective amendment to the registration statement, of
which this prospectus is a part, identifying the broker-dealer, providing
required information concerning the plan of distribution, and otherwise revising
the disclosures in this prospectus as needed. CEL-SCI will also file the
agreement between the selling shareholder and the broker-dealer as an exhibit to
the post-effective amendment to the registration statement.
The selling shareholders may also sell their shares pursuant to Rule 144
under the Securities Act of 1933.
CEL-SCI has advised the selling shareholders that they, and any securities
broker/dealers or others who may be deemed to be statutory underwriters, will be
subject to the prospectus delivery requirements under the Securities Act of
1933. CEL-SCI has also advised the selling shareholders that in the event of a
"distribution" of the shares owned by the selling shareholders, the selling
shareholders, any "affiliated purchasers", and any broker/dealer or other person
who participate in the distribution may be subject to Rule 102 of Regulation M
under the Securities Exchange Act of 1934 ("1934 Act") until their participation
in the distribution is completed. Rule 102 makes it unlawful for any person who
is participating in a distribution to bid for or purchase stock of the same
class as is the subject of the distribution. A "distribution" is defined in Rule
102 as an offering of securities "that is distinguished from ordinary trading
transactions by the magnitude of the offering and the presence of special
selling efforts and selling methods". CEL-SCI has also advised the selling
shareholders that Rule 101 of Regulation M under the 1934 Act prohibits any
"stabilizing bid" or "stabilizing purchase" for the purpose of pegging, fixing
or stabilizing the price of the common stock in connection with this offering.
DESCRIPTION OF SECURITIES
-------------------------
CEL-SCI is authorized to issue 200,000,000 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.
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
61
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.
Series K Notes and Warrants
---------------------------
On August 4, 2006, CEL-SCI sold Series K convertible notes, plus Series K
warrants, to a group of private investors for $8,300,000. The notes bear
interest annually at the greater of 8% or the six months LIBOR plus 3% per year.
The Notes are due and payable on August 4, 2011 and are secured by substantially
all of CEL-SCI's assets.
Interest is payable quarterly with the first interest payment due on
September 30, 2006. Beginning March 4, 2007 CEL-SCI is required to make monthly
payments of $207,500 toward the principal amount of the Notes.
At the holder's option the Series K notes are convertible into shares of
CEL-SCI's common stock equal in number to the amount determined by dividing each
$1,000 of note principal to be converted by the Conversion Price. As of April
20, 2007 the Conversion Price was $0.75.
At CEL-SCI's election, interest or principal may be paid in CEL-SCI's
common stock. In the event CEL-SCI elects to pay interest or principal in shares
of its common stock, the number of shares of common stock to be issued to each
holder will be determined by dividing the amount payable by the lower of the
Conversion Price (as it may be adjusted in accordance with the terms of the
note), or the Market Price as of the applicable payment date,
CEL-SCI may not use its common stock to pay interest or principal unless
each of the following conditions is satisfied: (i) the number of authorized but
unissued and otherwise unreserved shares of common stock is sufficient for the
issuance; (ii) the shares of common stock to be issued in payment for principal
and interest may be sold by the Holder pursuant to an effective Registration
Statement covering the shares or, in the alternative, all the shares may be sold
without volume restrictions pursuant to Rule 144(k); (iii) CEL-SCI's common
stock is listed (and is not suspended from trading) on the American Stock
Exchange and the shares of common stock are approved for listing on the American
Stock Exchange upon issuance; (iv) CEL-SCI is not the subject of any bankruptcy
proceeding; (v) CEL-SCI is not in default with respect to any material
obligation in its agreements with the investors which purchased the convertible
notes; and (vi) no public announcement of a proposed change in the control of
CEL-SCI has occurred that has not been consummated.
If CEL-SCI sells any additional shares of common stock, or any securities
convertible into common stock at a price below the then applicable Conversion
Price, the Conversion 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 CEL-SCI sells any additional shares of common stock, or any
securities convertible into common stock at a price above the Conversion Price
but below the average closing price of CEL-SCI's common stock over the five
62
trading days prior to the sale of the shares, the Conversion Price will be
reduced to equal the amount determined by the following formula:
CP x (S1 + S2) = NCP
----------------
S3
Where:
CP = the Conversion Price in effect immediately prior to the
issuance of common stock or securities convertible into common
stock
S1 = the sum of the number of shares of CEL-SCI's common stock
outstanding immediately prior to the issuance;
S2 = the number of shares of CEL-SCI's common stock that the
price paid for the common stock issued (or the lowest price at
which securities are convertible into CEL-SCI's common stock)
would purchase at the average closing price of CEL-SCI's
common stock over the five trading days prior to the sale of
the shares
S3 = the number of shares of common stock outstanding, or which
would be outstanding if all convertible securities were
converted into shares of CEL-SCI's common stock, immediately
after the issuance.
NCP = New Conversion Price
However, the Conversion Price will not 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 bona fide joint venture, strategic partnership,
or strategic alliance, the primary purpose of which is not to raise
cash;
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 the Company's stock option, stock bonus or similar
plans.;
o to key officers of CEL-SCI in lieu of their respective salaries.
o pursuant to the conversion or exercise of securities which were
outstanding prior to August 4, 2006;
o pursuant to a firm commitment underwritten public offering in an
amount greater than $15,000,000;
The Conversion Price will also be proportionately adjusted in the event of
any stock splits.
63
So long as the Series K notes are outstanding CEL-SCI may not:
o declare or pay any dividends (other than a stock dividend or stock
split) or make any distributions to any holders of its common stock;
o purchase or otherwise acquire for value any of its capital stock;
o become obligated on any debt that is senior or equal in any respect to
CEL-SCI's obligations under the Series K Notes, other than
indebtedness secured by purchase money security interests (which will
be senior only as to the underlying assets purchased) or indebtedness
under capital lease obligations (which will be senior only as to the
assets leased);
o issue securities convertible into common stock with a conversion price
or a number of shares issuable upon conversion that floats or is
subject to adjustment based upon the market price of CEL-SCI's common
stock.
Upon the occurrence of any of the following events CEL-SCI is required to
collectively pay the holders of the Series K notes $166,000 in cash at the time
of the occurrence and each month that the occurrence continues:
o the effectiveness of the Registration Statement covering the shares
issuable upon the conversation of the Series K notes or the exercise
of the Series K warrants lapses for any reason or the Registration
Statement is unavailable to the note holders and the lapse or
unavailability continues for a period of three or more consecutive
trading days, or five trading days which need not be consecutive, in
any twelve month period;
o the suspension from listing or the failure of CEL-SCI's common stock
to be listed on the American Stock Exchange for a period of three
consecutive trading days or seven trading days, which need not be
consecutive, in any twelve month period;
o the Series K warrants may not be exercised for any reason;
CEL-SCI will not have any liability when the shares of common stock issued
or issuable upon the conversion of the Series K Notes or the exercise of the
Series K Warrants can be sold pursuant to Rule 144(k) or to any note holder
which requires CEL-SCI to purchase the notes in an event of default.
The Series K warrants allow the note holders to initially purchase up to
5,211,628 shares of CEL-SCI's common stock at a price of $0.75 per share at any
time between February 4, 2007 and February 4, 2012.
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 K 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.
64
If CEL-SCI sells any additional shares of common stock, or any securities
convertible into common stock at a price above the exercise price but below the
market price of CEL-SCI's common stock, the exercise price of the Series K
warrants will be lowered to a price determined by the following formula:
EP x (S1 + S2) = NEP
----------------
S3
Where:
EP = the Exercise Price in effect immediately prior to the issuance
of common stock or securities convertible into common stock;
S1 = the sum of the number of shares of CEL-SCI's common stock
outstanding immediately prior to the issuance;
S2 = the number of shares of CEL-SCI's common stock that the price
paid for the common stock issued (or the lowest price at which
securities are convertible into CEL-SCI's common stock) would
purchase at the average closing price of CEL-SCI's common stock
over the five trading days prior to the sale of the shares;
S3 = the number of shares of common stock outstanding, or which would
be outstanding if all convertible securities were converted into
shares of CEL-SCI's common stock, immediately after the issuance;
NEP = New Exercise Price.
If the warrant exercise price is decreased, the number of shares of common
stock issuable upon the exercise of the warrant will be increased according to
the following formula:
WS x EP1 = NWS
---
EP2
Where:
WS = The number of shares issuable upon the exercise of warrants
based upon the exercise price prior to adjustment;
EP1 = The old exercise price of the warrants;
EP2 = The new exercise price of the warrants;
NWS = The number of shares of CEL-SCI's common stock issuable based
upon the new exercise price of the warrants.
65
The exercise price of the warrants, as well as the shares issuable upon
the exercise of the warrants, will also be proportionately adjusted in the event
of any stock splits.
However, neither the exercise price of the Series K warrants nor the
shares issuable upon the exercise of the warrant will be adjusted as the result
of shares issued in connection with a Permitted Financing.
Any of the following are an event of default:
o CEL-SCI fails to make any interest or principal payment when due;
o CEL-SCI fails for any reason to deliver a certificate within five
trading days after delivery of the certificate is required pursuant to
any agreement with the note holders;
o the conversion or exercise rights of the note or warrant holders is
suspended for any reason;
o CEL-SCI fails to have available a sufficient number of authorized but
unissued shares of common stock available for issuance upon the
conversion of the notes or the exercise of the warrants;
o CEL-SCI's common stock is not listed on the American Stock Exchange or
other public trading market;
o the effectiveness of the Registration Statement lapses for any reason;
o the holders of the notes and warrants are not permitted to sell any
shares under the Registration Statement, in either case, for three or
more consecutive trading days or five trading days (which need not be
consecutive trading days in any twelve month period) and the common
stock issued or issuable upon the conversion of the notes cannot be
sold pursuant to Rule 144(k);
o CEL-SCI breaches any representation or warranty or covenant or
defaults in the timely performance of any other obligation in its
agreement with the note holders and the breach or default continues
uncured for a period of 20 days after the date on which notice of the
breach or default is first given to CEL-SCI;
o CEL-SCI defaults in any of its obligations under any other note or
credit agreement or long term lease in an amount exceeding $1,000,000,
and the default continues for a period of five days and results in the
indebtedness becoming payable prior to the date on which it would
otherwise become payable;
o a judgment or judgments for the payment of money in excess of $250,000
are rendered against CEL-SCI and are not bonded, discharged or stayed
pending appeal within sixty (60) days after the entry of the judgment,
or are not discharged within sixty (60) days after the expiration of
the stay; provided, however, that any judgment which is covered by
66
insurance or an indemnity from a creditworthy party shall not be
included in calculating the $250,000 amount; or
o CEL-SCI files for protection from its creditors under the federal
bankruptcy code or a third party files an involuntary bankruptcy
petition against CEL-SCI.
At any time after an event of default, any holder has the option to
require CEL-SCI to repurchase all or any portion of:
o the outstanding principal amount of the note, at a price equal to the
greater of 115% of the outstanding principal, plus all accrued but
unpaid interest, or the Event Equity Value of the shares issuable upon
conversion of the outstanding note principal and all accrued but
unpaid interest, and
o any shares issued to the holder upon any conversion of notes, and
still owned by the holder, at a price per share equal to the Event
Equity Value for the shares.
At any time after August 4, 2009, any note holder will have the right to
require CEL-SCI to redeem all or any portion of the outstanding principal amount
of the notes, plus all accrued but unpaid interest.
So long as the Series K notes are outstanding, the note holders have a
right to participate in any subsequent financings, with the exception of
Permitted Financings, involving CEL-SCI.
CEL-SCI has filed a registration statement with the Securities and
Exchange Commission in order that the shares of common stock issuable upon the
conversion of the Series K notes or the exercise of the Series K warrants may be
resold in the public market.
For purposes of the notes the term:
"LIBOR" means the annual rate of interest offered for deposits in U.S.
dollars which appears on page six of any relevant Telerate, Bloomberg or Reuter
page as of 11:00 a.m. London time two business days prior to the first day of
any calendar quarter.
"Event Equity Value" means 115% of the average of the VWAP for each of the
five trading days preceding the date of the notice requiring any payment by this
method.
"Market Price" means 90% of the arithmetic average of the VWAP for each
of the 20 trading days ending immediately prior to the applicable interest or
principal payment date, as the case may be.
"VWAP" means for any particular period the volume weighted average trading
price per share of CEL-SCI's common stock.
67
Warrants Held by Private Investors
----------------------------------
See "Comparative Share Data" for information concerning the terms of
warrants held by private investors.
Transfer Agent
--------------
Computershare Trust Company, Inc., of Denver, Colorado, is the transfer
agent for CEL-SCI's common stock.
EXPERTS
The financial statements as of September 30, 2006 and for the three years
then ended included in this prospectus have been audited by BDO Seidman LLP, an
independent registered public accounting firm, as stated in their reports
appearing herein and elsewhere in the registration statement, and are included
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 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.
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
68
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
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.
69
CEL-SCI CORPORATION
Consolidated Financial Statements for the Years
Ended September 30, 2006, 2005, and 2004, and
Report of Independent Registered Public Accounting Firm
CEL-SCI CORPORATION
TABLE OF CONTENTS
Page
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM F - 2
CONSOLIDATED FINANCIAL STATEMENTS FOR THE YEARS ENDED
SEPTEMBER 30, 2006, 2005, AND 2004:
Consolidated Balance Sheets F - 3
Consolidated Statements of Operations F - 4
Consolidated Statements of Stockholders' Equity F - 5
Consolidated Statements of Cash Flows F - 7
Notes to Consolidated Financial Statements F - 11
Report of Independent Registered Public Accounting Firm
Board of Directors and Stockholders
CEL-SCI Corporation
Vienna, Virginia
We have audited the accompanying consolidated balance sheets of CEL-SCI
Corporation as of September 30, 2006 and 2005 and the related consolidated
statements of operations, stockholders' equity, and cash flows for each of the
three years in the period ended September 30, 2006. These financial statements
are the responsibility of the Company's management. Our responsibility is to
express an opinion on these financial statements based on our audits.
We conducted our audits in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that we plan
and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement. The Company is not required to
have, nor were we engaged to perform, an audit of its internal control over
financial reporting. Our audit included consideration of internal control over
financial reporting as a basis for designing audit procedures that are
appropriate in the circumstances, but not for the purpose of expressing an
opinion on the effectiveness of the Company's internal control over financial
reporting. Accordingly, we express no such opinion. An audit also includes
examining, on a test basis, evidence supporting the amounts and disclosures in
the financial statements, assessing the accounting principles used and
significant estimates made by management, as well as evaluating the overall
financial statement presentation. We believe that our audits provide a
reasonable basis for our opinion.
In our opinion, the consolidated financial statements referred to above present
fairly, in all material respects, the financial position of CEL-SCI Corporation
at September 30, 2006 and 2005, and the results of its operations and its cash
flows for each of the three years in the period ended September 30, 2006, in
conformity with accounting principles generally accepted in the United States of
America.
/s/ BDO SEIDMAN LLP
----------------------
Bethesda, Maryland
January 12, 2007
F-2
CEL-SCI CORPORATION
CONSOLIDATED BALANCE SHEETS
SEPTEMBER 30, 2006 AND 2005
ASSETS 2006 2005
------------------------
CURRENT ASSETS:
Cash and cash equivalents $ 8,080,365 $ 1,957,614
Interest and other receivables 35,626 21,164
Prepaid expenses 526,498 12,172
Inventory used for R&D and manufacturing 390,644 420,480
Deposits 14,828 -
------------- -------------
Total current assets 9,047,961 2,411,430
RESEARCH AND OFFICE EQUIPMENT--less
accumulated depreciation of $1,773,102
and $1,690,788 92,117 181,541
PATENT COSTS--less accumulated amortization
of $896,407 and $816,169 513,199 484,553
DEPOSITS - 14,828
------------- -------------
TOTAL ASSETS $ 9,653,277 $ 3,092,352
============= =============
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)
CURRENT LIABILITIES:
Accounts payable 98,056 74,354
Accrued expenses 74,894 74,619
Due to employees 17,425 22,880
Accrued interest on convertible debt 74,473 -
Deposits held 3,000 3,000
Derivative instruments - current portion 1,670,234 1,280
------------- -------------
Total current liabilities 1,938,082 176,133
Derivative instruments - noncurrent portion 8,645,796 811,180
------------- -------------
Total liabilities 10,583,878 987,313
COMMITMENTS AND CONTINGENCIES
STOCKHOLDERS' EQUITY (DEFICIT):
Preferred stock, $.01 par value - authorized
100,000 shares; issued and outstanding - 0 - -
Common stock, $.01 par value -- authorized
200,000,000 shares; issued and outstanding,
82,697,428 and 74,494,206 shares at
September 30, 2006 and 2005, respectively 826,974 744,942
Additional paid-in capital 105,180,834 100,359,296
Accumulated deficit (106,938,409) (98,999,199)
------------- -------------
Total stockholders' equity (deficit) (930,601) 2,105,039
------------- -------------
TOTAL LIABILITIES AND
STOCKHOLDERS' EQUITY (DEFICIT) $ 9,653,277 $ 3,092,352
============= =============
See notes to consolidated financial statements
F-3
CEL-SCI CORPORATION
CONSOLIDATED STATEMENTS OF OPERATIONS
YEARS ENDED SEPTEMBER 30, 2006, 2005 AND 2004
2006 2005 2004
-------------------------------------
GRANT REVENUE AND OTHER $ 125,457 $ 269,925 $ 325,479
OPERATING EXPENSES:
Research and development (excluding
R&D depreciation of $74,043, $96,442
and $115,420 respectively,
included below) 1,896,976 2,229,729 1,941,630
Depreciation and amortization 170,902 190,420 198,269
General & administrative 3,406,775 1,930,543 2,310,279
------------- ------------- ------------
Total operating expenses 5,474,653 4,350,692 4,450,178
------------- ------------- ------------
NET OPERATING LOSS (5,349,196) (4,080,767) (4,124,699)
GAIN ON DERIVATIVE INSTRUMENTS 2,325,784 363,028 1,174,660
COSTS ASSOCIATED WITH CONVERTIBLE DEBT (4,791,548) - -
OTHER INCOME - 625,472 -
INTEREST INCOME 92,487 52,660 51,817
INTEREST EXPENSE (216,737) - (53,855)
------------- ------------- ------------
NET LOSS BEFORE INCOME TAXES $ (7,939,210) $ (3,039,607) $(2,952,077)
INCOME TAX PROVISION - - -
------------- ------------- ------------
NET LOSS $ (7,939,210) $ (3,039,607) $(2,952,077)
============= ============= ============
NET LOSS PER COMMON SHARE
BASIC $ (0.10) $ (0.04) $ (0.04)
============= ============= ============
DILUTED $ (0.11) $ (0.05) $ (0.06)
============= ============= ============
WEIGHTED AVERAGE COMMON SHARES
OUTSTANDING
BASIC 78,971,290 72,703,395 67,273,133
============= ============= ============
DILUTED 93,834,078 73,581,925 68,924,099
============= ============= ============
See notes to consolidated financial statements.
F-4
CEL-SCI CORPORATION
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY
YEARS ENDED SEPTEMBER 30, 2006, 2005 AND 2004
Additional
Common Stock Paid-In Unearned Accumulated
Shares Amount Capital Compensation Deficit Total
-----------------------------------------------------------------------------
BALANCE, SEPTEMBER 30, 2003 61,166,345 $ 611,663 $ 90,616,673 $ - $(93,007,515) $(1,779,179)
Exercise of warrants 614,520 6,145 893,277 899,422
Stock issued to employees
for service 180,959 1,810 169,630 (14,237) 157,203
Stock issued to nonemployees
for service 7,414 74 7,859 7,933
Conversion of Series H
convertible debt 179,436 1,794 184,819 186,613
Interest on Series H
convertible debt paid in
common stock 3,210 32 3,306 3,338
Exercise of stock options 213,503 2,135 103,731 105,866
Modification of employee
stock options 7,597 7,597
401(k) contributions paid
in common stock 72,495 725 51,751 52,476
Issuance of common stock for
equity line of credit 307,082 3,071 341,994 345,065
Sale of common stock 9,402,403 94,025 6,899,679 6,993,704
Costs for equity related
transactions (591,611) (591,611)
Reclassification of
derivative instruments
to equity 685,992 685,992
Net loss (2,952,077) (2,952,077)
-------------- ----------- ------------ ----------- ------------- ------------
BALANCE, SEPTEMBER 30, 2004 72,147,367 721,474 99,374,697 (14,237) (95,959,592) 4,122,342
Stock issued to nonemployees
for service 8,687 86 4,084 4,170
Exercise of stock options 200,669 2,007 47,778 49,785
Issuance of stock options
to employees 7,972 7,972
401(k) contributions paid
in common stock 144,469 1,445 77,423 78,868
Issuance of common stock
for equity line of credit 743,014 7,430 359,842 367,272
Expense unearned
compensation 14,237 14,237
Private placement 1,250,000 12,500 487,500 500,000
Net loss (3,039,607) (3,039,607)
-------------- ----------- ------------ ----------- ------------- ------------
BALANCE SEPTEMBER 30, 2005 74,494,206 744,942 100,359,296 - (98,999,199) 2,105,039
F-5
CEL-SCI CORPORATION
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY
YEARS ENDED SEPTEMBER 30, 2006, 2005 AND 2004 (CONT'D)
Additional
Common Stock Paid-In Unearned Accumulated
Shares Amount Capital Compensation Deficit Total
-----------------------------------------------------------------------------
Stock issued to non-employees
for service 980,000 9,800 611,250 621,050
Exercise of stock options 150,000 1,500 37,217 38,717
Issuance of stock options
to nonemployees 271,893 271,893
Extension of options 86,864 86,864
401(k) contributions paid -
in common stock 132,989 1,330 84,150 85,480
Issuance of common stock
to employees 583,815 5,838 317,468 317,468
Issuance of common stock
for equity line of credit 1,419,446 14,194 663,533 677,727
Payment of interest on
convertible debt in common
stock 68,500 685 37,228 37,228
Penalty shares issued 186,250 1,863 130,624 132,487
Exercise of warrants 1,300,000 13,000 652,000 665,000
Cashless exercise of warrants 882,222 8,822 (8,822) -
Private placement 2,500,000 25,000 975,000 1,000,000
Reclassification of
derivatives 797,835 797,835
SFAS 123R cost of
employee options 180,298 180,298
Financing costs (15,000) (15,000)
Net loss (7,939,210) (7,939,210)
-------------- ----------- ------------ ----------- ------------- ------------
BALANCE, SEPTEMBER 30, 2006 82,697,428 $ 826,974 $105,180,834 $(106,938,409) $ (930,601)
============== =========== ============ =========== ============== ==========
See notes to consolidated financial statements
F-6
CEL-SCI CORPORATION
CONSOLIDATED STATEMENTS OF CASH FLOWS
YEARS ENDED SEPTEMBER 30, 2006, 2005 AND 2004
2006 2005 2004
---------------------------------------------
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss $ (7,939,210) $(3,039,607) $(2,952,077)
Adjustments to reconcile net loss to
net cash used for operating
activities:
Depreciation and amortization
170,902 190,420 198,269
Issuance of stock options to
nonemployees for services 271,893 7,972 -
Issuance of common stock for
services 621,050 4,170 165,136
Penalty shares issued to
non-employees 132,487 - -
Modification of stock options 86,864 - 7,597
Issuance of stock to employees 323,306 14,237 -
Employee option cost 180,298 - -
Common stock contributed to
401(k) plan 85,480 78,868 52,476
Impairment loss on abandonment of
patents - 3,716 43,351
(Gain) loss on retired equipment 645 1,806 -
Amortization of deferred
financing costs - - 16,243
Amortization of discount on
convertible note 104,351 - 22,082
Gain on derivative instruments (2,325,784) (363,028) (1,174,660)
Change in assets and liabilities:
Decrease (increase) in interest
and other receivables (14,462) 92 25,795
(Increase) decrease in prepaid
expenses (454,651) 57,795 (13,895)
(Increase) decrease in inventory
used in R&D and manufacturing (29,839) 18,150 (137,171)
Increase (decrease) in accounts
payable 3,637 (71,782) (385,952)
Increase (decrease) in accrued
expenses 275 10,259 (30,055)
Increase in accrued interest on
convertible debt 112,386 - -
Increase (decrease) in due to
employees (5,455) 17,560 (221,795)
Decrease in deferred rent - - (5,540)
------------- --------- ----------
Net cash used for operating activities (8,675,827) (3,069,372) (4,390,196)
------------- --------- ----------
CASH FLOWS USED FOR INVESTING
ACTIVITIES:
Purchases of equipment (1,885) (65,736) (52,175)
Expenditures for patent costs (88,819) (87,966) (121,430)
------------- --------- ----------
Net cash used for investing activities (90,704) (153,702) (173,605)
------------- --------- ----------
(continued)
See notes to consolidated financial statements.
F-7
CEL-SCI CORPORATION
CONSOLIDATED STATEMENTS OF CASH FLOWS
YEARS ENDED SEPTEMBER 30, 2006, 2005 AND 2004 (CONT'D)
2006 2005 2004
----------------------------------------
CASH FLOWS PROVIDED BY FINANCING
ACTIVITIES:
Proceeds from issuance of common stock $1,000,000 $ 500,000 $7,799,970
Proceeds from exercise of warrants 665,000 - 291,222
Draw-downs on equity line of credit 677,727 367,272 340,000
Proceeds from exercise of stock options 38,717 49,785 105,866
Payments on notes payable - - (871,322)
Proceeds from convertible debt 8,300,000 - -
Fair value adjustment for convertible
debt 3,163,265 - -
Fair value adjustment for warrants
issued in relation to convertible
debt 835,666 - -
Warrants issued to placement agent 223,907
Costs for equity related transactions
not completed (15,000) - (591,611)
----------- -------- --------
Net cash provided by financing activities 14,889,282 917,057 7,074,125
----------- -------- --------
NET INCREASE (DECREASE)
IN CASH AND CASH EQUIVALENTS 6,122,751 (2,306,017) 2,510,324
CASH AND CASH EQUIVALENTS, BEGINNING OF
YEAR 1,957,614 4,263,631 1,753,307
----------- -------- --------
CASH AND CASH EQUIVALENTS, END OF YEAR $8,080,365 $1,957,614 $4,263,631
=========== ========== ==========
See notes to consolidated financial statements.
(continued)
F-8
CEL-SCI CORPORATION
CONSOLIDATED STATEMENTS OF CASH FLOWS
YEARS ENDED SEPTEMBER 30, 2006, 2005 AND 2004 (CONT'D)
2006 2005 2004
----------------------------------------
CONVERSION OF CONVERTIBLE DEBT
INTO COMMON STOCK:
Decrease in convertible debt $ - $ - $ 186,613
Increase in common stock - - (1,794)
Increase in additional paid-in
capital - - (184,819)
--------- -------- ---------
$ - $ - $ -
========= ======== =========
CONVERSION OF INTEREST ON
CONVERTIBLE DEBT INTO COMMON STOCK:
Decrease in accrued liabilities $ 37,913 $ - $ 3,338
Increase in common stock (685) - (32)
Increase in additional paid-in
capital (111,701) - (3,306)
--------- -------- ---------
$ - $ - $ -
========= ======== =========
EXERCISE OF WARRANTS:
Decrease in derivative instruments $ - $ - $ 77,900
Increase in additional paid-in
capital - - (77,900)
--------- -------- ---------
$ - $ - $ -
========= ======== =========
SETTLEMENT OF DERIVATIVE INSTRUMENTS
ON DRAW-DOWNS OF EQUITY LINE
OF CREDIT:
Decrease in derivative instruments $ - $ - $ 5,065
Increase in additional paid-in
capital - - (5,065)
--------- -------- ---------
$ - $ - $ -
========= ======== =========
ISSUANCE OF WARRANTS ON SALE OF
COMMON STOCK:
Increase in derivative instruments $ - $ - $(806,266)
Decrease in additional paid-in
capital - - 806,266
--------- -------- ---------
$ - $ - $ -
========= ======== =========
EQUIPMENT COSTS INCLUDED IN
ACCOUNTS PAYABLE:
Increase in research and office
equipment $ - $ 268 $ 31,728
Increase in accounts payable - (268) (31,728)
--------- -------- ---------
$ - $ - $ -
========= ======== =========
(continued)
See notes to consolidated financial statements.
F-9
CEL-SCI CORPORATION
CONSOLIDATED STATEMENTS OF CASH FLOWS
YEARS ENDED SEPTEMBER 30, 2006, 2005 AND 2004 (CONT'D)
2006 2005 2004
----------------------------------------
PATENT COSTS INCLUDED IN
ACCOUNTS PAYABLE:
Increase in patent costs $ 20,065 2,568 15,539
Increase in accounts payable (20,065) $ (2,568) $ (15,539)
---------- -------- ----------
$ - $ - $ -
========== ======== =========
CASHLESS EXERCISE OF WARRANTS:
Decrease in derivative instruments $ - $ - $ 530,300
Increase in common stock (8,822) - (3,698)
Decrease (increase) in additional
paid-in capital 8,822 - (526,602)
---------- -------- ----------
$ - $ - $ -
========== ======== =========
RECLASSIFICATION OF DERIVATIVE
INSTRUMENTS:
Decrease in derivative instruments $ 797,835 $ - $ 685,992
Increase in additional paid-in
capital (797,835) - (685,992)
---------- -------- ----------
$ - $ - $ -
========== ======== =========
FAIR VALUE ADJUSTMENT FOR CONVERTIBLE
DEBT AND RELATED WARRANTS:
Increase in convertible debt $(3,998,931) $ - $ -
Increase in costs associated with
convertible debt 3,998,931 - -
---------- -------- ---------
$ - $ - $ -
========== ======== =========
COST OF NEW WARRANTS AND REPRICING OF
OLD WARRANTS ON PRIVATE PLACEMENT:
Increase in additional paid-in
capital $(1,192,949) $ - $ -
Decrease in additional paid-in
capital 1,192,949 - -
---------- -------- ----------
$ - $ - $ -
========== ======== =========
See notes to consolidated financial statements.
F-10
CEL-SCI CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
YEARS ENDED SEPTEMBER 30, 2006, 2005 and 2004
--------------------------------------------------------------------------------
1. ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
CEL-SCI Corporation (the "Company") was incorporated on March 22, 1983, in
the state of Colorado, to finance research and development in biomedical
science and ultimately to engage in marketing and selling products.
CEL-SCI's lead product, Multikine(R), is being developed for the treatment of
cancer. Multikine is a patented immunotherapeutic agent consisting of a
mixture of naturally occurring cytokines, including interleukins,
interferons, chemokines and colony-stimulating factors, currently being
developed for the treatment of cancer. 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 head & neck
cancer (500,000 new cases per annum). Since Multikine is not tumor specific,
it may also be applicable in many other solid tumors.
Significant accounting policies are as follows:
a. Principles of Consolidation--The consolidated financial statements include
the accounts of the Company and its wholly owned subsidiary, Viral
Technologies, Inc. (VTI). All significant intercompany transactions have
been eliminated upon consolidation.
b. Cash and Cash Equivalents--For purposes of the statements of cash flows,
cash and cash equivalents consists principally of unrestricted cash on
deposit and short-term money market funds. The Company considers all
highly liquid investments with a maturity when purchased of less than
three months, as cash and cash equivalents.
c. Prepaid Expenses and Inventory-- Prepaid expenses consist of expenses
which benefit a substantial period of time. Inventory consists of
manufacturing production advances and bulk purchases of laboratory
supplies to be consumed in the manufacturing of the Company's product for
clinical studies.
d. Research and Office Equipment--Research and office equipment is recorded
at cost and depreciated using the straight-line method over estimated
useful lives of five to seven years. Leasehold improvements are
depreciated over the shorter of the estimated useful life of the asset or
the terms of the lease. Repairs and maintenance which do not extend the
life of the asset are expensed when incurred. Depreciation expense for the
years ended September 30, 2006, 2005 and 2004 totaled $90,664, $116,268
and $128,997, respectively.
F-11
e. Patents--Patent expenditures are capitalized and amortized using the
straight-line method over the shorter of the expected useful life or the
legal life of the patent (17 years). In the event changes in technology or
other circumstances impair the value or life of the patent, appropriate
adjustment in the asset value and period of amortization is made. An
impairment loss is recognized when estimated future undiscounted cash flows
expected to result from the use of the asset, and from disposition, is less
than the carrying value of the asset. The amount of the impairment loss is
the difference between the estimated fair value of the asset and its
carrying value. During the years ended September 30, 2006, 2005 and 2004,
the Company recorded patent impairment charges of $-0-, $3,716 and $43,351,
respectively, for the net book value of patents abandoned during the year.
These amounts are included in general and administrative expenses.
Amortization expense for the years ended September 30, 2006, 2005 and 2004
totaled $80,238, $74,152 and $69,272, respectively.
f. Derivative Instruments--The Company enters into financing arrangements
that consist of freestanding derivative instruments or are hybrid
instruments that contain embedded derivative features. The Company accounts
for these arrangement in accordance with Statement of Financial Accounting
Standards No. 133, "Accounting for Derivative Instruments and Hedging
Activities", ("SFAS No. 133") and Emerging Issues Task Force Issue No.
00-19, "Accounting for Derivative Financial Instruments Indexed to, and
Potentially Settled in, a Company's Own Stock", ("EITF 00-19"), as well as
related interpretations of these standards. In accordance with accounting
principles generally accepted in the United States ("GAAP"), derivative
instruments and hybrid instruments are recognized as either assets or
liabilities in the statement of financial position and are measured at fair
value with gains or losses recognized in earnings or other comprehensive
income depending on the nature of the derivative or hybrid instruments.
Embedded derivatives that are not clearly and closely related to the host
contract are bifurcated and recognized at fair value with changes in fair
value recognized as either a gain or loss in earnings if they can be
reliably measured. When the fair value of embedded derivative features can
not be reliably measured, the Company measures and reports the entire
hybrid instrument at fair value with changes in fair value recognized as
either a gain or loss in earnings. The Company determines the fair value of
derivative instruments and hybrid instruments based on available market
data using appropriate valuation models, giving consideration to all of the
rights and obligations of each instrument and precluding the use of
"blockage" discounts or premiums in determining the fair value of a large
block of financial instruments. Fair value under these conditions does not
necessarily represent fair value determined using valuation standards that
give consideration to blockage discounts and other factors that may be
considered by market participants in establishing fair value.
g. Research and Development Grant Revenues--The Company's grant arrangements
are handled on a reimbursement basis. Grant revenues under the
arrangements are recognized as grant revenue when costs are incurred.
F-12
h. Research and Development Costs--Research and development expenditures are
expensed as incurred. The Company had an agreement with an unrelated
corporation for the production of Multikine, which is the Company's only
product source. This agreement expired on December 31, 2006. Total
research and development costs, excluding depreciation, were $1,896,976,
$2,229,729 and $1,941,630 for the years ended September 30, 2006, 2005 and
2004.
i. Other Costs of Financing--Other costs of financing represent the excess
fair value of warrants issued in conjunction with financing arrangements
where the warrants are required to be recorded as derivatives over the
proceeds of the financing received at issuance.
j. Net Loss Per Common Share--Net loss per common share is computed by
dividing the net loss by the weighted average number of common shares
outstanding during the period. Potentially dilutive common stock
equivalents, including convertible preferred stock, convertible debt and
options to purchase common stock, were excluded from the calculation for
all periods presented as they were antidilutive.
k. Concentration of Credit Risk--Financial instruments, which potentially
subject the Company to concentrations of credit risk, consist of cash and
cash equivalents. The Company maintains its cash and cash equivalents with
high quality financial institutions. At times, these accounts may exceed
federally insured limits. The Company has not experienced any losses in
such bank accounts. The Company believes it is not exposed to significant
credit risk related to cash and cash equivalents.
l. Income Taxes--Income taxes are accounted for using the asset and
liability method under which deferred tax liabilities or assets are
determined based on the difference between the financial statement and tax
basis of assets and liabilities (i.e., temporary differences) and are
measured at the enacted tax rates. Deferred tax expense is determined by
the change in the liability or asset for deferred taxes. The difference in
the Company's U.S. Federal statutory income tax rate and the Company's
effective tax rate is primarily attributable to the recording of a
valuation allowance due to the uncertainty of the amount of future tax
benefits that will be realized because it is more likely than not that
future taxable income will not be sufficient to realize such tax benefits.
m. Use of Estimates--The preparation of financial statements in conformity
with accounting principles generally accepted in the United States of
America requires management to make estimates and assumptions that affect
the reported amounts of assets and liabilities and disclosure of contingent
assets and liabilities at the date of the financial statements and the
reported amounts of revenues and expenses during the reporting period.
Actual results could differ from those estimates. Accounting for
derivatives is based upon valuations of derivative instrument determined
using various valuation techniques including the Black-Scholes and binomial
pricing methodologies. The Company considers such valuations to be
significant estimates.
F-13
n. Reclassifications--Certain items in the 2004 and 2005 consolidated
financial statements have been reclassified to conform to the current year
presentation.
o. Recent Accounting Pronouncements--In November 2004, the Financial
Accounting Standards Board ("FASB") issued Statement of Financial
Accounting Standards ("SFAS") No. 151, "Inventory Costs, an amendment of
Accounting Research Bulletin (ARB) 43, Chapter 4, Inventory Pricing". This
statement amends ARB 43, Chapter 4 "Inventory Pricing", to clarify
accounting for abnormal amounts of idle facility expense, freight, handling
costs and wasted material. SFAS No. 151 requires that those items be
recognized as current-period charges in all circumstances. SFAS No. 151 is
effective for fiscal years beginning after June 15, 2005. The Company does
not believe that the adoption of SFAS No. 151 will have a material effect
on its financial position, results of operations or cash flows.
In December 2004 the FASB issued SFAS No. 123R, "Share-Based Payment".
SFAS No. 123R requires companies to recognize compensation expense in an
amount equal to the fair value of the share-based payment (stock options
and restricted stock) issued to employees. 123R applies to all
transactions involving issuance of equity by a Company in exchange for
goods and services, including transactions with employees. SFAS No. 123R
is effective for the first fiscal period in the fiscal year beginning
after June 15, 2005. The Company recorded costs of $180,298 during the
year ended September 30, 2006 under 123R.
In March 2005, the FASB issued FIN No. 47, "Accounting for Conditional
Asset Retirement Obligations - an Interpretation of FASB Statement No.
143". The interpretation clarifies terms used in FASB Statement No. 143
and is effective no later than the end of fiscal periods ending after
December 15, 2005. The Company does not believe that FIN No. 47 will have
a material impact on its results of operations or cash flows.
In February 2006, the FASB issued SFAS No. 155, "Hybrid Instruments". The
statement amends SFAS No. 133 and SFAS No. 140, "Accounting for Transfers
and Servicing of Financial Assets and Extinguishments of Liabilities". The
statement also resolves issues addressed in Statement 133 Implementation
Issue No. D1, "Application of Statement 133 to Beneficial Interests in
Securitized Financial Assets." The statement: a) permits fair value
remeasurement for any hybrid financial instrument that contains an
embedded derivative that otherwise would require bifurcation, b) clarifies
which interest-only strips and principal-only strips are not subject to
the requirements of SFAS No. 133, c) establishes a requirement to evaluate
interests in securitized financial assets to identify interests that are
freestanding derivatives or that are hybrid financial instruments that
contain an embedded derivative requiring bifurcation, d) clarifies that
concentrations of credit risk in the form of subordination are not
embedded derivatives, and e) amends Statement 140 to eliminate the
prohibition on a qualifying special purpose entity from holding a
derivative financial instrument that pertains to a beneficial interest
other than another derivative financial instrument. SFAS No. 155 will not
have a material impact on its results of operations or cash flows.
F-14
In July 2006, the Financial Accounting Standards Board issued
Interpretation No. 48, "Accounting for Uncertainty in Income Taxes" ("FIN
48") which clarifies the accounting for income taxes by prescribing the
minimum recognition threshold a tax position is required to meet before
being recognized in the financial statements. FIN 48 also provides
guidance on derecognition, measurement, classification, interest and
penalties, accounting in interim periods, disclosure and transition. FIN
48 is effective for fiscal years beginning after December 15, 2006. The
Company does not expect the adoption of this Interpretation to have a
material impact on its financial statements.
In September 2006, FASB issued SFAS No. 157, "Fair Value Measurements".
The statement defines fair value, establishes a framework for measuring
fair value in GAAP and expands disclosures about fair value measurements.
The statement is effective for financial statements issued for fiscal
years beginning after November 15, 2007 and interim periods within those
fiscal years. The Company is evaluating whether this statement will affect
its current practice in valuing fair value of its derivatives each
quarter.
In September 2006, FASB issued SFAS No. 158, "Employers' Accounting for
Defined Benefit Pension and Other Postretirement Plans--an amendment of
FASB Statements No. 87, 88, 106, and 132(R)". The Company does not have a
defined benefit pension plan and does not believe that there will be an
impact on its results of operations or cash flows. The statement is
effective for fiscal years ending after December 15, 2006.
In September 2006, SAB No. 108 was issued by the Securities and Exchange
Commission. The interpretations in the SAB express the SEC staff's views
regarding the process of quantifying financial statement misstatements.
Beginning with annual financial statements covering fiscal years ending
after November 15, 2006, material misstatements in the current year may
result in the need to correct prior year financial statements, even if the
misstatement in the prior year or years is considered immaterial. SAB 108
does not require previously filed reports to be amended. Such correction
may be made the next time the company files the prior year financial
statements. CEL-SCI believes that there will be no impact on its results
of operations, cash flows or balance sheet because of this interpretation.
p. Stock-Based Compensation-- In October 1996, the FASB issued SFAS No.
123, "Accounting for Stock-Based Compensation". This statement encouraged
but did not require companies to account for employee stock compensation
awards based on their estimated fair value at the grant date with the
resulting cost charged to operations. The Company elected to continue to
account for its employee stock-based compensation using the intrinsic value
method prescribed in Accounting Principles Board No. 25, "Accounting for
Stock Issued to Employees, and related Interpretations". In December 2002,
the FASB issued SFAS No. 148, "Accounting for Stock-Based Compensation -
Transition and Disclosure" which amended SFAS No. 123. SFAS 148 provided
alternative methods of transition for a voluntary change to the fair value
based method of accounting for stock-based employee compensation and
required more prominent and more frequent disclosures in the financial
statements of the effects of stock-based compensation. The provisions of
SFAS 148 were
F-15
effective for fiscal years ending after December 15, 2002. At that time, the
Company elected to continue to account for its employee stock-based
compensation using the intrinsic value method. In December 2004, the FASB
issued SFAS No. 123R, "Share-Based Payment". SFAS No. 123R requires companies
to recognize compensation expense in an amount equal to the fair value of the
share-based payment (stock options and restricted stock) issued to employees.
123R applies to all transactions involving issuance of equity by a Company in
exchange for goods and services, including transactions with employees. SFAS
No. 123R is effective for the first fiscal period in the fiscal year
beginning after June 15, 2005. The Company recognized expense of $180,298 for
options issued or vested during the fiscal year ended September 30, 2006. The
following table summarizes stock option activity for the year ended September
30, 2006.
Non-Qualified Stock Option Plan
--------------------------------
Outstanding Exercisable
---------------------------------------------- ------------------------------------------------
Weighted Weighted
Average Average
Weighted Remaining Weighted Remaining
Number Average Contractual Aggregate Number Average Contractual Aggregate
of Exercise Term Intrinsic of Exercise Term Intrinsic
Shares Price (Years) Value Shares Price (Years) Value
---------------------------------------------- ------------------------------------------------
Outstanding at
October 1, 2005 6,215,363 $ 0.66 5.80 $642,085 4,642,893 $ 0.76 4.98 $ 432,032
Vested - 1,288,821 0.36
Granted 1,466,000 0.73 250,000 0.73
Exercised (150,001) 0.24 (150,001) 0.24
Forfeited - -
Expired (20,000) 1.05 (20,000) 1.05
Outstanding at
September 30, 2006 7,511,362 $0.66 5.15 $1,390,653 6,011,713 $ 0.68 4.81 $1,306,320
Incentive Stock Option Plan
---------------------------
Outstanding Exercisable
---------------------------------------------- ------------------------------------------------
Weighted Weighted
Average Average
Weighted Remaining Weighted Remaining
Number Average Contractual Aggregate Number Average Contractual Aggregate
of Exercise Term Intrinsic of Exercise Term Intrinsic
Shares Price (Years) Value Shares Price (Years) Value
---------------------------------------------- ------------------------------------------------
Outstanding at
October 1, 2005 3,972,633 $0.68 6.18 $630,833 2,885,968 $ 0.81 5.52 $ 418,334
Vested - 939,999
Granted 370,000 0.58 -
Exercised - -
Forfeited (1,200) 8.43 (1,200) 8.43
Expired (14,500) 5.10 (14,500) 5.10
Outstanding at
September 30, 2006 4,326,933 $0.65 6.03 $1,047,933 3,810,267 $ 0.66 5.59 $1,021,933
F-16
The total intrinsic value of options exercised during the year ended
September 30, 2006 was $67,432.
A summary of the status of the Company's non-vested options as of
September 30, 2006 is presented below:
Non-qualified Stock Option Plan:
-------------------------------
Nonvested at October 1, 2005 1,572,470 $0.25
Vested (1,538,821)
Granted 1,466,000
Forfeited -
Expired -
-----------
Nonvested at
September 30, 2006 1,499,649 $0.23
Incentive Stock Option Plan:
---------------------------
Nonvested at October 1, 2005 1,086,665 $0.21
Vested (939,999)
Granted 370,000
Forfeited -
Expired -
----------
Nonvested at
September 30, 2006 516,666 $0.46
For the year ended September 30, 2005, if the Company had elected to
recognize compensation expense based on the fair value of the awards
granted, consistent with the provisions of SFAS No. 123, the Company's net
loss and net loss per common share would have been increased to the pro
forma amounts indicated below:
September 30, 2005
------------------
Net loss:
As reported $(3,039,607)
Subtract: Total stock-based
employee compensation
expense determined under
fair-value based method for
all awards, net of related
tax effects (575,716)
------------
Pro forma net loss $(3,615,323)
============
F-17
Net loss per common share:
As reported $ (0.04)
================
Pro forma $ (0.05)
================
The weighted average fair value at the date of grant for options granted
during fiscal years 2006, 2005 and 2004 was $0.58, $0.48 and $0.48,
respectively.
The fair value of each option grant was estimated on the date of grant using
the Black-Scholes option-pricing model with the following assumptions:
2006 2005 2004
-------------------------------
Expected stock risk volatility 78% 74% 88%
Risk-free interest rate 4.88% 4.21% 3.13-4.25%
Expected life options 10 Years 5 Years 5 Years
Expected dividend yield - - -
The effects of applying SFAS No. 123 in this pro forma disclosure are not
necessarily indicative of the effect on future amounts.
The Company's stock options are not transferable, and the actual value of the
stock options that an employee may realize, if any, will depend on the excess
of the market price on the date of exercise over the exercise price. The
Company has based its assumption for stock price volatility on the variance
of monthly closing prices of the Company's stock. The risk-free rate of
return used for fiscal years 2006, 2005 and 2004 equals the yield on
five-year zero-coupon U.S. Treasury issues on the grant date. No discount was
applied to the value of the grants for non-transferability or risk of
forfeiture.
2. SERIES K CONVERTIBLE DEBT
In August 2006, the Company issued $8,300,000 million in aggregate
principal amount of convertible notes (the "Series K Notes") together with
warrants to purchase 4,825,581 shares of the Company's common stock (the
"Series K Warrants"). Additionally, in connection with issuance of the
Series K Notes and Series K Warrants, the placement agent received a fee of
$498,000 and 386,047 fully vested warrants (the "Placement Agent Warrants")
to purchase shares of the Company's common stock. Net proceeds were
$7,731,290, net of $568,710 in direct transaction costs, including the
placement agent fee.
F-18
2. SERIES K CONVERTIBLE DEBT (continued)
Features of the Convertible Debt Instrument and Warrants
The Series K Notes are convertible into 9,651,163 shares of the Company's
common stock at the option of the holder at any time prior to maturity at a
conversion price of $0.86 per share, subject to adjustment for certain
events described below. The Series K Warrants are exercisable over a
five-year period from February 4, 2007 through February 4, 2012 at $0.95
per share.
The Series K Notes bear interest at the greater of 8% or LIBOR plus 300
basis points, and are required to be repaid in thirty equal monthly
installments of $207,500 beginning on March 4, 2007 and continuing through
September 4, 2010. The remaining principal balance of $2,075,000 is
required to be repaid on August 4, 2011; however, holders of the Series K
Notes may require repayment of the entire remaining principal balance at
any time after August 4, 2010. Interest is payable quarterly beginning in
September 30, 2006. Each payment of principal and accrued interest may be
settled in cash or in shares of common stock at the option of the Company.
The number of shares deliverable under the share-settlement option is
determined based on the lower of (a) $0.86 per share, as adjusted pursuant
to the terms of the Series K Notes or (b) 90% applied to the arithmetic
average of the volume-weighted-average trading prices for the twenty day
period immediately preceding each share settlement.
In the event of default, as defined in the Series K Notes, all amounts due
and outstanding thereunder shall become, at the option of the holders,
immediately due and payable in cash, in an amount that equals the sum of
(i) the greater of (a) 115% of the outstanding balance plus all accrued and
unpaid interest or (b) 115% of the arithmetic average of the
volume-weighted-average trading prices for the five day period immediately
preceding notice requiring repayment, and (ii) all other amounts due in
connection with the Series K Notes and associated agreements. Additionally,
if a certain breach occurs under a related registration rights agreement,
the Company will be required to pay, as liquidated damages, 1.5% per month
of the outstanding balance of the Series K Notes, until such default is
cured (or 2% per month if such breach occurs after 180 days following
closing of the transaction). Events of default include circumstances in
which the Company either fails to have a registration statement for shares
into which the Series K Notes can be converted be declared effective by the
SEC within 180 days of the issuance date of the Series K Notes or that the
registration statement's effectiveness lapses for any reason.
The Company may not make payments in shares if such payments would result
in the cumulative issuance of shares of its common stock exceeding 19.999%
of the shares outstanding on the day immediately preceding the issuance
date of the Series K Notes, unless prior approval is given by vote of at
least a majority of the shares outstanding. The Company received such
approval on November 17, 2006. The Company cannot determine at this time if
it will be required to issue shares in excess of the Issuable Maximum
because the number of shares issuable as payments of principal and interest
under the Series K Notes will depend on future share prices. The conversion
price of the Series K Notes and exercise price of the Series K Warrants are
each subject to certain anti-dilution protections, including for stock
splits, stock dividends, change in control events and dilutive issuances of
common stock or common stock
F-19
2. SERIES K CONVERTIBLE DEBT (continued)
equivalents, such as stock options, at an effective price per share that is
lower than the then conversion price. In the event of a dilutive issuance
of common stock or common stock equivalents, the conversion price and
exercise price would be reduced to equal the lower per share price of the
subsequent transaction.
Accounting for the Convertible Debt Instrument and Warrants
-----------------------------------------------------------
The Company is accounting for the Series K Warrants as derivative
liabilities in accordance with SFAS No. 133. The Company has determined
that the Series K Notes constitute a hybrid instrument that has the
characteristics of a debt host contract containing several embedded
derivative features that would require bifurcation and separate accounting
as a derivative instrument pursuant to the provisions of FAS 133. The
Company has determined that certain of these features can not be reliably
measured and, in accordance with the requirements of SFAS No. 133, has
measured the entire hybrid instrument at fair value with changes in fair
value recognized as a either gain or loss.
Upon issuance of the Series K Notes and Series K Warrants, the Company
allocated proceeds received to the Series K Notes and the Series K Warrants
on a relative fair value basis. As a result of such allocation, the Company
determined the initial carrying value of the Series K Notes to be
$6,565,528. The Series K Notes were immediately marked to fair value
resulting in a derivative liability in the amount of $9,728,793 and
recognized a charge of $3,163,265, which was recorded as costs associated
with convertible debt. As of September 30, 2006, the fair value of the
Series K Notes is $8,094,916, and the Company recognized a gain of
$1,738,228 during the year ended September 30, 2006, arising from the
decrease in fair value from the date of issuance.
A debt discount in the amount of $1,734,472 is being amortized to interest
expense using the effective interest method over the expected term of the
Series K Notes. During the year ended September 30, 2006, the Company
recorded interest expense of $104,351 related amortization of the debt
discount, with a corresponding increase in the carrying amount of the debt.
Upon issuance, the Series K Warrants and Placement Agent Warrants did not
meet the requirements for equity classification set forth in EITF Issue No.
00-19, "Accounting for Derivative Financial Instruments Indexed to, and
Potentially Settled in, a Company's Own Stock," because such warrants (a)
must be settled in registered shares and (b) are subject to substantial
liquidated damages if the Company is unable to maintain the effectiveness
of the resale registration of the shares. Therefore such warrants must be
accounted for as freestanding derivative instruments pursuant to the
provisions of FAS 133. Accordingly, the Company allocated $2,570,138 of the
initial proceeds to the Series K Warrants and immediately marked them to
fair value resulting in a derivative liability of $2,570,138 and recognized
a charge of $835,666, which was recorded as costs associated with
convertible debt. As of September 30, 2006, the fair value of the Series K
Warrants is $2,043,532, and the Company recognized a gain of $526,606
during the year ended September 30, 2006, arising from the decrease in fair
value from the date of issuance.
F-20
2. SERIES K CONVERTIBLE DEBT (continued)
The Company paid $568,710 in cash transaction costs and incurred another
$223,907 in costs based upon the fair value of the Placement Agent
Warrants, which was recorded as costs associated with convertible debt.
Such costs were expensed immediately as part of fair value adjustments
required in connection with the convertible debt instrument and the
Company's irrevocable election to initially and subsequently measure the
Series K Notes at fair value. As of September 30, 2006 the fair value of
the Placement Agent Warrants was $177,582 and the Company recognized a gain
of $46,325 during the year then ended, arising from the decrease in fair
value from the date of issuance.
3. OPERATIONS AND FINANCING
The Company has incurred significant costs since its inception in connection
with the acquisition of certain patented and unpatented proprietary
technology and know-how relating to the human immunological defense system,
patent applications, research and development, administrative costs,
construction of laboratory facilities, and clinical trials. The Company has
funded such costs with proceeds realized from the public and private sale of
its common and preferred stock. The Company will be required to raise
additional capital or find additional long-term financing in order to
continue with its research efforts. To date, the Company has not generated
any revenue from product sales. The ability of the Company to complete the
necessary clinical trials and obtain FDA approval for the sale of products to
be developed on a commercial basis is uncertain. Ultimately, the Company must
complete the development of its products, obtain the appropriate regulatory
approvals and obtain sufficient revenues to support its cost structure.
Currently the Company has sufficient cash to support its operations at the
current expenditure rate until the fall of 2008. Even though the Company has
Phase III go-ahead for its Multikine drug from the Canadian regulators, the
Company has not started the Phase III trial because it feels that an
agreement with FDA on the trial design and the trial endpoints is very
important. The Company received the go-ahead from the FDA in January 2007.
The Company has not yet decided if it intends to run the Phase III trial
either through a partnership agreement, such as the one it has with Orient
Europharma in Asia, or a new partnering agreement with a pharmaceutical
company or a financial institution, or a secondary or private financing.
4. RESEARCH AND OFFICE EQUIPMENT
Research and office equipment at September 30, 2006 and 2005, consists of the
following:
2006 2005
---- ----
Research equipment $ 1,712,137 $ 1,718,895
Furniture and equipment 110,041 110,393
Leasehold improvements 43,041 43,041
----------- -----------
1,865,219 1,872,329
Less: Accumulated depreciation and
amortization (1,773,102) (1,690,788)
----------- -----------
Net research and office equipment $ 92,117 $ 181,541
=========== ===========
F-21
5. INCOME TAXES
At September 30, 2006 the Company had a federal net operating loss
carryforward of approximately $85.4 million expiring from 2007 through 2026.
The Company has deferred tax assets of approximately $32.7 million and $31.7
million at September 30, 2006 and 2005, respectively. The deferred tax assets
are principally a result of the net operating loss carryforwards and research
and development credits.
At both September 30, 2006 and 2005, the Company has recognized a valuation
allowance to the full extent of its deferred tax assets. The valuation
allowances at September 30, 2006 and 2005 were approximately $32,690,200 and
$31,660,200, respectively. In assessing the realization of the deferred tax
assets, management considered whether it was more likely than not that some
portion or all of the deferred tax asset will be realized. The ultimate
realization of the deferred tax assets are dependent upon the generation of
future taxable income. Management has considered the history of the Company's
operating losses and believes that the realization of the benefit of the
deferred tax assets cannot be determined. In addition, under the Internal
Revenue Code Section 382, the Company's ability to utilize these net
operating loss carryforwards may be limited or eliminated in the event of a
change in ownership. Internal Revenue Code Section 382 generally defines a
change in ownership as the situation where there has been a more than 50
percent change in ownership of the value of the Company within the last three
years.
The Company's effective tax rate is different from the applicable federal
statutory tax rate. The reconciliation of these rates for the years ended
September 30 is as follows:
2006 2005 2004
--------- -------- --------
Expected statutory rate (35.0%) (35.0%) (35.0%)
State tax rate, net of federal benefit (3.9%) (3.9%) (3.9%)
Nondeductible interest 0.9% 0.0% 0.0%
Nondeductible (nontaxable) derivative
losses (gains) (2.9%) (4.6%) (4.6%)
Other nondeductible expenses 6.1% 15.2% 0.2%
Increase in valuation allowance 34.8% 28.3% 53.9%
--------- -------- --------
Effective tax rate 0.0% 0.0% 0.0%
========= ======== ========
6. STOCK OPTIONS, BONUS PLAN AND WARRANTS
Non-Qualified Stock Option Plan--At September 30, 2006, the Company has
collectively authorized the issuance of 11,760,000 shares of common stock
under the Non-Qualified Stock Option Plan. Options typically vest over a
three-year period and expire no later than ten years after the grant date.
Terms of the options are to be determined by the Company's Compensation
Committee, which administers all of the plans. The Company's employees,
directors, officers, and consultants or advisors are eligible to be granted
options under the Non-Qualified Stock Option Plan.
F-22
6. STOCK OPTIONS, BONUS PLAN AND WARRANTS (continued)
Information regarding the Company's Non-Qualified Stock Option Plan is
summarized as follows:
Outstanding Exercisable
------------------- -------------------
Weighted Weighted
Average Average
Exercise Exercise
Shares Price Shares Price
------ -------- ------ ---------
Options outstanding,
October 1, 2003 6,453,973 $0.74 3,319,317 $1.18
Options granted 670,000 0.61
Options exercised (198,503) 0.43
Options forfeited (26,332) 0.28
----------
Options outstanding,
September 30, 2004 6,899,138 0.74 4,288,847 0.98
----------
Options granted 278,000 0.48
Options exercised (174,001) 0.24
Options forfeited (787,774) 1.35
----------
Options outstanding,
September 30, 2005 6,215,363 0.66 4,642,893 0.76
----------
Options granted 1,466,000 0.63
Options exercised (150,001) 0.26
Options forfeited (20,000) 1.05
----------
Options outstanding,
September 30, 2006 7,511,362 $0.66 6,011,713 $0.69
=========
At September 30, 2006, options outstanding and exercisable were as follows:
Weighted Weightede Weighted
Average Average Average
Range of Exercise Remaining Exercise
Exercise Number Price Contractual Number Price
Prices Outstanding Outstanding Life Exercisable Exercisable
-------- ----------- ----------- ----------- ----------- -----------
$0.16-$0.24 2,167,995 $ 0.22 6.49 years 2,167,995 $ 0.22
$0.33-$0.50 631,333 $ 0.40 7.11 years 446,006 $ 0.27
$0.54-$0.81 2,420,833 $ 0.61 6.01 years 1,106,511 $ 0.63
$1.05-$1.58 1,956,266 $ 1.07 2.24 years 1,956,266 $ 1.07
$1.67-$2.51 310,835 $ 1.93 2.24 years 310,835 $ 1.93
$3.25-$4.88 23,300 $ 3.29 0.76 years 23,300 $ 3.29
$6.25-$9.38 800 $ 6.25 2.00 years 800 $ 6.25
F-23
6. STOCK OPTIONS, BONUS PLAN AND WARRANTS (continued)
During March 2000, the Company agreed to restore and vest 40,000 options at
prices ranging from $5.25 to $5.62, to one former Director and one Director
as part of a settlement agreement. The options expired on September 25, 2006.
As of September 30, 2005, 20,000 options had been exercised.
In July 2001, the Company repriced 1,298,098 outstanding employee and
director stock options under the Nonqualified Plans that were priced over
$2.00 down to $1.05. Under FAS 123R these options are not longer variable
therefore no expense was recorded during the year ended September 30, 2006.
During the years ended September 30, 2005 and 2004 no expense was recorded
because the exercise price of the options exceeded the fair market value of
the Company's common stock. As of September 30, 2006, 757,266 of these
options remain outstanding.
In November 2001, the Company extended the expiration date on 242,000 options
at $1.05 from the Nonqualified Plans. The options were to expire between June
2002 and October 2002 and were extended by one year to June 2003 through
October 2003. The options had originally been granted between October 1989 to
December 1995. These dates were considered a new measurement date with
respect to all of the modified options. In addition, in February, April, and
July 2002, the Company modified options outstanding to employees who had been
terminated in conjunction with their change in employee status so that all
options vested on the date of termination. These dates were considered a new
measurement date with respect to all of the newly vested options. At each of
the dates of modification, the exercise price of the options exceeded the
fair market value of the Company's common stock and no compensation expense
was recorded.
In November 2002 and March 2003, the Company extended the expiration date on
897,000 options from the Nonqualified Stock Option Plan with exercise prices
ranging from $1.05 to $1.94. The options originally would have expired from
January 2003 to October 2003, but were extended to expiration dates ranging
from January 2005 to October 2005. Each of these extension dates was
considered a new measurement date. At each of the dates of modification, the
exercise price of the options exceeded the fair market value of the Company's
common stock and no compensation expense was recorded.
In June 2004, the vesting of 10,700 nonqualified stock options was
accelerated for an employee leaving the Company. Compensation expense of
$7,597 was recorded for the modification.
In April 2005, the Company extended the expiration date on 1,625,333 options
from the Nonqualified Stock Option Plan with exercise prices ranging from
$1.05 to $1.94. The options originally would have expired from June 2005 to
October 2005 and were extended for three years to expiration dates ranging
from June 2008 to October 2008. This extension was considered a new
measurement date with respect to the modified options. At the date of
F-24
6. STOCK OPTIONS, BONUS PLAN AND WARRANTS (continued)
modification, the exercise price of the options exceeded the fair market
value of the Company's common stock and no compensation expense was recorded.
As of September 30, 2006, all of these options remain outstanding.
In September 2006, the Company extended the expiration date on 126,666
options from the Nonqualified Stock Option Plan with exercise price of $1.05.
The options originally would have expired from September 2006 to May 2007 and
were extended for three years to expiration dates ranging from September 2009
to May 2010. This extension was considered a new measurement date with
respect to the modified options. At the date of modification, compensation
expense of $30,468 was recorded. As of September 30, 2006, all of these
options remain outstanding.
Incentive Stock Option Plan--At September 30, 2006, the Company has
collectively authorized the issuance of 8,100,000 shares of common stock
under the Incentive Stock Option Plan. Options vest over a one-year to
three-year period and expire no later than ten years after the grant date.
Terms of the options are to be determined by the Company's Compensation
Committee, which administers all of the plans. Only the Company's employees
and directors are eligible to be granted options under the Incentive Plan.
Information regarding the Company's Incentive Stock Option Plan is summarized
as follows:
Outstanding Exercisable
-------------------- --------------------
Weighted Weighted
Average Average
Exercise Exercise
Shares Price Shares Price
------ -------- ------ ---------
Options outstanding,
October 1, 2003 3,801,100 $0.68 1,162,768 $1.65
Options granted 100,000 1.13
Options exercised (15,000) 1.05
Options forfeited (53,000) 1.15
---------
Options outstanding,
September 30, 2004 3,833,100 0.68 2,006,435 1.05
Options granted 170,000 0.48
Options exercised (26,667) 0.22
Options forfeited (3,800) 2.16
---------
Options outstanding,
September 30, 2005 3,972,633 0.68 2,885,968 0.81
Options granted 370,000 0.58
Options exercised -
Options forfeited (15,700) 5.36
---------
Options outstanding,
September 30, 2006 4,326,933 $0.65 3,810,267 $0.66
=========
F-25
6. STOCK OPTIONS, BONUS PLAN AND WARRANTS (continued)
At September 30, 2006, options outstanding and exercisable were as follows:
Weighted Weighted Weighted
Average Average Average
Range of Exercise Remaining Exercise
Exercise Number Price Contractual Number Price
Prices Outstanding Outstanding Life Exercisable Exercisable
-------- ----------- ----------- ----------- ----------- -----------
$0.22-$0.33 2,523,333 $ 0.22 6.50 years 2,523,333 $ 0.22
$0.48-$0.72 540,000 $ 0.55 9.64 years 56,667 $ 0.48
$1.00-$1.50 1,036,766 $ 1.08 3.56 years 1,003,433 $ 1.08
$1.85-$2.78 81,167 $ 2.00 2.63 years 81,167 $ 2.00
$2.87-$4.31 28,667 $ 3.38 0.29 years 28,667 $ 3.38
$4.50-$6.75 117,000 $ 5.00 1.87 years 117,000 $ 5.00
During fiscal year 2001, the Company extended the expiration date on 50,000
options at $2.87 from the Incentive Stock Option Plan. The options were to
expire November 1, 2001, and were extended to November 1, 2002. The options
had originally been granted in November 1991. November 1, 2001 was considered
a new measurement date; however, the exercise price on all the options
modified exceeded the fair market value of the Company's common stock, and
therefore, no compensation expense was recorded. In March 2003, the options
were further extended to November 1, 2005. There was no compensation expense
recorded because the exercise price on these options exceeded the fair market
value of the Company's common stock.
In July 2001, the Company repriced 816,066 outstanding employee and director
stock options under the Incentive Stock Option Plan that were priced over
$2.00 down to $1.05. Under FAS 123R these options are no longer variable
therefore no expense was recorded during the year ended September 30, 2006.
During the years ended September 30, 2005 or 2004 no expense related to these
options was recorded because the exercise price of these options exceeded the
fair market value of the Company's common stock. As of September 30, 2006,
746,766 of these options remain outstanding. Changes in the fair market value
of the Company's common stock may result in future changes in compensation
expenses.
In November 2001, the Company extended the expiration date on 56,000
options at $1.05 from the Incentive Stock Option Plan. The options were to
expire between November 2002 and December 2002, and were extended by one
year to November 2003 and December 2003. The options had originally been
granted between November 1999 and December 1992. This date was considered a
new measurement date with respect to the modified options. At each of the
F-26
6. STOCK OPTIONS, BONUS PLAN AND WARRANTS (continued)
dates of modification, the exercise price of the options exceeded the fair
market value of the Company's common stock and no compensation expense was
recorded.
In March 2003, the Company extended the expiration date on 105,500 options
from the Incentive Stock Option Plan with exercise prices ranging from $1.05
to $1.94. The options originally would have expired from August 2003 to March
2004 but were extended to expiration dates ranging from August 2005 to March
2006. This was considered a new measurement date with respect to all of the
modified options. At each of the dates of modification, the exercise price of
the options exceeded the fair market value of the Company's common stock and
no compensation expense was recorded.
In April 2005, the Company extended the expiration date on 128,100 options
from the Incentive Stock Option Plan with exercise prices ranging from $1.05
to $1.94. The options originally would have expired from July 2005 to
December 2005 and were extended for three years to expiration dates ranging
from July 2008 to December 2008. This was considered a new measurement date
with respect to all of the modified options. At each of the dates of
modification, the exercise price of the options exceeded the fair market
value of the Company's common stock and no compensation expense was recorded.
As of September 30, 2006, all options remain outstanding.
In September 2006, the Company extended the expiration date on 268,166
options from the Incentive Stock Option Plan with an exercise price of $1.05.
The options originally would have expired from September 2006 to August 2007
and were extended for three years to expiration dates ranging from September
2009 to August 2010. This extension was considered a new measurement date
with respect to the modified options. At the date of modification,
compensation expense of $56,396 was recorded. As of September 30, 2006, all
of these options remain outstanding.
Other Options and Warrants -- During fiscal year 1999, the Company granted a
consultant options to purchase a total of 50,000 shares of the Company's
common stock. The fair value of the options is expensed over the life of the
consultant's contract. All 50,000 options became exercisable during fiscal
year 1999 at $2.50 per share. All options expired unexercised February 4,
2004.
During fiscal year 2001, the Company granted options to consultants to
purchase a total of 180,000 shares of the Company's common stock at exercise
prices ranging from $1.05 to $1.63 expiring from June to July of 2006. As of
September 30, 2006, all of these options expired.
F-27
6. STOCK OPTIONS, BONUS PLAN AND WARRANTS (continued)
In connection with the April 2001 Equity Line of Credit stock sale agreement
discussed in Note 12, the Company issued 200,800 common stock purchase
warrants. Each warrant entitled the holder to purchase one share of common
stock at $1.64 per share. The warrants represented derivative instruments and
were recorded as a liability upon issuance, as the common shares underlying
the warrants were required to be registered. The fair value of the warrants
totaling $235,562 was recorded as a derivative liability and a cost of
financing. For the years ended September 30, 2004 and 2003, the Company
recognized a gain of $36,597 and a loss of $34,307, respectively, resulting
from changes in fair value of the warrants. The warrants expired unexercised
in April 2004.
In August 2001, the Company issued 272,108 common stock purchase warrants in
connection with a private offering of common stock as discussed in Note 14.
Each warrant entitled the holder to purchase one share of common stock at
$1.75 per share. The warrants would have expired in July 2004, but were
extended to July 2007. At issuance the warrants did not meet the requirements
for equity classification because there were not sufficient authorized and
unissued shares of the Company's common stock to satisfy exercise of the
warrants, as the number of potentially issuable shares of common stock
required to satisfy all other commitments that may require the issuance of
common stock was not determinable. The fair value of the warrants totaling
$286,617 was recorded as a liability and offset against the proceeds from the
sale of stock as a cost of obtaining equity capital. On October 2, 2003, as
there were sufficient unauthorized and unissued shares to satisfy all other
commitments that may require the issuance of common stock, the fair value of
the warrants of $111,418 was reclassified from liabilities to equity. During
the year ended September 30, 2004, the Company recognized a loss of $38,561
arising from changes in the fair value of the warrants. As of September 30,
2006, 272,108 warrants remain outstanding.
In October 2001, the Company issued 150,000 shares of common stock in a
private offering for proceeds of $150,000. The investor also received
warrants which entitled the holder to purchase 75,000 shares of common stock
at $1.50 per share, expiring October 2004. Upon issuance, the warrants did
not meet the requirements for equity classification because there were not
sufficient authorized and unissued shares of the Company's common stock to
satisfy exercise of the warrants, as the number of potentially issuable
shares of common stock required to satisfy all other commitments that may
require the issuance of common stock was not determinable. Accordingly, the
warrants were accounted for as freestanding derivative instruments from the
date of issuance. Changes in the fair value of the warrants was recognized in
earnings as either a gain or loss in such period as the change occurred. The
warrants had a fair value of the warrants at issuance of $88,045 was recorded
as a liability and offset against proceeds from the sale of stock as a cost
of obtaining equity capital. On October 2, 2003, as there were sufficient
unauthorized and unissued shares to satisfy all other commitments that may
require the issuance of common stock, the fair value of the warrants of
$37,236 was reclassified from liabilities to equity. During the year ended
September 30, 2004, the Company recognized a loss of $12,031 arising from
changes in the fair value of the warrants.
F-28
6. STOCK OPTIONS, BONUS PLAN AND WARRANTS (continued)
Series E Callable Warrants were issued in connection with the issuance of
Series E Preferred Stock in August 2001. The Series E Callable Warrants
allowed the holders to purchase up to 815,351 shares of the Company's common
stock at a price of $1.19 per share expiring August 16, 2004. During the year
ended September 30, 2004, 244,724 warrants were exercised for proceeds of
$291,222. Upon issuance, the warrants did not meet the requirements for
equity classification because the Company was required to maintain an
effective registration statement covering the underlying shares. Accordingly,
the Series E Callable Warrants were accounted for as freestanding derivative
instruments from the date of issuance. As there were no proceeds associated
with the issuance of the Series E Preferred Stock, the fair value of the
warrants totaling $119,434 was recorded as a liability and charged to other
costs of financing. For the year ended September 30, 2004, the Company
recognized a gain of $59,156 arising from changes in fair value of the
warrants.
In August 2003, in accordance with the Series E Stock agreement the Company
issued 23,758 of Series E Non-Callable Warrants to purchase shares of common
stock at a price of $0.77 per share expiring August 16, 2006. The Series E
Non-Callable Warrants were exercisable at any time prior to August 17, 2006
and, upon issuance, did not meet the requirements for equity classification
because the Company was required to maintain an effective registration
statement covering the underlying shares. Accordingly, the Series E
Non-Callable Warrants were accounted for as freestanding derivative
instruments from date of issuance. As there were no proceeds from the
issuance, the fair value of the warrants totaling $12,374 was recorded as a
liability and charged to other costs of financing. All Series E Non-Callable
Warrants expired on August 17, 2006. For the years ended September 30, 2005
and 2004, the Company recognized a gain of $5,042 and $9,363, respectively,
arising from changes in fair value of the warrants.
Series F Warrants were issued in connection with the issuance of convertible
debt in December 2001. The Series F Warrants allowed the holders to purchase
up to 960,000 shares of the Company's common stock at $0.76 per share for
seven years from date of issuance. The warrant price was adjustable if the
Company sold any additional shares of its common stock or convertible
securities for less than fair market value or at an amount lower than the
exercise price of the Series F Warrants. The exercise price was adjusted
every three months to an amount equal to 110% of the conversion price on such
date, provided that the adjusted price was lower than the exercise price on
that date. During the year ended September 30, 2004, 420,000 warrants were
exercised in a cashless exercise. As of September 30, 2004 there were no
remaining Series F warrants outstanding. Upon issuance, the warrants did not
meet the requirements for equity classification because exercise of the
individual warrants was required to be settled in registered shares, at
issuance the number of potentially issuable shares of common stock required
to satisfy exercise of the warrants and all other commitments that may
require issuance of common stock was not determinable, and under certain
circumstances the holders could require the Company to settle the warrants in
cash. Accordingly, the Series F Warrants were accounted for as a derivative
liability and a discount on the debt which was immediately accreted to
interest expense. At each subsequent period, through November 19, 2003, when
all Series F warrants had been exercised, the warrants were marked to market
with changes in fair value recognized in earnings as gains or losses on
F-29
6. STOCK OPTIONS, BONUS PLAN AND WARRANTS (continued)
derivatives. During the year ended September 30, 2004, the Company recognized
a loss of $167,000 arising from changes in the fair value of the Series F
Warrants.
Series G Warrants were issued in connection with the issuance of convertible
debt in July 2002. The Series G Warrants allowed the holders to purchase up
to 900,000 shares of the Company's common stock at a price equal to $0.25 per
share at any time prior to July 12, 2009. If the Company sells any additional
shares of common stock, or any securities convertible into common stock at a
price below the then applicable warrant exercise price, the warrant exercise
price will be lowered to the price at which the shares were sold or the
lowest price at which the securities were convertible, as the case may be.
The warrant exercise price is adjusted every three months to an amount equal
to 110% of the Series G note conversion price on such date, provided that the
adjusted price is lower than the warrant exercise price on that date. If the
warrant exercise price is adjusted, the number of shares of common stock
issuable upon the exercise of the warrant would 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 was reduced. In accordance with the terms of the
warrants, the exercise price was adjusted to $0.18 on December 9, 2002. The
exercise price was adjusted to $0.145 on March 9, 2003. In accordance with
the terms of the warrants, there were no further adjustments since the price
would have been higher. Upon issuance, the warrants did not meet the
requirements for equity classification because exercise of the individual
warrants was required to be settled in registered shares, at issuance the
number of potentially issuable shares of common stock required to satisfy
exercise of the warrants and all other commitments that may require issuance
of common stock was not determinable, and under certain circumstances the
holders could require the Company to settle the warrants in cash.
Accordingly, the Series G warrants were recorded at fair value as a
derivative liability and a discount on debt which was immediately accreted to
interest expense. Subsequent changes in fair value are recognized in earnings
as either a gain or loss. As of September 30, 2005 and 2004, the fair value
of the Series G warrants was $186,200 and $235,100, respectively. During the
years ended September 30, 2006, 2005 and 2004, the Company recognized a loss
of $7,300 and gains of $48,900 and $172,100, respectively, arising from
changes in the fair value of the Series G warrants. On December 27, 2005,
these warrants reverted to equity. During the year ended September 30, 2003,
450,000 warrants were exercised at $0.18 for 450,000 shares of common stock.
The remaining 450,000 warrants were exercised in a cashless exercise,
resulting in the issuance of 350,168 shares of common stock. As of September
30, 2006, no Series G Warrants remain outstanding.
Series H Warrants were issued in connection with the issuance of convertible
debt in January 2003. The Series H Warrants allowed the holders to purchase
up to 1,100,000 shares of the Company's common stock at a price equal to
$0.25 per share at any time prior to January 7, 2010. If the Company 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 H warrants, the exercise price of the Series H warrants will be
lowered to the price at which the shares were sold or the lowest price at
F-30
6. STOCK OPTIONS, BONUS PLAN AND WARRANTS (continued)
which the securities are convertible. If the exercise price of the Series H
warrants is adjusted, the number of shares of common stock issuable upon
the exercise of the Series H warrants 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. However, neither the exercise price
nor the shares issuable upon the exercise of the Series H warrants will be
adjusted as the result of shares issued in connection with a permitted
financing, as defined in the agreement. Every three months after June 26,
2003, the exercise price of the Series H warrants will be adjusted to an
amount equal to 110% of the Series H notes conversion price on such date,
provided that the adjusted price is lower than the warrant exercise price
on that date. Upon issuance, the warrants did not meet the requirements for
equity classification because exercise of the individual warrants was
required to be settled in registered shares, at issuance the number of
potentially issuable shares of common stock to satisfy exercise of the
warrants and all other commitments that may require issuance of common
stock was not determinable, and under certain circumstances the holders
could require the Company to settle the warrants in cash. Accordingly, the
Series H warrants were initially recorded at fair value as a derivative
liability and a discount on debt which was immediately accreted to interest
expense. Subsequent changes in fair value are recognized in earnings as
either a gain or loss in the period such change occurs. As of September 30,
2005 and 2004, the fair value of the Series H warrants was $223,500 and
$290,800, respectively. During the years ended September 30, 2006, 2005 and
2004, the Company recognized a loss of $10,200 and gains of $67,300 and
$193,500, respectively, arising from changes in the fair value of the
Series H warrants. On December 27, 2005, these warrants reverted to equity.
During the year ended September 30, 2003, 550,000 warrants were exercised
at $0.25 for 550,000 shares of common stock. During the year ended
September 30, 2006, the remaining 550,000 warrants were exercised in a
cashless exercise for a total of 438,983 shares of common stock. As of
September 30, 2006, no Series H Warrants remain.
Warrants were issued in connection with obtaining an equity line of credit in
September 2003, discussed in Note 12. There were 395,726 warrants issued at
an exercise price of $0.83, which expire in September 2008. Upon issuance,
the warrants did not meet the requirements for equity classification because,
under certain conditions, the Company could be required to compensate the
investor for any decreases in the common stock price underlying the warrants
and are therefore accounted for as a derivative liability. Subsequent changes
in fair value are recognized in earnings as either a gain or loss in the
period such change occurs. The warrants were initially classified in
liabilities upon issuance at fair value of $258,290, as determined using the
Black-Scholes pricing methodology and the Company recognized a charge of
$258,290 which was included in other costs of financing as there were no
proceeds from the issuance of the agreement. As of September 30, 2005 and
2004, the fair value of the warrants was $93,745 and $165,359, respectively.
During the years ended September 30, 2006, 2005 and 2004 the Company
recognized gains of $6,988, $71,613 and $151,943, respectively, arising from
changes in the fair value of the warrants. On December 27, 2005, these
warrants reverted to equity. During the year ended September 30, 2006,
F-31
6. STOCK OPTIONS, BONUS PLAN AND WARRANTS (continued)
exercise for 84,071 shares of common stock. There are 197,863 warrants
outstanding at September 30, 2006.
In May 2003, 30,000 options were issued to a consultant at a price of $0.41
per share. The options vest over a three year period and expire in May 2013.
The compensation expense for these options was determined using the Black
Scholes pricing methodology with the following assumptions:
Expected stock risk volatility 84%
Risk-free interest rate 2.0%
Expected life of warrant 3 Years
Expected dividend yield -0-
The fair value of the options was recorded as a general and administrative
expense. Compensation expense of $6,727 was recorded for the year ended
September 30, 2003.
In connection with an agreement with a private investor in May 2003,
1,100,000 Series I Warrants were issued with an exercise price of $0.47. The
warrants were to initially expire May 30, 2006. In accordance with the terms
of the agreement, the warrant expiration was extended to May 30, 2008 on
September 30, 2003. Upon issuance, the warrants did not meet the requirements
for equity classification because exercise of the individual warrants was
required to be settled in registered shares, at issuance the number of
potentially issuable shares of common stock required to satisfy exercise of
the warrants and all other commitments that may require issuance of common
stock was not determinable, and under certain circumstances the holders could
require the Company to cash settle the warrants and are therefore accounted
for as freestanding derivative liabilities. Subsequent changes in fair value
are recognized in earnings as either a gain or loss. The fair value of the
warrants of $478,694 was recorded as a liability and offset against the
proceeds from the sale of stock as a cost of obtaining equity capital. As of
September 30, 2005 and 2004, the fair value of the warrants was $307,734 and
$477,904, respectively. For the years ended September 30, 2006, 2005 and
2004, the Company recognized a gain of $23,857, a loss of $170,173 and a gain
of $426,232, respectively, arising from changes in fair value of the
warrants. On December 27, 2005, the warrants reverted to equity upon an
amendment to the warrant agreement. On April 17, 2006, 700,000 warrants were
exercised at $0.47 for 700,000 shares of unregistered common stock. As of
September 30, 2006, 400,000 warrants remain outstanding.
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 in the private
offering received Series J Warrants which allow the investors to purchase
991,003 shares of CEL-SCI's common stock exercisable at a price of $1.32 per
share exercisable at any time prior to December 1, 2006. Additionally, an
investment broker received warrants totaling 5% of the investment of its
clients in the common stock of the Company at $1.32 per share at any time
F-32
6. STOCK OPTIONS, BONUS PLAN AND WARRANTS (continued)
prior to December 1, 2006. Upon issuance, the warrants did not meet the
requirements for equity classification until the shares were registered in
May 2004, because the warrants are required to be settled in registered
shares and were therefore accounted for as freestanding derivative
instruments. The fair value of the warrants of $806,266 was recorded as a
liability and offset against the proceeds from the sale as a cost of
obtaining equity capital. Subsequent changes in fair value were recognized
in earnings as either a gain or loss. On May 8, 2004 the criteria for
equity classification were met, as a registration statement covering the
underlying common shares was declared effective, and the fair value of the
warrants totaling $537,338 was reclassified from liabilities to equity. For
the year ended September 30, 2004, the Company recognized a gain of
$268,928 arising from changes in fair value of the warrants. On December 1,
2006, 549,827 warrants expired leaving 441,176 remaining that expire on
December 1, 2007.
On May 4, 2004, the Company sold 6,402,439 shares of its common stock to a
group of private institutional investors for $5,250,000 and total offering
costs of $498,452. As part of this transaction, the investors in the private
offering received warrants which allow the investors to purchase 76,642
shares of the Company's common stock at a price of $1.37 per share at any
time prior to May 4, 2009. These warrants were valued at $38,127. This fair
value was determined using the Black-Scholes pricing methodology with the
following assumptions:
Expected stock risk volatility 87%
Risk-free interest rate 2.00%
Expected life of options 3 Years
Expected dividend yield -0-
In February 2005, the Company granted a consultant options to purchase 15,000
shares of the Company's common stock at a price of $0.73 per share. The
options vest over a three year period and expire in February 2015. The
compensation expense for these options was determined using the Black Scholes
pricing methodology with the following assumptions:
Expected stock risk volatility 93%
Risk-free interest rate 3.89%
Expected life of warrant 5 Years
Expected dividend yield -0-
The fair value of the options was recorded as general and administrative
expense. Compensation expense of $7,972 was recorded for the year ended
September 30, 2005.
On July 18, 2005, CEL-SCI sold 1,250,000 shares of its common stock and
375,000 warrants to one investor for $500,000. Each warrant entitles the
holder to purchase one share of CEL-SCI's common stock at a price of $0.65
per share at any time prior to July 18, 2009. The shares of common stock and
warrants are "restricted" securities as defined in Rule 144 of the Securities
and Exchange Commission. The warrants were valued at $155,671. The value was
F-33
6. STOCK OPTIONS, BONUS PLAN AND WARRANTS (continued)
determined using the Black Scholes pricing methodology with the following
assumptions:
Expected stock risk volatility 75%
Risk-free interest rate 3.92%
Expected life of warrant 5 Years
Expected dividend yield -0-
On October 14, 2005, CEL-SCI granted a consultant options to purchase 80,000
shares of the Company's common stock at a price of $1.00 per share and 80,000
shares of the Company's common stock at a price of $2.00 per share. The
options expire in October 2010. The compensation expense for these options of
$66,718 was determined using the Black Scholes pricing methodology with the
following assumptions:
Expected stock risk volatility 75%
Risk-free interest rate 4.33%
Expected life of warrant 5 Years
Expected dividend yield -0-
On October 31, 2005 in connection with the 2005 Equity Line of Credit,
CEL-SCI granted options to purchase 271,370 shares of the Company's common
stock at a price of $0.55 per share. The options expire in October 2010. The
compensation expense for these options of $104,721 was determined using the
Black Scholes pricing methodology with the following assumptions:
Expected stock risk volatility 87%
Risk-free interest rate 4.33%
Expected life of warrant 5 Years
Expected dividend yield -0-
On February 9, 2006, CEL-SCI sold 2,500,000 shares of its common stock and
750,000 warrants to one investor for $1,000,000. Each warrant entitles the
holder to purchase one share of CEL-SCI's common stock at a price of $0.56
per share at any time prior to February 9, 2011. The warrants were valued at
$238,986. In addition, 441,176 warrants previously issued to the investor
were repriced and extended for one year. The revaluing of the warrants was
valued at $76,122. The Black Scholes pricing methodology was used with the
following assumptions:
New Warrants Extended Warrants
Expected stock risk volatility 78% 78%
Risk-free interest rate 4.57% 4.67%
Expected life of warrant 5 Years 1.83 years
Expected dividend yield -0- -0-
F-34
6. STOCK OPTIONS, BONUS PLAN AND WARRANTS (continued)
On April 1, 2006, CEL-SCI granted a consultant options to purchase 375,000
shares of the Company's common stock at a price of $0.73 per share. The
options vest over a three-month period and expire in March 2007. The
compensation expense of $87,007 for these options was determined using the
Black Scholes pricing methodology with the following assumptions:
Expected stock risk volatility 77%
Risk-free interest rate 4.86%
Expected life of warrant 1 Year
Expected dividend yield -0-
On April 12, 2006, CEL-SCI granted a consultant options to purchase 100,000
shares of the Company's common stock at a price of $1.50 per share. The
options expire in April 2009. The compensation expense of $79,976 for these
options was determined using the Black Scholes pricing methodology with the
following assumptions:
Expected stock risk volatility 77%
Risk-free interest rate 4.90%
Expected life of warrant 3 Years
Expected dividend yield -0-
On April 17, 2006, 800,000 warrants were issued to an investor. These
warrants granted the investor the right to purchase shares of the Company's
common stock at a price of $1.25. The warrants were given to the investor to
induce the investor to exercise 700,000 warrants at $0.47 for unregistered
common stock. The warrants expire in June 2008. The expense of $460,920 was
determined using the Black Scholes pricing methodology with the following
assumptions:
Expected stock risk volatility 77%
Risk-free interest rate 4.91%
Expected life of warrant 2.17 Years
Expected dividend yield -0-
On May 18, 2006, the Company issued 800,000 warrants to an investor to
purchase shares of the Company's common stock at a price of $0.82 per share.
The warrants were given to the investor to induce the investor to exercise
600,000 warrants at $0.56 for unregistered common stock. The expense of
$416,921 was determined using the Black Scholes pricing methodology with the
following assumptions:
Expected stock risk volatility 73%
Risk-free interest rate 4.96%
Expected life of warrant 5 Years
Expected dividend yield -0-
F-35
6. STOCK OPTIONS, BONUS PLAN AND WARRANTS (continued)
Series K Warrants were issued in connection with the issuance of convertible
debt in August 2006. The Series K Warrants allow the holders to purchase up
to 4,825,581 shares of the Company's common stock at a price equal to $0.95
per share between February 4, 2007 and February 4, 2012. The exercise price
of the Series K warrants, as well as the shares issuable upon the exercise
of the warrants, will be proportionately adjusted in the event of any stock
splits. 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 K 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
CEL-SCI sells any additional shares of common stock, or any securities
convertible into common stock at a price above the exercise price but below
the market price of CEL-SCI's common stock, the exercise price of the Series
K warrants will be lowered to a price determined by a formula contained in
the warrants.
On September 29, 2006, CEL-SCI granted a consultant options to purchase
375,000 shares of the Company's common stock at a price of $0.62 per share.
The options vest over a three month period and expire in September 2007. The
compensation expense of $74,992 for these options was determined using the
Black Scholes pricing methodology with the following assumptions:
Expected stock risk volatility 78%
Risk-free interest rate 5.08%
Expected life of warrant 1 Year
Expected dividend yield -0-
Stock Bonus Plan -- At September 30, 2006, the Company had been authorized to
issue up to 5,940,000 shares of common stock under the Stock Bonus Plan. All
employees, directors, officers, consultants, and advisors are eligible to be
granted shares. During the year ended September 30, 2004, 72,495 shares were
issued under the Plan with a fair value of $52,476. During the year ended
September 30, 2005, 144,469 shares were issued to the Company's 401(k) plan
for a cost of $78,868. During the year ended September 30, 2006, 132,989
shares were issued to the Company's 401(k) plan for a cost of $85,480.
Stock Compensation Plan-- At September 30, 2006, 3,500,000 shares were
authorized for use in the Company's stock compensation plan. During the year
ending September 30, 2004, 25,050 shares were issued as compensation in lieu
of salary increases extending through August 31, 2005. The shares were issued
at $0.62 per share for a total cost of $15,531. Of this, $14,237 was recorded
as unearned compensation in the consolidated balance sheet during the year
ended September 30, 2004. This amount was recorded as expense during the year
ended September 30, 2005. During the year ended September 30, 2006, 266,355
shares were issued in lieu of salary increases extending through August 31,
2007. These shares were issued at $0.58 per share for a total cost of
$154,486. Of this, $31,180 was recorded as unearned compensation in the
consolidated balance sheet during the year ended September 30, 2006.
F-36
7. EMPLOYEE BENEFIT PLAN
The Company maintains a defined contribution retirement plan, qualifying
under Section 401(k) of the Internal Revenue Code, subject to the Employee
Retirement Income Security Act of 1974, as amended, and covering
substantially all Company employees. Each participant's contribution is
matched by the Company with shares of common stock that have a value equal to
100% of the participant's contribution, not to exceed the lesser of $10,000
or 6% of the participant's total compensation. The Company's contribution of
common stock is valued each quarter based upon the closing bid price of the
Company's common stock. The expense for the years ended September 30, 2006,
2005, and 2004, in connection with this Plan was $88,054, $79,406, and
$56,158, respectively.
8. OPTIONAL SALARY ADJUSTMENT PLAN
In July 2001, the Company adopted an "Optional Salary Adjustment Plan" (the
"Plan"). In accordance with the Plan, employees received 40,000 stock options
for each salary increment of $6,000 that they elected to forgo. The total
amount of options to be granted under the Plan is limited to 1,200,000.
During the years ended September 30, 2006, 2005 and 2004, there were no
options issued in lieu of compensation.
9. COMMITMENTS AND CONTINGENCIES
Operating Leases-The future minimum annual rental payments due under
noncancelable operating leases for office and laboratory space are as
follows:
Year Ending September 30,
------------------------
2007 $144,060
2008 71,136
2009 29,640
2010 -
2011 -
2012 -
--------
Total minimum lease payments $244,836
Rent expense for the years ended September 30, 2006, 2005, and 2004, was
$250,994, $253,180 and $282,138, respectively. Minimum payments have not been
reduced by minimum sublease rental receivable under future cancelable
subleases. These leases expire between June 2007 and February 2009.
Employment Contracts--In April 2005 the Company entered into a three year
employment agreement with its President and Chairman of the Board which
expires April 30, 2008. On September 8, 2006 CEL-SCI agreed to extend its
employment agreement with Maximilian de Clara, CEL-SCI's President, to April
30, 2010. During the term of the employment agreement, CEL-SCI will pay Mr.
de Clara an annual salary of $363,000.
F-37
9. COMMITMENTS AND CONTINGENCIES (continued)
The employment agreement, as amended, also provided that on September 8,
2006, March 8, 2007, September 8, 2007, March 8, 2008, September 8, 2008 and
March 8, 2009, each date being a "Payment Date", CEL-SCI will issue Mr. de
Clara shares of its common stock equal in number to the amount determined by
dividing $200,000 by the average closing price of CEL-SCI's common stock for
the twenty trading days preceding the Payment Date.
The employment agreement provides that CEL-SCI will pay him an annual salary
of $363,000 during the term of the agreement. In the event that there is a
material reduction in his authority, duties or activities, or in the event
there is a change in the control of the Company, then the agreement allows
him to resign from his position at the Company and receive a lump-sum payment
from CEL-SCI equal to 18 months salary. For purposes of the employment
agreement,a change in the control of CEL-SCI means the sale of more than 50%
of the outstanding shares of CEL-SCI's Common Stock, or a change in a
majority of CEL-SCI's directors.
In September 2006 CEL-SCI agreed to extend its employment agreement with
Geert R. Kersten, CEL-SCI's Chief Executive Officer, to September 2011. The
employment agreement, which is essentially the same as Mr. Kersten's prior
employment agreement, provides that during the term of the agreement CEL-SCI
will pay Mr. Kersten an annual salary of $370,585. In the event there is a
change in the control of the Company, the agreement allows him to resign from
his position at the Company and receive a lump-sum payment from the Company
equal to 24 months of salary. For purposes of the employment agreement a
change in the control of the Company means: (1) the merger of the Company
with another entity if after such merger the shareholders of the Company do
not own at least 50% of voting capital stock of the surviving corporation;
(2) the sale of substantially all of the assets of the Company; (3) the
acquisition by any person of more than 50% of the Company's common stock; or
(4) a change in a majority of the Company's directors which has not been
approved by the incumbent directors.
10. CAMBREX NOTE
On November 15, 2001, the Company signed an agreement with Cambrex Bio
Science, Inc., (Cambrex) in which Cambrex provided manufacturing space and
support to the Company during November and December 2001 and January 2002. In
exchange, the Company signed a $1,172,517 note, which included imputed
interest of $300,000. In December 2001, the note was amended to extend the
due date to January 2, 2003. Unpaid principal began accruing interest on
November 16, 2002, at the Prime Rate plus 3%. The note was collateralized by
certain equipment. The imputed interest on this note was capitalized and was
expensed over the life of the loan. In December 2002, the Company negotiated
an extension of the note with Cambrex. Per the agreement, the Company gave
Cambrex certain equipment and surrendered a security deposit, which reduced
the amount owed by $225,000. The remaining balance was payable pursuant to a
note due January 2, 2004. In addition, the agreement required the Company to
pay $150,000 from the Series H convertible debt and 10% of all other future
financing transactions, including draws on the equity line-of-credit. There
were also conversion features added with the
F-38
10. CAMBREX NOTE (continued)
amendment allowing Cambrex to convert either all or part of the note into
shares of the Company's common stock. The principal balance of the note and
any accrued interest were convertible into common stock at 90% of the average
of the closing prices of the common stock for the three trading days
immediately prior to the conversion date, subject to a floor of $0.22 per
share. During the year ended September 30, 2003, the Company paid down the
note by $485,524. The Company also recorded interest expense of $49,486 and
amortized the remaining discount of $37,500 relating to the imputed interest.
The Company accounted for the amendment of the Cambrex note in December 2002
as a modification of the existing note under EITF 96-19, "Debtor's Accounting
for a Modification or Exchange of Debt Instruments". No gain or loss was
recorded at the time of the amendment. The Cambrex note was accounted for as
a hybrid instrument that had the characteristics of a debt host agreement and
contained an embedded conversion feature that was not clearly and closely
related to the debt host, and required bifurcation. The Company recorded a
liability of $84,107, the fair value of the embedded derivative feature in
connection with the December 2002 note modification, with a corresponding
offset to the note payable as a discount. The discount was amortized to
interest expense over the term of the note. As of September 30, 2003, the
remaining unamortized discount of $22,082 was amortized and recorded as
interest expense through December 23, 2003, when the note was paid in full.
During the year ended September 30, 2004, the Company recognized a gain of
$72,785 resulting from changes in fair value of the derivative liability. The
Company also recognized additional interest expense of $22,082, for the year
ended September 30, 2004 from amortization of the discounts.
11. CONVERTIBLE DEBT
As of September 30, 2006, the Company has outstanding convertible debt
totaling $8,300,000. In July, 2006, the Company sold Series K Notes and
Series K warrants to a group of private investors for proceeds of $8,300,000,
less transaction costs of $568,710. For a further discussion of this
transaction, see Note 2.
In January and July 2003, CEL-SCI sold Series H Notes, plus Series H
Warrants, to a group of private investors for $1,350,000. The notes bore
interest at 7% per year and were due and payable in January and July 2005.
The notes contained features that constituted embedded derivatives, certain
of which could not be reliably measured. Because certain of the embedded
derivatives could not be reliably measured, the Company accounted for the
entire instrument at fair value. The Series H Notes were immediately
convertible into a variable number of shares based on a factor of 76% applied
to the average of the lowest three trading prices in a fifteen day period
immediately preceding such conversion. The Company determined the fair value
of the notes for accounting purposes was equal to the fair value of the
shares into which it was convertible at each measurement date. No additional
value has been ascribed to the other embedded derivative features of the
Series H Notes in determining fair value of the Series H Notes as the Company
believes that the value of such features can not be reasonably estimated or
reliably measured due to the contingent nature of their occurrence. The notes
F-39
11. CONVERTIBLE DEBT (continued)
were recorded at the fair value of 131.58%, and accordingly, the discount
associated with the warrants was immediately accreted to interest expense.
The Company has also accrued interest on the notes at a rate of 9.2%
representing the stated 7% interest rate adjusted for the 76% rate at which
the interest was convertible into common shares. On May 30, 2003, fair
value for accounting purposes was adjusted to 142.86% of outstanding face
value due to a change in the discount factor used to compute the conversion
price of the Series H Notes, triggered by the failure of the Company to
have a registration statement declared effective. During the year ended
September 30, 2004, the Company recognized a gain of $6,703 arising from
changes in the fair value of the Series H Notes. As of October 2, 2003 all
of the Series H Notes had been converted into 3,233,229 shares of CEL-SCI's
common stock.
12. EQUITY LINES OF CREDIT
In September 2003, the Company entered into the 2003 Equity Line of Credit
that allows the Company at its discretion to sell up to $10 million of common
stock in increments of a minimum of $100,000 and a maximum amount that can be
drawn down at any one time that will be determined at the time of the
drawdown request, using a formula contained in the agreement. The Company is
restricted from entering into any other equity line of credit arrangement
until the earlier of the expiration of the agreement or two years from the
date of registration of the shares underlying the agreement. As discussed in
Note 6, the Company issued 395,726 warrants to the issuer at a price of $0.83
exercisable through September 16, 2008. The Company accounted for the 2003
Equity Line of Credit as a freestanding derivative instrument as the Company
could be required to compensate the investor for any decreases in the price
of the Company's common stock during the term of the agreement. The Company
determined that the instrument had no fair value as of September 30, 2005 and
2004. For the years ended September 30, 2005 and 2004, the Company recognized
a gain of $16,223 and a loss of $5,065, respectively resulting from changes
in fair value of the 2003 Equity Line of Credit. Expenses of $40,600 were
charged to additional paid-in capital as a cost of equity related transaction
during the year ended September 30, 2003. During the year ended September 30,
2006, the Company sold 1,419,446 shares of common stock totaling $677,727.
During the year ended September 30, 2005, the Company sold 743,014 shares of
its common stock pursuant to this agreement for gross proceeds of $366,238,
net of related costs of $1,035. During the year ended September 30, 2004, the
Company sold 307,082 shares of its common stock pursuant to this agreement
for gross proceeds of $340,000, net of related costs of $4,090. This line of
credit expired December 29, 2005.
On October 31, 2005, the Company entered into the 2005 Equity Line of Credit.
For a two-year period, the agreement allows the Company at its discretion to
sell up to $5 million of common stock in increments of a minimum of $100,000
and a maximum to be determined at the time of the drawdown request using a
formula contained in the agreement. The Company may request a drawdown once
every 22 trading days, although the Company is under no obligation to request
any drawdown. As consideration for extending the equity line of credit, the
F-40
12. EQUITY LINES OF CREDIT (continued)
Company granted warrants to purchase 271,370 shares of common stock at a
price of $0.55 per share at any time prior to October 24, 2010.
13. STOCKHOLDERS' EQUITY
In October 2001, the Company issued 150,000 shares of common stock in a
private offering for proceeds of $150,000. The investor also received
warrants which entitled the holder to purchase 75,000 shares of common stock
at $1.50 per share. These warrants expired unexercised October 5, 2004 and
are discussed in Note 6.
In May 2003, the Company sold 1,100,000 shares of common stock and an
additional 1,100,000 warrants to purchase common stock in conjunction with a
marketing agreement. The Company received proceeds of $500,000 for the stock
and warrants. The warrants are exercisable at a price of $0.47 per share. The
warrants initially expired May 30, 2006. In accordance with the terms of the
agreement, the expiration was extended to May 30, 2008. The warrants are
discussed in Note 6.
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. There were associated costs of $93,159. As part of this
transaction, the investors in the private offering received Series J Warrants
which allow 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.
See discussion of accounting for the Series J Warrants in Note 6.
On May 4, 2004, the CEL-SCI sold 6,402,439 shares of its common stock to a
group of private institutional investors at $0.82 per share for $5,250,000
and associated costs of $498,452. As part of this transaction, the investment
banker of the private offering received warrants which allow the investors to
purchase 76,642 shares of CEL-SCI's common stock at a price of $1.37 per
share at any time prior to May 4, 2009. See discussion of accounting for
warrants in Note 6.
On July 18, 2005, CEL-SCI sold 1,250,000 shares of its common stock and
375,000 warrants to one investor for $500,000. Each warrant entitles the
holder to purchase one share of CEL-SCI's common stock at a price of $0.65
per share at any time prior to July 18, 2009. The shares of common stock and
warrants are "restricted" securities as defined in Rule 144 of the Securities
and Exchange Commission.
On February 9, 2006, CEL-SCI sold 2,500,000 shares of its common stock and
750,000 warrants to one investor for $1,000,000. Each warrant entitles the
holder to purchase one share of CEL-SCI's common stock at a price of $0.56
per share at any time prior to February 9, 2011. The warrants were valued at
$238,986. In addition, 441,176 warrants previously issued to the investor
were repriced and extended for one year. The revaluing of the warrants was
valued at $76,122.
F-41
14. NET LOSS PER COMMON SHARE
Basic earnings per share (EPS) excludes dilution and is computed by dividing
net income by the weighted average of common shares outstanding for the
period. Diluted EPS reflects the potential dilution that could occur if
securities or other common stock equivalents (convertible preferred stock,
convertible debt, warrants to purchase common stock and common stock options)
were exercised or converted into common stock. The following table provides a
reconciliation of the numerators and denominators of the basic and diluted
per-share computations:
2006 2005 2004
--------------- -------------- -------------
Net loss - basic $ (7,939,210) $(3,039,607) $(2,952,077)
Add: Interest on
convertible debt 216,737 - 53,855
Gain on
derivative instruments (2,276,358) (363,028) (1,174,660)
------------ ----------- -----------
Net loss - diluted $ (9,998,831) $(3,402,635) $(4,072,882)
============ =========== ===========
Weighted average number of
shares - basic 78,971,290 72,703,395 67,273,133
Incremental shares from:
Warrants 5,211,628 878,530 1,461,552
Convertible debt 9,651,160 - 189,414
------------ ----------- -----------
Weighted average number
of shares - diluted 93,834,078 73,581,925 68,924,099
============ =========== ===========
Earnings per share - basic $ (0.10) $ (0.04) $ (0.04)
Earnings per share - diluted $ (0.11) $ (0.05) $ (0.06)
Excluded from the above computations of weighted-average shares for diluted
net loss per share were options and warrants to purchase 4,075,446,
10,787,480, and 13,429,012 shares of common stock as of September 30, 2006,
2005 and 2004, respectively. These securities were excluded because their
inclusion would have an anti-dilutive effect on net loss per share.
15. SEGMENT REPORTING
SFAS No. 131, "Disclosure about Segments of an Enterprise and Related
Information" establishes standards for reporting information regarding
operating segments in annual financial statements and requires selected
information for those segments to be presented in interim financial reports
issued to stockholders. SFAS No. 131 also establishes standards for related
disclosures about products and services and geographic areas. Operating
segments are identified as components of an enterprise about which separate
discrete financial information is available for evaluation by the chief
operating decision maker, or decision-making group, in making decisions how
to allocate resources and assess performance. The Company's chief decision
maker, as defined under SFAS No. 131, is the Chief Executive Officer. To
date, the Company has viewed its operations as principally one segment, the
F-42
15. SEGMENT REPORTING (continued)
research and development of certain drugs and vaccines. As a result, the
financial information disclosed herein, materially represents all of the
financial information related to the Company's principal operating segment.
16. QUARTERLY INFORMATION (UNAUDITED)
The following quarterly data are derived from the Company's Consolidated
Statements of Operations.
Financial Data
Fiscal 2006
-----------
Three Three Three Three
months months months months Year
ended ended ended ended ended
December March 31, June 30, September September
31, 2005 2006 2006 30, 2006 30, 2006
---------------------------------------------------------
Revenue $ 29,847 $ 36,815 $ 39,708 $ 19,087 $ 125,457
Operating expenses 1,051,715 1,378,062 1,345,165 1,699,711 5,474,653
Nonoperating
(expense) income 11,404 11,998 9,801 (157,453) (124,250)
Gain (loss) on
derivative
instruments 13,337 (1,822) 1,615 2,312,654 2,325,784
Net income (loss) (997,127) (1,331,071) (1,294,041) (4,316,971) (7,939,210)
Loss per common share
- basic (0.01) (0.02) (0.02) (0.05) (0.10)
Loss per common share
- diluted (0.01) (0.02) (0.02) (0.06) (0.11)
Fiscal 2005
-----------
Three Three Three Three
months months months months Year
ended ended ended ended ended
December March 31, June 30, September September
31, 2004 2005 2005 30, 2005 30, 2005
-----------------------------------------------------
Revenue $ 75,507 $109,785 $ 38,103 $ 46,530 $ 269,925
Operating expenses 1,289,997 1,198,617 1,022,474 839,604 4,350,692
Nonoperating (expense)
income (14,953) (60,608) 330,585 786,136 1,041,160
Net income (loss) (1,229,443) (1,149,440) (653,786) (6,938)(3,039,607)
Net income (loss)
attributable to common
shareholders (1,229,443) (1,149,440) (653,786) (6,938)(3,039,607)
Income (loss) per common
share - basic (0.02) (0.01) (0.01) - (0.04)
Income (loss) per common
share - diluted (0.02) (0.02) (0.01) - (0.05)
F-43
CEL-SCI CORPORATION
INTERIM FINANCIAL STAEMENTS
DECEMBER 31, 2006
(unaudited)
TABLE OF CONTENTS
PART I FINANCIAL INFORMATION
Item 1. Page
----
Condensed Consolidated Balance Sheet (unaudited) 3
Condensed Consolidated Statement of Operations (unaudited) 4
Condensed Consolidated Statement of Cash Flow (unaudited) 5
Notes to Condensed Consolidated Financial Statements (unaudited) 6
Item 2.
Management's Discussion and Analysis of Financial Condition 16
and Results of Operations
Item 3.
Quantitative and Qualitative Disclosures about Market Risks 21
Item 4.
Controls and Procedures 21
PART II
Item 2.
Changes in Securities and Use of Proceeds 22
Item 4.
Submission of Matters to a Vote of Security Holders 22
Item 5.
Other Information 22
Item 6.
Exhibits 22
Signatures 23
Item 1. FINANCIAL STATEMENTS
CEL-SCI CORPORATION
-------------------
CONDENSED CONSOLIDATED BALANCE SHEETS
------------------------
(unaudited)
ASSETS
December 31, September 30,
2006 2006
------------ -------------
CURRENT ASSETS:
Cash and cash equivalents $ 7,176,818 $ 8,080,365
Interest and other receivables 36,951 35,626
Prepaid expenses 187,537 526,498
Inventory used for R&D and manufacturing 379,858 390,644
Deposits 14,828 14,828
-------------- -------------
Total current assets 7,795,992 9,047,961
RESEARCH AND OFFICE EQUIPMENT-
Less accumulated depreciation of $1,788,430
and $1,773,102 118,924 92,117
PATENT COSTS- less accumulated
amortization of $917,288 and $896,407 519,308 513,199
-------------- -------------
TOTAL ASSETS $ 8,434,224 $ 9,653,277
============== =============
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)
CURRENT LIABILITIES:
Accounts payable $ 178,537 $ 98,056
Accrued expenses 88,551 74,894
Due to employees 28,016 17,425
Accrued interest on convertible debt 173,482 74,473
Derivative instruments - current portion 1,714,722 1,670,234
Deposits held 3,000 3,000
-------------- -------------
Total current liabilities 2,186,308 1,938,082
Derivative instruments - noncurrent portion 8,055,825 8,645,796
-------------- -------------
Total liabilities 10,242,133 10,583,878
COMMITMENTS AND CONTINGENCIES
STOCKHOLDERS' EQUITY (DEFICIT):
Preferred stock, $.01 par value; authorized,
100,000 shares; no shares issued and outstanding - -
Common stock, $.01 par value; authorized,
200,000,000 shares; issued and outstanding,
83,234,441 and 82,697,428 shares at December
31, 2006 and September 30, 2006, respectively 832,344 826,974
Additional paid-in capital 105,410,515 105,180,834
Accumulated deficit (108,050,768) (106,938,409)
-------------- -------------
Total stockholders' equity (deficit) (1,807,909) (930,601)
-------------- -------------
TOTAL LIABILITIES AND STOCKHOLDERS'
EQUITY (DEFICIT) $ 8,434,224 $ 9,653,277
============== =============
See notes to condensed consolidated financial statements.
3
CEL-SCI CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
Three Months Ended December 31,
2006 2005
--------------------------------
REVENUE:
Grant revenue $ 13,862 $ 23,757
Rent income 6,090 6,090
Other income 841 -
-------------- --------------
Total Revenue 20,793 29,847
EXPENSES:
Research and development, excluding
depreciation of $20,493 and $18,511
included below 506,158 434,889
Depreciation and amortization 41,842 43,790
General and administrative 1,052,704 573,036
-------------- --------------
Total Expenses 1,600,704 1,051,715
-------------- --------------
LOSS FROM OPERATIONS (1,579,911) (1,021,868)
GAIN ON DERIVATIVE INSTRUMENTS 719,247 13,337
INTEREST INCOME 95,551 11,404
INTEREST EXPENSE (347,246) -
-------------- --------------
NET LOSS BEFORE INCOME TAXES (1,112,359) (997,127)
INCOME TAX PROVISION - -
-------------- --------------
NET LOSS $ (1,112,359) $ (997,127)
============== ==============
NET LOSS PER COMMON SHARE (BASIC) $ (0.01) $ (0.01)
============== ==============
NET LOSS PER COMMON SHARE (DILUTED) $ (0.01) $ (0.01)
============== ==============
WEIGHTED AVERAGE COMMON
SHARES OUTSTANDING 82,928,432 74,998,621
============== ==============
See notes to condensed consolidated financial statements.
4
CEL-SCI CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOW
(unaudited)
Three Months Ended December 31,
2006 2005
-------------------------------
CASH FLOWS FROM OPERATING ACTIVITIES:
NET LOSS $ (1,112,359) $ (997,127)
Adjustments to reconcile net loss to
net cash used in operating activities:
Depreciation and amortization 41,842 43,790
Penalty shares issued to nonemployees 110,325 -
Issuance of common stock and stock options
for services - 66,718
Common stock contributed to 401(k) plan 22,314 20,479
Employee option cost 30,984 51,798
Impairment loss on retired equipment - 645
Gain on derivative instruments (719,247) (13,337)
Amortization of discount on convertible debt 173,764 -
(Increase) decrease in receivables (1,325) 5,676
Decrease in prepaid expenses 338,961 4,766
Decrease in inventory for R&D and manufacturing 10,786 7,984
Increase in deferred financing costs - (5,000)
Increase in accounts payable 44,906 50,679
Increase in accrued expenses 13,657 2,771
Increase (decrease) in amount due to employees 10,591 (28)
Increase in accrued interest on convertible
debt 99,009 -
------------- --------------
NET CASH USED IN OPERATING ACTIVITIES (935,792) (760,186)
------------- --------------
CASH FLOWS USED IN INVESTING ACTIVITIES:
Purchase of equipment (47,769) (1,360)
Patent costs 8,587 (3,861)
------------- --------------
NET CASH USED IN INVESTING ACTIVITIES (39,182) (5,221)
------------- --------------
CASH FLOWS PROVIDED BY FINANCING ACTIVITIES:
Drawdown on equity line - 677,727
Proceeds from exercise of stock options 71,427 15,693
------------- --------------
NET CASH PROVIDED BY FINANCING ACTIVITIES 71,427 693,420
------------- --------------
NET DECREASE IN CASH AND CASH EQUIVALENTS (903,547) (71,987)
CASH AND CASH EQUIVALENTS:
Beginning of period 8,080,365 1,957,614
------------- --------------
End of period $ 7,176,818 $ 1,885,627
============= ==============
(continued)
See notes to condensed consolidated financial statements.
5
CEL-SCI CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOW
(unaudited)
Three Months Ended December 31,
2006 2005
-------------------------------
SUPPLEMENTAL INFORMATION ON NONCASH TRANSACTIONS:
Patent costs included in accounts payable:
Increase in accounts payable $ (35,576) $ (8,250)
Increase in patent costs 35,576 8,250
------------- -------------
$ - $ -
============= =============
Reclassification of derivative instruments:
Decrease in derivative instruments $ - $ 797,835
Increase in additional paid-in capital - (797,835)
------------- -------------
$ - $ -
============= =============
NOTE:
Interest expense paid during the quarter ended December 31, 2006 totaled
$74,473.
concluded
See notes to condensed consolidated financial statements.
6
CEL-SCI CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
THREE MONTHS ENDED DECEMBER 31, 2006 AND 2005
A. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation
The accompanying condensed consolidated financial statements of CEL-SCI
Corporation and subsidiary (the Company) are unaudited and certain
information and footnote disclosures normally included in the annual
financial statements prepared in accordance with accounting principles
generally accepted in the United States of America have been omitted
pursuant to the rules and regulations of the Securities and Exchange
Commission. While management of the Company believes that the disclosures
presented are adequate to make the information presented not misleading,
interim consolidated financial statements should be read in conjunction
with the consolidated financial statements and notes included in the
Company's annual report on Form 10-K for the year ended September 30,
2006.
In the opinion of management, the accompanying unaudited condensed
consolidated financial statements contain all accruals and adjustments
(each of which is of a normal recurring nature) necessary for a fair
presentation of the financial position as of December 31, 2006 and the
results of operations for the three month period then ended. The condensed
consolidated balance sheet as of September 30, 2006 is derived from the
September 30, 2006 audited consolidated financial statements. Significant
accounting policies have been consistently applied in the interim
financial statements and the annual financial statements. The results of
operations for the three month period ended December 31, 2006 are not
necessarily indicative of the results to be expected for the entire year.
Significant accounting policies are as follows:
Principles of Consolidation--The consolidated financial statements include
the accounts of CEL-SCI Corporation and its wholly owned subsidiary, Viral
Technologies, Inc. All intercompany transactions have been eliminated upon
consolidation.
Cash and Cash Equivalents--For purposes of the statements of cash flows,
cash and cash equivalents consists principally of unrestricted cash on
deposit and short-term money market funds. The Company considers all
highly liquid investments with a maturity when purchased of less than
three months to be cash equivalents.
Prepaid Expenses and Inventory--Prepaid expenses are those expenses which
benefit a substantial period of time. Inventory consists of bulk purchases
of laboratory supplies used on a daily basis in the lab and items that
will be used for future production. These items are disposables and
consumables and can be used for both the manufacturing of Multikine for
clinical studies and in the laboratory for quality control and bioassay
use. They can be used in training, testing and daily laboratory
activities.
7
CEL-SCI CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
THREE MONTHS ENDED DECEMBER 31, 2006 AND 2005
Research and Office Equipment--Research and office equipment is recorded
at cost and depreciated using the straight-line method over estimated
useful lives of five to seven years. Leasehold improvements are
depreciated over the shorter of the estimated useful life of the asset or
the term of the lease. Repairs and maintenance are expensed when incurred.
Depreciation expense for the three-month period ended December 31, 2006
and 2005 were $20,962 and $24,605 respectively.
Patents--Patent expenditures are capitalized and amortized using the
straight-line method over the shorter of the expected useful life or the
legal life of the patent (17 years). In the event changes in technology or
other circumstances impair the value or life of the patent, appropriate
adjustment in the asset value and period of amortization is made. An
impairment loss is recognized when estimated future undiscounted cash
flows expected to result from the use of the asset, and from disposition,
is less than the carrying value of the asset. The amount of the impairment
loss would be the difference between the estimated fair value of the asset
and its carrying value. During the three month periods ended December 31,
2006 and 2005, the Company recorded no patent impairment charges. For the
three-month period ended December 31, 2006 and 2005, amortization of
patent costs totaled $20,880 and $19,185 respectively.
Derivative Instruments--The Company enters into financing arrangements
that consist of freestanding derivative instruments or are hybrid
instruments that contain embedded derivative features. The Company
accounts for these arrangements in accordance with Statement of Financial
Accounting Standards No. 133, "Accounting for Derivative Instruments and
Hedging Activities", ("SFAS No. 133") AND Emerging Issues Task Force Issue
No. 00-19, "Accounting for Derivative Financial Instruments Indexed to,
and Potentially Settled in, a Company's Own Stock", ("EITF 00-19"), as
well as related interpretations of these standards. In accordance with
accounting principles generally accepted in the United States ("GAAP"),
derivative instruments and hybrid instruments are recognized as either
assets or liabilities in the statement of financial position and are
measured at fair value with gains or losses recognized in earnings or
other comprehensive income depending on the nature of the derivative or
hybrid instruments. Embedded derivatives that are not clearly and closely
related to the host contract are bifurcated and recognized at fair value
with changes in fair value recognized as either a gain or loss in earnings
if they can be reliably measured. When the fair value of embedded
derivative features can not be reliably measured, the Company measures and
reports the entire hybrid instrument at fair value with changes in fair
value recognized as either a gain or loss in earnings. The Company
determines the fair value of derivative instruments and hybrid instruments
based on available market data using appropriate valuation models, giving
consideration to all of the rights and obligations of each instrument and
precluding the use of "blockage" discounts or premiums in determining the
fair value of a large block of financial instruments. Fair value under
these conditions does not necessarily represent fair value determined
using valuation standards that give consideration to blockage discounts
and other factors that may be considered by market participants in
establishing fair value.
8
CEL-SCI CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
THREE MONTHS ENDED DECEMBER 31, 2006 AND 2005
Research and Development Grant Revenues--The Company's grant arrangements
are handled on a reimbursement basis. Grant revenues under the
arrangements are recognized as grant revenue when costs are incurred.
Research and Development Costs--Research and development (R&D)
expenditures are expensed as incurred. The Company has an agreement with
Cambrex Bio Science, an unrelated corporation, for the production of
Multikine(R), which is the Company's only product source. All production
costs of Multikine are expensed to R&D immediately. This agreement expired
on December 31, 2006.
Net Loss per Common Share--Net loss per common share is computed by
dividing the net loss by the weighted average number of common shares
outstanding during the period. Potentially dilutive common stock
equivalents, including convertible preferred stock, convertible debt and
options to purchase common stock, were excluded from the calculation
because they are antidilutive.
Concentration of Credit Risk--Financial instruments, which potentially
subject the Company to concentrations of credit risk, consist of cash and
cash equivalents. The Company maintains its cash and cash equivalents with
high quality financial institutions. At times, these accounts may exceed
federally insured limits. The Company has not experienced any losses in
such bank accounts. The Company believes it is not exposed to significant
credit risk related to cash and cash equivalents.
Income Taxes--Income taxes are accounted for using the asset and liability
method under which deferred tax liabilities or assets are determined based
on the difference between the financial statement and tax basis of assets
and liabilities (i.e., temporary differences) and are measured at the
enacted tax rates. Deferred tax expense is determined by the change in the
liability or asset for deferred taxes. The difference in the Company's
U.S. Federal statutory income tax rate and the Company's effective tax
rate is primarily attributable to the recording of a valuation allowance
due to the uncertainty of the amount of future tax benefits that will be
realized because it is more likely than not that future taxable income
will not be sufficient to realize such tax benefits.
Use of Estimates--The preparation of financial statements in conformity
with accounting principles generally accepted in the United States of
America requires management to make estimates and assumptions that affect
the reported amounts of assets and liabilities and disclosure of
contingent assets and liabilities at the date of the financial statements
and the reported amounts of revenues and expenses during the reporting
period. Actual results could differ from those estimates. Accounting for
derivatives is based upon valuations of derivative instrument determined
using various valuation techniques including the Black-Scholes and
binomial pricing methodologies. The Company considers such valuations to
be significant estimates.
9
CEL-SCI CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
THREE MONTHS ENDED DECEMBER 31, 2006 AND 2005
Asset Valuations and Review for Potential Impairments--The Company reviews
its fixed assets every quarter. This review requires that the Company make
assumptions regarding the value of these assets and the changes in
circumstances that would affect the carrying value of these assets. If
such analysis indicates that a possible impairment may exist, the Company
is then required to estimate the fair value of the asset and, as deemed
appropriate, expense all or a portion of the asset. The determination of
fair value includes numerous uncertainties, such as the impact of
competition on future value. The Company believes that it has made
reasonable estimates and judgments in determining whether its long-lived
assets have been impaired; however, if there is a material change in the
assumptions used in our determination of fair values or if there is a
material change in economic conditions or circumstances influencing fair
value, the Company could be required to recognize certain impairment
charges in the future.
Stock-Based Compensation--In October 1996, the Financial Accounting
Standards Board (FASB) issued Statement of Financial Accounting Standards
No. 123, "Accounting for Stock-Based Compensation" (SFAS No. 123). This
statement encouraged but did not require companies to account for employee
stock compensation awards based on their estimated fair value at the grant
date with the resulting cost charged to operations. The Company had
elected to continue to account for its employee stock-based compensation
using the intrinsic value method prescribed in Accounting Principles Board
Opinion No. 25, "Accounting for Stock Issued to Employees and related
Interpretations". In December 2004 the FASB issued SFAS No. 123R,
"Share-Based Payment". SFAS No. 123R requires companies to recognize
expense associated with share based compensation arrangements, including
employee stock options, using a fair value-based option pricing model.
SFAS No. 123R applies to all transactions involving issuance of equity by
a company in exchange for goods and services, including employees. Using
the modified prospective transition method of adoption, the Company
reflects compensation expense in the financial statements beginning
October 1, 2005. The modified prospective transition method does not
require restatement of prior periods to reflect the impact of SFAS No.
123R. As such, compensation expense will be recognized for awards that
were granted, modified, repurchased or cancelled on or after October 1,
2005 as well as for the portion of awards previously granted that vested
during the period ended December 31, 2006. For the three months ended
December 31, 2006 and 2005, the Company recorded $30,984 and $51,798,
respectively in general and administrative expense for the cost of
employee options. The Company's options vest over a three-year period from
the date of grant. After one year, the stock is one-third vested, with an
additional one-third vesting after two years and the final one-third
vesting at the end of the three-year period. There were no options granted
during the three-month periods ended December 31, 2006 and 2005. Options
are granted with an exercise price equal to the closing bid price of the
Company's stock on the day before the grant. The Company determines the
fair value of the employee compensation using the Black Scholes method of
valuation. This method requires several assumptions, including the
following assumptions for the options vesting during the three months
ended December 31, 2006. No options vested during the three months ended
December 31, 2005.
10
CEL-SCI CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
THREE MONTHS ENDED DECEMBER 31, 2006 AND 2005
December 31, 2006
-----------------
Volatility 78%
Dividend yield 0%
Risk-free interest rate 5.08%
Expected average life 1 year
Exercise price per option $0.62
The Company has Incentive Stock Option Plans, Non-Qualified Stock Option
Plans, a Stock Compensation Plan and Stock Bonus Plans. All Stock Option
and Bonus Plans have been approved by the stockholders. A summary
description of these Plans follows. In some cases these Plans are
collectively referred to as the "Plans".
Incentive Stock Option Plan. The Incentive Stock Option Plans authorize
the issuance of shares of the Company's common stock to persons who
exercise options granted pursuant to the Plan. Only Company employees may
be granted options pursuant to the Incentive Stock Option Plan.
To be classified as incentive stock options under the Internal Revenue
Code, options granted pursuant to the Plans must be exercised prior to the
following dates:
(a) The expiration of three months after the date on which an option
holder's employment by the Company is terminated (except if such
termination is due to death or permanent and total disability);
(b) The expiration of 12 months after the date on which an option holder's
employment by the Company is terminated, if such termination is due to
the Employee's permanent and total disability;
(c) In the event of an option holder's death while in the employ of the
Company, his executors or administrators may exercise, within three
months following the date of his death, the option as to any of the
shares not previously exercised;
The total fair market value of the shares of Common Stock (determined at
the time of the grant of the option) for which any employee may be granted
options which are first exercisable in any calendar year may not exceed
$100,000.
Options may not be exercised until one year following the date of grant.
Options granted to an employee then owning more than 10% of the Common
Stock of the Company may not be exercisable by its terms after five years
from the date of grant. Any other option granted pursuant to the Plan may
not be exercisable by its terms after ten years from the date of grant.
11
CEL-SCI CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
THREE MONTHS ENDED DECEMBER 31, 2006 AND 2005
The purchase price per share of Common Stock purchasable under an option
is determined by the Committee but cannot be less than the fair market
value of the Common Stock on the date of the grant of the option (or 110%
of the fair market value in the case of a person owning more than 10% of
the Company's outstanding shares).
Non-Qualified Stock Option Plans. The Non-Qualified Stock Option Plans
authorize the issuance of shares of the Company's common stock to persons
that exercise options granted pursuant to the Plans. The Company's
employees, directors, officers, consultants and advisors are eligible to
be granted options pursuant to the Plans, provided however that bona fide
services must be rendered by such consultants or advisors and such
services must not be in connection with the offer or sale of securities in
a capital-raising transaction. The option exercise price is determined by
the Committee but cannot be less than the market price of the Company's
Common Stock on the date the option is granted.
The following table summarizes stock option activity for the three months
ended December 31, 2006.
Non-Qualified Stock Option Plan
Outstanding Exercisable
------------------------------------------- -------------------------------------------
Weighted Weighted
Average Average
Weighted Remaining Weighte Remaining
Number Average Contractual Aggregate Number Average Contractual Aggregate
of Exercise Term Intrinsic of Exercise Term Intrinsic
Shares Price (Years) Value Shares Price (Years) Value
-------------------------------------------- -----------------------------------------------
Outstanding 7,511,362 $0.66 5.15 $1,390,653 6,011,713 $0.68 4.81 $1,306,320
at October
1, 2006
Vested - 250,000 0.62
Granted - -
Exercised (324,666) 0.22 6.33 131,644 (324,666) 0.22 6.33 131,644
Forfeited - -
Expired - -
--------- ------- --------
Outstanding
at December
31, 2006 7,186,696 $0.65 4.81 1,100,337 5,937,047 $0.71 4.70 1,042,917
--------- ---------
12
Incentive Stock Option Plan
Outstanding Exercisable
------------------------------------------- -------------------------------------------
Weighted Weighted
Average Average
Weighted Remaining Weighte Remaining
Number Average Contractual Aggregate Number Average Contractual Aggregate
of Exercise Term Intrinsic of Exercise Term Intrinsic
Shares Price (Years) Value Shares Price (Years) Value
-------------------------------------------- -----------------------------------------------
Outstanding 4,326,933 $0.65 6.03 $1,047,933 3,810,267 $0.66 6.12 1,021,933
at October
1, 2006
Vested - -
Granted - -
Exercised - -
Forfeited - -
Expired - -
--------- ---------
Outstanding 4,326,933 $0.65 5.78 $ 871,533 3,810,267 $0.66 5.29 $ 865,133
at December
31, 2006
The total intrinsic value of options exercised during the three months
ended December 31, 2006 and 2005 was $131,644 and $19,260, respectively.
A summary of the status of the Company's non-vested options as of December
31, 2006 is presented below:
Weighted Average
Number of Grant Date
Shares Fair Value
-------------------------------------
Non-Qualified Stock Option Plan
Nonvested at October 1, 2006 1,499,649 $0.23
Vested (250,000) 0.62
Granted -
Forfeited -
Expired -
---------
Nonvested at December 31, 2006 1,249,649 0.27
13
Incentive Stock Option Plan
Nonvested at October 1, 2006 516,666 $0.46
Vested
Granted -
Forfeited -
Expired -
-------
Nonvested at December 31, 2006 516,666 $0.46
-------
Options to non-employees are accounted for in accordance with FASB's
Emerging Issues Task Force (EITF) Issue 96-18 Accounting for Equity
Instruments That Are Issued to Other Than Employees for Acquiring, or in
Conjunction with Selling, Goods or Services. Accordingly, compensation is
recognized when goods or services are received and is measured using the
Black-Scholes valuation model. The Black-Scholes model requires management
to make assumptions regarding the fair value of the options at the date of
grant and the expected life of the options. There were no option grants to
non-employees during the three months ended December 31, 2006. For the
three months ended December 31, 2005, common stock and options with a
value of $66,718 were issued for services.
B. NEW ACCOUNTING PRONOUNCEMENTS
In February 2006, the FASB issued SFAS No. 155, "Hybrid Instruments". The
statement amends SFAS No. 133 and SFAS No. 140, "Accounting for Transfers
and Servicing of Financial Assets and Extinguishments of Liabilities". The
statement also resolves issues addressed in Statement 133 Implementation
Issue No. D1, "Application of Statement 133 to Beneficial Interests in
Securitized Financial Assets." The statement: a) permits fair value
remeasurement for any hybrid financial instrument that contains an
embedded derivative that otherwise would require bifurcation, b) clarifies
which interest-only strips and principal-only strips are not subject to
the requirements of SFAS No. 133, c) establishes a requirement to evaluate
interests in securitized financial assets to identify interests that are
freestanding derivatives or that are hybrid financial instruments that
contain an embedded derivative requiring bifurcation, d) clarifies that
concentrations of credit risk in the form of subordination are not
embedded derivatives, and e) amends Statement 140 to eliminate the
prohibition on a qualifying special purpose entity from holding a
derivative financial instrument that pertains to a beneficial interest
other than another derivative financial instrument. The Company adopted
SFAS No. 155 on October 1, 2006. SFAS No. 155 does not have a material
impact on operations or cash flows because these instruments were
originally treated as hybrid instruments as permitted under FAS No. 133.
14
In July 2006, the FASB issued interpretation No. 48, "Accounting for
Uncertainty in Income Taxes" ("FIN 48") which clarifies the accounting for
income taxes by prescribing the minimum recognition threshold a tax
position is required to meet before being recognized in the financial
statements. FIN 48 also provides guidance on derecognition, measurement,
classification, interest and penalties, accounting in interim periods,
disclosure and transition. FIN 48 is effective for fiscal years beginning
after December 15, 2006. The Company does not expect the adoption of this
Interpretation to have a material impact on its financial statements.
In September 2006, FASB issued SFAS No. 157, "Fair Value Measurements".
The statement defines fair value, establishes a framework for measuring
fair value in GAAP and expands disclosures about fair value measurements.
The statement is effective for financial statements issued for fiscal
years beginning after November 15, 2007 and interim periods within those
fiscal years. The Company is evaluating whether this statement will affect
its current practice in valuing fair value of its derivatives each
quarter.
In September 2006, SAB No. 108 was issued by the Securities and Exchange
Commission. The interpretations in the SAB express the SEC staff's views
regarding the process of quantifying financial statement misstatements.
Beginning with annual financial statements covering fiscal years ending
after November 15, 2006, material misstatements in the current year may
result in the need to correct prior year financial statements, even if the
misstatement in the prior year or years is considered immaterial. SAB 108
does not require previously filed reports to be amended. Such correction
may be made the next time the company files the prior year financial
statements. The Company believes that there will be in impact on its
results of operations, cash flows or balance sheet because of this
interpretation.
C. STOCKHOLDERS' EQUITY (DEFICIT)
During the three months ended December 31, 2006, the Company issued stock
to two nonemployees in accordance with their respective agreements with a
fair value of $110,325. This expense was recorded in general and
administrative expense. During the three months ended December 31, 2005,
the Company issued stock or stock options for services to a nonemployee
with a fair value of $66,718. The fair value of the options issued during
the three months ended December 31, 2005 was determined using the Black
Scholes method with the following assumptions:
December 31, 2005
Volatility 87%
Dividend yield 0%
Risk-free interest rate 4.33%
Expected average life 5 year
Exercise price per option $0.55
15
D. SERIES K CONVERTIBLE DEBT
In August 2006, the Company issued $8,300,000 in aggregate principal
amount of convertible notes (the "Series K Notes") together with warrants
to purchase 4,825,581 shares of the Company's common stock (the Series K
Warrants"). Additionally, in connection with issuance of the Series K
Notes and Series K Warrants, the placement agent received a fee of
$498,000 and 386,047 fully vested warrants (the "Placement Agent
Warrants") to purchase shares of the Company's common stock. Net proceeds
were $7,731,290, net of $568,710 in direct transaction costs, including
the placement agent fee.
The Series K Notes are convertible into 9,651,163 shares of the Company's
common stock at the option of the holder at any time prior to maturity at
a conversion price of $0.86 per share, subject to adjustment for certain
events. The Series K Warrants are exercisable over a five-year period from
February 4, 2007 through February 4, 2012 at $0.95 per share.
The Series K Notes bear interest at the greater of 8% or LIBOR plus 300
basis points, and are required to be repaid in thirty equal monthly
installments of $207,500 beginning on March 4, 2007 and continuing through
September 4, 2010. The remaining principal balance of $2,075,000 is
required to be repaid on August 4, 2011; however, holders of the Series K
Notes may require repayment of the entire remaining principal balance at
any time after August 4, 2010. Interest is payable quarterly beginning
September 30, 2006. Each payment of principal and accrued interest may be
settled in cash or in shares of common stock at the option of the Company.
The number of shares deliverable under the share-settlement option is
determined based on the lower of (a) $0.86 per share, as adjusted pursuant
to the terms of the Series K Notes or (b) 90% applied to the arithmetic
average of the volume-weighted-average trading prices for the twenty day
period immediately preceding each share settlement. The Company may not
make payments in shares if such payments would result in the cumulative
issuance of shares of its common stock exceeding 19.999% of the shares
outstanding on the day immediately preceding the issuance date of the
Series K Notes, unless prior approval is given by vote of at least a
majority of the shares outstanding. The Company received such approval on
November 17, 2006.
The Company is accounting for the Series K Warrants as derivative
liabilities in accordance with SFAS No. 133. A debt discount of $1,734,472
is being amortized to interest expense using the effective interest method
over the expected term of the Series K Notes. During the three month
period ended December 31, 2006, the Company recorded interest expense of
$173,764 in amortization of the debt discount. As of December 31, 2006,
the fair value of the Series K notes is $7,878,326 and the fair value of
the investor and placement agent warrants is $1,892,221. The Company
recorded a gain on derivative instruments of $719,247 during the three
months ended December 31, 2006.
16
E. OPERATIONS AND FINANCING
The Company has incurred significant costs since its inception in
connection with the acquisition of an exclusive worldwide license to
certain patented and unpatented proprietary technology and know-how
relating to the human immunological defense system, patent applications,
research and development, administrative costs, construction of laboratory
facilities and clinical trials. The Company has funded such costs with
proceeds realized from the public and private sale of its common and
preferred stock. The Company will be required to raise additional capital
or find additional long-term financing in order to continue with its
research efforts. To date, the Company has not generated any revenue from
product sales. The ability of the Company to complete the necessary
clinical trials and obtain FDA approval for the sale of products to be
developed on a commercial basis is uncertain. The Company plans to seek
continued funding of the Company's development by raising additional
capital. It is the opinion of management that sufficient funds will be
available from the Series K convertible debt, other external financing and
additional capital and/or expenditure reductions in order to meet the
Company's liabilities and commitments as they come due during fiscal years
2007 and 2008. Ultimately, the Company must complete the development of
its products, obtain the appropriate regulatory approvals and obtain
sufficient revenues to support its cost structure.
F. COMMITMENTS AND CONTINGENCIES
During fiscal year 2005 the Company was involved in a restatement of the
Company's prior years financials, a time when Deloitte & Touche LLP (D&T)
was the Company's auditor. For its work in the restatement D&T presented
the Company with an invoice of approximately $350,000 in October 2006. In
prior discussions with D&T the Company's Audit Committee had repeatedly
requested detailed information regarding this bill which D&T failed to
give. The Company's Audit Committee and Board of Directors are unable to
review the appropriateness of this invoice without the detailed
information that it has repeatedly requested. This invoice was not
included in the Company's liabilities because the Company does not believe
that it represents a real claim against the Company.
G. SUBSEQUENT EVENTS
In January 2007 the Company received a "no objection" letter from the FDA
indicating that it could proceed with the Phase III protocol with
Multikine in head & neck cancer patients. The protocol for the Phase III
clinical trial was designed to develop conclusive evidence of the safety
and efficacy of Multikine in the treatment of advanced primary squamous
cell carcinoma of the oral cavity. The Company had previously received a
"no objection" letter from the Canadian Biologics and Genetic Therapies
Directorate which enabled the Company to begin its Phase III clinical
trial in Canada.
17
On January 22, 2007, the Company announced that it has signed
a letter of intent with a privately held real estate firm specialized in
the biomedical sector to acquire and build out to the Company's
specifications a turn-key cGMP (current good manufacturing practices) drug
manufacturing facility for the Company's cancer product. This
manufacturing facility is an integral part of moving Multikine into the
Phase III clinical trial and later commercialization. The commitment by
the real estate firm, subject to a final contract, is for $15 million. The
facility is expected to cost about $12-14 million, to be paid through a
long-term lease agreement.
On January 23, 2007, the Company entered into an agreement
with a public relations consulting firm. Per the terms of the agreement
the consultant received 200,000 shares of restricted stock on January 29,
2007. In addition, on April 1, 2007 and June 1, 2007 the consultant will
receive 105,000 and 85,000 shares of restricted stock, respectively.
18
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 .....................................
Market for CEL-SCI's Common Stock...........................
Management's Discussion and Analysis of
Financial Condition and Results of Operations.............
Business....................................................
Management..................................................
Principal Shareholders .....................................
Selling Shareholders and Plan of Distribution ..............
Description of Securities ..................................
Experts ....................................................
Indemnification ............................................
Additional Information .....................................
Financial Statements .......................................
Common stock
CEL-SCI CORPORATION
PROSPECTUS
PART II
Information Not Required in Prospectus
Item 13. Other Expenses of Issuance and Distribution
-------------------------------------------
SEC Filing Fee $ 4,046
Legal Fees and Expenses 20,000
Accounting Fees and Expenses 10,000
Miscellaneous Expenses 5,954
--------
TOTAL $ 40,000
========
All expenses other than the SEC filing fees are estimated.
Item 14. Indemnification of Officers and Directors.
Section 7-109-102 of the Colorado Revised Statutes and CEL-SCI's Bylaws
provides that CEL-SCI may indemnify any and all of its officers, directors,
employees or agents or former officers, directors, employees or agents, against
expenses actually and necessarily incurred by them, in connection with the
defense of any legal proceeding or threatened legal proceeding, except as to
matters in which such persons shall be determined to not have acted in good
faith and in the best interest of CEL-SCI.
Item 15. Recent Sales of Unregistered Securities.
----------------------------------------
The following table lists all unregistered sales of CEL-SCI's common stock
during the past three years.
Number of
Shareholder Date Issued Shares Consideration
----------- ----------- ---------- -------------
Riverview Group LLC 5/04/04 6,402,439 $5,250,000
Patricia Prichep 9/15/04 5,860 3,633
Eyal Talor 9/15/04 7,724 4,789
Daniel Zimmerman 9/15/04 5,927 3,675
W. Brooke Jones 9/15/04 5,539 3,434
Cher Ami Holdings Inc. 7/26/05 1,250,000 500,000
Hilda Maibach 9/21/05 8,687 4,170
Lucci Financial Group, LLC 10/14/05 80,000 36,000
TGR Group LLC 2/01/06 150,000 78,000
Cher Ami Holdings Inc. 2/10/06 2,500,000 1,000,000
SDS Capital Group SPC, Ltd. 3/07/06 121,750 30,438
SDS Capital Group SPC, Ltd. 3/07/06 148,806 37,202
Riviera Ventures 4/01/06 375,000 273,750
SDS Capital Group SPC, Ltd. 4/10/06 237,418 59,355
SDS Capital Group SPC, Ltd. 4/10/06 290,177 72,544
Eastern Biotech 4/17/06 700,000 329,000
1
Number of
Shareholder Date Issued Shares Consideration
----------- ----------- ---------- -------------
Cher Ami Holdings Inc. 5/15/06 600,000 $336,000
Cher Ami Holdings Inc. 6/09/06 25,000 *
Cher Ami Holdings Inc. 7/10/06 50,000 *
Cher Ami Holdings Inc. 8/04/06 50,000 *
Riviera Ventures 8/04/06 3,750 *
Cher Ami Holdings Inc. 9/05/06 50,000 *
Riviera Ventures 9/05/06 7500 *
Maximilian de Clara 9/25/06 317,460 Services rendered
and valued at
$200,000
Riviera Ventures 9/29/06 375,000 Consulting services
valued at $232,500
Cher Ami Holdings Inc. 10/02/06 50,000 *
Riviera Ventures 10/02/06 7,500 *
Cher Ami Holdings Inc. 11/03/06 50,000 *
Riviera Ventures 11/03/06 7,500 *
Riviera Ventures 12/01/06 7,500 *
Cher Ami Holdings Inc. 12/11/06 50,000 *
Riviera Ventures 1/02/07 7,500 *
Cher Ami Holdings Inc. 1/10/07 50,000 *
Riviera Ventures 2/02/07 7,500 *
Riviera Ventures 3/02/07 7,500 *
Riviera Ventures, Inc. 4/03/07 375,000 Consulting services
IT International 4/03/07 500,000 Consulting services
Ozal Ltd. 4/03/07 2,000,000 Consulting services
APE invest A/S 4/18/07 2,000,000 $1,500,000
Notabene.net A/S 4/18/07 133,333 $ 100,000
Handelsbanken A/S 4/18/07 1,200,000 $ 900,000
Eric Damgaard Portef0lje Invest A/S 4/18/07 666,667 $ 500,000
Finn Helmer 4/18/07 1,333,333 $1,000,000
KBUS 8, nr. 2051 Aps 4/18/07 1,333,333 $1,000,000
Ardent Holding 4/18/07 666,667 $ 500,000
Fundamental Fondsmaeglerselskab 4/18/07 1,333,333 $1,000,000
Sydbank A/S 4/18/07 2,000,000 $1,500,000
DKA Consult APS 4/18/07 1,333,333 $1,000,000
MCS Holding Aps 4/18/07 792,400 $ 594,300
Kgs. Nytorv 21 Aps 4/18/07 2,000,000 $1,500,000
Ole Trist 4/18/07 100,000 $ 75,000
Forstaedernes Bank A/S 4/18/07 40,933 $ 30,700
Synerco ApS 4/18/07 133,333 $ 100,000
Soren Degn 4/18/07 133,333 $ 100,000
Sparekassen Kronjylland A/S 4/18/07 800,000 $ 600,000
UBS Luxembourg SA 4/18/07 1,333,333 $1,000,000
Landsbanki Luxembourg SA 4/18/07 2,666,667 $2,000,000
2
Number of
Shareholder Date Issued Shares Consideration
----------- ----------- ---------- -------------
Iroquois Master Fund Ltd. 4/18/07 33,333 $ 25,000
RAQ LLC 4/18/07 10,000 $ 7,500
* Penalty for not having registration statement effective within time required
by agreement.
Item 16. Exhibits
--------
3(a) Articles of Incorporation Incorporated by reference to Exhibit
3(a) of CEL-SCI's combined
Registration Statement on Form S-1
and Post-Effective Amendment
("Registration Statement"),
Registration Nos. 2-85547-D and
33-7531.
(b) Amended Articles Incorporated by reference to Exhibit
3(a) of CEL-SCI's Registration
Statement on Form S-1, Registration
Nos. 2-85547-D and 33-7531.
(c) Amended Articles Filed as Exhibit 3(c) to CEL-SCI's
(Name change only) Registration Statement on Form S-1
Registration Statement (No.
33-34878).
(d) Bylaws Incorporated by reference to
Exhibit 3(b) of CEL-SCI's
Registration Statement on Form S-1,
Registration Nos. 2-85547-D and
33-7531.
5. Opinion of Counsel
10(d) Employment Agreement with Incorporated by reference to Exhibit
Maximilian de Clara 10(d) of CEL-SCI's report on Form 8-K
(dated April 21, 2005) and Exhibit
10(d) to CEL-SCI's report on Form 8-K
dated September 8, 2006.
10(e) Employment Agreement with Incorporated by reference to Exhibit
Geert Kersten 10(e) of CEL-SCI's Registration
Statement on Form S-3 (Commission File
#106879) and Exhibit 10(c) to
CEL-SCI's report on Form 8-K dated
September 8, 2006.
3
10(g) Securities Purchase Agreement Incorporated by reference to Exhibit 10
(together with schedule to CEL-SCI's Report on Form 8-K dated
required by Instruction 2 to August 4, 2005.
Item 601 of Regulation S-K)
pertaining to Series K notes
and warrants, together with the
exhibits to the Securities
Purchase Agreement.
10(h) Subscription Agreement (together Incorporated by reference to Exhibit 10
with schedule required by to CEL-SCI's Report on Form 8-K dated
Instruction 2 to Item 601 of April 25, 2007.
Regulation S-K).
10(i) Form of Series L Warrant. Incorporated by reference to Exhibit
10.2 to CEL-SCI's Report on Form 8-K
dated April 25, 2007.
10(j) Form of Series M Warrant. Incorporated by reference to Exhibit
10.3 to CEL-SCI's Report on Form 8-K
dated April 25, 2007.
23(a) Consent of Hart & Trinen ______________________________
(b) Consent of BDO Seidman LLP ______________________________
Item 17. Undertakings.
------------
The undersigned Registrant hereby undertakes:
(1) To file, during any period in which offers or sales are being made, a
post-effective amendment to this Registration Statement.
(i) To include any prospectus required by Section l0(a)(3) of the
Securities Act of l933;
(ii) To reflect in the prospectus any facts or events arising after
the effective date of the Registration Statement (or the most recent
post-effective amendment thereof) which, individually or in the aggregate,
represent a fundamental change in the information set forth in the Registration
Statement;
(iii) To include any material information with respect to the plan
of distribution not previously disclosed in the Registration Statement or any
material change to such information in the Registration Statement, including
(but not limited to) any addition or deletion of a managing underwriter.
(2) That, for the purpose of determining any liability under the
Securities Act of l933, each such post-effective amendment shall be deemed to be
a new registration statement relating to the securities offered therein, and the
4
offering of such securities at that time shall be deemed to be the initial bona
fide offering thereof.
(3) To remove from registration by means of a post-effective amendment
any of the securities being registered which remain unsold at the termination of
the offering.
Insofar as indemnification for liabilities arising under the Securities
Act of l933 may be permitted to directors, officers and controlling persons of
the Registrant, the Registrant has been advised 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. In the event that a
claim for indemnification against such liabilities (other than the payment by
the Registrant of expenses incurred or paid by a director, officer or
controlling person of the Registrant in the successful defense of any action,
suit or proceeding) is asserted by such director, officer or controlling person
in connection with the securities being registered, the Registrant will, unless
in the opinion of its counsel the matter has been settled by controlling
precedent, submit to a court of appropriate jurisdiction the question of whether
such indemnification by it is against public policy as expressed in the Act and
will be governed by the final adjudication of such issue.
5
POWER OF ATTORNEY
The registrant and each person whose signature appears below hereby
authorizes the agent for service named in this Registration Statement, with full
power to act alone, to file one or more amendments (including post-effective
amendments) to this Registration Statement, which amendments may make such
changes in this Registration Statement as such agent for service deems
appropriate, and the Registrant and each such person hereby appoints such agent
for service as attorney-in-fact, with full power to act alone, to execute in the
name and in behalf of the Registrant and any such person, individually and in
each capacity stated below, any such amendments to this Registration Statement.
SIGNATURES
Pursuant to the requirements of the Securities Act of l933, the Registrant
certifies that it has reasonable grounds to believe that it meets all the
requirements for filing on Form S-1 and has duly caused this Registration
Statement to be signed on its behalf by the undersigned, thereunto duly
authorized, in the City of Vienna, Commonwealth of Virginia, on the 30th day of
April 2007.
CEL-SCI CORPORATION
By: /s/ Maximilian de Clara
------------------------------------
Maximilian de Clara, President
Pursuant to the requirements of the Securities Act of l933, this
Registration Statement has been signed by the following persons in the
capacities and on the dates indicated.
Signature Title Date
--------- ----- ----
/s/ Maximilian de Clara Director and Principal April 30, 2007
------------------------ Executive Officer
Maximilian de Clara
/s/ Geert R. Kersten Director, Principal April 30, 2007
------------------------ Financial Officer, Principal
Geert R. Kersten Accounting Officer and Chief
Executive Officer
------------------------ Director
Alexander G. Esterhazy
/s/ C. Richard Kinsolving
------------------------ Director April 30, 2007
C. Richard Kinsolving, Ph.D.
/s/ Peter R. Young
------------------------ Director April 30, 2007
Peter R. Young, Ph.D.
CEL-SCI CORPORATION
REGISTRATION STATEMENT ON
FORM S-1
EXHIBITS