UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
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FORM 8-K
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CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): April 11, 2014
CEL-SCI CORPORATION
(Exact name of registrant as specified in its charter)
Colorado 001-11889 84-0916344
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(State or other jurisdiction (Commission File No.) (IRS Employer
of incorporation) Identification No.)
8229 Boone Blvd. #802
Vienna, VA 22182
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(Address of principal executive offices, including Zip Code)
Registrant's telephone number, including area code: (703) 506-9460
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N/A
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(Former name or former address if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligations of the registrant under any of the
following provisions:
[ ] Written communications pursuant to Rule 425 under the Securities Act
(17CFR 230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17
CFR 240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the
Exchange Act (17 CFR 240.14d-2(b)
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the
Exchange Act (17 CFR 240.13e-14c))
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Item 8.01 Other Events.
On April 11, 2014, the Company issued a press release announcing the
Company's intention to offer, subject to market and other conditions, shares of
Company common stock and warrants in an underwritten public offering pursuant to
its existing shelf registration statement. Dawson James Securities, Inc. and
Laidlaw & Company (UK) Ltd. are the underwriters for the offering. A copy of
this press release is attached as Exhibit 99.1.
On April 11, 2014, the Company filed with the Securities and Exchange
Commission a preliminary prospectus supplement to its effective shelf
registration statement on Form S-3 (the "Preliminary Prospectus Supplement")
pursuant to Rule 424 under the Securities Act of 1933, as amended, relating to
its proposed public offering of shares of the common stock and warrants. The
Preliminary Prospectus Supplement contains certain supplemental and revised
disclosure regarding the Company's business in the sections entitled "Prospectus
Supplement Summary" and "Risk Factors" which are attached as Exhibit 99.2 and
incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit
Number Description
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99.1 Press release dated April 11, 2014 regarding the launch of a
proposed public offering
99.2 Selected sections the Company's Preliminary Prospectus Supplement
dated April 11, 2014.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
Date: April 11, 2014
CEL-SCI CORPORATION
By: /s/ Patricia B. Prichep
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Patricia B. Prichep
Senior Vice President of Operations
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EXHIBIT 99.1
CEL-SCI CORPORATION NEWS RELEASE
8229 Boone Boulevard, Suite 802 COMPANY CONTACT:
Vienna, VA 22182. USA Gavin de Windt
Telephone (703) 506-9460 CEL-SCI Corporation
www.cel-sci.com (703) 506-9460
CEL-SCI CORPORATION ANNOUNCES PROPOSED PUBLIC OFFERING OF
COMMON STOCK AND SIX MONTH WARRANTS
Vienna, VA, April 11, 2014 - CEL-SCI Corporation (NYSE MKT: CVM), a late-stage
oncology company, today announced that it intends to offer and sell common stock
and six month warrants in a "best efforts" underwritten public offering. The
offering is subject to market conditions, and there can be no assurance as to
whether or when the offering may be completed.
Dawson James Securities, Inc, and Laidlaw & Company (UK) Ltd. are acting as
joint book-running managers and underwriters for the proposed offering.
A shelf registration statement and accompanying base prospectus on Form S-3
relating to the securities was filed with the Securities and Exchange Commission
and is effective. The offering may be made only by means of a prospectus, copies
of which may be obtained, when available, from the offices of Laidlaw & Company
(UK) Ltd., 546 Fifth Avenue, 5th Floor, New York, NY, 10036, telephone:
212-953-4900, or from Dawson James Securities, 1 North Federal Highway, Suite
500, Boca Raton, FL 33432, telephone: 561-391-5555.
This press release shall not constitute an offer to sell or the solicitation of
an offer to buy these securities, nor shall there be any sale of these
securities in any jurisdiction in which such offer, solicitation or sale would
be unlawful prior to the registration or qualification under the securities laws
of any such jurisdiction.
About CEL-SCI Corporation
CEL-SCI is dedicated to research and development directed at improving the
treatment of cancer and other diseases by utilizing the immune system, the
body's natural defense system. Its lead investigational therapy is Multikine
(Leukocyte Interleukin, Injection), currently being studied in a pivotal global
Phase III clinical trial. CEL-SCI is also investigating an immunotherapy
(LEAPS-H1N1-DC) as a possible treatment for H1N1 hospitalized patients and as a
vaccine (CEL-2000) for Rheumatoid Arthritis (currently in preclinical testing)
using its LEAPS technology platform. The investigational immunotherapy
LEAPS-H1N1-DC treatment involves non-changing regions of H1N1 Pandemic Flu,
Avian Flu (H5N1), and the Spanish Flu, as CEL-SCI scientists are very concerned
about the possible emergence of a new more virulent hybrid virus through the
combination of H1N1 and Avian Flu, or maybe Spanish Flu. The Company has
operations in Vienna, Virginia, and in/near Baltimore, Maryland.
*Multikine is the trademark that CEL-SCI has registered for this investigational
therapy, and this proprietary name is subject to FDA review in connection with
its future anticipated regulatory submission for approval. Multikine has not
been licensed or approved for sale, barter or exchange by the FDA or any other
regulatory agency. Similarly, its safety or efficacy has not been established
for any use. Moreover, no definitive conclusions can be drawn from the
early-phase, clinical-trials data involving the investigational therapy
Multikine (Leukocyte Interleukin, Injection). Further research is required, and
early-phase clinical trial results must be confirmed in the well-controlled,
Phase III clinical trial of this investigational therapy that is currently in
progress.
Safe Harbor Statement
When used in this release, the words "intends," "believes," "anticipated" and
"expects" and similar expressions are intended to identify forward-looking
statements. Forward-looking statements include, without limitation, the
company's ability to complete the proposed public offering of its common stock
and warrants described above. Such statements are subject to risks and
uncertainties which could cause actual results to differ materially from those
projected. The Company undertakes no obligation to publicly release the result
of any revision to these forward-looking statements which may be made to reflect
the events or circumstances after the date hereof or to reflect the occurrence
of unanticipated events.
EXHIBIT 99.2
PROSPECTUS SUPPLEMENT SUMMARY
This summary highlights certain information about us, this offering and
information appearing elsewhere in this prospectus supplement, in the
accompanying prospectus and in the documents we incorporate by reference. This
summary is not complete and does not contain all of the information that you
should consider before investing in our securities. To fully understand this
offering and its consequences to you, you should read this entire prospectus
supplement and the accompanying prospectus carefully, including the information
referred to under the heading "Risk Factors" in the accompanying prospectus and
set forth herein, the financial statements and other information incorporated by
reference in this prospectus supplement and the accompanying prospectus when
making an investment decision.
About CEL-SCI Corporation
We were formed as a Colorado corporation in 1983. Our principal office is
located at 8229 Boone Boulevard, Suite 802, Vienna, VA 22182. Our telephone
number is 703-506-9460 and our web site is www.cel-sci.com. The information on
our website is not part of this prospectus.
Our business consists of the following:
1) Multikine(R) (Leukocyte Interleukin, Injection) investigational
immunotherapy against cancer and Human Papilloma Virus (HPV);
2) LEAPS technology, with two investigational therapies, LEAPS-H1N1-DC
pandemic flu treatment for hospitalized patients and CEL-2000, a
rheumatoid arthritis treatment vaccine.
MULTIKINE
Our lead investigational therapy, Multikine, is currently being developed
as a potential therapeutic agent directed at using the immune system to produce
an anti-tumor immune response. Data from Phase I and Phase II clinical trials
suggest that Multikine simulates the activities of a healthy person's immune
system, enabling it to use the body's own anti-tumor immune response. Multikine
(Leukocyte Interleukin, Injection) is the full name of this investigational
therapy, which, for simplicity, is referred to in the remainder of this document
as Multikine. Multikine is the trademark that we have registered for this
investigational therapy, and this proprietary name is subject to FDA review in
connection with our future anticipated regulatory submission for approval.
Multikine has not been licensed or approved for sale, barter or exchange by the
FDA or any other regulatory agency. Neither has its safety or efficacy been
established for any use.
Multikine has been cleared by the regulators in twelve countries around
the world, including the U.S. FDA, for a global Phase III clinical trial in
advanced primary (not yet treated) head and neck cancer patients. The trial is
currently under the management of two new clinical research organizations (CROs)
who are adding approximately 60 clinical centers in existing and new countries
to increase the speed of patient enrollment.
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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.
The primary clinical endpoint in CEL-SCI's ongoing Phase III clinical
trial is that a 10% improvement in overall survival in the Multikine treatment
arm, plus the current standard of care (SOC - consisting of surgery +
radiotherapy or surgery + radiochemotherapy), over that which can be achieved in
the SOC arm alone (in the well-controlled Phase III clinical trial currently
ongoing) must be achieved. Based on what is presently known about the current
survival statistics for this population, CEL-SCI believes that achievement of
this endpoint should enable CEL-SCI, subject to further consultations with FDA,
to move forward, prepare and submit a Biologic License Application to FDA for
Multikine.
The clinical trial involves giving Multikine to cancer patients prior to
their receiving any conventional treatment for cancer, including surgery,
radiation and/or chemotherapy. This could be shown to be important because
conventional therapy may weaken the immune system, and may compromise the
potential effect of immunotherapy. Because Multikine is given before
conventional cancer therapy, when the immune system may be more intact, we
believe the possibility exists for it to have a greater likelihood of activating
an anti-tumor immune response under these conditions. This likelihood is one of
the clinical aspects being evaluated in the ongoing global Phase III clinical
trial.
Multikine is a different kind of investigational therapy in the fight
against cancer. Multikine is a defined mixture of cytokines. It is a combination
immunotherapy, possessing both active and passive properties.
In October 2012 and again in November 2013, in an interim review of the
safety data from the Phase III study, an Independent Data Monitoring Committee
(IDMC) raised no safety concerns. The IDMC also indicated that no safety signals
were found that would call into question the benefit/risk of continuing the
study. CEL-SCI considers the results of the IDMC review to be important since
studies have shown that up to 30% of Phase III trials fail due to safety
considerations and the IDMC's safety findings from this interim review were
similar to those reported by investigators during CEL-SCI's Phase I-II trials.
Ultimately, the decision as to whether a drug is safe is made by the FDA based
on an assessment of all of the data from a trial.
On October 7, 2013, CEL-SCI announced a Cooperative Research and
Development Agreement with the U.S. Naval Medical Center, San Diego. Pursuant to
this agreement, the Naval Medical Center will conduct Human Subjects
Institutional Review Board approved Phase I study of CEL-SCI's investigational
immunotherapy, Multikine, in HIV/HPV co-infected men and women with peri-anal
warts. Anal and genital warts are commonly associated with the Human Papilloma
Virus, the most common sexually transmitted disease. Men and women with a
history of anogenital warts have a 30 fold increased risk of anal cancer.
Persistent HPV infection in the anal region is thought to be responsible for up
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to 80% of anal cancers. HPV is a significant health problem in the HIV infected
population as individuals are living longer as a result of greatly improved HIV
medications.
The purpose of this study is to evaluate the safety and clinical impact of
Multikine as a treatment of peri-anal warts and assess its effect on anal
intraepithelial dysplasia (AIN) in HIV/HPV co-infected men and women.
CEL-SCI will contribute the investigational study drug Multikine, will
retain all rights to any currently owned technology, and will have the right to
exclusively license any new technology developed from the collaboration.
Multikine is being given to the HIV/HPV co-infected patients with
peri-anal warts since promising early results were seen in another Institutional
Review Board approved Multikine Phase I study conducted at the University of
Maryland. In this study, investigational therapy Multikine was given to HIV/HPV
co-infected women with cervical dysplasia resulting in visual and histological
evidence of clearance of lesions. Furthermore, elimination of a number of HPV
strains was determined by in situ polymerase chain reaction (PCR) performed on
tissue biopsy collected before and after Multikine treatment. As reported by the
investigators in the earlier study, the study volunteers all appeared to
tolerate the treatment with no reported serious adverse events.
The treatment regimen for the study of up to 15 HIV/HPV co-infected
patient volunteers with peri-anal warts to be conducted by the Naval Medical
Center will be identical to the regimen that was used in the earlier Multikine
cervical study in HIV/HPV co-infected patients.
In October 2013, CEL-SCI entered into a co-development and profit sharing
agreement with Ergomed for Multikine in HIV/HPV co-infected men and women with
peri-anal warts. This agreement will initially be in support of the development
with the US Navy. Ergomed will assume up to $3 million in clinical and
regulatory costs.
Also in October 2013, CEL-SCI entered into a co-development and profit
sharing agreement with Ergomed for Multikine in HIV/HPV co-infected women with
cervical dysplasia. Human Papilloma Virus (HPV) is the most common sexually
transmitted disease. HPV is a significant health problem in the HIV infected
population as individuals are living longer as a result of greatly improved HIV
medications. People living with HIV and others with compromised immunity are
more at risk for HPV-related complications. Persistent HPV infection can also be
a precursor to cervical cancer. Ergomed will assume up to $3 million in clinical
and regulatory costs.
CEL-SCI's focus in HPV is not the development of an antiviral against HPV
in the general population. Instead it is the development of an immunotherapy to
be used in patients who are immune suppressed by diseases such as HIV and are
therefore less able or unable to control HPV and its resultant diseases. This
group of patients has no good treatments available to them and there are, to the
Company's knowledge, no competitors at the current time. HPV is also relevant to
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the head and neck cancer Phase III study since it is now known that HPV is a
cause of head and neck cancer. Multikine was shown to kill HPV in an earlier
study of HIV infected women with cervical dysplasia.
LEAPS
CEL-SCI's patented T-cell Modulation Process, referred to as LEAPS (Ligand
Epitope Antigen Presentation System), uses "heteroconjugates" to direct the body
to choose a specific immune response. LEAPS is designed to stimulate the human
immune system to more effectively fight bacterial, viral and parasitic
infections as well as autoimmune, allergies, transplantation rejection and
cancer, when it cannot do so on its own. Administered like a vaccine, LEAPS
combines T-cell binding ligands with small, disease associated, peptide antigens
and may provide a new method to treat and prevent certain diseases.
The ability to generate a specific immune response is important because
many diseases are often not combated effectively due to the body's selection of
the "inappropriate" immune response. The capability to specifically reprogram an
immune response may offer a more effective approach than existing vaccines and
drugs in attacking an underlying disease.
Using the LEAPS technology, we have created a potential peptide treatment
for H1N1 (swine flu) hospitalized patients. This LEAPS flu treatment is designed
to focus on the conserved, non-changing epitopes of the different strains of
Type A Influenza viruses (H1N1, H5N1, H3N1, etc.), including "swine", "avian or
bird", and "Spanish Influenza", in order to minimize the chance of viral "escape
by mutations" from immune recognition. Therefore one should think of this
treatment not really as an H1N1 treatment, but as a pandemic flu treatment.
CEL-SCI's LEAPS flu treatment contains epitopes known to be associated with
immune protection against influenza in animal models.
Additional work on this treatment for the pandemic flu work is being
pursued in collaboration with the National Institute of Allergy and Infectious
Diseases (NIAID), part of the National Institutes of Health, USA. In May 2011
NIAID scientists presented data at the Keystone Conference on "Pathogenesis of
Influenza: Virus-Host Interactions" in Hong Kong, China, showing the positive
results of efficacy studies in mice of L.E.A.P.S. H1N1 activated dendritic cells
(DCs) to treat the H1N1 virus. Scientists at the NIAID found that H1N1-infected
mice treated with LEAPS-H1N1 DCs showed a survival advantage over mice treated
with control DCs. The work was performed in collaboration with scientists led by
Kanta Subbarao, M.D., Chief of the Emerging Respiratory Diseases Section in
NIAID's Division of Intramural Research, part of the National Institutes of
Health, USA.
In July 2013, CEL-SCI announced the publication of the results of
additional influenza studies by researchers from the NIAID in the Journal of
Clinical Investigation (www.jci.org/articles/view/67550). The studies described
in the publication show that when CEL-SCI's investigational J-LEAPS Influenza
Virus treatments were used "in vitro" to activate immune cells called dendritic
cells (DCs), these activated dendritic cells, when injected into influenza
infected mice, arrested the progression of lethal influenza virus infection in
these mice. The work was performed in the laboratory of Dr. Subbarao.
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With our LEAPS technology, we have also developed a second peptide named
CEL-2000, a potential rheumatoid arthritis vaccine. The data from animal studies
of rheumatoid arthritis using the CEL-2000 treatment vaccine demonstrated that
CEL-2000 is an effective treatment against arthritis with fewer administrations
than those required by other anti-rheumatoid arthritis treatments, including
Enbrel(R). CEL-2000 is also potentially a more disease type-specific therapy, is
calculated to be significantly less expensive, and may be useful in patients
unable to tolerate or who may not be responsive to existing anti-arthritis
therapies.
RISK FACTORS
Investing in our common stock and warrants involves significant risks. You
should carefully consider the "Risk Factors" included and incorporated by
reference in the accompanying prospectus, this prospectus supplement and any
other applicable prospectus supplement, including the risk factors incorporated
by reference from our most recent Annual Report on Form 10-K for the fiscal year
ended September 30, 2013, as updated by our Quarterly Report on Form 10-Q for
the period ended December 31, 2013 and our other filings with the SEC, filed
after the Annual Report. The risks and uncertainties we described are not the
only ones facing us. Additional risks not presently known to us, or that we
currently deem immaterial, may also impair our business operations. If any of
these risks were to occur, our business, financial condition, or result of
operations would likely suffer. In that event, the trading price of our common
stock would decline, and you could lose all or part of your investment.
Management will have broad discretion as to the use of the proceeds of this
offering.
We currently intend to use the net proceeds from this offering for our
Phase III clinical trial, other research and development, and general and
administrative expenses. See "Use of Proceeds" on page 12. We have not
designated the amount of net proceeds we will receive from this offering for any
particular purpose. Accordingly, our management will have broad discretion as to
the application of these net proceeds and could use them for purposes other than
those contemplated at the time of this offering. You will be relying on the
judgment of our management with regard to the use of these net proceeds, and you
will not have the opportunity, as part of your investment decision, to assess
whether the net proceeds are being used appropriately. It is possible that the
net proceeds will be invested in a way that does not yield a favorable, or any,
return for us. The failure of our management to use such funds effectively could
have a material adverse effect on our business, financial condition, operating
results and cash flow.
You will experience immediate and substantial dilution.
Since the offering price of the securities offered pursuant to this
prospectus supplement and the accompanying prospectus is higher than the net
tangible book value per share of our common stock, you will suffer substantial
dilution in the net tangible book value of the common stock you purchase in this
offering. After giving effect to the sale of __________ shares of common stock
and _____ warrants in this offering at the public offering price shown on the
cover page of this prospectus, and after deducting estimated underwriting
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commissions and estimated offering expenses payable by us, if you purchase
securities in this offering, you will suffer immediate and substantial dilution
of approximately $___ per share in the net tangible book value of the common
stock you acquire. See the "Dilution" section of this prospectus supplement for
a more detailed discussion of the dilution you will incur if you purchase
securities in this offering.
You may experience future dilution as a result of future equity offerings or
other equity issuances.
We expect that significant additional capital will be needed in the future
to continue our planned operations. To raise additional capital, we may in the
future offer additional shares of our common stock or other securities
convertible into or exchangeable for our common stock. We cannot assure you that
we will be able to sell shares or other securities in any other offering at a
price per share that is equal to or greater than the price per share paid by
investors in this offering. The price per share at which we sell additional
shares of our common stock or other securities convertible into or exchangeable
for our common stock in future transactions may be higher or lower than the
price per share in this offering. To the extent we raise additional capital by
issuing equity securities, our stockholders may experience substantial dilution.
If we sell common stock, convertible securities or other equity securities, your
investment in our common stock will be diluted. These sales may also result in
material dilution to our existing shareholders, and new investors could gain
rights superior to our existing shareholders.
Our outstanding options and warrants may adversely affect the trading price of
our common stock.
As of March 31, 2014, there were outstanding options which allows the
holders to purchase approximately 6,000,000 shares of our common stock, at
prices ranging between $0.85 and $20.00 per share, outstanding warrants which
allow the holders to purchase approximately 35,132,000 shares of our common
stock, at prices ranging between $0.53 and $17.50 per share, and a convertible
note which allows the holder to acquire approximately 276,000 shares of our
common stock at a conversion price of $4.00. The outstanding options and
warrants could adversely affect our ability to obtain future financing or engage
in certain mergers or other transactions, since the holders of options and
warrants can be expected to exercise them at a time when we may be able to
obtain additional capital through a new offering of securities on terms more
favorable to us than the terms of the outstanding options and warrants. For the
life of the options, warrants and the convertible note, the holders have the
opportunity to profit from a rise in the market price of our common stock
without assuming the risk of ownership. The issuance of shares upon the exercise
of outstanding options and warrants, or the conversion of the note, will also
dilute the ownership interests of our existing stockholders.
We may have exposure for certain securities we sold in October 2013.
In September 2012, we filed a shelf registration statement covering the
sale of $50,000,000 of securities (the "2012 Registration Statement"), and in
January 2013 we filed another shelf registration statement covering the sale of
an additional $50,000,000 of securities (the "2013 Registration Statement"). In
October 2013, we filed a prospectus supplement to the 2012 Registration
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Statement for the sale in an underwritten public offering of 17,826,087 shares
of our common stock, 20,475,000 Series S Warrants, as well as up to 20,475,000
shares of common stock issuable upon the exercise of the Series S warrants (the
"October Prospectus"). Collectively, we offered approximately $43.4 million of
securities pursuant to the October Prospectus. This amount includes
approximately $17.8 million for the sale of the common stock and Series S
warrants and $25.6 million upon the exercise of the Series S Warrants. We
subsequently realized that at the time of the October 2013 offering we had
approximately $28.9 million available for issuance under the 2012 Registration
Statement. As a result, we issued securities that were not registered with the
SEC, and that may not have been eligible for an exemption from registration
under the federal or state securities laws. We had securities available under
the 2013 Registration Statement to register all of the securities not covered by
the 2012 Registration Statement. In December 2013, we filed a prospectus
supplement to the 2013 Registration Statement registering the offer and sale of
all of the shares of common stock issuable upon exercise of the Series S
Warrants included in the October 2013 offering to assure that the offering and
sale of all of the shares issuable upon exercise of the Series S Warrants were
registered (the "December Prospectus"). Prior to the filing of the December
Prospectus, no Series S Warrants issued in the October offering had been
exercised. Notwithstanding the above, the actions we have taken to mitigate our
possible non-compliance with securities laws will not prevent regulators from
asserting that we violated the law, from imposing penalties and fines against us
with respect to any potential violations of securities laws, and may subject us
to possible claims for damages from certain investors.
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