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Filed Pursuant to Rule 424(b)(3) and Rule 424(c)
Registration No. 333-162632
December 15, 2009
PROSPECTUS SUPPLEMENT NO. 1
80,671,250 SHARES OF COMMON STOCK
ADVAXIS, INC.
This prospectus supplement amends the prospectus dated November 6, 2009 to allow the selling stockholders named in the prospectus (the “Selling Stockholders”) to resell, from time to time, up to an aggregate of 80,671,250 shares of our common stock issuable upon the exercise of warrants held by the Selling Stockholders.
We will not receive any proceeds from any such sale of these shares. To the extent any of the warrants are exercised for cash, if at all, we will receive the exercise price for those warrants.
This prospectus supplement is being filed to include the information set forth in our Current Report on Form 8-K filed on December 15, 2009, which is set forth below. This prospectus supplement should be read in conjunction with the prospectus dated November 6, 2009 which is to be delivered with this prospectus supplement.
Our common stock is quoted on the Over-The-Counter Bulletin Board, or OTC Bulletin Board, under the symbol ADXS.OB. On December 14, 2009, the last reported sale price per share for our common stock as reported by the OTC Bulletin Board was $0.11.
Investing in our common stock involves a high degree of risk. We urge you to carefully consider the ‘‘Risk Factors’’ beginning on page 9 of the prospectus.
Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or passed upon the adequacy or accuracy of this prospectus. Any representation to the contrary is a criminal offense.
The date of this Prospectus Supplement No. 1 is December 15, 2009.
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON D.C. 20549
_______________________
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported):
December 15, 2009
ADVAXIS, INC.
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction of incorporation)
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00028489
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02-0563870
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(Commission File Number)
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(IRS Employer Identification Number)
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Technology Centre of New Jersey
675 Rt. 1, Suite B113
North Brunswick, N.J. 08902
(Address of principal executive offices)
Registrant’s telephone number, including area code:
(732) 545-1590
Not applicable
(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 obligation of the registrant under any of the following provisions:
¨
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 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-4(c))
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Item 8.01. Other Events.
On December 15, 2009, Advaxis, Inc. (the “Company”) issued a press release regarding its planned collaboration with the National Cancer Institute’s Gynecological Oncology Group in a Phase II clinical trial of the Company’s drug candidate ADXS11-001. A copy of the press release, which is attached as Exhibit 99.1 to this Current Report, is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
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99.1
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Advaxis, Inc. press release, dated December 15, 2009.
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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.
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Dated: December 15, 2009
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Advaxis, Inc.
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By:
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/s/ Thomas A. Moore
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Thomas A. Moore
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Chief Executive Officer
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EXHIBIT
INDEX
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Exhibit
No.
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Document
Description
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99.1
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Advaxis,
Inc. press release, dated December 15,
2009.
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FOR IMMEDIATE
RELEASE
ADVAXIS
ANNOUNCES PHASE II TRIAL COLLABORATION
WITH
THE NATIONAL CANCER INSTITUTE
Gynecologic
Oncology Group to Study ADXS11-001 in Sixty-Patient Study
North Brunswick, NJ - December 15,
2009 -
Advaxis,
Inc.,
(OTCBB:
ADXS)
, the live, attenuated
Listeria monocytogenes
(
Lm
) vaccine company, will
collaborate with the Gynecologic Oncology Group (GOG), a collaborative research
group of the National Cancer Institute (NCI), in a multicenter, Phase II
clinical trial of the Company’s lead drug candidate, ADXS1 1-001 in the
treatment of advanced cervix cancer in women who have failed prior cytotoxic
therapy.
This
Phase II trial will be conducted by GOG investigators and largely underwritten
by the NCI. The study’s patient population – a very sick and rapidly progressive
patient population for whom no therapy has been found to be effective – will be
the same patient population that was treated in Advaxis Phase I trial of ADXS1
1-001.
Advaxis
will contribute the study drug and some funds to the cost of the trial,
including the translational clinical immunology research. Advaxis will update
its IND and file the final protocol with FDA before the study
begins.
In an
Advaxis Phase I clinical trial, it was found that multiple doses of the agent
were safely administered to this patient population at two (2) different dose
levels and that the side effect profile, comprised of a flu-like syndrome, was
consistent with strong immune stimulation. Although this firstin-human
trial was not powered for efficacy, it was observed that the response rate and
survival data compared favorably with historical controls. The new study will
investigate this response with greater statistical power. The Phase I trial
results were published earlier this year in
Vaccine
(
Vaccine
. 2009, 27
3975–3983).
Advaxis
has separately announced its plans of Phase II studies of cervical cancer and
cervical intraepithelial neoplasia (CIN), which are anticipated to begin dosing
shortly.
About
the ADXS11-001 Immunotherapy
ADXS11-001
is a therapeutic vaccine that treats human papilloma virus (H PV) related
tumors. Unlike marketed prophylactic vaccines that require treatment prior to
exposure to the virus, A DX S1 1-001 treats patients who have already developed
cancer as a result of HPV infection. Today, HPV is the most prevalent sexually
transmitted disease in the US and the cause of cervix cancer, 40% of head and
neck cancer, as well as penile, vulvar and anal cancer. Other clinical trials
are planned for this agent in 2010, including a trial in cervical
intraepithelial neoplasia (CIN). For additional information please see
www.advaxis.com.
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Advaxis,
Incorporated
Based in
North Brunswick, New Jersey, Advaxis is developing proprietary
Listeria monocytogenes
(
Lm
) cancer vaccines based on
technology developed by Dr. Yvonne Paterson, professor of microbiology at the
University of Pennsylvania and chairperson of Advaxis’ scientific advisory
board. Advaxis is developing attenuated live
Lm
vaccines that deliver
engineered tumor antigens, which stimulate multiple simultaneous immunological
mechanisms to fight cancer.
In a
recent Advaxis Phase I clinical trial, a live
Lm
vaccine directed against
the tumor-associated antigen HPV-16-E7 was safely administered to fifteen (15)
women with advanced metastatic cancer of the cervix. Although this first trial
of an
Lm
vaccine in
humans was not designed or powered to prove efficacy, Advaxis believes an
efficacy signal was observed that will be further explored in two (2) planned
Phase II trials in the US and India in cervical cancer and its predecessor
condition, cervical intraepithelial neoplasia (CIN). Advaxis now has nine (9)
distinct cancer fighting constructs in various stages of development, both
directly and with academic collaborators. For further information on the
Company, please visit:
www.advaxis.com
.
Forward-Looking
Statements
Certain
statements contained in this press release are forward-looking statements that
involve risks and uncertainties. The statements contained herein that are not
purely historical are forward looking statements within the meaning of Section
27A of the Securities Act of 1933, as amended and Section 21E of the Securities
Exchange Act of 1934, as amended. Forward-looking statements deal with the
Company’s current plans, intentions, beliefs and expectations and statements of
future economic performance. Forward-looking statements involve known and
unknown risks and uncertainties that may cause the Company's actual results in
future periods to differ materially from what is currently anticipated. Factors
that could cause or contribute to such differences include those discussed from
time to time in reports filed by the Company with the Securities and Exchange
Commission. The Company cannot guarantee its future results, levels of activity,
performance or achievements.
For
Further Information:
Conrad
Mir
Director,
Business Development Advaxis, Incorporated
732.545.1590
(Office)
732.545.1084
(FAX)
conradmir@advaxis.com
www.advaxis.com
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