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): September 24,
2010
ADVAXIS,
INC.
(Exact
name of registrant as specified in its charter)
Delaware
(State or
other jurisdiction of incorporation)
|
00028489
|
02-0563870
|
|
(Commission
File Number)
|
(IRS
Employer Identification Number)
|
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))
Item
7.01 Regulation FD Disclosure.
On
September 24, 2010, Advaxis, Inc. (the “Company”) issued a press release
regarding its operations. A copy of such press release is furnished as Exhibit
99.1 to this Current Report on Form 8-K. Pursuant to the rules and regulations
of the Securities and Exchange Commission, such exhibit and the information set
forth therein are deemed to have been furnished and shall not be deemed to be
“filed” under the Securities Exchange Act of 1934.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits.
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Exhibit No.
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Description
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|
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99.1
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Press
Release of Advaxis, Inc., dated September 24,
2010
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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: September
24, 2010
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Advaxis,
Inc.
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|
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By:
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/S/ Mark J. Rosenblum
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|
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Mark
J. Rosenblum
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||
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Chief
Financial Officer and
Secretary
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EXHIBIT
INDEX
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Exhibit No.
|
Description
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|
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99.1
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Press
Release of Advaxis, Inc., dated September 24,
2010
|
Exhibit
99.1
Advaxis
Chairman and CEO Issues Statement to Shareholders
Investor Conference Call on Tuesday,
September 28, 2010
Time: 12:30 pm EDT | Dial-in: (218)
862-6400 | Code: 3460141 #
RSVP by 11:00 am EDT, Monday,
September 27, 2010 to: ceo@advaxis.com
Press Release Source: Advaxis,
Inc. On Friday September 24, 2010, 3:49 pm
NORTH
BRUNSWICK, N.J.--(BUSINESS WIRE)—Thomas A. Moore, chairman and CEO of Advaxis,
Inc., (OTCBB:
ADXS - News), the live, attenuated Listeria monocytogenes (Listeria) immunotherapy
company, issued the following statement to shareholders Friday, September 24,
2010:
Dear
Fellow Shareholders,
Over the past three days, the
Company received numerous calls concerning the atypical volatility in our share
price, as of late. We
have experienced a significant reduction in price with some very high
volume. Naturally,
shareholders are concerned that there may be some major new development with our
business that may be responsible for this movement. I am writing to assure you, as
Advaxis’ Chairman, CEO and a fellow shareholder, that this is not the
case. Please let me
explain:
Our U.S. phase II cervical
dysplasia study is on
track. The first three
patient cohort is complete with all three dose regimen having had with no side
effects in any patient. Recruitment of the next cohort of
seven is slated for completion over the next 30-45 days with the first dosing
leg expected to be reported by next September 2011 as promised. This market is extremely important
to Advaxis as cervical dysplasia is diagnosed in approximately 500,000 women
annually in the U.S. alone. This is more than prostate and
breast cancer, combined.
The 110 patient Phase II
cervical cancer
study in India should
be underway within weeks. The doses are already at the centers
in India and are ready to go with government testing of our product to be
completed next week. And, as announced at our Annual
Meeting, we expect to begin reporting survival data this coming Spring of
2011. If we match our
Phase I results but this time using three doses instead of two, we will create a
true milestone in the treatment of cancer.
The
U.S. National Cancer Institute
study in cervical cancer, a 63 patient trial and the Cancer Research U.K. studies in Head
and Neck cancer are funded and should be underway, soon.
We also are progressing nicely with
our new research work. Our veterinary programs at the
University of Pennsylvania in canine osteosarcoma and the Department of Homeland
Security research with bovine hoof and
mouth are moving
forward..
We have also been extremely diligent
in building our patent portfolio as evidenced in the flurry of new patents
recently approved. Today, we have 29 patents issued
with another 40 in the process. We believe our portfolio is already
extremely comprehensive and being built for the long haul. In short, your Company is moving
forward, as expected, across a broad range of fronts.
So why the recent stock
activity? We believe,
but cannot know for sure, it may be related to recent financing activity. As we
reported, in our 10-Q, 9.8 million common shares were issued in August and other
activity is going on. This could cause additional trading activity in shares of
our stock.
Thanks
for your continuing support,
Thomas A
Moore
Chairman
and CEO
Advaxis,
Inc.
For
further information on the information discussed in this press release, all
readers are encouraged to refer to Advaxis’ most recent Form 10-Q filed on
September 14, 2010. This SEC filing and all company filing can be viewed and/or
downloaded from the U.S. Securities and Exchange Commission’s website (www.sec.gov).
There
will be conference call, Tuesday, September 28, 2010
at 12:30 p.m. EDT to
openly field questions about this press release. All those interested in
participating in the call are welcome to RSVP us at ceo@advaxis.com by
5:00 p.m. EDT, Monday, September 27, 2010. Although we would like to accommodate
all shareholders, please be mindful the available bridge lines are limited.
Please RSVP as soon as practicable. The call will also be recorded and posted on
our website www.advaxis.com and
our corporate portal on facebook by
Wednesday, September 29, 2010 before Market open.”
About
Advaxis, Inc.
Advaxis
is a biotechnology company developing proprietary, live, attenuated Listeria monocytogenes (Listeria) vaccines that
deliver engineered tumor antigens, which stimulate multiple, simultaneous
immunological mechanisms to fight cancer. Today, the Company has nine (9)
distinct, cancer-fighting constructs in various stages of development, directly
and through strategic collaborations with such recognized sites of excellence as
the City of
Hope, the Roswell Park Cancer
Institute, the National Cancer
Institute, the University of
Pittsburgh, Cancer Research – UK
and the U.S.
Department of Homeland Security. Advaxis’ technology was developed by Dr.
Yvonne Paterson, professor of microbiology at the University of Pennsylvania and
chairperson of Advaxis’ scientific advisory board.
Please
visit the Company’s portals: advaxis.com | facebook
| twitter
| LinkedIn
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.
Contact:
Advaxis,
Incorporated
Conrad F.
Mir, 732-545-1590
Executive
Director
732-545-1084
(FAX)
mir@advaxis.com
or
Diana
Moore, 732-545-1590
Analyst
732-545-1084
(FAX)
dmoore@advaxis.com