Current Report Filing (8-k)
March 12 2018 - 4:11PM
Edgar (US Regulatory)
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):
March 12, 2018
ADVAXIS,
INC.
(Exact
Name of Registrant as Specified in Charter)
Delaware
|
|
001-36138
|
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02-0563870
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(State
or Other Jurisdiction
of
Incorporation)
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|
(Commission
File
Number)
|
|
(IRS
Employer
Identification
No.)
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305
College Road East
Princeton,
New Jersey, 08540
(Address
of Principal Executive Offices)
(609)
452-9813
(Registrant’s
telephone number, including area code)
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:
[ ]
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Written
communications pursuant to Rule 425 under the Securities Act.
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[ ]
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act.
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[ ]
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Pre-commencement
communications pursuant to Rule 14d-2b under the Exchange Act.
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[ ]
|
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act.
|
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company [ ]
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for
complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.[ ]
On M
arch
12, 2018, Advaxis, Inc. (the “Company”) issued a press release announcing results of operations and providing a
business update for the three months ended January 31, 2018. The Company also announced that on Monday, March 12, 2018 at
4:30 p.m. EST, the Company will host an investor conference call during which the Company will provide a business update and a
brief overview of its financial results. A copy of such press release is being furnished as Exhibit 99.1
.
On March 12, 2018, the
Company announced that it received notification from the U.S. Food and Drug Administration (“FDA”) that its Investigational
New Drug (IND) application for its Phase 1/2 combination study of axalimogene filolisbac with IMFINZI (durvalumab) for the treatment
of patients with advanced, recurrent or refractory human papillomavirus (HPV)-associated cervical cancer and HPV-associated head
and neck cancer was placed on clinical hold. The clinical hold pertains to a recent submission of a safety report to the FDA regarding
a Grade 5 Serious Adverse Event on February 27, 2018 involving respiratory failure which occurred following the sixth combination
cycle in the trial.
Item
9.01. Financial Statements and Exhibits.
(d)
Exhibits.
The
following exhibit is furnished as part of this report:
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed
on its behalf by the undersigned hereunto duly authorized.
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ADVAXIS,
INC.
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(Registrant)
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Date:
March 12, 2018
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By:
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/s/
Sara Bonstein
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Sara
Bonstein
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Executive
Vice President and Chief Financial Officer
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