Current Report Filing (8-k)
February 15 2018 - 4:29PM
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):
February 13, 2018
ADVAXIS,
INC.
(Exact
Name of Registrant as Specified in Charter)
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Delaware
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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)
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(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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[ ]
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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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[ ]
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act.
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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. [ ]
Item
7.01 Regulation FD Disclosure.
A copy of the
press release of the Company, dated February 13, 2018, relating to the announcement discussed in Item 8.01
below is attached hereto as Exhibit 99.1.
The
information provided pursuant to this Item 7.01, including Exhibit 99.1, is “furnished” and shall not
be deemed to be “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the
liabilities of that Section or of Sections 11 and 12(a)(2) of the Securities Act, and shall not be incorporated
by reference into any filing with the SEC made by the Company, whether made before or after the date hereof, regardless
of any general incorporation language in such filing.
Item 8.01
Other Events.
On February
13, 2018, the Company issued a press release announcing the submission of a conditional Marketing Authorization Application
(“MAA”) to the European Medicines Agency (the “EMA”) for the Company’s lead
Lm
Technology
product candidate, axalimogene filolisbac, for the treatment of adult women who progress beyond first-line therapy of persistent,
recurrent or metastatic carcinoma of the cervix (“PRmCC”).
The
MAA submission was built around data from the GOG-0265 study which examined overall survival rates in 50 women and showed a 12-month
overall survival rate (primary efficacy endpoint) of 38% (n=19/50) in women with PRmCC, representing a 55% improvement over an expected, model-predicted, 12-month survival rate
of 24.5%. In the GOG-0256 study, axalimogene filolisbac was generally well-tolerated with mostly Grade 1 and 2 flu-like adverse
events associated with cytokine release which were managed with standard medical care. This safety profile is consistent
with the ongoing clinical experience of axalimogene filolisbac across all clinical trials. The EMA will evaluate the totality
of the data, including results from GOG-0265 as well as supportive data from other clinical trials evaluating axalimogene filolisbac.
In parallel with the MAA review process, the Company will continue assessing partnership opportunities for the potential commercialization
of axalimogene filolisbac in Europe.
The Company
has also decided to align and simplify its strategy by using axalimogene filolisbac exclusively in all ongoing and planned HPV-related
cancer clinical trials, including the upcoming ADVANCE trial, previously planned with ADXS-DUAL. The Company believes that harmonizing
to a single product candidate for all HPV-related programs will streamline developmental, regulatory and commercialization strategies.
Forward-Looking
Statements
This
report contains forward-looking statements, including, but not limited to, statements regarding the Company’s
ability and strategies to develop and commercialize cancer immunotherapies, timing of planned clinical trials and
regulatory milestones
,
potential partnership opportunities and the safety and
efficacy of the Company’s proprietary immunotherapies. These forward-looking statements are subject to a number of
risks including the risk factors set forth from time to time in the Company’s SEC filings including, but not limited
to, its report on Form 10-K for the fiscal year ended October 31, 2017, which is available at www.sec.gov. Any
forward-looking statements set forth in this report speak only as of the date of this report. We do not intend to update any
of these forward-looking statements to reflect events or circumstances that occur after the date hereof other than as
required by law. You are cautioned not to place undue reliance on any forward-looking statements. Information contained on the
Company’s website does not constitute part of this report.
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:
February 15, 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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