Current Report Filing (8-k)
July 10 2018 - 5:22PM
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):
July 10, 2018
ADVAXIS,
INC.
(Exact
Name of Registrant as Specified in Charter)
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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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 July 10, 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
July 10, 2018, the Company issued a press release announcing its plans to withdraw its Conditional Marketing Authorization Application
in the European Union for axalimogene filolisbac to treat metastatic cervical cancer in patients who progress beyond first-line
therapy; submission of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration to study its first
ADXS-HOT drug candidate for the treatment of non-small cell lung cancer; and selection of prostate cancer as the second cancer
type within its ADXS-HOT program to move towards the clinic, with an IND filing anticipated within the next six months.
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:
July 10, 2018
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By:
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/s/
Kenneth A. Berlin
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Kenneth
A. Berlin
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President
and Chief Executive Officer
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