UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-K
(AMENDMENT
NO. 1)
[X]
ANNUAL REPORT UNDER SECTION 13 OR 15(d)
OF
THE SECURITIES EXCHANGE ACT OF 1934
FOR
THE FISCAL YEAR ENDED - OCTOBER 31, 2019
OR
[ ]
TRANSITION REPORT UNDER SECTION 13 OR 15 (d)
OF
THE SECURITIES EXCHANGE ACT OF 1934
FOR
THE TRANSITION PERIOD FROM ______ TO ______
COMMISSION
FILE NUMBER 001-36138
ADVAXIS,
INC.
(Exact
name of registrant as specified in its charter)
Delaware |
|
02-0563870 |
(State
or other jurisdiction of |
|
(IRS
Employer |
incorporation
or organization) |
|
Identification
No.) |
305
College Road East, Princeton, NJ |
|
08540 |
(Address
of principal executive offices) |
|
(Zip
Code) |
(609)
452-9813
(Registrant’s
telephone number)
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common
Stock, par value $0.001 per share |
|
ADXS |
|
Nasdaq
Global Select Market |
Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.
Yes
[ ] No [X]
Indicate
by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Exchange Act.
Yes
[ ] No [X]
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports),
and (2) has been subject to such filing requirements for the past 90 days.
Yes
[X] No [ ]
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant
to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that
the registrant was required to submit such files).
Yes
[X] No [ ]
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See definition of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
Accelerated Filer |
[ ] |
Accelerated
Filer |
[ ] |
Non-accelerated
Filer |
[X] |
Smaller Reporting
Company |
[X] |
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. [ ]
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes
[ ] No [X]
As
of April 30, 2019, the aggregate market value of the voting common equity held by non-affiliates was approximately $28,098,000
based on the closing bid price of the registrant’s common stock on the Nasdaq Capital Market. (For purposes of determining
this amount, only directors, executive officers, and 10% or greater shareholders and their respective affiliates have been deemed
affiliates). [X]
The
registrant had 50,211,424 shares of common stock, par value $0.001 per share, outstanding as of December 16, 2019.
DOCUMENTS
INCORPORATED BY REFERENCE
Portions
of the Proxy Statement for the registrant’s 2020 Annual Meeting of Stockholders (the “Proxy Statement”) to be
filed within 120 days of the end of the fiscal year ended October 31, 2019 are incorporated by reference into Part III hereof.
Except with respect to information specifically incorporated by reference in this Form 10-K, the Proxy Statement is not deemed
to be filed as a part hereof.
EXPLANATORY
NOTE
Advaxis,
Inc. (the “Company”) is filing this Amendment No. 1 (the “Amendment”) to its Annual Report on Form 10-K
for the fiscal year ended October 31, 2019 (the “Form 10-K”) filed with the Securities and Exchange Commission (the
“SEC”) on December 20, 2019. The sole purpose for filing this Amendment is to (i) include the consent of the
independent registered public accounting firm as Exhibit 23.1, (ii) include the Sixth Amendment to the Amended and Restated Patent
License Agreement between the Company and the Trustees of the University of Pennsylvania as Exhibit 10.31, and (iii) revise
the list of exhibits in Item 15(b) to include five previously-filed exhibit documents (Exhibits 3.10, 3.11, 10.32, 10.33,
and 10.34) that were inadvertently omitted from the exhibit list in the Form 10-K.
This
Amendment is an exhibits-only filing solely for the purpose of filing additional exhibits and updating the exhibit index of the
Form 10-K.
This
Amendment also updates, amends and supplements Part IV, Item 15 of the Form 10-K to include the filing of new Exhibits 31.1, 31.2,
32.1 and 32.2, certifications of our Chief Executive Officer and Chief Financial Officer, pursuant to Rule 13a-14(a) and (b) of
the Securities Exchange Act of 1934, as amended.
This
Amendment does not affect any other parts of, or exhibits to, the Form 10-K, and those unaffected parts or exhibits are not included
in this Amendment. Except as expressly stated in this Amendment, the Form 10-K continues to speak as of the date of the original
filing of the Form 10-K, and the Company has not updated the disclosure contained in this Amendment to reflect events that have
occurred since the filing of the Form 10-K. Accordingly, this Amendment must be read in conjunction with the Company’s other
filings made with the SEC subsequent to the filing of the Form 10-K, including amendments to those filings, if any.
PART
IV
3.
List of Exhibits.
See
the Exhibit Index in Item 15(b) below.
|
3.4 |
|
Certificate
of Amendment to Amended and Restated Certificate of Incorporation filed with the Delaware Secretary of State on August 16,
2012. Incorporated by reference to Exhibit 3.1 to Current Report on Form 8-K filed with the SEC on August 17, 2012. |
|
|
|
|
|
3.5 |
|
Certificate
of Amendment to Amended and Restated Certificate of Incorporation filed with the Delaware Secretary of State on July 11, 2013
(reverse stock split). Incorporated by reference to Exhibit 3.1 to Current Report on Form 8-K filed with the SEC on July 15,
2013. |
|
|
|
|
|
3.6 |
|
Certificate
of Amendment to Amended and Restated Certificate of Incorporation filed with the Delaware Secretary of State on July 12, 2013
(reverse stock split). Incorporated by reference to Exhibit 3.2 to Current Report on Form 8-K filed with the SEC on July 15,
2013. |
|
|
|
|
|
3.7 |
|
Certificate
of Amendment to Amended and Restated Certificate of Incorporation filed with the Delaware Secretary of State on July 9, 2014.
Incorporated by reference to Exhibit 3.1 to Current Report on Form 8-K filed with the SEC on July 10, 2014. |
|
|
|
|
|
3.8 |
|
Certificate
of Amendment to Amended and Restated Certificate of Incorporation filed with the Delaware Secretary of State on March 10,
2016. Incorporated by reference to Exhibit 3.1 to Current Report on Form 8-K filed with the SEC on March 11, 2016. |
|
|
|
|
|
3.9 |
|
Certificate
of Amendment to Amended and Restated Certificate of Incorporation filed with the Delaware Secretary of State on March 21,
2018. Incorporated by reference to Exhibit 3.1 to Current Report on Form 8-K filed with the SEC on March 21, 2018. |
|
|
|
|
|
3.10 |
|
Certificate
of Amendment of the Amended and Restated Certificate of Incorporation filed with the Delaware Secretary of State on February
28, 2019. Incorporated by reference to Exhibit 3.1 to Current Report on Form 8-K filed with the SEC on March 1, 2019. |
|
|
|
|
|
3.11 |
|
Certificate of Amendment of the Amended and Restated Certificate of Incorporation filed with the Delaware Secretary of State on March 29, 2019. Incorporated by reference to Exhibit 3.1 to Current Report on Form 8-K filed with the SEC on March 29, 2019. |
|
|
|
|
|
3.12 |
|
Amended
and Restated Bylaws. Incorporated by reference to Exhibit 10.4 to Quarterly Report on Form 10-QSB filed with the SEC on September
13, 2006. |
|
|
|
|
|
4.1 |
|
Form
of Common Stock certificate. Incorporated by reference to Exhibit 4.1 to Current Report on Form 8-K filed with the SEC on
October 23, 2007. |
|
|
|
|
|
4.2 |
|
Form
of Common stock Purchase Warrant. Incorporated by reference to Exhibit 4.1 to Current Report on Form 8-K filed with the SEC
on August 31, 2011. |
|
|
|
|
|
4.3 |
|
Form
of Representative’s Warrant. Incorporated by reference to Exhibit 4.19 to Registration Statement on Form S-1/A (File
No. 333-188637) filed with the SEC on September 27, 2013. |
|
|
|
|
|
4.4 |
|
Form
of Representative’s Warrant related to the Underwriting Agreement, dated as of March 31, 2014, by and between Advaxis,
Inc. and Aegis Capital Group. Incorporated by reference to Exhibit 4.2 to Quarterly Report on Form 10-Q filed with the SEC
on June 10, 2014. |
|
|
|
|
|
4.5 |
|
Form
of Warrant Agency Agreement, dated as of September 11, 2018 between Advaxis, Inc. and Continental Stock Transfer and Trust
Company (and Form of Warrant contained therein), Incorporated by reference to Exhibit 4.1 to Current Report on Form 8-K filed
with the SEC on September 11, 2018. |
|
|
|
|
|
4.6 |
|
Form
of Common Stock Warrant dated September 11, 2018 (included in Exhibit 4.5) |
|
|
|
|
|
10.3 |
|
License
Agreement, between the Trustees of the University of Pennsylvania and the registrant dated as of June 17, 2002, as Amended
and Restated on February 13, 2007. Incorporated by reference to Exhibit 10.11 to Annual Report on Form 10-KSB filed with the
SEC on February 13, 2007. |
|
|
|
|
|
10.4 |
|
Amended
and Restated 2009 Stock Option Plan of the registrant. Incorporated by reference to Annex A to DEF 14A Proxy Statement filed
with the SEC on April 30, 2010. |
|
|
|
|
|
10.5 |
|
Second
Amendment to the Amended and Restated Patent License Agreement between the registrant and the Trustees of the University of
Pennsylvania dated as of May 10, 2010. Incorporated by reference to Exhibit 10.1 to Quarterly Report on Form 10-Q filed with
the SEC on June 3, 2010. |
|
|
|
|
|
10.6 |
|
2011
Omnibus Incentive Plan of registrant. Incorporated by reference to Annex A to DEF 14A Proxy Statement filed with the SEC on
August 29, 2011. |
|
10.8 |
|
Amendment
No. 1, dated as of March 26, 2007, to the License Agreement, between the Trustees of the University of Pennsylvania and Advaxis,
Inc. dated as of June 17, 2002, as amended and restated on February 13, 2007. Incorporated by reference to Exhibit 10.1 to
Quarterly Report on Form 10-Q filed with the SEC on June 14, 2012. |
|
|
|
|
|
10.9 |
|
Amendment
No. 3, dated as of December 12, 2011, to the License Agreement, between the Trustees of the University of Pennsylvania and
Advaxis, Inc. dated as of June 17, 2002, as amended and restated on February 13, 2007. Incorporated by reference to Exhibit
10.5 to Quarterly Report on Form 10-Q filed with the SEC on June 14, 2012. |
|
|
|
|
|
10.10 |
|
Amendment
No. 1 to 2011 Omnibus Incentive Plan of registrant. Incorporated by reference to Annex B to DEF 14A Proxy Statement filed
with the SEC on July 19, 2012. |
|
|
|
|
|
10.11 |
|
Indemnification
Agreement. Incorporated by reference to Exhibit 10.3 to Current Report on Form 8-K filed with the SEC on August 20, 2013. |
|
|
|
|
|
10.12 ‡ |
|
Employment
Agreement between Advaxis, Inc. and Robert Petit, dated September 26, 2013. Incorporated by reference to Exhibit 10.70 to
Registration Statement on Form S-1/A (File No. 333-188637) filed with the SEC on September 27, 2013. |
|
|
|
|
|
10.13 |
|
Exclusive
License and Technology Transfer Agreement by and between Advaxis, Inc. and Global BioPharma, Inc., dated December 9, 2013.
Incorporated by reference to Exhibit 10.79 to Annual Report on Form 10-K/A filed with the SEC on February 6, 2014. |
|
|
|
|
|
10.14‡ |
|
Amendment
No. 1, dated as of December 19, 2013, to the Employment Agreement by and between Advaxis, Inc. and Robert G. Petit. Incorporated
by reference to Exhibit 10.82 to Annual Report on Form 10-K/A filed with the SEC on February 6, 2014. |
|
|
|
|
|
10.15 |
|
Distribution
and Supply Agreement, dated as of January 20, 2014, by and between Advaxis, Inc. and Biocon, Limited. Incorporated by reference
to Exhibit 10.7 to Quarterly Report on Form 10-Q filed with the SEC on March 17, 2014. |
|
|
|
|
|
10.16 |
|
Exclusive
License Agreement, dated March 19, 2014, by and between Advaxis, Inc. and Aratana Therapeutics, Inc. Incorporated by reference
to Exhibit 10.1 to Quarterly Report on Form 10-Q filed with the SEC on June 10, 2014. |
|
|
|
|
|
10.17‡ |
|
Amendment
No. 2, dated as of June 5, 2014, to the Employment Agreement by and between Advaxis, Inc. and Robert G. Petit. Incorporated
by reference to Exhibit 10.6 to Quarterly Report on Form 10-Q filed with the SEC on June 10, 2014. |
|
|
|
|
|
10.18 |
|
Clinical
Trial Collaboration Agreement, dated July 21, 2014, by and between Advaxis, Inc. and MedImmune, LLC. Incorporated by reference
to Exhibit 10.1 to Quarterly Report on Form 10-Q filed with the SEC on September 9, 2014. |
|
|
|
|
|
10.19 |
|
5th
Amendment to the Amended & Restated License Agreement, dated July 25, 2014, by and between Advaxis, Inc. and University
of Pennsylvania. Incorporated by reference to Exhibit 10.2 to Quarterly Report on Form 10-Q filed with the SEC on September
9, 2014. |
|
|
|
|
|
10.20 |
|
Amendment
No. 2 to the Advaxis, Inc. 2011 Omnibus Incentive Plan, effective July 9, 2014. Incorporated by reference to Annex A to Current
Report on Schedule 14A filed with the SEC on May 20, 2014. |
|
|
|
|
|
10.21 |
|
Amended
and Restated 2011 Omnibus Incentive Plan, dated September 8, 2014. Incorporated by reference to Exhibit 10.4 to Quarterly
Report on Form 10-Q filed with the SEC on September 9, 2014. |
|
|
|
|
|
10.22 |
|
Master
Services Agreement for Technical Transfer and Clinical Supply, dated February 5, 2014, by and between Advaxis, Inc. and SynCo
Bio Partners B.V. Incorporated by reference to Exhibit 10.1 to Current Report to Form 8-K filed with the SEC on February 11,
2014. |
|
|
|
|
|
10.23 |
|
Clinical
Trial Collaboration and Supply Agreement by and between Advaxis, Inc. and Merck & Co. dated August 22, 2014. Incorporated
by reference to Exhibit 10.101 to Annual Report on Form 10-K filed with the SEC on January 6, 2015 |
|
|
|
|
|
10.24‡ |
|
Amendment
No. 3, dated as of April 17, 2015, to the Employment Agreement by and between Advaxis, Inc. and Robert G. Petit. Incorporated
by reference to Exhibit 10.6 to Quarterly Report on Form 10-Q filed with the SEC on June 15, 2015. |
|
10.26 |
|
Co-Development
and Commercialization Agreement between Advaxis, Inc. and Especificos Stendhal SA de CV dated February 3, 2016. Incorporated
by reference to Exhibit 10.1 to Quarterly Report on Form 10-Q filed with the SEC on February 26, 2016. |
|
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|
|
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10.27‡ |
|
Separation
Agreement and General Release, dated July 6, 2017, between Advaxis, Inc. and Daniel J. O’Connor. Incorporated by reference
to Exhibit 10.1 to Current Report on Form 8-K filed with the SEC on July 7, 2017. |
|
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10.28 |
|
2015
Incentive Plan of registrant. Incorporated by reference to Annex A to DEF 14A Proxy Statement filed with the SEC on April
7, 2015. |
|
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|
|
|
10.30‡ |
|
Employment
Agreement between Advaxis, Inc. and Molly Henderson, dated June 6,2018. Incorporated by reference to Exhibit 10.1 to Current
Report on Form 8-K filed with the SEC on June 6, 2018. |
|
|
|
|
|
10.31* |
|
Sixth Amendment to the Amended and Restated Patent License Agreement between the registrant and the Trustees of the University of Pennsylvania dated as of March 22, 2016. |
|
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10.32 |
|
Securities
Purchase Agreement between the registrant and Amgen, Inc., dated as of August 1, 2016. Incorporated by reference to Exhibit
10.1 to Current Report on Form 8-K filed with the SEC on August 2, 2016. |
|
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|
|
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10.33 |
|
Amendment to the Advaxis, Inc. 2015 Incentive Plan. Incorporated by reference to Exhibit B to DEF 14A Proxy Statement filed with the SEC on February 11, 2016. |
|
|
|
|
|
10.34 |
|
Amendment to the Advaxis, Inc. 2015 Incentive Plan. Incorporated by reference to Exhibit A to DEF 14A Proxy Statement filed with the SEC on February 10, 2017. |
|
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|
|
|
14.1 |
|
Code
of Business Conduct and Ethics dated July 9, 2014. Incorporated by reference to Exhibit 14.1 to Current Report on Form 8-K
filed with the SEC on July 10, 2014. |
|
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|
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23.1* |
|
Consent of Independent Registered Public Accounting Firm. |
|
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31.1* |
|
Certification of Chief Executive Officer pursuant to section 302 of the Sarbanes-Oxley Act of 2002 |
|
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31.2* |
|
Certification of Chief Financial Officer pursuant to section 302 of the Sarbanes-Oxley Act of 2002 |
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32.1* |
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Certification of Chief Executive Officer pursuant to section 906 of the Sarbanes-Oxley Act of 2002 |
|
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32.2* |
|
Certification of Chief Financial Officer pursuant to section 906 of the Sarbanes-Oxley Act of 2002 |
|
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101.INS** |
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XBRL
Instance Document |
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101.SCH** |
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XBRL
Taxonomy Extension Schema Document |
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101.CAL** |
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XBRL
Taxonomy Extension Calculation Linkbase Document |
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101.DEF** |
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XBRL
Taxonomy Extension Definitions Linkbase Document |
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101.LAB** |
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XBRL
Taxonomy Extension Label Linkbase Document |
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101.PRE** |
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XBRL
Taxonomy Extension Presentation Linkbase Document |
* |
Filed herewith. |
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** |
Furnished herewith. |
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‡ |
Denotes management
contract or compensatory plan or arrangement. |
SIGNATURE
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, thereunto duly authorized, in Princeton, Mercer County, State of New Jersey, on this 21st day of January 2020.
|
ADVAXIS,
INC. |
|
|
|
|
By: |
/s/
Kenneth Berlin |
|
|
Kenneth Berlin |
|
|
President and Chief
Executive Officer |