Filed
Pursuant Rule 424(b)(5)
Registration
No. 333-226988
PROSPECTUS
SUPPLEMENT
17,577,400
Shares of Common Stock
Pre-Funded
Warrants to Purchase up to 7,671,937 Shares of Common Stock
Warrants
to Purchase up to 11,244,135 Shares of Common Stock
We
are offering on a “best efforts” basis 17,577,400 shares of our common stock, $0.001 par value per share (the “Shares”).
The purchase price of each Share is $0.7921. We are also offering on a “best efforts” basis pre-funded warrants to
purchase up to 7,671,937 shares of our Common Stock to certain purchasers whose purchase of additional Shares in this offering
would otherwise result in the purchaser, together with its affiliates and certain related parties, beneficially owning more than
9.99% of our outstanding common stock immediately following the consummation of this offering (the “Pre-Funded Warrants”).
The purchase price of each Pre-Funded Warrant is equal to $0.7911, which is equal to the sale price of the Shares minus
$0.001, the exercise price of each Pre-Funded Warrant. The Pre-Funded Warrants are immediately exercisable and may be exercised
at any time until all of the Pre-Funded Warrants are exercised in full.
The
Shares and Pre-Funded Warrants are being sold together with warrants to purchase up to 11,244,135 shares of our common stock (the
“Accompanying Warrants” and together with the Shares and the Pre-Funded Warrants, the “Securities”). Each
Accompanying Warrant has an exercise price per share of $0.70, will be exercisable immediately and will expire on the fifth anniversary
of the original issuance date.
The
Shares, Pre-Funded Warrants and Accompanying Warrants can only be purchased together in this offering but will be issued separately
and will be immediately separable upon issuance.
The
Securities are being sold in this offering to certain investors under a securities purchase agreement dated April 12, 2021 between
us and the investors.
Our
common stock is traded on the Nasdaq Capital Market under the symbol “ADXS.” On April 9, 2021, the last reported sale
price of our common stock on the Nasdaq Capital Market was $0.6661 per share. There is no established public trading market
for the Pre-Funded Warrants or the Accompanying Warrants, and we do not expect a market to develop. In addition, we do not intend
to apply for a listing of the Pre-Funded Warrants or the Accompanying Warrants on any national securities exchange or other nationally
recognized trading system.
Pursuant
to the investor agreement dated as of April 12, 2021, by and between us, the placement agent and the investors identified therein,
any investor that purchases Securities in this offering, as a condition to such purchase, agrees to vote the shares of our common
stock that they own or control on the record date of our 2021 annual meeting of stockholders (or any postponement, adjournment
or reconvening thereof) (the “2021 Annual Meeting”) in a manner that is consistent with the recommendations of our
Board of Directors (the “Board”) on each proposal being presented for shareholder vote at the 2021 Annual Meeting.
The record date for the 2021 Annual Meeting is April 15, 2021.
In
addition, the investor agreement also provides that the purchasers in this offering will be restricted from selling any shares
of our common stock purchased in this offering through April 15, 2021 (such restriction, the “lock-up”).
In
a concurrent private placement (the “Private Placement”), we are also selling, to the purchasers of Securities in
this offering, warrants to purchase 14,005,202 shares of our common stock (the “Private Placement Warrants”). The
Private Placement Warrants will have an exercise price of $0.70 per share and will become exercisable on such date, if ever, that
is fourteen (14) days after we file an amendment to our Amended and Restated Certificate of Incorporation (as amended to date,
the “Charter”) to increase the number of authorized shares of common stock from 170,000,000 shares to 300,000,000
shares (the “Authorized Shares Amendment”) with the Delaware Secretary of State and the Private Placement Warrants
will remain exercisable for a period of 5 years from such date. The Private Placement Warrants and the shares of our common stock
issuable upon exercise of the Private Placement Warrants are not being registered under the Securities Act of 1933, as amended
(the “Securities Act”), are not being offered pursuant to this prospectus supplement and the accompanying prospectus,
and are being offered pursuant to the exemption provided in Section 4(a)(2) under the Securities Act and Rule 506(b) promulgated
thereunder. We have agreed to use commercially reasonable best efforts to file a registration statement on Form S-3 (or other
appropriate form) providing for the resale by the purchasers of the Private Placement Warrants and the shares of common stock
issuable upon exercise of the Private Placement Warrants as soon as practicable (and in any event within 60 calendar days) of
the such date, if ever, that we file the Authorized Shares Amendment. Further, we have agreed to use commercially reasonable best
efforts to cause such registration to become effective within 90 calendar days (or, in the event of a full review, 120 calendar
days) following such date, if ever, that that we file the Authorized Shares Amendment and to keep such registration statement
effective at all times until no purchaser owns any Private Placement Warrants or underlying shares of common stock issuable upon
exercise thereof.
Investing
in our common stock involves a high degree of risk. See “Risk Factors” beginning on page S-7 of this prospectus supplement
and in the documents incorporated by reference into this prospectus supplement.
Neither
the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or
passed upon the adequacy or accuracy of this prospectus supplement or the accompanying prospectus. Any representation to the contrary
is a criminal offense.
We
have engaged A.G.P. / Alliance Global Partners, or the placement agent, as our exclusive placement agent in connection with this
offering. This offering is being conducted on a “best efforts” basis and the placement agent has no obligation to
buy any of the Securities from us or to arrange for the purchase or sale of any specific number or dollar amount of Securities.
We have agreed to pay the placement agent fees set forth in the table below. See “Plan of Distribution” beginning
on page S-18 of this prospectus supplement for more information.
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Per share and Accompanying Warrant
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PER PRE-FUNDED WARRANT AND ACCOMPANYING WARRANT
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Total
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Public offering price
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$
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0.7921
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$
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0.7911
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$
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19,992,327.90
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Placement agent fees(1)
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$
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0.0404
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$
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0.0514
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$
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1,104,501.34
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Proceeds to Advaxis (before expenses)
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$
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0.7517
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$
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0.7397
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$
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18,887,826.56
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(1)
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We have
agreed to pay the placement agent a placement agent’s fee equal to $1,104,501.34, or 6.5% of the aggregate purchase price
of the Shares and Pre-Funded Warrants sold in this offering, excluding any Shares or Pre-Funded Warrants sold to Lincoln Park
Capital Fund, LLC. These amounts have therefore been calculated to exclude 3,787,400 Shares which are expected to be sold to Lincoln
Park Capital Fund, LLC. See “Plan of Distribution” beginning on page S-18 of this prospectus supplement for a description
of the compensation payable to the placement agent.
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Delivery
of the Securities is expected to be made on or about April 14, 2021.
A.G.P.
Prospectus
Supplement dated April 12, 2021
Table
of Contents
ABOUT
THIS PROSPECTUS SUPPLEMENT
This
prospectus supplement and the accompanying prospectus relate to the offering of the Securities. You should read this prospectus
supplement, the accompanying prospectus, the documents incorporated by reference into this prospectus supplement and the accompanying
prospectus, and any free writing prospectus that we may authorize for use in connection with this offering in their entirety before
making an investment decision. You should also read and consider the information in the documents to which we have referred you
in the section of this prospectus supplement entitled “Where You Can Find More Information; Incorporation by Reference.”
These documents contain important information that you should consider when making your investment decision.
This
document is in two parts. The first part is this prospectus supplement, which describes the specific terms of this offering and
certain other matters and also adds to and updates information contained in the accompanying prospectus and the documents incorporated
by reference herein or therein. The second part, the accompanying prospectus, including the documents incorporated by reference
into the accompanying prospectus, provides more general information. Generally, when we refer to this prospectus, we are referring
to the combined document consisting of this prospectus supplement and the accompanying prospectus. To the extent there is a conflict
between the information contained in this prospectus supplement and the information contained in the accompanying prospectus or
any document incorporated by reference herein or therein that was filed with the Securities and Exchange Commission (the “SEC”)
before the date of this prospectus supplement, you should rely on the information in this prospectus supplement; provided that
if any statement in one of these documents is inconsistent with a statement in another document having a later date — for
example, a document incorporated by reference in the accompanying prospectus —the statement in the document having the later
date modifies or supersedes the earlier statement.
We
further note that the representations, warranties and covenants made by us in any agreement that is filed as an exhibit to any
document that is incorporated by reference herein or therein were made solely for the benefit of the parties to such agreement,
including, in some cases, for the purpose of allocating risk among the parties to such agreements, and should not be deemed to
be a representation, warranty or covenant to you. Moreover, such representations, warranties or covenants were accurate only as
of the date when made. Accordingly, such representations, warranties and covenants should not be relied on as accurately representing
the current state of our affairs.
We
are responsible for the information contained in, or incorporated by reference into, this prospectus supplement, the accompanying
prospectus and in any free writing prospectus that we may authorize for use in connection with this offering. We have not, and
the placement agent has not, authorized any other person to provide you with different information, and neither we nor the placement
agent take any responsibility for any other information that others may give you. When you make a decision about whether to invest
in our common stock, you should not rely upon any information other than the information in this prospectus supplement or the
accompanying prospectus, including any free writing prospectus that we have authorized for use in this offering.
You
should assume that the information appearing in this prospectus supplement, the accompanying prospectus, the documents incorporated
by reference into this prospectus supplement and the accompanying prospectus, and in any free writing prospectus that we may authorize
for use in connection with this offering is accurate only as of the date of those respective documents. Our business, financial
condition, results of operations and prospects may have changed since those dates.
We
are offering to sell, and seeking offers to buy, and the placement agent are soliciting offers to buy, Securities only in jurisdictions
where offers and sales are permitted. The distribution of this prospectus supplement and the accompanying prospectus and the offering
of the Securities in certain jurisdictions may be restricted by law. Persons outside the United States who come into possession
of this prospectus supplement and the accompanying prospectus must inform themselves about, and observe any restrictions relating
to, the offering of the Securities and the distribution of this prospectus supplement and the accompanying prospectus outside
the United States. This prospectus supplement and the accompanying prospectus do not constitute, and may not be used in connection
with, an offer to sell, or a solicitation of an offer to buy, any securities offered by this prospectus supplement and the accompanying
prospectus by any person in any jurisdiction in which it is unlawful for such person to make such an offer or solicitation.
Unless
otherwise stated, all references in this prospectus supplement to “we,” “us,” “our,” “Advaxis,”
the “Company” and similar designations refer to Advaxis, Inc. This prospectus supplement, the accompanying prospectus
and the information incorporated by reference herein and therein contain trademarks, service marks and trade names of Advaxis,
Inc., including our name and logo. Other trademarks, service marks and trade names referred to in this prospectus supplement or
the accompanying prospectus or the information incorporated by reference herein and therein are the property of their respective
owners.
SPECIAL
CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS
This
prospectus supplement, the accompanying prospectus and the other documents we have filed with the SEC that are incorporated herein
by reference contain forward-looking statements that involve substantial risks and uncertainties. Any statements, other than statements
of historical facts, contained in this prospectus supplement, the accompanying prospectus or the information incorporated by reference
herein or therein may be deemed to be forward-looking statements. In some cases, these forward-looking statements can be identified
by the use of forward-looking terminology, including the terms “believes,” “estimates,” “anticipates,”
“expects,” “plans,” “intends,” “may,” “could,” “might,”
“will,” “should,” “approximately” or, in each case, their negative or other variations thereon
or comparable terminology, although not all forward-looking statements contain these words. Such forward-looking statements include
statements about our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things,
our ongoing and planned discovery and development of drug candidates, the strength and breadth of our intellectual property, our
ongoing and planned preclinical studies and clinical trials, the timing of and our ability to make regulatory filings and obtain
and maintain regulatory approvals for our product candidates, the degree of clinical utility of our product candidates, particularly
in specific patient populations, expectations regarding clinical trial data, our results of operations, financial condition, liquidity,
prospects, growth and strategies, the length of time that we will be able to continue to fund our operating expenses and capital
expenditures, our expected financing needs and sources of financing, the industry in which we operate and the trends that may
affect the industry or us.
By
their nature, forward-looking statements involve risks and uncertainties because they relate to events, competitive dynamics,
and healthcare, regulatory and scientific developments and depend on the economic circumstances that may or may not occur in the
future or may occur on longer or shorter timelines than anticipated. Although we believe that we have a reasonable basis for each
forward-looking statement contained in this prospectus supplement, we caution you that forward-looking statements are not guarantees
of future performance and they may not be predictive of results or developments in future periods.
Forward-looking
statements involve risks and uncertainties that could cause actual results or outcomes to differ materially from those expressed
therein. We express our estimates, expectations, beliefs, and projections in good faith and believe them to have a reasonable
basis. However, we make no assurances that management’s estimates, expectations, beliefs, or projections will be achieved
or accomplished. We have identified the following important factors that could cause actual results to differ materially from
those discussed in our forward-looking statements. These may be in addition to other factors and matters discussed in “Risk
Factors,” beginning on page S-7 of this prospectus; Part I, Item 1A. Risk Factors of our Annual Report on Form 10-K for
the fiscal year ended October 31, 2020 (as filed with the SEC on January 22, 2021, and amended by Amendment No. 1 thereto on Form
10-K/A filed with the SEC on February 26, 2021, as so amended the “2020 Form 10-K/A”); and as updated from time to
time in the Company’s filings with the SEC These factors include:
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the
success and timing of our clinical trials, including patient accrual;
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our
ability to obtain and maintain regulatory approval or reimbursement of our product candidates for marketing;
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our
ability to obtain the appropriate labeling of our products under any regulatory approval;
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our
ability to develop and commercialize our products;
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potential
effects of the COVID-19 pandemic on our business, financial condition, liquidity and results of operations, and our ability
to continue operations in the same manner as previously conducted prior to the macroeconomic effects of the COVID-19 pandemic;
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the
successful development and implementation of our sales and marketing campaigns;
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the
change of key scientific or management personnel;
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the
size and growth of the potential markets for our product candidates and our ability to serve those markets;
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our
ability to successfully compete in the potential markets for our product candidates, if commercialized;
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regulatory
developments in the United States and other countries;
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the
rate and degree of market acceptance of any of our product candidates;
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new
products, product candidates or new uses for existing products or technologies introduced or announced by our competitors
and the timing of these introductions or announcements;
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market
conditions in the pharmaceutical and biotechnology sectors;
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our
available cash;
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the
accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for additional financing;
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our
ability to obtain additional funding;
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our
ability to obtain and maintain intellectual property protection for our product candidates;
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the
success and timing of our preclinical studies, including IND enabling studies;
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the
ability of our product candidates to successfully perform in clinical trials and to resolve any clinical holds that may occur;
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our
ability to obtain and maintain approval of our product candidates for trial initiation;
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our
ability to manufacture and the performance of third-party manufacturers;
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our
ability to identify license and collaboration partners and to maintain existing relationships;
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the
performance of our clinical research organizations, clinical trial sponsors, clinical trial investigators and collaboration
partners for any clinical trials we conduct;
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any
outcomes from our review of strategic transactions;
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our
ability to successfully implement our strategy;
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our
ability to maintain the listing of our common stock on the Nasdaq Capital Market; and
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the
factors described in the “Risk Factors” section of the 2020 Form 10-K/A.
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This
prospectus supplement includes statistical and other industry and market data that we obtained from industry publications and
research, surveys and studies conducted by third-parties. Industry publications and third-party research, surveys and studies
generally indicate that their information has been obtained from sources believed to be reliable, although they do not guarantee
the accuracy or completeness of such information. While we believe these industry publications and third-party research, surveys
and studies are reliable, we have not independently verified such data.
PROSPECTUS
SUPPLEMENT SUMMARY
This
summary highlights information contained elsewhere or incorporated by reference in this prospectus supplement and the accompanying
prospectus and in the documents we incorporate by reference. This summary does not contain all of the information that you should
consider before deciding to invest in our common stock. You should read this entire prospectus supplement and the accompanying
prospectus carefully, including the ‘‘Risk Factors’’ section contained in this prospectus supplement and
our consolidated financial statements and the related notes and the other documents incorporated by reference herein, as well
as the information included in any free writing prospectus that we have authorized for use in connection with this offering.
Our
Business
We
are a clinical-stage biotechnology company focused on the development and commercialization of proprietary Lm Technology antigen
delivery products based on a platform technology that utilizes live attenuated Listeria monocytogenes, or Lm, bioengineered to
secrete antigen/adjuvant fusion proteins. These Lm-based strains are believed to be a significant advancement in immunotherapy
as they integrate multiple functions into a single immunotherapy by accessing and directing antigen presenting cells to stimulate
anti-tumor T cell immunity, stimulate and activate the innate immune system with the equivalent of multiple adjuvants, and simultaneously
reduce tumor protection in the Tumor Microenvironment, or TME, to enable the T cells to attack tumor cells.
We
believe that Lm Technology immunotherapies can complement and address significant unmet needs in the current oncology treatment
landscape. Specifically, our product candidates (i.e., ADXS-PSA and ADXS-503) have the potential to optimize checkpoint performance,
while having a generally well-tolerated safety profile, and most of our product candidates have an expected low cost of goods.
A new Investigator-Sponsored-Study with our FDA-approved IND is expected to start with ADXS-504-HOT construct in biochemically
recurrent prostate cancer patients at Columbia University Irving Medical Center in the first half of 2021.
We
are currently winding down clinical studies of Lm Technology immunotherapies in three program areas:
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Human
Papilloma Virus (“HPV”)-associated cancers
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Personalized
neoantigen-directed therapies
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Human
epidermal growth factor receptor-2 (HER-2) associated cancers
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All
these clinical program areas are anchored in our Lm TechnologyTM, a unique platform designed for its ability to safely
and effectively target various cancers in multiple ways. While we are currently winding down clinical studies of Lm Technology
immunotherapies in these three program areas, our license agreements continue with OS Therapies, LLC for ADXS-HER2 and with Global
BioPharma, or GBP, for the exclusive license for the development and commercialization of AXAL in Asia, Africa, and the former
USSR territory, exclusive of India and certain other countries.
Company
Information
We
were originally incorporated in the State of Colorado on June 5, 1987 under the name Great Expectations, Inc. We were a publicly-traded
“shell” company without any business until November 12, 2004 when we acquired Advaxis, Inc., a Delaware corporation,
through a Share Exchange and Reorganization Agreement, dated as of August 25, 2004, which we refer to as the Share Exchange, by
and among Advaxis, the stockholders of Advaxis and us. As a result of the Share Exchange, Advaxis became our wholly-owned subsidiary
and our sole operating company. On December 23, 2004, we amended and restated our articles of incorporation and changed our name
to Advaxis, Inc. On June 6, 2006, our stockholders approved the reincorporation of our company from Colorado to Delaware by merging
the Colorado entity into our wholly-owned Delaware subsidiary. Our date of inception, for financial statement purposes, is March
1, 2002 and we were uplisted to Nasdaq in 2014.
Our
principal executive offices are located at 9 Deer Park Drive, Suite K-1, Monmouth Junction, New Jersey 08852 and our telephone
number is (609) 452-9813. We maintain a corporate website at www.advaxis.com which contains descriptions of our technology, our
product candidates and the development status of each drug. We make available free of charge through our Internet website our
annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, and any amendments to these reports,
as soon as reasonably practicable after we electronically file such material with, or furnish such material to, the SEC. We are
not including the information on our website as a part of, nor incorporating it by reference into, this report. The SEC maintains
a website that contains annual, quarterly, and current reports, proxy statements, and other information that issuers (including
us) file electronically with the SEC. The SEC’s website address is www.sec.gov.
The
Offering
Shares
offered by us
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17,577,400
Shares
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Per
Share offering price
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$0.7921
per Share
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Pre-Funded
Warrants
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We
are also offering Pre-Funded Warrants to purchase up to 7,671,937 shares of our Common Stock to certain purchasers whose purchase
of additional Shares in this offering would otherwise result in the purchaser, together with its affiliates and certain related
parties, beneficially owning more than 9.99% of our outstanding common stock immediately following the consummation of this
offering. The purchase price of each Pre-Funded Warrant is equal to $0.7911, which is equal to the purchase price of the Shares
minus $0.001, the exercise price of each Pre-Funded Warrant. The Pre-Funded Warrants are immediately exercisable and may be
exercised at any time until all of the Pre-Funded Warrants are exercised in full. This offering also relates to the shares
of common stock issuable upon exercise of any Pre-Funded Warrants sold in this offering.
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Accompanying
Warrants
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We
are also offering Accompanying Warrants to purchase an aggregate of 11,244,135 shares of our common stock. The Shares and
the Pre-Funded Warrant are being sold together with the Accompanying Warrants. Each Accompanying Warrants has an exercise
price per share of $0.70, will be exercisable immediately, and will expire on the fifth anniversary of the original issuance
date. This offering also relates to the offering of the shares of common stock issuable upon exercise of the Accompanying
Warrants.
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Common
stock to be outstanding immediately after the offering
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137,044,020
shares (assuming all Shares offered in this offering are sold to the investors and assuming no exercise of the Pre-Funded
Warrants, the Accompanying Warrants, or the Private Placement Warrants).
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Investor
Agreement
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Pursuant
to the investor agreement dated as of April 12, 2021, by and between us and the investors identified therein, any investor that
purchases Securities in this offering, as a condition to such purchase, agrees to vote the shares of our common stock that they
own or control on the record date of our 2021 Annual Meeting in a manner that is consistent with the recommendations of our Board
on each proposal being presented for shareholder vote at the 2021 Annual Meeting. The record date for the 2021 Annual Meeting
is April 15, 2021.
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In addition, the investor agreement also provides that the purchasers in this offering will be restricted from selling any Shares purchased
in this offering through April 15, 2021.
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Use
of proceeds
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We
expect the net proceeds from this offering will be approximately $18.77 million after deducting the discounts and commissions
and estimated offering expenses payable by us, as described in “Plan of Distribution,” on page S-18 of this
prospectus supplement. We intend to use the net proceeds from this offering to fund our continued research and development
initiatives in connection with our product pipeline including, but not limited to, investment in our ADXS-HOT program
and for general corporate purposes. We may also use a portion of the net proceeds to acquire or invest in complementary
businesses, products and technologies. Although we currently have no specific agreements, commitments or understandings
with respect to any acquisition or investment, we evaluate acquisition and investment opportunities and may engage in
related discussions with other companies from time to time.
See
“Use of Proceeds” on page S-14 of this prospectus supplement for a more complete description of the intended
use of proceeds from this offering.
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Best
Efforts
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We
have agreed to issue and sell the Securities offered hereby to the investors through the placement agent, and the placement
agent has agreed to offer and sell such Securities on a “best efforts” basis. The placement agent is not required
to sell any specific number or dollar amount of the Securities offered hereby, but will use its best efforts to sell such
Securities. See “Plan of Distribution” on page S-18 of this prospectus supplement.
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Risk
factors
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Investing
in our securities involves significant risks. Please read the information contained in or incorporated by reference under
the heading “Risk Factors” beginning on page S-7 of this prospectus supplement, and under similar headings in
documents incorporated by reference into this prospectus supplement and the accompanying prospectus.
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Nasdaq
Capital Market symbol
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“ADXS.”
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Concurrent
Private Placement Transaction
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In
the concurrent Private Placement, we are also selling, to the purchasers of Securities in this offering, Private Placement
Warrants to purchase 14,005,202 shares of our common stock. The Private Placement Warrants will have an exercise price of
$0.70 per share and will become exercisable on such date, if ever, that is fourteen (14) days after we file the Authorized
Shares Amendment with the Delaware Secretary of State and the Private Placement Warrants will remain exercisable for a period
of 5 years from such date. The Private Placement Warrants and the shares of our common stock issuable upon exercise of the
Warrants are not being registered under the Securities Act, are not being offered pursuant to this prospectus supplement and
the accompanying prospectus, and are being offered pursuant to the exemption provided in Section 4(a)(2) under the Securities
Act and Rule 506(b) promulgated thereunder. We have agreed to use commercially reasonable best efforts to file a registration
statement on Form S-3 (or other appropriate form) providing for the resale by the purchasers of the Private Placement Warrants
and the shares of common stock issuable upon exercise of the Private Placement Warrants as soon as practicable (and in any
event within 60 calendar days) of the such date, if ever, that we file the Authorized Shares Amendment. Further, we have agreed
to use commercially reasonable best efforts to cause such registration to become effective within 90 calendar days (or, in
the event of a full review, 120 calendar days) following such date, if ever, that that we file the Authorized Shares Amendment
and to keep such registration statement effective at all times until no purchaser owns any Private Placement Warrants or underlying
shares of common stock issuable upon exercise thereof. See “Private Placement Transaction” below.
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The
number of shares of common stock to be outstanding immediately after the offering is based on 119,466,620 shares of common stock
outstanding as of March 8, 2021. The number of shares outstanding as of March 8, 2021 excludes:
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5,001,626
shares of our common stock reserved for issuance upon the exercise of outstanding warrants at a weighted average exercise
price of $0.45 per share;
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5,556
shares of our common stock reserved for issuance upon settlement of restricted stock units;
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1,047,377
shares of our common stock reserved for issuance upon the exercise of outstanding stock options at a weighted average exercise
price of $32.02 per share;
|
|
●
|
976,517
shares of our common stock reserved for issuance under our employee stock purchase plan;
|
|
●
|
4,844,725
shares of our common stock reserved for future awards under our 2015 Incentive Plan; and
|
|
●
|
886,048
shares of our common stock issued and sold pursuant to our at-the-market program during the period between March 9, 2021 and
April 9, 2021.
|
Except
as otherwise indicated, all information in this prospectus supplement assumes no exercise or forfeiture of the outstanding options
or warrants or settlement of restricted stock units after March 8, 2021, including, for the avoidance of doubt, any Pre-Funded
Warrants, Accompanying Warrants, or Private Placement Warrants.
RISK
FACTORS
Investment
in our common stock involves risks. Before deciding whether to invest in our common stock, you should consider carefully the risk factors
discussed below and those contained in the section entitled “Risk Factors” contained in 2020 Form 10-K/A, which is incorporated
herein by reference in its entirety, as well as any amendment or update to our risk factors reflected in subsequent filings with the
SEC. If any of the risks or uncertainties described in our SEC filings actually occurs, our business, financial condition, results of
operations or cash flow could be materially and adversely affected. This could cause the trading price of our common stock to decline,
resulting in a loss of all or part of your investment. The risks and uncertainties we have described are not the only ones facing our
company. Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also affect our business
operations.
Risks
Related to this Offering
Our
stock price can be volatile, which increases the risk of litigation, and may result in a significant decline in the value of your investment.
The
stock market in general and the market for biopharmaceutical companies in particular have experienced extreme volatility that has often
been unrelated to the operating performance of particular companies. As a result of this volatility, you may not be able to sell your
common stock at or above the price at which it was acquired. The market price for our common stock may be influenced by many factors,
including:
|
●
|
changes
in the market valuations, stock market prices and trading volumes of similar companies;
|
|
●
|
actual
or anticipated changes in our net loss or fluctuations in our operating results or in the expectations of securities analysts;
|
|
●
|
the
issuance of new equity securities pursuant to a future offering, including potential issuances of preferred stock;
|
|
●
|
sales
of large blocks of our stock;
|
|
●
|
failure
of our common stock or warrants to be listed or quoted on the Nasdaq Stock Market, NYSE Amex Equities or other national market system;
|
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●
|
additions
or departures of key personnel;
|
|
●
|
changes
in the regulatory status of our immunotherapies, including results of our pre-clinical and clinical trials;
|
|
●
|
regulatory
developments in the United States and other countries;
|
|
●
|
positive
and negative changes in relationships with partners;
|
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●
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events
affecting the University of Pennsylvania or any of our other current or future collaborators;
|
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●
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announcements
of new products or technologies, commercial relationships or other events by us or our competitors;
|
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●
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changes
in accounting principles;
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|
●
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discussion
of us or our stock price by the financial and scientific press and in online investor communities;
|
|
●
|
market
conditions and events in the pharmaceutical and biotech sectors; and
|
|
●
|
general
economic, industry, and market conditions.
|
These
broad market and industry factors may materially affect the market price of our common stock, regardless of our development and operating
performance. In the past, following periods of volatility in the market price of a company’s securities, securities class-action
litigation has often been instituted against that company. Due to the volatility of our stock price, we have been and may be the target
of securities litigation in the future. Securities litigation could result in substantial costs and divert management’s in the
future attention and resources from our business.
You
will experience immediate and substantial dilution in the book value per share of the common stock you purchase in the offering.
You
will incur immediate and substantial dilution as a result of this offering. The public offering price per share of our common
stock offered pursuant to this prospectus supplement is substantially higher than the net tangible book value per share. Accordingly,
at the public offering price of $0.7921 per share, purchasers of common stock in this offering will experience immediate dilution
of $0.4159 per share in as adjusted net tangible book value of the common stock. In addition, as of March 8, 2021,
there were 1,047,377 shares subject to outstanding options at a weighted average exercise price per share of $32.02, and
5,001,626 shares subject to outstanding warrants at a weighted average exercise price of $0.45 per share. To the extent
that additional shares of common stock are issued upon exercise of these outstanding warrants or options, you will incur further
dilution. See “Dilution” for a more detailed discussion of the dilution you will incur if you purchase shares of common
stock in this offering. We may also acquire or license other technologies or finance strategic alliances by issuing equity, which
may result in additional dilution to our stockholders.
If
our former warrant holders resell the shares of our common stock they received in the 2019 Warrant Exchange or 2020 Warrant
Exchange, it may have an adverse effect on the market price of our shares of common stock.
On
March 14, 2019, we entered into private exchange agreements with certain holders of warrants issued in connection with our September
2018 public offering of common stock and warrants (the “2019 Warrant Exchange”). In the 2019 Warrant Exchange, we issued
856,865 shares of our common stock and 70,863 of the warrants issued in September 2018 remain outstanding as of January 31, 2021. Additionally,
on October 16, 2020, we entered into private exchange agreements with certain holders of warrants issued in connection with our January
2020 public offering of common stock and warrants (the “2020 Warrant Exchange”). In the 2020 Warrant Exchange, we issued
3,000,000 shares of our common stock and none of the warrants issued in January 2020 remain outstanding. Following the 2019 Warrant Exchange
and the 2020 Warrant Exchange, the holders of shares of our common stock issued in the 2019 Warrant Exchange and the 2020 Warrant Exchange,
who are not affiliates of ours (and who have not been affiliates of ours within three months preceding a proposed sale) may resell those
shares without restriction under the Federal securities laws. If former warrant holders who received shares of our common stock in the
2019 Warrant Exchange or 2020 Warrant Exchange choose to sell such shares, the presence of these additional shares of common stock trading
in the public market may have an adverse effect on the market price of our common stock.
Future
sales or other issuances of our common stock could depress the market for our common stock.
Sales
of a substantial number of shares of our common stock, or the perception by the market that those sales could occur, could cause the
market price of our common stock to decline or could make it more difficult for us to raise funds through the sale of equity in the future.
In
connection with this offering and pursuant to the investor agreement, the purchasers will be restricted from selling any shares of our
common stock purchased in this offering through April 15, 2021 (such restriction, the “lock-up”). Upon expiration of the
lock-up, the purchasers in this offering may sell shares into the market, which could adversely affect the market price of shares of
our common stock.
Future
issuances of common stock could further depress the market for our common stock. We expect to continue to incur drug development and
selling, general and administrative costs, and to satisfy our funding requirements, we will need to sell additional equity securities,
which may include sales of significant amounts of common stock to strategic investors, and which common stock may be subject to registration
rights and warrants with anti-dilutive protective provisions. The sale or the proposed sale of substantial amounts of our common stock
or other equity securities in the public markets or in private transactions may adversely affect the market price of our common stock
and our stock price may decline substantially. Our stockholders may experience substantial dilution and a reduction in the price that
they are able to obtain upon sale of their shares. Also, new equity securities issued may have greater rights, preferences or privileges
than our existing common stock. In addition, we have a significant number of shares of restricted stock, restricted stock units, stock
options and warrants outstanding. To the extent that outstanding stock options or warrants have been or may be exercised or other shares
issued, investors purchasing our common stock in this offering may experience further dilution.
If
we make one or more significant acquisitions in which the consideration includes stock or other securities, our stockholders’ holdings
may be significantly diluted. In addition, stockholders’ holdings may also be diluted if we enter into arrangements with third
parties permitting us to issue shares of common stock in lieu of certain cash payments upon the achievement of milestones.
There
is no public market for the Pre-Funded Warrants or the Accompanying Warrants being offered in this offering.
There
is no established public trading market for the Pre-Funded Warrants or the Accompanying Warrants being offered in this offering, and
we do not expect a market to develop. In addition, we do not intend to apply to list the Pre-Funded Warrants or the Accompanying Warrants
on any securities exchange or nationally recognized trading system. Without an active market, the liquidity of the Pre-Funded Warrants
or the Accompanying Warrants will be limited.
Holders
of our Pre-Funded Warrants or the Accompanying Warrants will have no rights as a common stockholder until they acquire our common stock.
Until
you acquire shares of our common stock upon exercise of your Pre-Funded Warrants or the Accompanying Warrants, you will have no rights
with respect to shares of our common stock issuable upon exercise of your Pre-Funded Warrants or the Accompanying Warrants. Upon exercise
of your Pre-Funded Warrants or the Accompanying Warrants, you will be entitled to exercise the rights of a common stockholder only as
to matters for which the record date occurs after the exercise date.
If
we do not maintain a current and effective prospectus relating to the common stock issuable upon exercise of the Pre-Funded Warrants
or the Accompanying Warrants, public holders will only be able to exercise such Pre-Funded Warrants or the Accompanying Warrants on a
“cashless basis.”
If
we do not maintain a current and effective prospectus relating to the shares of common stock issuable upon exercise of the Pre-Funded
Warrants or the Accompanying Warrants at the time that holders wish to exercise such warrants, they will only be able to exercise them
on a “cashless basis,” and under no circumstances would we be required to make any cash payments or net cash settle such
warrants to the holders. As a result, the number of shares of common stock that holders will receive upon exercise of the Pre-Funded
Warrants or the Accompanying Warrants will be fewer than it would have been had such holders exercised their Pre-Funded Warrants or the
Accompanying Warrants for cash. Under the terms of the Pre-Funded Warrants or the Accompanying Warrants, we have agreed to use our best
efforts to maintain a current and effective prospectus relating to the shares of common stock issuable upon exercise of such warrants
until the expiration of such warrants. However, we cannot assure you that we will be able to do so. If we are unable to do so, the potential
“upside” of the holder’s investment in our company may be reduced.
The
Pre-Funded Warrants are speculative in nature.
The
Pre-Funded Warrants offered hereby do not confer any rights of common stock ownership on their holders, such as voting rights or the
right to receive dividends, but rather merely represent the right to acquire shares of common stock at a fixed price. Specifically, commencing
on the date of issuance, holders of the Pre-Funded Warrants may acquire the common stock issuable upon exercise of such warrants at an
exercise price of $0.01 per share of common stock. Moreover, following this offering, the market value of the Pre-Funded Warrants is
uncertain and there can be no assurance that the market value of the Pre-Funded Warrants will equal or exceed their public offering price.
There can be no assurance that the market price of the common stock will ever equal or exceed the exercise price of the Pre-Funded Warrants,
and consequently, whether it will ever be profitable for holders of the Pre-Funded Warrants to exercise the Pre-Funded Warrants.
The
Accompanying Warrants may not have any value.
Each
Accompanying Warrants have an exercise price per share of $0.70 and will expire on the fifth anniversary of the date they first become
exercisable. In the event our common stock price does not exceed the exercise price of the Accompanying Warrants during the period when
the warrants are exercisable, the Accompanying Warrants may not have any value.
We
do not intend to pay cash dividends.
We
have not declared or paid any cash dividends on our common stock, and we do not anticipate declaring or paying cash dividends for the
foreseeable future. Any future determination as to the payment of cash dividends on our common stock will be at our Board’s’
discretion and will depend on our financial condition, operating results, capital requirements and other factors that our Board considers
to be relevant.
You
may experience future dilution as a result of future equity offerings.
To
raise additional capital, we may in the future offer additional shares of our common stock or other securities convertible into or exchangeable
for our common stock at prices that may not be the same as the prices per share in this offering. We may sell shares or other securities
in any other offering at a price per share that is less than the prices per share paid by investors in this offering, and investors purchasing
shares of our common stock or other securities in the future could have rights superior to existing stockholders. The price per share
at which we sell additional shares of our common stock, or securities convertible or exchangeable into common stock, in future transactions
may be higher or lower than the prices per share paid by investors in this offering.
Our
management will have broad discretion to use the net proceeds from this offering and our investment of these proceeds pending any such
use may not yield a favorable return.
Our
management will have broad discretion as to the use of the net proceeds from any offering by us and could use them for purposes other
than those contemplated at the time of this offering. Accordingly, you will be relying on the judgment of our management with regard
to the use of these net proceeds, and you will not have the opportunity, as part of your investment decision, to assess whether the proceeds
are being used appropriately. It is possible that the proceeds will be invested in a way that does not yield a favorable, or any, return
for Advaxis.
This
offering is being conducted on a “best efforts” basis.
The
placement agent is offering the shares on a “best efforts” basis, and the placement agent are under no obligation to purchase
any shares for their own account. The placement agent is not required to sell any specific number or dollar amount of shares of common
stock in this offering but will use their best efforts to sell the securities offered in this prospectus supplement. As a “best
efforts” offering, there can be no assurance that the offering contemplated hereby will ultimately be consummated.
We
will require additional capital funding, the receipt of which may impair the value of our common stock.
Our
future capital requirements depend on many factors, including our research, development, sales and marketing activities. We will need
to raise additional capital through public or private equity or debt offerings or through arrangements with strategic partners or other
sources in order to continue to develop our drug candidates. There can be no assurance that additional capital will be available when
needed or on terms satisfactory to us, if at all. To the extent we raise additional capital by issuing equity securities, our stockholders
may experience substantial dilution and the new equity securities may have greater rights, preferences or privileges than our existing
common stock.
We
are not currently in compliance with the continued listing requirements for Nasdaq. If the price of our common stock continues to trade
below $1.00 per share for a sustained period or we do not meet other continued listing requirements, our common stock may be delisted
from the Nasdaq Capital Market, which could affect the market price and liquidity for our common stock and reduce our ability to raise
additional capital.
In
order to maintain listing on the Nasdaq Capital Market, we must satisfy minimum financial and other requirements including, without limitation,
a requirement that our closing bid price be at least $1.00 per share. On April 8, 2020, the Company received written notice from Nasdaq
indicating that the Company was not in compliance with this minimum bid price requirement because the Company’s common stock had
closed below $1.00 per share for the previous 30 consecutive business days. On April 17, 2020, the Company received an additional notice
from Nasdaq indicating that, due to extraordinary market conditions, Nasdaq had tolled the compliance period for the bid-price requirement
through June 30, 2020 (the “tolling period”) and that on April 16, 2020, Nasdaq filed an immediately effective rule change
with the SEC to implement the tolling period. In accordance with the April 17, 2020 notice from Nasdaq, the Company had until December
21, 2020 to regain compliance with the minimum bid price requirement.
As
of December 21, 2020, the Company was yet to be in compliance with the minimum bid requirement as discussed above. On December 22, 2020,
the Company received notification from the Nasdaq that the Company’s application to transfer the listing of its common stock from
the Nasdaq Global Select Market to the Nasdaq Capital Market had been approved. The Company’s securities were transferred to the
Nasdaq Capital Market at the opening of business on December 24, 2020 and the Company will have an additional 180 days, or until June
21, 2021, to regain compliance with the minimum bid price per share requirement.
If
compliance cannot be demonstrated by June 21, 2021 or the Company does not comply with the terms of this extension, Nasdaq will provide
written notification that the Company’s securities will be delisted which could adversely affect the market price and liquidity
of our common stock and reduce our ability to raise additional capital.
As
a matter of course, we explore and evaluate strategic transactions for our company. We may not be successful in identifying or completing
any strategic transaction and any such strategic transaction completed may not yield additional value for stockholders.
As
a matter of course, we are reviewing strategic transactions and alternatives and there can be no assurance that we will be successful
in identifying or completing any strategic transactions, that any such strategic transaction will result in additional value for our
stockholders or that the process will not have an adverse impact on our business. These transactions could include, but are not limited
to, collaboration agreements, co-development agreements, strategic mergers, reverse mergers, the issuance or buyback of public shares,
or the purchase or sale of specific assets, in addition to other potential actions aimed at increasing stockholder value. There can be
no assurance that the review of strategic transactions will result in the identification or consummation of any transaction. Our Board
of Directors may also determine that our most effective strategy is to continue to effectuate our current business plan. The process
of reviewing strategic transactions may be time consuming and disruptive to our business operations and, if we are unable to effectively
manage the process, our business, financial condition and results of operations could be adversely affected. We could incur substantial
expenses associated with identifying and evaluating potential strategic alternatives. No decision has been made with respect to any transaction
and we cannot assure you that we will be able to identify and undertake any transaction that allows our shareholders to realize an increase
in the value of their common stock or provide any guidance on the timing of such action, if any.
We
also cannot assure you that any potential strategic transaction or other alternative transaction, if identified, evaluated and consummated,
will provide greater value to our stockholders than that reflected in the current price of our common stock. Any potential transaction
would be dependent upon a number of factors that may be beyond our control, including, but not limited to, market conditions, industry
trends, the interest of third parties in our business and the availability of financing to potential buyers on reasonable terms. We do
not intend to comment regarding the evaluation of strategic alternatives until such time as our Board of Directors has determined the
outcome of the process or otherwise has deemed that disclosure is appropriate or required by applicable law. As a consequence, perceived
uncertainties related to our future may result in the loss of potential business opportunities and volatility in the market price of
our common stock and may make it more difficult for us to attract and retain qualified personnel and business partners.
Provisions
of the Pre-Funded Warrants and Accompanying Warrants offered by this prospectus could discourage an acquisition of us by a third party.
Certain
provisions of the Pre-Funded Warrants and Accompanying Warrants offered by this prospectus could make it more difficult or expensive
for a third party to acquire us. The Pre-Funded Warrants and Accompanying Warrants prohibit us from engaging in certain transactions
constituting “fundamental transactions” unless, among other things, the surviving entity assumes our obligations under the
Pre-Funded Warrants and Accompanying Warrants. Further, the Pre-Funded Warrants and Accompanying Warrants provide that, in the event
of certain transactions constituting “fundamental transactions,” with some exception, holders of such warrants will have
the right, at their option, to require us to repurchase such Pre-Funded Warrants and Accompanying Warrants at a price described in such
warrants. These and other provisions of the Pre-Funded Warrants and Accompanying Warrants offered by this prospectus could prevent or
deter a third party from acquiring us even where the acquisition could be beneficial to you.
USE
OF PROCEEDS
We
estimate the net proceeds to us from the sale of Securities in this offering will be approximately $18.77 million, after deducting the
discounts and commissions and estimated offering expenses payable by us.
We
expect to use the net proceeds from this offering to fund our continued research and development initiatives in connection with our product
pipeline including, but not limited to, investment in our ADXS-HOT program and for general corporate purposes. We may also use a portion
of the net proceeds to acquire or invest in complementary businesses, products and technologies. Although we currently have no specific
agreements, commitments or understandings with respect to any acquisition or investment, we evaluate acquisition and investment opportunities
and may engage in related discussions with other companies from time to time.
As
of the date of this prospectus supplement, we cannot specify with certainty all of the particular uses for the net proceeds to us from
this offering. Accordingly, our management will have broad discretion in the timing and application of these proceeds. Pending application
of the net proceeds as described above, we may invest the net proceeds of this offering in a variety of capital preservation investments,
including but not limited to short-term, interest-bearing investment grade securities, money market accounts, certificates of deposit
and direct or guaranteed obligations of the U.S. government.
DIVIDEND
POLICY
We
have never declared or paid any cash dividends on our common stock and do not anticipate paying any cash dividends in the foreseeable
future. Any future determination to pay dividends will be at the discretion of our board of directors and will depend on our financial
condition, operating results, capital requirements and other factors that our board of directors considers to be relevant.
DILUTION
If
you invest in our common stock, your ownership interest will be diluted to the extent of the difference between the price per share you
pay in this offering and the net tangible book value per share of our common stock immediately after this offering. The net tangible
book value of our common stock as of March 8, 2021 was approximately $28.729 million, or approximately $0.2405 per share of common stock
based upon 119,466,620 shares outstanding. Net tangible book value per share is equal to our total tangible assets, less our total liabilities,
divided by the total number of shares outstanding as of March 8, 2021.
The
following table illustrates this per share dilution:
Public offering price per Share
|
|
|
|
|
|
$
|
0.7921
|
|
Net tangible book value per share as of March 8, 2021
|
|
$
|
0.2405
|
|
|
|
|
|
Increase per share attributable to new investors
|
|
$
|
0.1357
|
|
|
|
|
|
As adjusted net tangible book value per share as of March 8, 2021, after giving effect to this offering
|
|
|
|
|
|
$
|
0.3762
|
|
Dilution per share to new investors purchasing shares in this offering
|
|
|
|
|
|
$
|
0.4159
|
|
The
number of shares of common stock to be outstanding immediately after the offering is based on 119,466,620 shares of common stock outstanding
as of March 8, 2021. The number of shares outstanding as of March 8, 2021 excludes:
|
●
|
5,001,626
shares of our common stock reserved for issuance upon the exercise of outstanding warrants at a weighted average exercise price of
$0.45 per share;
|
|
●
|
5,556
shares of our common stock reserved for issuance upon settlement of restricted stock units;
|
|
●
|
1,047,377
shares of our common stock reserved for issuance upon the exercise of outstanding stock options at a weighted average exercise price
of $32.02 per share;
|
|
●
|
976,517
shares of our common stock reserved for issuance under our employee stock purchase plan;
|
|
●
|
4,844,725
shares of our common stock reserved for future awards under our 2015 Incentive Plan; and
|
|
●
|
886,048
shares of our common stock issued and sold pursuant to our at-the-market program during the period between March 9, 2021 and April
9, 2021.
|
Except
as otherwise indicated, all information in this prospectus supplement assumes no exercise or forfeiture of the outstanding options or
warrants or settlement of restricted stock units after March 8, 2021, including, for the avoidance of doubt, any of Pre-Funded Warrants,
Accompanying Warrants or Private Placement Warrants.
Private
placement transaction
In
a concurrent Private Placement, we are selling to purchasers of Securities this offering Private Placement Warrants to purchase
14,005,202 shares of our Common Stock.
The
Private Placement Warrants will have an exercise price of $0.70 per share and will become exercisable on such date, if ever, that is
fourteen (14) days after we file the Authorized Shares Amendment with the Delaware Secretary of State and the Warrants will remain exercisable
for a period of 5 years from such date.
The
Private Placement Warrants and the shares of our common stock issuable upon the exercise of the Private Placement Warrants are not being
registered under the Securities Act, are not being offered pursuant to this prospectus supplement and the accompanying prospectus and
are being offered pursuant to the exemption provided in Section 4(a)(2) under the Securities Act and Rule 506(b) promulgated thereunder.
Accordingly, purchasers may only sell shares of common stock issued upon exercise of the Private Placement Warrants pursuant to an effective
registration statement under the Securities Act covering the resale of those shares, an exemption under Rule 144 under the Securities
Act or another applicable exemption under the Securities Act.
A
holder of Private Placement Warrants will not have the right to exercise any portion of its warrants if the holder, together with its
affiliates, would beneficially own in excess of 4.99% at the election of the investor, of the number of shares of our common
stock outstanding immediately after giving effect to such exercise (the “Beneficial Ownership Limitation”); provided, however,
that upon notice to the Company, the holder may increase or decrease the Beneficial Ownership Limitation, provided further that in no
event shall the Beneficial Ownership Limitation exceed 9.99% and any increase in the Beneficial Ownership Limitation will not be effective
until 61 days following notice of such increase from the holder to us.
We
have agreed to use commercially reasonable best efforts to file a registration statement on Form S-3 (or other appropriate form) providing
for the resale by the purchasers of the Private Placement Warrants and the shares of common stock issuable upon exercise of the Private
Placement Warrants as soon as practicable (and in any event within 60 calendar days) of the such date, if ever, that we file the Authorized
Shares Amendment. Further, we have agreed to use commercially reasonable best efforts to cause such registration to become effective
within 90 calendar days (or, in the event of a full review, 120 calendar days) following such date, if ever, that that we file the Authorized
Shares Amendment and to keep such registration statement effective at all times until no purchaser owns any Private Placement Warrants
or underlying shares of common stock issuable upon exercise thereof.
Unless
and until we file the Authorized Shares Amendment, we will not have sufficient authorized shares under our Charter
to issue the shares of common stock underlying the Private Placement Warrants. We must receive appropriate shareholder
approval prior to the filing of the Authorized Shares Amendment and there can be no assurance that such shareholder approval will
be received. We are seeking appropriate shareholder approval for the Authorized Shares Amendment at our 2021
Annual Meeting of Stockholders. If such approval is not received at the 2021 Annual Meeting, or any subsequent meeting, we
have agreed to file an additional proxy statement no later than 90 days after the 2021 Annual Meeting, or subsequent meeting,
at which such stockholder approval is not received, in order to seek stockholder approval and use our best efforts to obtain
the stockholder approval.
The
exercise price and number of the shares of our common stock issuable upon the exercise of the Private Placement Warrants will be subject
to adjustment for stock splits, reverse splits, and similar capital transactions, as described in the Private Placement Warrants.
Plan
of Distribution
A.G.P./Alliance
Global Partners, which we refer to herein as the placement agent, has agreed to act as our exclusive placement agent in connection with
this offering subject to the terms and conditions of the placement agency agreement dated April 12, 2021. The placement agent is not
purchasing or selling any of the Securities offered by this prospectus supplement, nor is it required to arrange the purchase or sale
of any specific number or dollar amount of Securities, but has agreed to use its reasonable best efforts to arrange for the sale of all
of the Securities offered hereby. Therefore, we will enter into a securities purchase agreement directly with investors in connection
with this offering and we may not sell the entire amount of Securities offered pursuant to this prospectus supplement. We will make offers
only to a limited number of qualified institutional buyers and accredited investors. A.G.P./Alliance Global Partners is also acting as
placement agent for the Private Placement.
We
have agreed to indemnify the placement agent against specified liabilities, including liabilities under the Securities Act, and to contribute
to payments the placement agent may be required to make in respect thereof.
Fees
and Expenses
We
have agreed to pay the placement agent a placement agent’s fee equal to $1,104,501.34, or 6.5% of the aggregate purchase
price of the Shares and Pre-Funded Warrants in this offering, excluding any Shares or Pre-Funded Warrants sold to Lincoln Park
Capital Fund, LLC. The following table shows the per share and total cash placement agent’s fees we will pay to the placement
agent in connection with the sale of the Securities offered pursuant to this prospectus supplement and the accompanying prospectus,
assuming the purchase of all of the Securities hereby on a best efforts basis:
|
|
Per share and Accompanying Warrant
|
|
|
PER PRE-FUNDED WARRANT AND ACCOMPANYING WARRANT
|
|
|
Total
|
|
Public offering price
|
|
$
|
0.7921
|
|
|
$
|
0.7911
|
|
|
$
|
19,992,327.90
|
|
Placement agent fees(1)
|
|
$
|
0.0404
|
|
|
$
|
0.0514
|
|
|
$
|
1,104,501.34
|
|
Proceeds to Advaxis (before expenses)
|
|
$
|
0.7517
|
|
|
$
|
0.7397
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$
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18,887,826.56
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(1)
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We
have agreed to pay the placement agent a placement agent’s fee equal to $1,104,501.34, or 6.5% of the aggregate purchase price
of the Shares and Pre-Funded Warrants sold in this offering, excluding any Shares or Pre-Funded Warrants sold to Lincoln Park Capital
Fund, LLC. These amounts have therefore been calculated to exclude 3,787,400 Shares which are expected to be sold to Lincoln Park
Capital Fund, LLC.
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We
have also agreed to reimburse the placement agent at closing for legal and other expenses incurred by them in connection with the offering
in an amount not to exceed $50,000. We estimate the total expenses payable by us for this offering, excluding the placement agent fees
and expenses, will be approximately $65,000.
The
placement agent may be deemed to be an underwriter within the meaning of Section 2(a)(11) of the Securities Act, and any commissions
received by it and any profit realized on the resale of the shares sold by it while acting as principal might be deemed to be underwriting
discounts or commissions under the Securities Act. As an underwriter, the placement agent would be required to comply with the requirements
of the Securities Act and the Exchange Act, including, without limitation, Rule 415(a)(4) under the Securities Act and Rule 10b-5 and
Regulation M under the Exchange Act. These rules and regulations may limit the timing of purchases and sales of shares by the placement
agent acting as principal. Under these rules and regulations, the placement agent:
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may
not engage in any stabilization activity in connection with our securities; and
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may
not bid for or purchase any of our securities or attempt to induce any person to purchase any of our securities, other than as permitted
under the Exchange Act, until it has completed its participation in the distribution.
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Listing.
Our
common stock is listed on the Nasdaq Capital Market under the trading symbol “ADXS.”
Lock-Up
Agreements
Our
directors have entered into lock-up agreements. Under these agreements, these individuals have agreed, subject to specified exceptions,
not to sell or transfer any shares of common stock or securities convertible into, or exchangeable or exercisable for, our shares of
common stock during a period ending 60 days after the date of this prospectus supplement, without first obtaining the written consent
of A.G.P./Alliance Global Partners. Specifically, these individuals have agreed, in part, not to:
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sell,
offer, contract or grant any option to sell (including any short sale), pledge, transfer, establish an open “put equivalent
position” within the meaning of Rule 16a-l(h) under the Securities Exchange Act of 1934, as amended;
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enter
into any swap or other arrangement that transfers to another, in whole or in part, any of the economic consequences of ownership
of our securities, whether any such transaction is to be settled by delivery of our shares of common stock, in cash or otherwise;
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make
any demand for or exercise any right with respect to the registration of any of our securities; or
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publicly
disclose the intention to make any offer, sale, pledge or disposition, or to enter into any transaction, swap, hedge or other arrangement
relating to any of our securities.
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Notwithstanding
these limitations, these shares of common stock may be transferred under limited circumstances, including, without limitation, by gift,
will or intestate succession.
In
addition, we have agreed that (i) we will not conduct any issuances of our common stock for a period of 60 days following closing of
this offering and that (ii) we will not conduct any sales of common stock under our at-the-market facility or under our existing equity
line with Lincoln Park Capital Fund, LLC, in each case for a period of 90 days following the closing of this offering. However, if we
file a registration statement with the SEC with respect to the Private Placement Warrants and the shares of common stock issuable upon
the exercise of such Private Placement Warrants, then such restrictions will expire on the date that is 30 days following the effectiveness
of such registration statement (if such date is otherwise earlier than the expiration of the restrictions described above).
Discretionary
Accounts
The
placement agent does not intend to confirm sales of the securities offered hereby to any accounts over which it has discretionary authority.
Other
Activities and Relationships
The
placement agent and certain of its affiliates are full service financial institutions engaged in various activities, which may include
securities trading, commercial and investment banking, financial advisory, investment management, investment research, principal investment,
hedging, financing and brokerage activities. The placement agent and certain of its affiliates have, from time to time, performed, and
may in the future perform, various commercial and investment banking and financial advisory services for us and our affiliates, for which
they received or will receive customary fees and expenses.
In
the ordinary course of their various business activities, the placement agent and certain of its affiliates may make or hold a broad
array of investments and actively trade debt and equity securities (or related derivative securities) and financial instruments (including
bank loans) for their own account and for the accounts of their customers, and such investment and securities activities may involve
securities and/or instruments issued by us and our affiliates. If the placement agent or its affiliates have a lending relationship with
us, they routinely hedge their credit exposure to us consistent with their customary risk management policies. The placement agent and
its affiliates may hedge such exposure by entering into transactions that consist of either the purchase of credit default swaps or the
creation of short positions in our securities or the securities of our affiliates, including potentially the common stock offered hereby.
Any such short positions could adversely affect future trading prices of the common stock offered hereby. The placement agent and certain
of its affiliates may also communicate independent investment recommendations, market color or trading ideas and/or publish or express
independent research views in respect of such securities or instruments and may at any time hold, or recommend to clients that they acquire,
long and/or short positions in such securities and instruments.
Specifically, on November 24, 2020,
we sold an aggregate of 26,666,666 shares of our common stock and warrants to purchase up to 13,333,333 shares of our common stock,
for aggregate gross proceeds of $8,000,000, in a firm commitment underwritten offering, pursuant to which A.G.P./Alliance Global
Partners acted as underwriter.
LEGAL
MATTERS
Certain
legal matters with respect to the securities offered by this prospectus supplement will be passed upon for us by Morgan, Lewis &
Bockius LLP, Princeton, NJ. Certain legal matters will be passed upon for the placement agent by Sullivan & Worcester LLP, New York,
NY.
EXPERTS
The
financial statements of Advaxis, Inc. incorporated in this prospectus supplement by reference to the Annual Report on Form 10-K for the
fiscal year ended October 31, 2020 have been so incorporated in reliance upon the report of Marcum LLP, an independent registered public
accounting firm, and upon the authority of said firm as experts in accounting and auditing.
WHERE
YOU CAN FIND MORE INFORMATION
We
file annual, quarterly and current reports, proxy statements, and other information with the SEC. We file these documents with the SEC
electronically. You can access the electronic versions of these filings on the SEC’s website found at www.sec.gov. You can also
obtain copies of materials we file with the SEC, free of charge, from our website found at www.advaxis.com. Information contained on
our website does not constitute part of this prospectus supplement or the accompanying prospectus. Our stock is quoted on the Nasdaq
Capital Market under the symbol “ADXS.”
INCORPORATION
OF CERTAIN INFORMATION BY REFERENCE
The
SEC allows us to “incorporate by reference” the information we file with them which means that we can disclose important
information to you by referring you to those documents instead of having to repeat the information in this prospectus supplement and
accompanying prospectus. The information incorporated by reference is considered to be part of this prospectus supplement and accompanying
prospectus, and later information that we file with the SEC will automatically update and supersede this information. We incorporate
by reference the documents listed below and any future filings made with the SEC under Sections 13(a), 13(c), 14 or 15(d) of the Exchange
Act between the date of this prospectus supplement and the termination of the offering (other than, unless otherwise specifically indicated,
current reports furnished under Item 2.02 or Item 7.01 of Form 8-K and exhibits filed on such form that are related to such items):
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our
2020 Form 10-K/A;
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our
Quarterly Report on Form 10-Q for the quarter ended January 31, 2021, filed with the SEC on March 16, 2021;
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our
Current Reports on Form 8-K filed with the SEC on February 4, 2021, February 16, 2021, March 5, 2021, March 30, 2021, and April 6,
2021; and
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the
description of our common stock, par value $0.001 per share, contained in Exhibit 4.11 to our 2020 Form 10-K/A, and all amendments
and reports updating such description.
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We
will provide to each person, including any beneficial owner, to whom a copy of this prospectus supplement and the related prospectus
is delivered, a copy of any or all of the information that we have incorporated by reference into this prospectus supplement and the
related prospectus, but not delivered with this prospectus supplement and the related prospectus. We will provide this information upon
written or oral request at no cost to the requester. You may request this information by contacting our corporate headquarters at the
following address: 9 Deer Park Drive, Suite K-1, Monmouth Junction, New Jersey 08852, Attn: Igor Gitelman, or by calling (609) 452-9813.
PROSPECTUS
$250,000,000
Advaxis,
Inc.
Common
Stock
Preferred
Stock
Debt
Securities
Warrants
Units
We
may offer and sell up to $250,000,000 in the aggregate of any combination of the securities described in this prospectus, from
time to time in one or more offerings. We may offer these securities separately or together
in units.
We
may offer and sell the securities described in this prospectus and any prospectus supplement to or through one or more underwriters,
dealers and agents, or directly to purchasers, or through a combination of these methods. If any underwriters, dealers or agents
are involved in the sale of any of the securities, their names and any applicable purchase price, fee, commission or discount
arrangement between or among them will be set forth, or will be calculable from the information set forth, in the applicable prospectus
supplement. See the sections of this prospectus entitled “About this Prospectus” and “Plan of Distribution”
for more information. No securities may be sold without delivery of this prospectus and the applicable prospectus supplement describing
the method and terms of the offering of such securities.
This
prospectus provides a general description of the securities we may offer. Each time we offer and sell securities, we will provide
specific terms of the securities offered in a supplement to this prospectus. The prospectus supplement may also add, update or
change information contained in this prospectus. You should read this prospectus and the applicable prospectus supplement carefully
before you invest in any securities being offered. This prospectus may not be used to consummate a sale of securities unless accompanied
by the applicable prospectus supplement.
Our common stock is traded
on the NASDAQ Global Select Market under the symbol “ADXS.” On August 22, 2018, the per share closing price
of our common stock as reported on the NASDAQ Global Select Market was $1.47 per share. We will provide information in
any applicable prospectus supplement regarding any listing of securities other than shares of our common stock on any securities
exchange.
Investing
in our securities involves certain risks. See “Risk Factors” on page 3 of this prospectus and any similar
section contained in the applicable prospectus supplement concerning factors you should consider before investing in our securities.
Neither
the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or
determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.
The
date of this prospectus is , 2018
Table
of Contents
ABOUT
THIS PROSPECTUS
This
prospectus is part of a registration statement that we filed with the Securities and Exchange Commission, or the SEC, using a
“shelf” registration process. Under this shelf registration process, we may from time to time offer and sell any combination
of the securities described in this prospectus in one or more offerings for an aggregate initial offering price of up to $250,000,000.
Each time we sell securities, we will provide a prospectus supplement to this prospectus that contains specific information about
the terms of such offering. The prospectus supplement may also add, update or change information contained in this prospectus.
Before purchasing any securities, you should carefully read both this prospectus and any prospectus supplement, together with
the additional information incorporated into this prospectus or described under the heading “Where You Can Find More Information.”
You
should rely only on the information contained or incorporated by reference in this prospectus and any prospectus supplement. We
have not authorized any other person to provide you with different information. If anyone provides you with different or inconsistent
information, you should not rely on it. We will not make an offer to sell securities in any jurisdiction where the offer or sale
is not permitted. You should assume that the information appearing in this prospectus, as well as information we previously filed
with the SEC and have incorporated by reference, is accurate as of the date on the front cover of this prospectus only, or when
such document was filed with the SEC. Our business, financial condition, results of operations and prospects may have changed
since the relevant date.
We
will not use this prospectus to offer and sell securities unless it is accompanied by a prospectus supplement that more fully
describes the terms of the offering.
When
we refer to “Advaxis,” “we,” “our,” “us” and the “Company” in this
prospectus, we mean Advaxis, Inc., unless otherwise specified.
We
own various U.S. federal and foreign trademark registrations and applications, as well as pending and unregistered trademarks
and service marks. All trademarks or trade names referred to in this prospectus are the property of their respective owners. Solely
for convenience, the trademarks and trade names in this prospectus may be referred to without the ® and ™
symbols, but such references should not be construed as any indicator that their respective owners will not assert, to the fullest
extent under applicable law, their rights thereto.
WHERE
YOU CAN FIND MORE INFORMATION
We file reports with the
Securities and Exchange Commission, or the SEC, annually using Form 10-K, quarterly reports on Form 10-Q and current reports on
Form 8-K. You may read and copy any such reports and amendments thereto at the SEC’s Public Reference Room at 100 F Street,
N.E., Washington, D.C. 20549. Please call the SEC at 1-800-SEC-0330 for information on the Public Reference Room. Additionally,
the SEC maintains a website that contains annual, quarterly, and current reports, proxy statements, and other information that
issuers (including us) file electronically with the SEC. The SEC’s website address is www.sec.gov. You can also obtain copies
of materials we file with the SEC from our Internet website found at www.advaxis.com. The information on our website, however,
is not, and should not be deemed to be, a part of this prospectus or any prospectus supplement. We have included our website address
as an inactive textual reference only. Our stock is quoted on the NASDAQ Global Select Market under the symbol “ADXS.”
INCORPORATION
OF CERTAIN INFORMATION BY REFERENCE
The
SEC allows us to “incorporate by reference” into this prospectus the information we file with the SEC. This means
that we can disclose important information to you by referring you to those documents without restating that information in this
document. The information incorporated by reference into this prospectus is considered to be part of this prospectus, and information
we file with the SEC pursuant to Section 13(a), 13(c), 14 or 15(d) of the Securities Exchange Act of 1934, as amended, or the
Exchange Act, including those made on or after the date of the initial filing of the registration statement of which this prospectus
is a part and prior to the effectiveness of such registration statement, will be deemed to be incorporated by reference into this
prospectus and will automatically update and supersede the information contained in this prospectus and documents listed below.
We incorporate by reference into this prospectus the documents listed below, except to the extent information in those documents
differs from information contained in this prospectus, and any future filings made by us with the SEC under Sections 13(a), 13(c),
14 or 15(d) of the Exchange Act prior to the termination of the offering, including exhibits (however, unless specifically indicated,
we do not incorporate by reference, whether listed below or filed in the future, current reports furnished under Item 2.02 or
Item 7.01 of Form 8-K or related exhibits furnished pursuant to Item 9.01 of Form 8-K):
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our
Annual Report on Form 10-K for the fiscal year ended October 31, 2017 filed with the
Commission on December 21, 2017;
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the
portions of our Definitive Proxy Statement on Schedule 14A filed with the Commission
on February 6, 2018 that are incorporated by reference into our Annual Report on Form
10-K for the fiscal year ended October 31, 2017;
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our
Quarterly Reports on Form 10-Q filed with the Commission on March 12, 2018 and June 7,
2018;
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our
Current Reports on Form 8-K filed with the Commission on December 20, 2017, February
15, 2018, February 21, 2018, February 22, 2018, March 12, 2018, March 21, 2018, April
23, 2018, June 6, 2018, June 8, 2018, July 10, 2018, July 13, 2018, July 17, 2018 and
July 30, 2018; and
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the
description of our common stock, par value $0.001 per share, contained in our Registration
Statement on Form 8-A, filed with the Commission on October 15, 2013 and under the caption
“Description of Securities” in the Registrant’s prospectus, dated as
of October 15, 2013, forming a part of the Registration Statement on Form S-1 (Registration
No. 333-188637) filed with the Commission, including any amendments or reports filed
for the purpose of updating such description.
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We
will provide to each person, including any beneficial owner, to whom a copy of this prospectus is delivered, a copy of any or
all of the information that we have incorporated by reference into this prospectus. We will provide this information upon written
or oral request at no cost to the requester. You may request this information by contacting our corporate headquarters at the
following address: 305 College Road East, Princeton, New Jersey 08540, Attn: Molly Henderson, or by calling (609) 452-9813.
RISK
FACTORS
Investment
in our common stock involves risks. You should consider carefully the risk factors set forth below as well as those contained
in the section entitled “Risk Factors” contained in our Annual Report on Form
10-K for the year ended October 31, 2017, as filed with the SEC on December 21, 2017, which is incorporated herein by reference
in its entirety, as well as any amendment or update to our risk factors reflected in subsequent filings with the SEC incorporated
by reference into this prospectus and other information contained in the applicable prospectus supplement. If any of the risks
or uncertainties described in our SEC filings actually occurs, our business, financial condition, results of operations or cash
flow could be materially and adversely affected. This could cause the trading price of our common stock to decline, resulting
in a loss of all or part of your investment. The risks and uncertainties we have described are not the only ones facing our company.
Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also affect our business
operations.
Risks Related to Our Common Stock
Our stock price can be volatile,
which increases the risk of litigation, and may result in a significant decline in the value of your investment.
The trading price of our common stock is
likely to be highly volatile and subject to wide fluctuations in price in response to various factors, many of which are beyond
our control and may not be related to our operating performance. These fluctuations could cause you to lose part or all of your
investment in our common stock. These factors include, but are not limited to, the following:
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price and volume
fluctuations in the overall stock market from time to time;
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changes in the
market valuations, stock market prices and trading volumes of similar companies;
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actual or anticipated
changes in our net loss or fluctuations in our operating results or in the expectations of securities analysts;
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the issuance
of new equity securities pursuant to a future offering, including potential issuances of preferred stock;
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general economic
conditions and trends;
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positive and
negative events relating to healthcare and the overall pharmaceutical and biotech sector;
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major catastrophic
events;
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sales of large
blocks of our stock;
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additions or
departures of key personnel;
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changes in the
regulatory status of our immunotherapies, including results of our pre-clinical and clinical trials;
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positive and
negative changes in relationships with partners;
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events affecting
the University of Pennsylvania or any of our other current or future collaborators;
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announcements
of new products or technologies, commercial relationships or other events by us or our competitors;
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regulatory developments
in the United States and other countries;
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failure of our
common stock or warrants to be listed or quoted on the Nasdaq Stock Market, NYSE Amex Equities or other national market system;
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changes in accounting
principles; and
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discussion of
us or our stock price by the financial and scientific press and in online investor communities.
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In addition, equity markets in general,
and the market for biotechnology and life sciences companies in particular, have experienced extreme price and volume fluctuations
that have often been unrelated or disproportionate to the operating performance of companies traded in those markets. These broad
market and industry factors may materially affect the market price of our common stock, regardless of our development and operating
performance. In the past, following periods of volatility in the market price of a company’s securities, securities class-action
litigation has often been instituted against that company. Due to the volatility of our stock price, we have been and may be the
target of securities litigation in the future. Securities litigation could result in substantial costs and divert management’s
in the future attention and resources from our business.
Future sales or other issuances of
our common stock could depress the market for our common stock.
Sales of a substantial number of shares of our common stock, or the perception by the market that those
sales could occur, could cause the market price of our common stock to decline or could make it more difficult for us to raise
funds through the sale of equity in the future.
In
connection with future offerings, we and our directors and executive officers may enter into lock-up agreements for certain periods
of time following such offerings. See “Plan of Distribution” below. Upon expiration or earlier release of the lock-up,
we and our directors and executive officers may sell shares into the market, which could adversely affect the market price of
shares of our common stock.
Future
issuances of common stock could further depress the market for our common stock. We expect to continue to incur drug development
and selling, general and administrative costs, and to satisfy our funding requirements, we will need to sell additional equity
securities, which may be subject to registration rights and warrants with anti-dilutive protective provisions. The sale or the
proposed sale of substantial amounts of our common stock or other equity securities in the public markets may adversely affect
the market price of our common stock and our stock price may decline substantially. Our stockholders may experience substantial
dilution and a reduction in the price that they are able to obtain upon sale of their shares. Also, new equity securities issued
may have greater rights, preferences or privileges than our existing common stock. In addition, we have a significant number of
shares of restricted stock, restricted stock units, stock options and warrants outstanding. To the extent that outstanding stock
options or warrants have been or may be exercised or other shares issued, investors in our common stock may experience further
dilution.
If
we make one or more significant acquisitions in which the consideration includes stock or other securities, our stockholders’
holdings may be significantly diluted. In addition, stockholders’ holdings may also be diluted if we enter into arrangements
with third parties permitting us to issue shares of common stock in lieu of certain cash payments upon the achievement of milestones.
We
do not intend to pay cash dividends.
We
have not declared or paid any cash dividends on our common stock, and we do not anticipate declaring or paying cash dividends
for the foreseeable future. Any future determination as to the payment of cash dividends on our common stock will be at our Board
of Directors’ discretion and will depend on our financial condition, operating results, capital requirements and other factors
that our Board of Directors considers to be relevant.
Certain
anti-takeover provisions in our charter documents and Delaware law could make a third-party acquisition of us difficult. This
could limit the price investors might be willing to pay in the future for our common stock.
Provisions
in our amended and restated certificate of incorporation and amended and restated bylaws could have the effect of making it more
difficult for a third party to acquire, or of discouraging a third party from attempting to acquire, or control us. These factors
could limit the price that certain investors might be willing to pay in the future for shares of our common stock. Our amended
and restated certificate of incorporation allows us to issue preferred stock without the approval of our stockholders. The issuance
of preferred stock could decrease the amount of earnings and assets available for distribution to the holders of our common stock
or could adversely affect the rights and powers, including voting rights, of such holders. In certain circumstances, such issuance
could have the effect of decreasing the market price of our common stock. Our amended and restated bylaws also provide our board
of directors with the ability to alter such bylaws without stockholder approval. Any of these provisions could also have the effect
of delaying or preventing a change in control.
Risks
Related to Our Business
We
expect that we will need to raise additional funding to complete the development and commercialization of our product candidates.
This additional financing may not be available on acceptable terms, or at all. Failure to obtain this necessary capital when needed
may force us to delay, limit, or terminate our product development efforts or other operations.
We estimate
that our current cash, cash equivalents and investments will be sufficient for us to fund our operating expenses and capital expenditure
requirements through 2019. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available
capital resources sooner than we currently expect. We will need to raise substantial additional capital to complete the development
and commercialization of our product candidates. We will continue to seek funds through equity or debt financings, collaborative
or other arrangements with corporate sources, or through other sources of financing. Adequate additional funding may not be available
to us on acceptable terms, or at all. Any failure to raise capital as and when needed, as a result of insufficient authorized
shares or otherwise, could have a negative impact on our financial condition and on our ability to pursue our business plans and
strategies.
Our
existing and future collaborations are important to our business. If we are unable to establish or manage strategic collaborations,
our revenue and drug development may be limited.
Our
strategy includes eventual substantial reliance upon strategic collaborations for marketing and commercialization of our clinical
product candidates, and we currently rely on strategic collaborations for research, development, marketing and commercialization
for some of our immunotherapies. To date, we have been heavily reliant upon third party outsourcing for our clinical trials execution
and production of drug supplies for use in clinical trials.
In
addition, as discussed below in “Advaxis, Inc.—Cervical Cancer,” we are currently seeking a partner to fund
the development and commercialization of axalimogene filolisbac in cervical cancer. If a partner is not found, subject to ongoing
discussions with our collaboration partners over our obligations with respect the program, we anticipate winding down the program
in a clinically responsible manner. We may incur additional costs in connection with such a wind-down, including in severing our
relationship with our collaboration partners. Some of the costs are indeterminable at this time and there is no guarantee that
we will be able to wind down the program effectively, which could lead to considerable expense and could negatively affect our
financial results.
Establishing
strategic collaborations is difficult and time-consuming. Our discussions with potential collaborators may not lead to the establishment
of collaborations on favorable terms, if at all. For example, potential collaborators may reject collaborations based upon their
assessment of our financial, clinical, regulatory or intellectual property position. Our current collaborations, as well as any
future new collaborations, may never result in the successful development or commercialization of our immunotherapies or the generation
of sales revenue. To the extent that we have entered or will enter into co-promotion or other collaborative arrangements, our
product revenues are likely to be lower than if we directly marketed and sold any products that we may develop.
Management
of our relationships with our collaborators requires:
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significant time
and effort from our management team;
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financial funding
to support said collaboration;
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coordination
of our research and development programs with the research and development priorities of our collaborators; and
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effective allocation
of our resources to multiple projects.
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In
addition, our existing collaborations, and any future collaborations we may enter into, may pose a number of risks, including
the fact that:
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we will not directly
control the amount or timing of resources devoted by our collaborators to activities related to our immunotherapies;
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our collaborators
may not commit sufficient resources to our research and development programs or the commercialization, marketing or distribution
of our immunotherapies;
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our collaborators
may not perform their obligations as expected;
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our collaborators
may fail to comply with applicable regulatory requirements regarding the development, manufacture, distribution or marketing
of a product candidate or product;
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our collaborators
may pursue existing or other development-stage products or alternative technologies in preference to those being developed
in collaboration with us;
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our collaborators
could independently develop, or develop with third parties, products that compete directly or indirectly with our products
and product candidates, or product candidates discovered in collaboration with us may be viewed by our collaborators as competitive
with their own product candidates or products, which in either case may cause our collaborators to cease to devote resources
to us;
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if we fail to
make required milestone or royalty payments to our collaborators or to observe other obligations in our agreements with them,
our collaborators may have the right to terminate those agreements;
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our collaborators
may seek to renegotiate agreements we have entered into, or may disagree with us about the terms and implementation of these
agreements;
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disagreements
with our collaborators, including disagreements over proprietary rights, contract interpretation or the preferred course of
development, might cause delays or terminations of the research, development or commercialization of product candidates, might
lead to additional responsibilities for us with respect to product candidates, or might result in litigation or arbitration,
any of which would be time-consuming and expensive;
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our collaborators
may not properly maintain or defend our intellectual property rights or may use our proprietary information in a manner that
may invite litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us
to potential litigation; and
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our collaborators
may infringe the intellectual property rights of third parties, which may expose us to litigation and potential liability.
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If
any of the above risks develop into actual events, it may result in considerable expense to us and could negatively affect our
drug development, revenue and financial results.
We
are subject to numerous risks inherent in conducting clinical trials.
We
outsource the management of our clinical trials to third parties. Agreements with clinical research organizations, clinical investigators
and medical institutions for clinical testing and data management services, place substantial responsibilities on these parties
that, if unmet, could result in delays in, or termination of, our clinical trials. For example, if any of our clinical trial sites
fail to comply with FDA-approved good clinical practices, we may be unable to use the data gathered at those sites. If these clinical
investigators, medical institutions or other third parties do not carry out their contractual duties or regulatory obligations
or fail to meet expected deadlines, or if the quality or accuracy of the clinical data they obtain is compromised due to their
failure to adhere to our clinical protocols or for other reasons, our clinical trials may be extended, delayed or terminated,
and we may be unable to obtain regulatory approval for, or successfully commercialize, our agents. We are not certain that we
will successfully recruit enough patients to complete our clinical trials nor that we will reach our primary endpoints. Delays
in recruitment, lack of clinical benefit or unacceptable side effects would delay or prevent the initiation of future development
of our agents. We or our regulators may suspend or terminate our clinical trials for a number of reasons. We may voluntarily suspend
or terminate our clinical trials if at any time we believe they present an unacceptable risk to the patients enrolled in our clinical
trials or do not demonstrate clinical benefit. In addition, regulatory agencies may order the temporary or permanent discontinuation
of our clinical trials, or place our products on temporary or permanent hold, at any time if they believe that the clinical trials
are not being conducted in accordance with applicable regulatory requirements or that they present an unacceptable safety risk
to the patients enrolled in our clinical trials. For example, our Phase 1/2 trial of axalimogene filolisbac in combination with
durvalumab for the treatment of patients with metastatic squamous or non-squamous carcinoma of the cervix and metastatic HPV-associated
SCCHN was placed on clinical hold by FDA on March 9, 2018, following its review of a safety report regarding a Grade 5 Serious
Adverse Event occurring on February 27, 2018 and involving respiratory failure which followed a sixth combination cycle (11th
dose of axalimogene filolisbac, 21st dose of durvalumab) in the trial. Although this has been a single event in our development
of axalimogene filolisbac to date, we agreed on new guidelines for the early detection and treatment of such rare events with
the FDA that will be implemented for all axalimogene filolisbac programs. As development of axalimogene filolisbac continues
we may find that this event is not as rare as our experience to date indicates, our development of axalimogene filolisbac may
be put on clinical hold by regulatory authorities or terminated voluntarily by us for safety concerns.
Our
clinical trial operations are subject to regulatory inspections at any time. If regulatory inspectors conclude that we or our
clinical trial sites are not in compliance with applicable regulatory requirements for conducting clinical trials, we may receive
reports of observations or warning letters detailing deficiencies, and we will be required to implement corrective actions. If
regulatory agencies deem our responses to be inadequate, or are dissatisfied with the corrective actions we or our clinical trial
sites have implemented, our clinical trials may be temporarily or permanently discontinued, we may be fined, we or our investigators
may be precluded from conducting any ongoing or any future clinical trials, the government may refuse to approve our marketing
applications or allow us to manufacture or market our products, and we may be criminally prosecuted. The lengthy approval process
as well as the unpredictability of future clinical trial results may result in our failing to obtain regulatory approval for our
product candidates, which would materially harm our business, results of operations and prospects.
The
recently enacted tax reform bill could adversely affect our business and financial condition.
On December
22, 2017, President Trump signed into law the “Tax Cuts and Jobs Act,” or the TCJA, which significantly amends the
Internal Revenue Code of 1986. The TCJA, among other things, reduces the corporate tax rate from a top marginal rate of 35% to
a flat rate of 21%, limits the tax deduction for interest expense to 30% of adjusted earnings, eliminates net operating loss carrybacks,
imposes a one-time tax on offshore earnings at reduced rates regardless of whether they are repatriated, allows immediate deductions
for certain new investments instead of deductions for depreciation expense over time, and modifies or repeals many business deductions
and credits (including reducing the business tax credit for certain clinical testing expenses incurred in the testing of certain
drugs for rare diseases or conditions generally referred to as “orphan drugs”). We continue to examine the impact
these changes may have on our business. Notwithstanding the reduction in the corporate income tax rate, the overall impact of
the TCJA is uncertain and our business and financial condition could be adversely affected. The impact of the TCJA on holders
of our common stock is also uncertain and could be adverse. This prospectus does not discuss the TCJA or the manner in which it
might affect us or purchasers of our common stock. We urge our stockholders to consult with their legal and tax advisers with
respect to the TCJA and the potential tax consequences of investing in our common stock.
We
are subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws, and anti-money
laundering laws and regulations. We can face criminal liability and other serious consequences for violations which can harm our
business.
We
are subject to U.S. export control and economic sanctions laws and regulations and other restrictions on international trade.
As such, we are required to export our technology, products, and services in compliance with those laws and regulations. If we
export our technology, products, or services, the exports may require authorizations, including a license, a license exception
or other appropriate government authorization. In addition, the United States and other governments and their agencies impose
sanctions and embargoes on certain countries, their governments and designated parties, which may prohibit the export of certain
technology, products, and services to such persons altogether.
We
are also subject to the U.S. Foreign Corrupt Practices Act of 1977, as amended, the U.S. domestic bribery statute contained in
18 U.S.C. § 201, the U.S. Travel Act, the USA PATRIOT Act, and possibly other state and national anti-bribery and anti-money
laundering laws in countries in which we conduct activities. Anti-corruption laws are interpreted broadly and prohibit companies
and their employees, third-party intermediaries, and other associated persons from authorizing, promising, offering, providing,
soliciting, or accepting directly or indirectly, improper payments or benefits to or from any person whether in the public or
private sector. We have direct or indirect interactions with officials and employees of government agencies. We can be held liable
for the corrupt or other illegal activities of our employees, representatives, contractors, business partners, and agents, in
violation of U.S. and applicable foreign anti-corruption, export, import, sanctions, or anti-money laundering laws and regulations,
even if we do not explicitly authorize or have actual knowledge of such activities.
Any violation
of the laws and regulations described above may result in substantial civil and criminal fines and penalties, imprisonment, the
loss of export or import privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm,
and other consequences.
SPECIAL
CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS
This
prospectus includes statements that are, or may be deemed, “forward-looking statements.” In some cases, these forward-looking
statements can be identified by the use of forward-looking terminology, including the terms “believes,” “estimates,”
“anticipates,” “expects,” “plans,” “intends,” “may,” “could,”
“might,” “will,” “should,” “approximately” or, in each case, their negative or
other variations thereon or comparable terminology, although not all forward-looking statements contain these words. They appear
in a number of places throughout this prospectus and include statements regarding our intentions, beliefs, projections, outlook,
analyses or current expectations concerning, among other things, our ongoing and planned discovery and development of drug candidates,
the strength and breadth of our intellectual property, our ongoing and planned preclinical studies and clinical trials, the timing
of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates, the degree
of clinical utility of our product candidates, particularly in specific patient populations, expectations regarding clinical trial
data, our results of operations, financial condition, liquidity, prospects, growth and strategies, the length of time that we
will be able to continue to fund our operating expenses and capital expenditures, our expected financing needs and sources of
financing, the industry in which we operate and the trends that may affect the industry or us.
By
their nature, forward-looking statements involve risks and uncertainties because they relate to events, competitive dynamics,
and healthcare, regulatory and scientific developments and depend on the economic circumstances that may or may not occur in the
future or may occur on longer or shorter timelines than anticipated. Although we believe that we have a reasonable basis for each
forward-looking statement contained in this prospectus, we caution you that forward-looking statements are not guarantees of future
performance and that our actual results of operations, financial condition and liquidity, and the development of the industry
in which we operate may differ materially from the forward-looking statements contained in this prospectus. In addition, even
if our results of operations, financial condition and liquidity, and the development of the industry in which we operate are consistent
with the forward-looking statements contained in this prospectus, they may not be predictive of results or developments in future
periods.
Some
of the factors that we believe could cause actual results to differ from those anticipated or predicted include:
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the
success and timing of our clinical trials, including patient accrual;
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our
ability to obtain and maintain regulatory approval and/or reimbursement of our product
candidates for marketing;
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our
ability to obtain the appropriate labeling of our products under any regulatory approval;
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our
plans to develop and commercialize our products;
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the
successful development and implementation of our sales and marketing campaigns;
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the
change of key scientific or management personnel;
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the
size and growth of the potential markets for our product candidates and our ability to
serve those markets;
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our
ability to successfully compete in the potential markets for our product candidates,
if commercialized;
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regulatory
developments in the United States and other countries;
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the
rate and degree of market acceptance of any of our product candidates;
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new
products, product candidates or new uses for existing products or technologies introduced
or announced by our competitors and the timing of these introductions or announcements;
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market
conditions in the pharmaceutical and biotechnology sectors;
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any
stockholder dilution that will result from future capital raising efforts and the exercise
or conversion, as applicable, of our outstanding options and warrants;
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the
accuracy of our estimates regarding expenses, future revenues, capital requirements and
needs for additional financing;
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our
ability to obtain additional funding;
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our
ability to obtain and maintain intellectual property protection for our product candidates;
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the
success and timing of our preclinical studies including investigational new drug application,
or IND, enabling studies;
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the
ability of our product candidates to successfully perform in clinical trials;
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our
ability to establish and manage strategic collaborations;
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our
ability to initiate trials, enroll our trials, obtain and maintain approval of our product
candidates;
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our
ability to manufacture and the performance of third-party manufacturers;
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the
performance of our clinical research organizations, clinical trial sponsors and clinical
trial investigators; and
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our
ability to successfully implement our strategy.
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Any
forward-looking statements that we make in this prospectus speak only as of the date of such statement, and we undertake no
obligation to update such statements to reflect events or circumstances after the date of this prospectus. You should also
read carefully the factors described in the “Risk Factors” section of this prospectus and of our Annual Report on
Form 10-K for the year ended October 31, 2017, as filed with the SEC on December 21, 2017, or in our subsequent filings with
the SEC incorporated by reference herein to better understand the risks and uncertainties inherent in our business and
underlying any forward-looking statements. As a result of these factors, we cannot assure you that the forward-looking
statements in this prospectus will prove to be accurate.
This
prospectus includes statistical and other industry and market data that we obtained from industry publications and research, surveys
and studies conducted by third-parties. Industry publications and third-party research, surveys and studies generally indicate
that their information has been obtained from sources believed to be reliable, although they do not guarantee the accuracy or
completeness of such information. While we believe these industry publications and third-party research, surveys and studies are
reliable, we have not independently verified such data.
We
qualify all of our forward-looking statements by these cautionary statements. In addition, with respect to all of our forward-looking
statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation
Reform Act of 1995.
ADVAXIS,
INC.
We
are a late-stage biotechnology company focused on the discovery, development and commercialization of proprietary Listeria
monocytogenes, or Lm, based antigen delivery products. We are using our Lm platform directed against tumor-specific
targets in order to engage the patient’s immune system to destroy tumor cells. Through a license from the University of
Pennsylvania, we have exclusive access to this proprietary formulation of attenuated Lm called Lm Technology. Our
proprietary approach deploys a unique mechanism of action that redirects the immune system to attack cancer in three distinct
ways by:
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Alerting
and training the immune system by activating multiple pathways in antigen-presenting
cells, or APCs, with the equivalent of multiple adjuvants;
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Attacking
the tumor by generating a strong, cancer-specific T cell response; and
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Breaking
down tumor protection through suppression of the protective cells in the tumor microenvironment
that shields the tumor from the immune system, enabling the activated T cells to begin
working to eliminate the tumor.
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During
the second fiscal quarter, in an effort to maximize stockholder value and reduce operating expenses, we began assessing the clinical
and commercial viability of our R&D programs in order to determine which were best suited for internal development and which
were better suited for external development opportunities. In particular, we announced plans to take the following actions:
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Minimize
future investment in cervical cancer and focus on potential partnership opportunities.
While our lead Human Papillomavirus, or HPV, program, axalimogene filolisbac, has shown
meaningful clinical efficacy and supports the manageable safety profile of our Lm
platform in HPV-related cancers, we plan to expand our search for a U.S. and/or European
partner who will take on all development and commercialization activities and costs related
to the HPV program. In the event no partner emerges, we intend to wind down the ongoing
trial in high-risk, locally advanced cervical cancer (AIM2CERV) and not conduct the PD-1
combination trial in metastatic cervical cancer (ADVANCE), which has yet to be initiated.
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Evaluate
cost effective ways to invest in axalimogene filolisbac in head-and-neck cancer through
internal or external partnerships, or both.
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Determine,
in the first quarter of 2019, a path forward for our program related to our ongoing trial
in metastatic prostate cancer with ADXS-PSA in combination with KEYTRUDA®
(pembrolizumab), Merck & Co.’s, or Merck’s, anti PD-1 antibody, which
early clinical data have proven worthy of continued evaluation.
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Increase
internal investment in our ADXS-NEO and ADXS-HOT programs, both of which target neoantigens,
which are antigens encoded by tumor-specific mutated genes, a potentially transformational,
next-generation approach to treating cancer.
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In
addition, on June 7, 2018, we announced that we would be implementing a reduction in force to align our staffing needs with our
new strategy. The reduction involved the elimination of approximately 24% of our work force to better align our resources with
our strategy outlined above.
ADXS-HOT
We
are currently prioritizing product development in the most prevalent cancers, with the first tumor type to be non-small cell lung
cancer, or NSCLC. On July 30, 2018, we announced the U.S. Food and Drug Administration’s, or FDA’s, allowance of our
ADXS-HOT IND in NSCLC. We plan to commence a first-in-human trial in NSCLC in 2018. We plan to submit additional INDs for the
ADXS-HOT program with prostate cancer in 2018 and bladder cancer in 2019, as well as a fourth ADXS-HOT drug candidate to be selected
from breast, colorectal, ovarian or head and neck cancers.
ADXS-HOT
preclinical data was presented in a poster presentation at the 2018 Annual Meeting of the American Association of Cancer Research,
or AACR. The study, entitled “Targeting Shared Hotspot Cancer Mutations with a Listeria monocytogenes Immunotherapy
Induce Potent Anti-Tumor Immunity” demonstrated that the ADXS-HOT platform could effectively target common (public or shared)
mutations (hotspots) and control tumor growth with both single and multi-target constructs.
ADXS-NEO
On
August 1, 2016, we entered into a global agreement, or the Amgen Agreement, with Amgen Inc., or Amgen, for the development and
commercialization of ADXS-NEO, a novel, preclinical investigational immunotherapy, using our proprietary Listeria monocytogenes
attenuated bacterial vector, which activates a patient’s immune system to respond against unique mutations, or neoepitopes,
contained in and identified from an individual patient’s tumor. Under the terms of the Amgen Agreement, Amgen received an
exclusive worldwide license to develop and commercialize ADXS-NEO. Under the Amgen Agreement, Amgen made an upfront payment to
us of $40 million and purchased an additional $25 million of our common stock. Amgen will fund the clinical development and commercialization
of ADXS-NEO while we will retain manufacturing responsibilities. We will collaborate with Amgen through a joint steering committee
for the development and commercialization of ADXS-NEO. We will also receive development, regulatory and sales milestone payments
of up to $475 million and high single-digit to double-digit royalty payments based on worldwide sales.
Preclinical
findings in our ADXS-NEO program were discussed in poster presentations at the 2018 AACR Annual Meeting. Additionally, portions
of these data were presented by Amgen at a podium presentation during the European Neoantigen Summit 2018.
The
first study, as discussed in a poster presentation at the AACR 2018 Annual Meeting, entitled “Neoantigens that fail to elicit
measurable T cell responses following peptide immunization can control tumor growth when delivered using a Listeria-based immunotherapy
platform,” showed that ADXS-NEO generates T cell responses against neoantigen peptides that control tumor growth, even when
they were identified as “non-immunogenic” using a conventional peptide-adjuvant immunization.
In
the second study, discussed in a poster presentation at the AACR 2018 Annual Meeting entitled “Targeting frameshift mutations
with a Listeria monocytogenes immunotherapy drives neoantigen-specific antitumor immunity in MC38 and CT26 mouse tumor
models,” Our Lm platform was shown to target frameshift mutations and generate T cells to multiple neoantigens per
frameshift in these models. This data highlighted the physical capacity of our Lm platform and its ability to target frameshift
mutations of greater than 90 amino acids, and to generate T cells to multiple neoantigens per frameshift in tumor mouse models.
The
initial tumor types for the ADXS-NEO Phase 1 trial are microsatellite stable colorectal cancer, head and neck cancer, and NSCLC.
On June 11, 2018, we announced that the first patient, being treated for metastatic NSCLC, was dosed in our ADXS-NEO Phase 1 trial.
ADXS-PSA
We
are conducting a Phase 1/2, open-label, multicenter, dose determination and expansion trial in collaboration with Merck evaluating
the safety and efficacy of ADXS-PSA as a monotherapy and in combination with KEYTRUDA® in patients with previously
treated metastatic, castration-resistant prostate cancer. We presented data at the 2018 American Society of Clinical Oncology,
or ASCO, annual meeting. ADXS-PSA was tested alone or in combination with KEYTRUDA in an advanced and heavily pretreated patient
population who had progressed on androgen deprivation therapy. A total of 13 and 37 patients were evaluated on monotherapy and
combination therapy, respectively. Overall, the safety profile was consistent with findings from prior clinical studies using
the Lm platform. Treatment-related adverse events were mostly mild or moderate constitutional symptoms such as fever, chills,
rigors, hypotension, nausea and fatigue, consistent with immune activation and manageable with standard care. There were no new
toxicities observed with the combination therapy. In all treated patients, those who received the combination therapy experienced
the longest overall survival, or OS, at data cut-off. Additional efficacy related data include:
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Median
overall survival had not been reached in the combination arm after 13 months of follow-up
(95%CI 7.16-NR), and was 7.79 months (95%CI 3.52-11.9) in the monotherapy arm.
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56.8%
of patients on combination therapy and 38.5% of patients on monotherapy did not experience
disease progression.
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The
percentage of patients with prostate-specific antigen, or PSA, declines from baseline
in the combination therapy arm was 40.5%, and 15.4% in the monotherapy arm.
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In
all treated patients, an improvement in survival was observed in patients with PSA declines
from baseline of 50% or greater vs. those with PSA declines of less than 50%. There were
7 patients in the combination arm with 50% or greater declines in PSA from baseline,
and none in the monotherapy arm.
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HPV
Related Cancers
We
have several programs in HPV-related cancers based on axalimogene filolisbac, an Lm –based antigen delivery product
designed to target cells expressing HPV. Axalimogene filolisbac is currently under investigation in three HPV-associated cancers:
cervical cancer, head and neck cancer, and anal cancer, either as a monotherapy or in combination with other therapies, and has
shown encouraging safety and efficacy in numerous clinical studies to date.
Cervical
Cancer
We
completed a randomized Phase 2 clinical study (Lm -LLO-E7-15), conducted exclusively in India, in 110 women with recurrent/refractory
cervical cancer. The final results showed that 34.9% (38/109) of patients were alive at 12 months, 24.8% (27/109) of patients
were Long-term Survivors, or LTS, alive greater than 18 months. Of the 15 patients consenting to further follow-up beyond 18 months,
12 (or 11%) achieved 24-month OS status (range 24 – 34+ months) at the time of study closure. Axalimogene filolisbac was
found to be well tolerated with the majority of the AEs were mild to moderate in severity (566 of 704 reported adverse events,
or 80.4%) and were not related to study drug (539 of 704 reported AEs, 76.6%). These data were published in the May 2018 edition
of the peer-reviewed International Journal of Gynecological Cancer.
We
also previously reported results from a Phase 2 clinical study (GOG-0265) in 50 patients, which showed a 12-month overall survival
rate (primary efficacy endpoint) of 38% (n=19/50) in women with persistent, recurrent or metastatic carcinoma of the cervix, representing
a 55% improvement over a model-predicted 12-month overall survival rate of 24.5%. As more than half of the women treated in this
study had received multiple prior lines of therapy including with bevacizumab treatment, the 38% 12-month overall survival rate
was unprecedented when compared against historical data. We continue to believe that the results from the GOG-0265 study are clinically
meaningful and provide proof-of-concept that axalimogene filolisbac demonstrated clinical activity in metastatic cervical cancer.
Our
ongoing Phase 3 trial, AIM2CERV or “Advaxis Immunotherapy 2 Prevent Cervical Recurrence, is
evaluating axalimogene filolisbac in patients with high-risk, locally advanced cervical. The study is being conducted under a
Special Protocol Assessment, and has been determined by the FDA to be adequate, well-designed, and suitable for registration if
successful. This study is being conducted in collaboration with the GOG/NRG Oncology, and we have initiated the AIM2CERV study
to support a Biologics License Application submission in the United States and regulatory registration in other territories around
the world.
AIM2CERV
is a double-blind, randomized, placebo-controlled, Phase 3 study of adjuvant axalimogene filolisbac, following primary chemoradiation
treatment of women with high-risk locally advanced cervical cancer, or HRLACC. The primary objective of AIM2CERV is to compare
the disease free survival of axalimogene filolisbac to placebo administered in the adjuvant setting following standard concurrent
chemotherapy and radiotherapy administered with curative intent to patients with HRLACC. Secondary endpoints include examining
overall survival and safety. Our goal is to develop a treatment to prevent or reduce the risk of cervical cancer recurrence after
primary, standard of care, treatment in women who are at high risk of recurrence. The study is active in fourteen countries with
129 sites open to date.
In
February 2018, we submitted a conditional marketing authorization application, or MAA, to the European Medicines Agency’s,
or EMA, Committee for our lead Lm Technology product candidate, axalimogene filolisbac, for the treatment of adult women
who progress beyond first-line therapy of persistent/recurrent metastatic cervical cancer, or PRmCC. The MAA submission was primarily
based on data from the GOG-0265 study, as well as supportive data from other clinical trials evaluating axalimogene filolisbac
and was validated by the EMA in March 2018.
On
July 10, 2018, we announced plans to withdraw our conditional MAA based on EMA feedback following its initial review indicating
the application will likely need additional data to support a conditional approval. We continue to believe the results from the
GOG-0265 study are clinically meaningful and provide proof-of-concept that axalimogene filolisbac demonstrated clinical activity
in metastatic cervical cancer. The withdrawal of this application does not impact the ongoing clinical trials of axalimogene filolisbac.
We are seeking a U.S. and/or European partner to fund the development and commercialization of axalimogene filolisbac in cervical
cancer including the completion of the AIM2CERV study. If a partner is not found, subject to ongoing discussions with our collaboration
partners over our obligations with respect the program, we anticipate winding down the program in a clinically responsible manner.
We may incur additional costs in connection with such a wind-down, including in severing our relationship with our collaboration
partners, some of which are indeterminable at this time and there is no guarantee that we will be able to wind down the program
effectively.
MedImmune
Collaboration
We
have a clinical trial collaboration agreement with MedImmune, the global biologics research and development arm of AstraZeneca,
and are conducting a Phase 1/2, open-label, multicenter, two-part study to evaluate the safety and efficacy of axalimogene filolisbac
in combination with MedImmune’s investigational anti-PD-L1 immune checkpoint inhibitor, durvalumab, as a combination treatment
for patients with metastatic squamous or non-squamous carcinoma of the cervix and metastatic HPV-associated SCCHN. The dose-escalation
part of this study has been completed. We have commenced enrollment in the Part A (20 patients with SCCHN) and B (90 patients
with cervical cancer) expansion phases; however, this trial was placed on clinical hold by FDA on March 9, 2018, following its
review of a safety report regarding a Grade 5 Serious Adverse Event occurring on February 27, 2018 and involving respiratory failure
which followed a sixth combination cycle (11th dose of axalimogene filolisbac, 21st dose of durvalumab) in the trial. Over 430
patients have received axalimogene filolisbac, and approximately 1,259 doses have been delivered across multiple trials in HPV-associated
cancers, to date, and this is the first time we have seen this type of event. New guidelines for the early detection and treatment
of such rare events were agreed to with the FDA and will be implemented for all axalimogene filolisbac programs. Enrollment and
dosing in all other Advaxis and durvalumab clinical programs were not affected by the clinical hold. On July 13, 2018, we announced
that the FDA lifted its clinical hold for this trial.
BMS
Collaboration
We
entered into a clinical development collaboration agreement with Bristol-Myers Squibb to evaluate their PD-1 immune checkpoint
inhibitor, OPDIVO® (nivolumab), in combination with axalimogene filolisbac as a potential treatment option for
women with metastatic cervical cancer. The ADVANCE trial was planned to evaluate this combination regimen in women with persistent,
recurrent or metastatic (squamous or non-squamous cell) carcinoma of the cervix who have failed at least one prior line of systemic
chemotherapy. Under the terms of the agreement, each party would bear its own internal costs and provide its immunotherapy agents.
This trial has not yet been initiated as the Company is seeking a U.S. and/or European partner to fund the cervical cancer program.
If a partner is not found, the study will not be initiated.
Head-and-Neck
Cancer
We
have entered into a clinical trial collaboration agreement with MedImmune to collaborate on a Phase 1/2, open-label, multicenter,
two part trial to evaluate safety and efficacy of axalimogene filolisbac, in combination with durvalumab (MEDI4736), for patients
with metastatic squamous or non-squamous carcinoma of the cervix and metastatic HPV-associated squamous cell carcinoma of the
head and neck, or SCCHN. Part 1 of this trial is complete, and we have commenced enrollment in the Part A (20 patients with SCCHN)
and B (90 patients with cervical cancer) expansion phases; however, this trial was placed on clinical hold as detailed above.
New guidelines for the early detection and treatment of such rare events were agreed to with the FDA and will be implemented for
this combination study. On July 13, 2018, we announced that FDA lifted its clinical hold for this trial.
We
are evaluating opportunities to conduct a capital-efficient trial evaluating axalimogene filolisbac in head-and-neck cancer and
are in discussions with third parties about a potential study.
Company
Information
We
were originally incorporated in the State of Colorado on June 5, 1987 under the name Great Expectations, Inc. We were a publicly-traded
“shell” company without any business until November 12, 2004 when we acquired Advaxis, Inc., a Delaware corporation,
through a Share Exchange and Reorganization Agreement, dated as of August 25, 2004, which we refer to as the Share Exchange, by
and among Advaxis, the stockholders of Advaxis and us. As a result of the Share Exchange, Advaxis became our wholly owned subsidiary
and our sole operating company. On December 23, 2004, we amended and restated our articles of incorporation and changed our name
to Advaxis, Inc. On June 6, 2006, our stockholders approved the reincorporation of our company from Colorado to Delaware by merging
the Colorado entity into our wholly owned Delaware subsidiary. Our date of inception, for financial statement purposes, is March
1, 2002 and we were uplisted to Nasdaq in 2013. Our common stock is traded on the Nasdaq Global Select Market under the symbol
“ADXS.”
Our
principal executive offices are located at 305 College Road East, Princeton, New Jersey 08540 and our telephone number is (609)
452-9813. We maintain a corporate website at www.advaxis.com which contains descriptions of our technology, our product candidates
and the development status of each drug. We are not including the information on our website as a part of, nor incorporating it
by reference into, this prospectus supplement or the accompanying prospectus. For further information regarding us and our financial
information, you should refer to our recent filings with the SEC. See “Where You Can Find More Information” and “Incorporation
of Certain Information by Reference.”
USE
OF PROCEEDS
We
intend to use the net proceeds from the sale of any securities offered under this prospectus for general corporate purposes unless
otherwise indicated in the applicable prospectus supplement. General corporate purposes may include research and development costs,
including the conduct of one or more clinical trials, potential strategic acquisitions of complementary businesses, services or
technologies, expansion of our technology infrastructure and capabilities, working capital, capital expenditures and general corporate
purposes. We may temporarily invest the net proceeds in a variety of capital preservation instruments, including investment grade,
interest bearing instruments and U.S. government securities, until they are used for their stated purpose. We have not determined
the amount of net proceeds to be used specifically for such purposes. As a result, management will retain broad discretion over
the allocation of net proceeds.
RATIO
OF EARNINGS TO FIXED CHARGES
The
following table sets forth our ratio of earnings to fixed charges for the periods shown. You should read this table in conjunction
with the financial statements and notes incorporated by reference in this prospectus. As of the date of this prospectus, we have
no preferred shares outstanding and paid no dividends on preferred shares during the periods indicated. Therefore, the ratios
of earnings to combined fixed charges and preferred dividends are the same as the ratios of earnings to fixed charges presented
below.
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Years
Ended October 31,
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Nine
Months
Ended
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2017
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2016
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2015
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2014
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2013
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July
31, 2018
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Ratio
of earnings (loss) to fixed charges
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N/A
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N/A
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N/A
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N/A
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N/A
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N/A
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For
purposes of calculating the ratios in the table above, earnings consist of net loss before income taxes. Fixed charges include
interest expense on indebtedness and an estimate of the interest expense within rental expense.
Due
to our net losses for the years ended October 31, 2017, 2016, 2015, 2014 and 2013 and for
the nine months ended July 31, 2018, earnings were insufficient to cover fixed charges for such periods and we are unable
to disclose a ratio of earnings to fixed charges for such periods. The dollar amount of the deficiency in earnings available for
fixed charges for the years ended October 31, 2017, 2016, 2015, 2014 and 2013 and for the
nine months ended July 31, 2018 was approximately $97.8 million, $76.1 million, $48.6 million, $18.9 million, $20.7 million
and $47.8 million, respectively.
SECURITIES
WE MAY OFFER
We
may issue from time to time, in one or more offerings, the following securities:
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shares
of common stock;
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shares
of preferred stock;
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warrants
for the purchase of common stock, preferred stock or debt securities; and
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units
consisting of any combination of the other types of securities described in this prospectus.
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This
prospectus contains summary descriptions of the securities we may offer from time to time. These summary descriptions are not
meant to be complete descriptions of each security. The particular terms of any security, including the offering price and the
net proceeds to us, will be described in the applicable prospectus supplement.
DESCRIPTION
OF CAPITAL STOCK
The
following description of our common stock and preferred stock, together with the additional information we include in any applicable
prospectus supplements, summarizes the material terms and provisions of the common stock and preferred stock that we may offer
under this prospectus. The following description of our capital stock does not purport to be complete and is subject to, and qualified
in its entirety by, our Amended and Restated Certificate of Incorporation and our Amended and Restated Bylaws, which are exhibits
to the registration statement of which this prospectus forms a part, and by applicable law. We refer in this section to our Amended
and Restated Certificate of Incorporation as our “certificate of incorporation”, and we refer to our Amended and Restated
Bylaws as our “bylaws.” The terms of our common stock and preferred stock may also be affected by Delaware law.
Authorized
Capital Stock
Under
our certificate of incorporation, we are authorized to issue a total of 95,000,000 shares of common stock, par value $0.001 per
share, and 5,000,000 shares of “blank check” preferred stock, par value $0.001 per share. As of August 22, 2018, we
had issued and outstanding 52,823,483 shares of our common stock and no shares of preferred stock outstanding. There were approximately
93 holders of record.
Common
Stock
Holders
of our common stock are entitled to one vote for each share held of record on all matters submitted to a vote of shareholders
and do not have any cumulative voting rights. Holders of our common stock are entitled to receive ratably any dividends declared
by the board of directors out of funds legally available for that purpose, subject to any preferential dividend rights of any
outstanding preferred stock. Our common stock has no preemptive rights, conversion rights or other subscription rights or redemption
or sinking fund provisions. In the event of our liquidation, dissolution or winding up, holders of our common stock will be entitled
to share ratably in all assets remaining after payment of all debts and other liabilities and any liquidation preference of any
outstanding preferred stock. All outstanding shares are fully-paid and non-assessable.
Listing
Our
common stock is listed on the NASDAQ Global Select Market under the symbol “ADXS.” On August 22, 2018, the
closing price for our common stock, as reported on the NASDAQ Global Select Market, was $1.47 per share.
Transfer
Agent
The
transfer agent and registrar for our common stock is Continental Stock Transfer and Trust Company, 17 Battery Place, 8th Floor,
New York, NY 10004.
Preferred
Stock
Our
board of directors is authorized, without action by the stockholders, to designate and issue up to an aggregate of 5,000,000 shares
of preferred stock in one or more series. Our board of directors can designate the rights, preferences and privileges of the shares
of each series and any of its qualifications, limitations or restrictions. Our board of directors may authorize the issuance of
preferred stock with voting or conversion rights that could adversely affect the voting power or other rights of the holders of
common stock.
The
issuance of preferred stock, while providing flexibility in connection with possible future financings and acquisitions and other
corporate purposes could, under certain circumstances, have the effect of restricting dividends on our common stock, diluting
the voting power of our common stock, impairing the liquidation rights of our common stock, or delaying, deferring or preventing
a change in control of our company, which might harm the market price of our common stock. See also “Antitakeover Effects
of Delaware Law and Provisions of our Amended and Restated Certificate of Incorporation and Amended and Restated By-laws—Provisions
of our Amended and Restated Certificate of Incorporation and Amended and Restated By-laws—Undesignated preferred stock”
below.
If
a specific series of preferred stock is offered under this prospectus, we will describe the terms of the preferred stock in the
prospectus supplement for such offering and will file a copy of the certificate establishing the terms of the preferred stock
with the SEC. To the extent required, this description will include:
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the
title and stated value;
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the
number of shares offered, the liquidation preference per share and the purchase price;
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the
liquidation preference per share;
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the
dividend rate(s), period(s) and/or payment date(s), or method(s) of calculation for such
dividends;
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whether
dividends will be cumulative or non-cumulative and, if cumulative, the date from which
dividends will accumulate;
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the
procedures for any auction and remarketing, if any;
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the
provisions for a sinking fund, if any;
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the
provisions for redemption or repurchase, if applicable, and any restrictions on our ability
to exercise those redemption and repurchase rights;
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any
listing of the preferred stock on any securities exchange or market;
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whether
the preferred stock will be convertible into our common stock, and, if applicable, the
conversion price (or how it will be calculated) and conversion period;
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whether
the preferred stock will be exchangeable into debt securities, and, if applicable, the
exchange price (or how it will be calculated) and exchange period;
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voting
rights, if any, of the preferred stock;
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preemptive
rights, if any, of the preferred stock;
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a
discussion of any material and/or special U.S. federal income tax considerations applicable
to the preferred stock;
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restrictions
on transfer, sale or other assignment, if any;
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the
relative ranking and preferences of the preferred stock as to dividend rights and rights
upon liquidation, dissolution or winding up of the affairs of Advaxis; and
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any
material limitations on issuance of any class or series of preferred stock ranking senior
to or on a parity with the series of preferred stock as to dividend rights and rights
upon liquidation, dissolution or winding up of Advaxis.
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Dividends
Subject
to the dividend rights of the holders of any outstanding series of preferred stock, holders of our common stock are entitled to
receive ratably such dividends and other distributions of cash or any other right or property as may be declared by our board
of directors out of our assets or funds legally available for such dividends or distributions.
Voting
Rights
The
holders of our common stock are entitled to one vote for each share held of record on each matter submitted to a vote of stockholders.
Holders of our common stock do not have a cumulative voting right, which means that the holders of more than one-half of the outstanding
shares of common stock, subject to the rights of the holders of the preferred stock, if any, can elect all of our directors, if
they choose to do so. In this event, the holders of the remaining shares of common stock would not be able to elect any directors.
Except as otherwise required by Delaware law, and subject to the rights of the holders of preferred stock, if any, all stockholder
action is taken by the vote of a majority of the outstanding shares of common stock voting as a single class present at a meeting
of stockholders at which a quorum consisting of one-third of the outstanding shares of common stock is present in person or proxy.
Liquidation
and Dissolution
In
the event of any voluntary or involuntary liquidation, dissolution or winding up of our affairs, holders of common stock would
be entitled to share ratably in our assets that are legally available for distribution to stockholders after payment of liabilities.
If we have any preferred stock outstanding at such time, holders of the preferred stock may be entitled to distributions and/or
liquidation preferences. In either such case, we must pay the applicable distribution to the holders of our preferred stock (if
any) before we may pay distributions to the holders of common stock.
Anti-Takeover
Provisions
Delaware
Law
We
are subject to Section 203 of the Delaware General Corporation Law, or Section 203. This provision generally prohibits a Delaware
corporation from engaging in any business combination with any interested stockholder for a period of three years following the
date the stockholder became an interested stockholder, unless:
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prior
to such date, the board of directors approved either the business combination or the
transaction that resulted in the stockholder becoming an interested stockholder;
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upon
consummation of the transaction that resulted in the stockholder becoming an interested
stockholder, the interested stockholder owned at least 85% of the voting stock of the
corporation outstanding at the time the transaction commenced, excluding for purposes
of determining the number of shares outstanding those shares owned by persons who are
directors and also officers and by employee stock plans in which employee participants
do not have the right to determine confidentially whether shares held subject to the
plan will be tendered in a tender or exchange offer; or
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on
or subsequent to such date, the business combination is approved by the board of directors
and authorized at an annual meeting or special meeting of stockholders and not by written
consent, by the affirmative vote of at least 66-2/3% of the outstanding voting stock
that is not owned by the interested stockholder.
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Section
203 defines a business combination to include:
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any
merger or consolidation involving the corporation and the interested stockholder;
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any
sale, transfer, pledge or other disposition of 10% or more of the assets of the corporation
involving the interested stockholder;
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subject
to certain exceptions, any transaction that results in the issuance or transfer by the
corporation of any stock of the corporation to the interested stockholder;
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any
transaction involving the corporation that has the effect of increasing the proportionate
share of the stock of any class or series of the corporation beneficially owned by the
interested stockholder; or
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the
receipt by the interested stockholder of the benefit of any loans, advances, guarantees,
pledges or other financial benefits provided by or through the corporation.
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In
general, Section 203 defines an “interested stockholder” as any entity or person beneficially owning 15% or more of
the outstanding voting stock of a corporation, or an affiliate or associate of the corporation and was the owner of 15% or more
of the outstanding voting stock of a corporation at any time within three years prior to the time of determination of interested
stockholder status; and any entity or person affiliated with or controlling or controlled by such entity or person.
These
statutory provisions could delay or frustrate the removal of incumbent directors or a change in control of our company. They could
also discourage, impede, or prevent a merger, tender offer, or proxy contest, even if such event would be favorable to the interests
of stockholders.
Amended
and Restated Certificate of Incorporation and Bylaw Provisions
Our
amended and restated certificate of incorporation and bylaws contain provisions that could have the effect of discouraging potential
acquisition proposals or making a tender offer or delaying or preventing a change in control, including changes a stockholder
might consider favorable. In particular, the certificate of incorporation and bylaws, as applicable, among other things:
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provide
our board of directors with the ability to alter its bylaws without stockholder approval;
and
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provide
that vacancies on our board of directors may be filled by a majority of directors in
office, although less than a quorum.
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Such
provisions may have the effect of discouraging a third-party from acquiring us, even if doing so would be beneficial to our stockholders.
These provisions are intended to enhance the likelihood of continuity and stability in the composition of our board of directors
and in the policies formulated by them, and to discourage some types of transactions that may involve an actual or threatened
change in control of our company. These provisions are designed to reduce our vulnerability to an unsolicited acquisition proposal
and to discourage some tactics that may be used in proxy fights. We believe that the benefits of increased protection of our potential
ability to negotiate with the proponent of an unfriendly or unsolicited proposal to acquire or restructure our company outweigh
the disadvantages of discouraging such proposals because, among other things, negotiation of such proposals could result in an
improvement of their terms. However, these provisions could have the effect of discouraging others from making tender offers for
our shares that could result from actual or rumored takeover attempts. These provisions also may have the effect of preventing
changes in our management.
DESCRIPTION
OF DEBT SECURITIES
The
paragraphs below describe the general terms and provisions of the debt securities we may issue. When we offer to sell a particular
series of debt securities, we will describe the specific terms of the securities in a supplement to this prospectus, including
any additional covenants or changes to existing covenants relating to such series. The prospectus supplement also will indicate
whether the general terms and provisions described in this prospectus apply to a particular series of debt securities. You should
read the actual indenture if you do not fully understand a term or the way we use it in this prospectus.
We
may offer senior or subordinated debt securities. Each series of debt securities may have different terms. The senior debt securities
will be issued under one or more senior indentures, dated as of a date prior to such issuance, between us and the trustee identified
in the applicable prospectus supplement, as amended or supplemented from time to time. We will refer to any such indenture throughout
this prospectus as the “senior indenture.” Any subordinated debt securities will be issued under one or more separate
indentures, dated as of a date prior to such issuance, between us and the trustee identified in the applicable prospectus supplement,
as amended or supplemented from time to time. We will refer to any such indenture throughout this prospectus as the “subordinated
indenture” and to the trustee under the senior or subordinated indenture as the “trustee.” The senior indenture
and the subordinated indenture are sometimes collectively referred to in this prospectus as the “indentures.” The
indentures will be subject to and governed by the Trust Indenture Act of 1939, as amended. We included copies of the forms of
the indentures as exhibits to our registration statement and they are incorporated into this prospectus by reference.
If
we issue debt securities at a discount from their principal amount, then, for purposes of calculating the aggregate initial offering
price of the offered securities issued under this prospectus, we will include only the initial offering price of the debt securities
and not the principal amount of the debt securities.
We
have summarized below the material provisions of the indentures and the debt securities, or indicated which material provisions
will be described in the related prospectus supplement. The prospectus supplement relating to any particular securities offered
will describe the specific terms of the securities, which may be in addition to or different from the general terms summarized
in this prospectus. Because the summary in this prospectus and in any prospectus supplement does not contain all of the information
that you may find useful, you should read the documents relating to the securities that are described in this prospectus or in
any applicable prospectus supplement. Please read “Where You Can Find More Information” to find out how you can obtain
a copy of those documents. Except as otherwise indicated, the terms of the indentures are identical. As used under this caption,
the term “debt securities” includes the debt securities being offered by this prospectus and all other debt securities
issued by us under the indentures.
General
The
indentures:
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do
not limit the amount of debt securities that we may issue;
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allow
us to issue debt securities in one or more series;
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do
not require us to issue all of the debt securities of a series at the same time;
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allow
us to reopen a series to issue additional debt securities without the consent of the
holders of the debt securities of such series; and
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provide
that the debt securities will be unsecured, except as may be set forth in the applicable
prospectus supplement.
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Unless
we give you different information in the applicable prospectus supplement, the senior debt securities will be unsubordinated obligations
and will rank equally with all of our other senior unsecured and unsubordinated indebtedness. Payments on the subordinated debt
securities will be subordinated to the prior payment in full of all of our senior indebtedness, as described under “Description
of Debt Securities — Subordination” and in the applicable prospectus supplement.
Each
indenture provides that we may, but need not, designate more than one trustee under an indenture. Any trustee under an indenture
may resign or be removed and a successor trustee may be appointed to act with respect to the series of debt securities administered
by the resigning or removed trustee. If two or more persons are acting as trustee with respect to different series of debt securities,
each trustee shall be a trustee of a trust under the applicable indenture separate and apart from the trust administered by any
other trustee. Except as otherwise indicated in this prospectus, any action described in this prospectus to be taken by each trustee
may be taken by each trustee with respect to, and only with respect to, the one or more series of debt securities for which it
is trustee under the applicable indenture.
The
prospectus supplement for each offering will provide the following terms, where applicable:
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the
title of the debt securities and whether they are senior or subordinated;
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the
aggregate principal amount of the debt securities being offered, the aggregate principal
amount of the debt securities outstanding as of the most recent practicable date and
any limit on their aggregate principal amount, including the aggregate principal amount
of debt securities authorized;
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the
price at which the debt securities will be issued, expressed as a percentage of the principal
and, if other than the principal amount thereof, the portion of the principal amount
thereof payable upon declaration of acceleration of the maturity thereof or, if applicable,
the portion of the principal amount of such debt securities that is convertible into
common stock or other securities of ours or the method by which any such portion shall
be determined;
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if
convertible, the terms on which such debt securities are convertible, including the initial
conversion price or rate and the conversion period and any applicable limitations on
the ownership or transferability of common stock or other securities of ours received
on conversion;
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the
date or dates, or the method for determining the date or dates, on which the principal
of the debt securities will be payable;
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the
fixed or variable interest rate or rates of the debt securities, or the method by which
the interest rate or rates is determined;
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the
date or dates, or the method for determining the date or dates, from which interest will
accrue;
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the
dates on which interest will be payable;
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the
record dates for interest payment dates, or the method by which such dates will be determined;
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the
persons to whom interest will be payable;
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the
basis upon which interest will be calculated if other than that of a 360-day year of
twelve 30-day months;
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any
make-whole amount, which is the amount in addition to principal and interest that is
required to be paid to the holder of a debt security as a result of any optional redemption
or accelerated payment of such debt security, or the method for determining the make-whole
amount;
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the
place or places where the principal of, and any premium or make-whole amount, and interest
on, the debt securities will be payable;
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where
the debt securities may be surrendered for registration of transfer or conversion or
exchange;
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where
notices or demands to or upon us in respect of the debt securities and the applicable
indenture may be served;
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the
times, prices and other terms and conditions upon which we may redeem the debt securities;
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any
obligation we have to redeem, repay or purchase the debt securities pursuant to any sinking
fund or analogous provision or at the option of holders of the debt securities, and the
times and prices at which we must redeem, repay or purchase the debt securities as a
result of such obligation;
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the
currency or currencies in which the debt securities are denominated and payable if other
than U.S. dollars, which may be a foreign currency or units of two or more foreign currencies
or a composite currency or currencies and the terms and conditions relating thereto,
and the manner of determining the equivalent of such foreign currency in U.S. dollars;
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whether
the principal of, and any premium or make-whole amount, or interest on, the debt securities
of the series are to be payable, at our election or at the election of a holder, in a
currency or currencies other than that in which the debt securities are denominated or
stated to be payable, and other related terms and conditions;
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whether
the amount of payments of principal of, and any premium or make-whole amount, or interest
on, the debt securities may be determined according to an index, formula or other method
and how such amounts will be determined;
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whether
the debt securities will be in registered form, bearer form, or both, and (i) if in registered
form, the person to whom any interest shall be payable, if other than the person in whose
name the security is registered at the close of business on the regular record date for
such interest, or (ii) if in bearer form, the manner in which, or the person to whom,
any interest on the security shall be payable if otherwise than upon presentation and
surrender upon maturity;
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any
restrictions applicable to the offer, sale or delivery of securities in bearer form and
the terms upon which securities in bearer form of the series may be exchanged for securities
in registered form of the series and vice versa, if permitted by applicable laws and
regulations;
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whether
any debt securities of the series are to be issuable initially in temporary global form
and whether any debt securities of the series are to be issuable in permanent global
form with or without coupons and, if so, whether beneficial owners of interests in any
such permanent global security may, or shall be required to, exchange their interests
for other debt securities of the series, and the manner in which interest shall be paid;
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the
identity of the depositary for securities in registered form, if such series are to be
issuable as a global security;
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the
date as of which any debt securities in bearer form or in temporary global form shall
be dated if other than the original issuance date of the first security of the series
to be issued;
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the
applicability, if any, of the defeasance and covenant defeasance provisions described
in this prospectus or in the applicable indenture;
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whether
and under what circumstances we will pay any additional amounts on the debt securities
in respect of any tax, assessment or governmental charge and, if so, whether we will
have the option to redeem the debt securities in lieu of making such a payment;
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whether
and under what circumstances the debt securities being offered are convertible into common
stock or other securities of ours, as the case may be, including the conversion price
or rate and the manner or calculation thereof;
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the
circumstances, if any, specified in the applicable prospectus supplement, under which
beneficial owners of interests in the global security may obtain definitive debt securities
and the manner in which payments on a permanent global debt security will be made if
any debt securities are issuable in temporary or permanent global form;
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any
provisions granting special rights to holders of securities upon the occurrence of such
events as specified in the applicable prospectus supplement;
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if
the debt securities of such series are to be issuable in definitive form only upon receipt
of certain certificates or other documents or satisfaction of other conditions, then
the form and/or terms of such certificates, documents or conditions;
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the
name of the applicable trustee and the nature of any material relationship with us or
any of our affiliates, and the percentage of debt securities of the class necessary to
require the trustee to take action;
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any
deletions from, modifications of or additions to our events of default or covenants with
regard to such debt securities and any change in the right of any trustee or any of the
holders to declare the principal amount of any of such debt securities due and payable;
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applicable
CUSIP numbers; and
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any
other terms of such debt securities not inconsistent with the provisions of the applicable
indenture.
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We
may issue debt securities that provide for less than the entire principal amount thereof to be payable upon declaration of acceleration
of the maturity of the debt securities. We refer to any such debt securities throughout this prospectus as “original issue
discount securities.” The applicable prospectus supplement will describe the U.S. federal income tax consequences and other
relevant considerations applicable to original issue discount securities.
We
also may issue indexed debt securities. Payments of principal of, and premium and interest on, indexed debt securities are determined
with reference to the rate of exchange between the currency or currency unit in which the debt security is denominated and any
other currency or currency unit specified by us, to the relationship between two or more currencies or currency units or by other
similar methods or formulas specified in the prospectus supplement.
Except
as described under “Description of Debt Securities — Merger, Consolidation or Sale of Assets” or as may be set
forth in any prospectus supplement, the debt securities will not contain any provisions that (i) would limit our ability to incur
indebtedness or (ii) would afford holders of debt securities protection in the event of (a) a highly leveraged or similar transaction
involving us, or (b) a change of control or reorganization, restructuring, merger or similar transaction involving us that may
adversely affect the holders of the debt securities. In the future, we may enter into transactions, such as the sale of all or
substantially all of our assets or a merger or consolidation, that may have an adverse effect on our ability to service our indebtedness,
including the debt securities, by, among other things, substantially reducing or eliminating our assets.
Our
governing instruments do not define the term “substantially all” as it relates to the sale of assets. Additionally,
Delaware cases interpreting the term “substantially all” rely upon the facts and circumstances of each particular
case. Consequently, to determine whether a sale of “substantially all” of our assets has occurred, a holder of debt
securities must review the financial and other information that we have disclosed to the public.
We
will provide you with more information in the applicable prospectus supplement regarding any deletions, modifications, or additions
to the events of default or covenants that are described below, including any addition of a covenant or other provision providing
event risk or similar protection.
Payment
Unless
we give you different information in the applicable prospectus supplement, the principal of, and any premium or make-whole amount,
and interest on, any series of the debt securities will be payable at the corporate trust office of the trustee. We will provide
you with the address of the trustee in the applicable prospectus supplement. We may also pay interest by mailing a check to the
address of the person entitled to it as it appears in the applicable register for the debt securities or by wire transfer of funds
to that person at an account maintained within the United States.
All
monies that we pay to a paying agent or a trustee for the payment of the principal of, and any premium or make-whole amount, or
interest on, any debt security will be repaid to us if unclaimed at the end of two years after the obligation underlying payment
becomes due and payable. After funds have been returned to us, the holder of the debt security may look only to us for payment,
without payment of interest for the period which we hold the funds.
Denomination,
Interest, Registration and Transfer
Unless
otherwise described in the applicable prospectus supplement, the debt securities of any series will be issuable in denominations
of $1,000 and integral multiples of $1,000.
Subject
to the limitations imposed upon debt securities that are evidenced by a computerized entry in the records of a depository company
rather than by physical delivery of a note, a holder of debt securities of any series may:
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exchange
them for any authorized denomination of other debt securities of the same series and
of a like aggregate principal amount and kind upon surrender of such debt securities
at the corporate trust office of the applicable trustee or at the office of any transfer
agent that we designate for such purpose; and
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surrender
them for registration of transfer or exchange at the corporate trust office of the applicable
trustee or at the office of any transfer agent that we designate for such purpose.
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Every
debt security surrendered for registration of transfer or exchange must be duly endorsed or accompanied by a written instrument
of transfer satisfactory to the applicable trustee or transfer agent. Payment of a service charge will not be required for any
registration of transfer or exchange of any debt securities, but we or the trustee may require payment of a sum sufficient to
cover any tax or other governmental charge payable in connection therewith. If in addition to the applicable trustee, the applicable
prospectus supplement refers to any transfer agent initially designated by us for any series of debt securities, we may at any
time rescind the designation of any such transfer agent or approve a change in the location through which any such transfer agent
acts, except that we will be required to maintain a transfer agent in each place of payment for such series. We may at any time
designate additional transfer agents for any series of debt securities.
Neither
we, nor any trustee, will be required to:
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issue,
register the transfer of or exchange debt securities of any series during a period beginning
at the opening of business 15 days before the day that the notice of redemption of any
debt securities selected for redemption is mailed and ending at the close of business
on the day of such mailing;
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register
the transfer of or exchange any debt security, or portion thereof, so selected for redemption,
in whole or in part, except the unredeemed portion of any debt security being redeemed
in part; and
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issue,
register the transfer of or exchange any debt security that has been surrendered for
repayment at the option of the holder, except the portion, if any, of such debt security
not to be so repaid.
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Merger,
Consolidation or Sale of Assets
The
indentures provide that we may, without the consent of the holders of any outstanding debt securities, (i) consolidate with, (ii)
sell, lease or convey all or substantially all of our assets to, or (iii) merge with or into, any other entity provided that:
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either
we are the continuing entity, or the successor entity, if other than us, assumes the
obligations (a) to pay the principal of, and any premium or make-whole amount, and interest
on, all of the debt securities and (b) to duly perform and observe all of the covenants
and conditions contained in each indenture;
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after
giving effect to the transaction, there is no event of default under the indentures and
no event which, after notice or the lapse of time, or both, would become such an event
of default, occurs and continues; and
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an
officers’ certificate and legal opinion covering such conditions are delivered
to each applicable trustee.
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Covenants
Existence.
Except as described under “Description of Debt Securities — Merger, Consolidation or Sale of Assets,” the indentures
require us to do or cause to be done all things necessary to preserve and keep in full force and effect our existence, rights
and franchises. However, the indentures do not require us to preserve any right or franchise if we determine that any right or
franchise is no longer desirable in the conduct of our business.
Payment
of taxes and other claims. The indentures require us to pay, discharge or cause to be paid or discharged, before they become
delinquent (i) all taxes, assessments and governmental charges levied or imposed on us, and (ii) all lawful claims for labor,
materials and supplies which, if unpaid, might by law become a lien upon our property. However, we will not be required to pay,
discharge or cause to be paid or discharged any such tax, assessment, charge or claim whose amount, applicability or validity
is being contested in good faith by appropriate proceedings.
Provision
of financial information. The indentures require us to (i) within 15 days of each of the respective dates by which we are
required to file our annual reports, quarterly reports and other documents with the SEC, file with the trustee copies of the annual
report, quarterly report and other documents that we file with the SEC under Section 13 or 15(d) of the Exchange Act, (ii) file
with the trustee and the SEC any additional information, documents and reports regarding compliance by us with the conditions
and covenants of the indentures, as required, (iii) within 30 days after the filing with the trustee, mail to all holders of debt
securities, as their names and addresses appear in the applicable register for such debt securities, without cost to such holders,
summaries of any documents and reports required to be filed by us pursuant to (i) and (ii) above, and (iv) supply, promptly upon
written request and payment of the reasonable cost of duplication and delivery, copies of such documents to any prospective holder.
Additional
covenants. The applicable prospectus supplement will set forth any of our additional covenants relating to any series of debt
securities.
Events
of Default, Notice and Waiver
Unless
the applicable prospectus supplement states otherwise, when we refer to “events of default” as defined in the indentures
with respect to any series of debt securities, we mean:
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default
in the payment of any installment of interest on any debt security of such series continuing
for 30 days;
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default
in the payment of principal of, or any premium or make-whole amount on, any debt security
of such series for five business days at its stated maturity;
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default
in making any sinking fund payment as required for any debt security of such series for
five business days;
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default
in the performance or breach of any covenant or warranty in the debt securities or in
the indenture by us continuing for 60 days after written notice as provided in the applicable
indenture, but not of a covenant added to the indenture solely for the benefit of a series
of debt securities issued thereunder other than such series;
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a
default under any bond, debenture, note, mortgage, indenture or instrument:
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(a)
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having
an aggregate principal amount of at least $30,000,000; or
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(b)
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under
which there may be issued, secured or evidenced any existing or later created indebtedness
for money borrowed by us, if we are directly responsible or liable as obligor or guarantor,
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if
the default results in the indebtedness becoming or being declared due and payable prior to the date it otherwise would have,
without such indebtedness having been discharged, or such acceleration having been rescinded or annulled, within 30 days after
notice to the issuing company specifying such default. Such notice shall be given to us by the trustee, or to us and the trustee
by the holders of at least 10% in principal amount of the outstanding debt securities of that series. The written notice shall
specify such default and require us to cause such indebtedness to be discharged or cause such acceleration to be rescinded or
annulled and shall state that such notice is a “Notice of Default” under such indenture;
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bankruptcy,
insolvency or reorganization, or court appointment of a receiver, liquidator or trustee
of us; and
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any
other event of default provided with respect to a particular series of debt securities.
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If
an event of default occurs and is continuing with respect to debt securities of any series outstanding, then the applicable trustee
or the holders of 25% or more in principal amount of the debt securities of that series will have the right to declare the principal
amount of all the debt securities of that series to be due and payable. If the debt securities of that series are original issue
discount securities or indexed securities, then the applicable trustee or the holders of 25% or more in principal amount of the
debt securities of that series will have the right to declare the portion of the principal amount as may be specified in the terms
thereof to be due and payable. However, at any time after such a declaration of acceleration has been made, but before a judgment
or decree for payment of the money due has been obtained by the applicable trustee, the holders of at least a majority in principal
amount of outstanding debt securities of such series or of all debt securities then outstanding under the applicable indenture
may rescind and annul such declaration and its consequences if:
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we
have deposited with the applicable trustee all required payments of the principal, any
premium or make-whole amount, interest and, to the extent permitted by law, interest
on overdue installment of interest, plus applicable fees, expenses, disbursements and
advances of the applicable trustee; and
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all
events of default, other than the non-payment of accelerated principal, or a specified
portion thereof, and any premium or make-whole amount, have been cured or waived.
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The
indentures also provide that the holders of at least a majority in principal amount of the outstanding debt securities of any
series or of all debt securities then outstanding under the applicable indenture may, on behalf of all holders, waive any past
default with respect to such series and its consequences, except a default:
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in
the payment of the principal, any premium or make-whole amount, or interest;
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in
respect of a covenant or provision contained in the applicable indenture that cannot
be modified or amended without the consent of the holders of the outstanding debt security
that is affected by the default; or
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in
respect of a covenant or provision for the benefit or protection of the trustee, without
its express written consent.
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The
indentures require each trustee to give notice to the holders of debt securities within 90 days of a default unless such default
has been cured or waived. However, the trustee may withhold notice if specified persons of such trustee consider such withholding
to be in the interest of the holders of debt securities. The trustee may not withhold notice of a default in the payment of principal,
any premium or interest on any debt security of such series or in the payment of any sinking fund installment in respect of any
debt security of such series.
The
indentures provide that holders of debt securities of any series may not institute any proceedings, judicial or otherwise, with
respect to such indenture or for any remedy under the indenture, unless the trustee fails to act for a period of 60 days after
the trustee has received a written request to institute proceedings in respect of an event of default from the holders of 25%
or more in principal amount of the outstanding debt securities of such series, as well as an offer of indemnity reasonably satisfactory
to the trustee. However, this provision will not prevent any holder of debt securities from instituting suit for the enforcement
of payment of the principal of, and any premium or make-whole amount, and interest on, such debt securities at the respective
due dates thereof.
The
indentures provide that, subject to provisions in each indenture relating to its duties in the case of a default, a trustee has
no obligation to exercise any of its rights or powers at the request or direction of any holders of any series of debt securities
then outstanding under the indenture, unless the holders have offered to the trustee reasonable security or indemnity. The holders
of at least a majority in principal amount of the outstanding debt securities of any series or of all debt securities then outstanding
under an indenture shall have the right to direct the time, method and place of conducting any proceeding for any remedy available
to the applicable trustee, or of exercising any trust or power conferred upon such trustee. However, a trustee may refuse to follow
any direction which:
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is
in conflict with any law or the applicable indenture;
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may
involve the trustee in personal liability; or
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may
be unduly prejudicial to the holders of debt securities of the series not joining the
proceeding.
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Within
120 days after the close of each fiscal year, we will be required to deliver to each trustee a certificate, signed by one of our
several specified officers, stating whether or not that officer has knowledge of any default under the applicable indenture. If
the officer has knowledge of any default, the notice must specify the nature and status of the default.
Modification
of the Indentures
The
indentures provide that modifications and amendments may be made only with the consent of the affected holders of a majority in
principal amount of all outstanding debt securities issued under that indenture. However, no such modification or amendment may,
without the consent of the holders of the debt securities affected by the modification or amendment:
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change
the stated maturity of the principal of, or any premium or make-whole amount on, or any
installment of principal of or interest on, any such debt security;
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reduce
the principal amount of, the rate or amount of interest on, or any premium or make-whole
amount payable on redemption of, any such debt security;
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reduce
the amount of principal of an original issue discount security that would be due and
payable upon declaration of acceleration of the maturity thereof or would be provable
in bankruptcy, or adversely affect any right of repayment of the holder of any such debt
security;
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change
the place of payment or the coin or currency for payment of principal of, or any premium
or make-whole amount, or interest on, any such debt security;
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impair
the right to institute suit for the enforcement of any payment on or with respect to
any such debt security;
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reduce
the percentage in principal amount of any outstanding debt securities necessary to modify
or amend the applicable indenture with respect to such debt securities, to waive compliance
with particular provisions thereof or defaults and consequences thereunder or to reduce
the quorum or voting requirements set forth in the applicable indenture; and
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modify
any of the foregoing provisions or any of the provisions relating to the waiver of particular
past defaults or covenants, except to increase the required percentage to effect such
action or to provide that some of the other provisions may not be modified or waived
without the consent of the holder of such debt security.
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The
holders of a majority in aggregate principal amount of the outstanding debt securities of each series may, on behalf of all holders
of debt securities of that series, waive, insofar as that series is concerned, our compliance with material restrictive covenants
of the applicable indenture.
We
and our respective trustee may make modifications and amendments of an indenture without the consent of any holder of debt securities
for any of the following purposes:
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to
evidence the succession of another person to us as obligor under such indenture;
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to
add to our covenants for the benefit of the holders of all or any series of debt securities
or to surrender any right or power conferred upon us in such indenture;
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to
add events of default for the benefit of the holders of all or any series of debt securities;
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to
add or change any provisions of an indenture (i) to change or eliminate restrictions
on the payment of principal of, or premium or make-whole amount, or interest on, debt
securities in bearer form, or (ii) to permit or facilitate the issuance of debt securities
in uncertificated form, provided that such action shall not adversely affect the interests
of the holders of the debt securities of any series in any material respect;
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to
change or eliminate any provisions of an indenture, provided that any such change or
elimination shall become effective only when there are no debt securities outstanding
of any series created prior thereto which are entitled to the benefit of such provision;
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to
secure the debt securities;
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to
establish the form or terms of debt securities of any series;
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to
provide for the acceptance of appointment by a successor trustee or facilitate the administration
of the trusts under an indenture by more than one trustee;
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to
cure any ambiguity, defect or inconsistency in an indenture, provided that such action
shall not adversely affect the interests of holders of debt securities of any series
issued under such indenture; and
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to
supplement any of the provisions of an indenture to the extent necessary to permit or
facilitate defeasance and discharge of any series of such debt securities, provided that
such action shall not adversely affect the interests of the holders of the outstanding
debt securities of any series.
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Voting
The
indentures provide that in determining whether the holders of the requisite principal amount of outstanding debt securities of
a series have given any request, demand, authorization, direction, notice, consent or waiver under the indentures or whether a
quorum is present at a meeting of holders of debt securities:
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the
principal amount of an original issue discount security that shall be deemed to be outstanding
shall be the amount of the principal thereof that would be due and payable as of the
date of such determination upon declaration of acceleration of the maturity thereof;
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the
principal amount of any debt security denominated in a foreign currency that shall be
deemed outstanding shall be the U.S. dollar equivalent, determined on the issue date
for such debt security, of the principal amount or, in the case of an original issue
discount security, the U.S. dollar equivalent on the issue date of such debt security
of the amount determined as provided in the preceding bullet point;
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the
principal amount of an indexed security that shall be deemed outstanding shall be the
principal face amount of such indexed security at original issuance, unless otherwise
provided for such indexed security under such indenture; and
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debt
securities owned by us or any other obligor upon the debt securities or by any affiliate
of ours or of such other obligor shall be disregarded.
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The
indentures contain provisions for convening meetings of the holders of debt securities of a series. A meeting will be permitted
to be called at any time by the applicable trustee, and also, upon request, by us or the holders of at least 25% in principal
amount of the outstanding debt securities of such series, in any such case upon notice given as provided in such indenture. Except
for any consent that must be given by the holder of each debt security affected by the modifications and amendments of an indenture
described above, any resolution presented at a meeting or adjourned meeting duly reconvened at which a quorum is present may be
adopted by the affirmative vote of the holders of a majority of the aggregate principal amount of the outstanding debt securities
of that series represented at such meeting.
Notwithstanding
the preceding paragraph, except as referred to above, any resolution relating to a request, demand, authorization, direction,
notice, consent, waiver or other action that may be made, given or taken by the holders of a specified percentage, which is less
than a majority of the aggregate principal amount of the outstanding debt securities of a series, may be adopted at a meeting
or adjourned meeting duly reconvened at which a quorum is present by the affirmative vote of such specified percentage.
Any
resolution passed or decision taken at any properly held meeting of holders of debt securities of any series will be binding on
all holders of such series. The quorum at any meeting called to adopt a resolution, and at any reconvened meeting, will be persons
holding or representing a majority in principal amount of the outstanding debt securities of a series. However, if any action
is to be taken relating to a consent or waiver which may be given by the holders of at least a specified percentage in principal
amount of the outstanding debt securities of a series, the persons holding such percentage will constitute a quorum.
Notwithstanding
the foregoing provisions, the indentures provide that if any action is to be taken at a meeting with respect to any request, demand,
authorization, direction, notice, consent, waiver or other action that such indenture expressly provides may be made, given or
taken by the holders of a specified percentage in principal amount of all outstanding debt securities affected by such action,
or of the holders of such series and one or more additional series:
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there
shall be no minimum quorum requirement for such meeting; and
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the
principal amount of the outstanding debt securities of such series that vote in favor
of such request, demand, authorization, direction, notice, consent, waiver or other action
shall be taken account in determining whether such request, demand, authorization, direction,
notice, consent, waiver or other action has been made, given or taken under such indenture.
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Subordination
Unless
otherwise provided in the applicable prospectus supplement, subordinated debt securities will be subject to the following subordination
provisions.
Upon
any distribution to our creditors in a liquidation, dissolution or reorganization, the payment of the principal of and interest
on any subordinated debt securities will be subordinated to the extent provided in the applicable indenture in right of payment
to the prior payment in full of all senior debt. However, our obligation to make payments of the principal of and interest on
such subordinated debt securities otherwise will not be affected. No payment of principal or interest will be permitted to be
made on subordinated debt securities at any time if a default on senior debt exists that permits the holders of such senior debt
to accelerate its maturity and the default is the subject of judicial proceedings or we receive notice of the default. After all
senior debt is paid in full and until the subordinated debt securities are paid in full, holders of subordinated debt securities
will be subrogated to the rights of holders of senior debt to the extent that distributions otherwise payable to holders of subordinated
debt securities have been applied to the payment of senior debt. The subordinated indenture will not restrict the amount of senior
debt or other indebtedness of ours. As a result of these subordination provisions, in the event of a distribution of assets upon
insolvency, holders of subordinated debt securities may recover less, ratably, than our general creditors.
The
term “senior debt” will be defined in the applicable indenture as the principal of and interest on, or substantially
similar payments to be made by us in respect of, other outstanding indebtedness, whether outstanding at the date of execution
of the applicable indenture or subsequently incurred, created or assumed. The prospectus supplement may include a description
of additional terms implementing the subordination feature.
No
restrictions will be included in any indenture relating to subordinated debt securities upon the creation of additional senior
debt.
If
this prospectus is being delivered in connection with the offering of a series of subordinated debt securities, the accompanying
prospectus supplement or the information incorporated in this prospectus by reference will set forth the approximate amount of
senior debt outstanding as of the end of our most recent fiscal quarter.
Discharge,
Defeasance and Covenant Defeasance
Unless
otherwise indicated in the applicable prospectus supplement, the indentures allow us to discharge our obligations to holders of
any series of debt securities issued under any indenture when:
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either
(i) all securities of such series have already been delivered to the applicable trustee
for cancellation; or (ii) all securities of such series have not already been delivered
to the applicable trustee for cancellation but (a) have become due and payable, (b) will
become due and payable within one year, or (c) if redeemable at our option, are to be
redeemed within one year, and we have irrevocably deposited with the applicable trustee,
in trust, funds in such currency or currencies, currency unit or units or composite currency
or currencies in which such debt securities are payable, an amount sufficient to pay
the entire indebtedness on such debt securities in respect of principal and any premium
or make-whole amount, and interest to the date of such deposit if such debt securities
have become due and payable or, if they have not, to the stated maturity or redemption
date;
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we
have paid or caused to be paid all other sums payable; and
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an
officers’ certificate and an opinion of counsel stating the conditions to discharging
the debt securities have been satisfied has been delivered to the trustee.
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Unless
otherwise indicated in the applicable prospectus supplement, the indentures provide that, upon our irrevocable deposit with the
applicable trustee, in trust, of an amount, in such currency or currencies, currency unit or units or composite currency or currencies
in which such debt securities are payable at stated maturity, or government obligations, or both, applicable to such debt securities,
which through the scheduled payment of principal and interest in accordance with their terms will provide money in an amount sufficient
to pay the principal of, and any premium or make-whole amount, and interest on, such debt securities, and any mandatory sinking
fund or analogous payments thereon, on the scheduled due dates therefor, the issuing company may elect either:
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to
defease and be discharged from any and all obligations with respect to such debt securities;
or
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to
be released from its obligations with respect to such debt securities under the applicable
indenture or, if provided in the applicable prospectus supplement, its obligations with
respect to any other covenant, and any omission to comply with such obligations shall
not constitute an event of default with respect to such debt securities.
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Notwithstanding
the above, we may not elect to defease and be discharged from the obligation to pay any additional amounts upon the occurrence
of particular events of tax, assessment or governmental charge with respect to payments on such debt securities and the obligations
to register the transfer or exchange of such debt securities, to replace temporary or mutilated, destroyed, lost or stolen debt
securities, to maintain an office or agency in respect of such debt securities, or to hold monies for payment in trust.
The
indentures only permit us to establish the trust described in the paragraph above if, among other things, we have delivered to
the applicable trustee an opinion of counsel to the effect that the holders of such debt securities will not recognize income,
gain or loss for U.S. federal income tax purposes as a result of such defeasance or covenant defeasance and will be subject to
U.S. federal income tax on the same amounts, in the same manner and at the same times as would have been the case if such defeasance
or covenant defeasance had not occurred. Such opinion of counsel, in the case of defeasance, will be required to refer to and
be based upon a ruling received from or published by the Internal Revenue Service or a change in applicable U.S. federal income
tax law occurring after the date of the indenture. In the event of such defeasance, the holders of such debt securities would
be able to look only to such trust fund for payment of principal, any premium or make-whole amount, and interest.
When
we use the term “government obligations,” we mean securities that are:
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direct
obligations of the United States or the government that issued the foreign currency in
which the debt securities of a particular series are payable, for the payment of which
its full faith and credit is pledged; or
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obligations
of a person controlled or supervised by and acting as an agency or instrumentality of
the United States or other government that issued the foreign currency in which the debt
securities of such series are payable, the payment of which is unconditionally guaranteed
as a full faith and credit obligation by the United States or such other government,
which are not callable or redeemable at the option of the issuer thereof and shall also
include a depository receipt issued by a bank or trust company as custodian with respect
to any such government obligation or a specific payment of interest on or principal of
any such government obligation held by such custodian for the account of the holder of
a depository receipt. However, except as required by law, such custodian is not authorized
to make any deduction from the amount payable to the holder of such depository receipt
from any amount received by the custodian in respect of the government obligation or
the specific payment of interest on or principal of the government obligation evidenced
by such depository receipt.
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Unless
otherwise provided in the applicable prospectus supplement, if after we have deposited funds and/or government obligations to
effect defeasance or covenant defeasance with respect to debt securities of any series, (i) the holder of a debt security of such
series is entitled to, and does, elect under the terms of the applicable indenture or the terms of such debt security to receive
payment in a currency, currency unit or composite currency other than that in which such deposit has been made in respect of such
debt security, or (ii) a conversion event occurs in respect of the currency, currency unit or composite currency in which such
deposit has been made, the indebtedness represented by such debt security will be deemed to have been, and will be, fully discharged
and satisfied through the payment of the principal of, and premium or make-whole amount, and interest on, such debt security as
they become due out of the proceeds yielded by converting the amount so deposited in respect of such debt security into the currency,
currency unit or composite currency in which such debt security becomes payable as a result of such election or such cessation
of usage based on the applicable market exchange rate.
When
we use the term “conversion event,” we mean the cessation of use of:
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a
currency, currency unit or composite currency both by the government of the country that
issued such currency and for the settlement of transactions by a central bank or other
public institutions of or within the international banking community;
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the
European Currency Unit both within the European Monetary System and for the settlement
of transactions by public institutions of or within the European Communities; or
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any
currency unit or composite currency other than the European Currency Unit for the purposes
for which it was established.
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Unless
otherwise provided in the applicable prospectus supplement, all payments of principal of, and any premium or make-whole amount,
and interest on, any debt security that is payable in a foreign currency that ceases to be used by its government of issuance
shall be made in U.S. dollars.
In
the event that (i) we effect covenant defeasance with respect to any debt securities and (ii) those debt securities are declared
due and payable because of the occurrence of any event of default, the amount in the currency, currency unit or composite currency
in which such debt securities are payable, and government obligations on deposit with the applicable trustee, will be sufficient
to pay amounts due on such debt securities at the time of their stated maturity but may not be sufficient to pay amounts due on
such debt securities at the time of the acceleration resulting from such event of default. However, the issuing company would
remain liable to make payments of any amounts due at the time of acceleration.
The
applicable prospectus supplement may further describe the provisions, if any, permitting such defeasance or covenant defeasance,
including any modifications to the provisions described above, with respect to the debt securities of or within a particular series.
Conversion
Rights
The
terms and conditions, if any, upon which the debt securities are convertible into common stock or other securities of ours will
be set forth in the applicable prospectus supplement. The terms will include whether the debt securities are convertible into
shares of common stock or other securities of ours, the conversion price, or manner of calculation thereof, the conversion period,
provisions as to whether conversion will be at the issuing company’s option or the option of the holders, the events requiring
an adjustment of the conversion price and provisions affecting conversion in the event of the redemption of the debt securities
and any restrictions on conversion.
No
Recourse
There
is no recourse under any obligation, covenant or agreement in the applicable indenture or with respect to any security against
any of our or our successor’s past, present or future shareholders, employees, officers or directors.
DESCRIPTION
OF WARRANTS
We
may issue warrants for the purchase of shares of our common stock or preferred stock or of debt securities. We may issue warrants
independently or together with other securities, and the warrants may be attached to or separate from any offered securities.
Each series of warrants will be issued under a separate warrant agreement to be entered into between us and the investors or a
warrant agent. The following summary of material provisions of the warrants and warrant agreements are subject to, and qualified
in their entirety by reference to, all the provisions of the warrant agreement and warrant certificate applicable to a particular
series of warrants. The terms of any warrants offered under a prospectus supplement may differ from the terms described below.
We urge you to read the applicable prospectus supplement and any related free writing prospectus, as well as the complete warrant
agreements and warrant certificates that contain the terms of the warrants.
The
particular terms of any issue of warrants will be described in the prospectus supplement relating to the issue. Those terms may
include:
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the
number of shares of common stock or preferred stock purchasable upon the exercise of
warrants to purchase such shares and the price at which such number of shares may be
purchased upon such exercise;
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the
designation, stated value and terms (including, without limitation, liquidation, dividend,
conversion and voting rights) of the series of preferred stock purchasable upon exercise
of warrants to purchase preferred stock;
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the
principal amount of debt securities that may be purchased upon exercise of a debt warrant
and the exercise price for the warrants, which may be payable in cash, securities or
other property;
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the
date, if any, on and after which the warrants and the related debt securities, preferred
stock or common stock will be separately transferable;
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the
terms of any rights to redeem or call the warrants;
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the
date on which the right to exercise the warrants will commence and the date on which
the right will expire;
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U.S.
Federal income tax consequences applicable to the warrants; and
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any
additional terms of the warrants, including terms, procedures, and limitations relating
to the exchange, exercise and settlement of the warrants.
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Holders
of equity warrants will not be entitled:
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to
vote, consent or receive dividends;
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receive
notice as stockholders with respect to any meeting of stockholders for the election of
our directors or any other matter; or
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exercise
any rights as stockholders of Advaxis.
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Each
warrant will entitle its holder to purchase the principal amount of debt securities or the number of shares of preferred stock
or common stock at the exercise price set forth in, or calculable as set forth in, the applicable prospectus supplement. Unless
we otherwise specify in the applicable prospectus supplement, holders of the warrants may exercise the warrants at any time up
to the specified time on the expiration date that we set forth in the applicable prospectus supplement. After the close of business
on the expiration date, unexercised warrants will become void.
A
holder of warrant certificates may exchange them for new warrant certificates of different denominations, present them for registration
of transfer and exercise them at the corporate trust office of the warrant agent or any other office indicated in the applicable
prospectus supplement. Until any warrants to purchase debt securities are exercised, the holder of the warrants will not have
any rights of holders of the debt securities that can be purchased upon exercise, including any rights to receive payments of
principal, premium or interest on the underlying debt securities or to enforce covenants in the applicable indenture. Until any
warrants to purchase common stock or preferred stock are exercised, the holders of the warrants will not have any rights of holders
of the underlying common stock or preferred stock, including any rights to receive dividends or payments upon any liquidation,
dissolution or winding up on the common stock or preferred stock, if any.
DESCRIPTION
OF UNITS
We
may issue units consisting of any combination of the other types of securities offered under this prospectus in one or more series.
We may evidence each series of units by unit certificates that we will issue under a separate agreement. We may enter into unit
agreements with a unit agent. Each unit agent will be a bank or trust company that we select. We will indicate the name and address
of the unit agent in the applicable prospectus supplement relating to a particular series of units.
The
following description, together with the additional information included in any applicable prospectus supplement, summarizes the
general features of the units that we may offer under this prospectus. You should read any prospectus supplement and any free
writing prospectus that we may authorize to be provided to you related to the series of units being offered, as well as the complete
unit agreements that contain the terms of the units. Specific unit agreements will contain additional important terms and provisions
and we will file as an exhibit to the registration statement of which this prospectus is a part, or will incorporate by reference
from another report that we file with the SEC, the form of each unit agreement relating to units offered under this prospectus.
If
we offer any units, certain terms of that series of units will be described in the applicable prospectus supplement, including,
without limitation, the following, as applicable:
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the
title of the series of units;
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identification
and description of the separate constituent securities comprising the units;
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the
price or prices at which the units will be issued;
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the
date, if any, on and after which the constituent securities comprising the units will
be separately transferable;
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a
discussion of certain U.S. federal income tax considerations applicable to the units;
and
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any
other terms of the units and their constituent securities.
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GLOBAL
SECURITIES
Book-Entry,
Delivery and Form
Unless
we indicate differently in a prospectus supplement, the securities initially will be issued in book-entry form and represented
by one or more global notes or global securities, or, collectively, global securities. The global securities will be deposited
with, or on behalf of, The Depository Trust Company, New York, New York, as depositary, or DTC, and registered in the name of
Cede & Co., the nominee of DTC. Unless and until it is exchanged for individual certificates evidencing securities under the
limited circumstances described below, a global security may not be transferred except as a whole by the depositary to its nominee
or by the nominee to the depositary, or by the depositary or its nominee to a successor depositary or to a nominee of the successor
depositary.
DTC
has advised us that it is a:
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limited-purpose
trust company organized under the New York Banking Law;
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“banking
organization” within the meaning of the New York Banking Law;
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member
of the Federal Reserve System;
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“clearing
corporation” within the meaning of the New York Uniform Commercial Code; and
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“clearing
agency” registered pursuant to the provisions of Section 17A of the Exchange Act.
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DTC
holds securities that its participants deposit with DTC. DTC also facilitates the settlement among its participants of securities
transactions, such as transfers and pledges, in deposited securities through electronic computerized book-entry changes in participants’
accounts, thereby eliminating the need for physical movement of securities certificates. “Direct participants” in
DTC include securities brokers and dealers, including underwriters, banks, trust companies, clearing corporations and other organizations.
DTC is a wholly-owned subsidiary of The Depository Trust & Clearing Corporation, or DTCC. DTCC is the holding company for
DTC, National Securities Clearing Corporation and Fixed Income Clearing Corporation, all of which are registered clearing agencies.
DTCC is owned by the users of its regulated subsidiaries. Access to the DTC system is also available to others, which we sometimes
refer to as indirect participants, that clear through or maintain a custodial relationship with a direct participant, either directly
or indirectly. The rules applicable to DTC and its participants are on file with the SEC.
Purchases
of securities under the DTC system must be made by or through direct participants, which will receive a credit for the securities
on DTC’s records. The ownership interest of the actual purchaser of a security, which we sometimes refer to as a beneficial
owner, is in turn recorded on the direct and indirect participants’ records. Beneficial owners of securities will not receive
written confirmation from DTC of their purchases. However, beneficial owners are expected to receive written confirmations providing
details of their transactions, as well as periodic statements of their holdings, from the direct or indirect participants through
which they purchased securities. Transfers of ownership interests in global securities are to be accomplished by entries made
on the books of participants acting on behalf of beneficial owners. Beneficial owners will not receive certificates representing
their ownership interests in the global securities, except under the limited circumstances described below.
To
facilitate subsequent transfers, all global securities deposited by direct participants with DTC will be registered in the name
of DTC’s partnership nominee, Cede & Co., or such other name as may be requested by an authorized representative of
DTC. The deposit of securities with DTC and their registration in the name of Cede & Co. or such other nominee will not change
the beneficial ownership of the securities. DTC has no knowledge of the actual beneficial owners of the securities. DTC’s
records reflect only the identity of the direct participants to whose accounts the securities are credited, which may or may not
be the beneficial owners. The participants are responsible for keeping account of their holdings on behalf of their customers.
So
long as the securities are in book-entry form, you will receive payments and may transfer securities only through the facilities
of the depositary and its direct and indirect participants. We will maintain an office or agency in the location specified in
the prospectus supplement for the applicable securities, where notices and demands in respect of the securities and the indenture
may be delivered to us and where certificated securities may be surrendered for payment, registration of transfer or exchange.
Conveyance
of notices and other communications by DTC to direct participants, by direct participants to indirect participants and by direct
participants and indirect participants to beneficial owners will be governed by arrangements among them, subject to any legal
requirements in effect from time to time.
Redemption
notices will be sent to DTC. If less than all of the securities of a particular series are being redeemed, DTC’s practice
is to determine by lot the amount of the interest of each direct participant in the securities of such series to be redeemed.
Neither
DTC nor Cede & Co. (or such other DTC nominee) will consent or vote with respect to the securities. Under its usual procedures,
DTC will mail an omnibus proxy to us as soon as possible after the record date. The omnibus proxy assigns the consenting or voting
rights of Cede & Co. to those direct participants to whose accounts the securities of such series are credited on the record
date, identified in a listing attached to the omnibus proxy.
So
long as securities are in book-entry form, we will make payments on those securities to the depositary or its nominee, as the
registered owner of such securities, by wire transfer of immediately available funds. If securities are issued in definitive certificated
form under the limited circumstances described below, we will have the option of making payments by check mailed to the addresses
of the persons entitled to payment or by wire transfer to bank accounts in the United States designated in writing to the applicable
trustee or other designated party at least 15 days before the applicable payment date by the persons entitled to payment, unless
a shorter period is satisfactory to the applicable trustee or other designated party.
Redemption
proceeds, distributions and dividend payments on the securities will be made to Cede & Co., or such other nominee as may be
requested by an authorized representative of DTC. DTC’s practice is to credit direct participants’ accounts upon DTC’s
receipt of funds and corresponding detail information from us on the payment date in accordance with their respective holdings
shown on DTC records. Payments by participants to beneficial owners will be governed by standing instructions and customary practices,
as is the case with securities held for the account of customers in bearer form or registered in “street name.” Those
payments will be the responsibility of participants and not of DTC or us, subject to any statutory or regulatory requirements
in effect from time to time. Payment of redemption proceeds, distributions and dividend payments to Cede & Co., or such other
nominee as may be requested by an authorized representative of DTC, is our responsibility, disbursement of payments to direct
participants is the responsibility of DTC, and disbursement of payments to the beneficial owners is the responsibility of direct
and indirect participants.
Except
under the limited circumstances described below, purchasers of securities will not be entitled to have securities registered in
their names and will not receive physical delivery of securities. Accordingly, each beneficial owner must rely on the procedures
of DTC and its participants to exercise any rights under the securities and the indenture.
The
laws of some jurisdictions may require that some purchasers of securities take physical delivery of securities in definitive form.
Those laws may impair the ability to transfer or pledge beneficial interests in securities.
DTC
may discontinue providing its services as securities depositary with respect to the securities at any time by giving reasonable
notice to us. Under such circumstances, in the event that a successor depositary is not obtained, securities certificates are
required to be printed and delivered.
As
noted above, beneficial owners of a particular series of securities generally will not receive certificates representing their
ownership interests in those securities. However, if:
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DTC
notifies us that it is unwilling or unable to continue as a depositary for the global
security or securities representing such series of securities or if DTC ceases to be
a clearing agency registered under the Exchange Act at a time when it is required to
be registered and a successor depositary is not appointed within 90 days of the notification
to us or of our becoming aware of DTC’s ceasing to be so registered, as the case
may be;
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we
determine, in our sole discretion, not to have such securities represented by one or
more global securities; or
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an
Event of Default has occurred and is continuing with respect to such series of securities,
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we
will prepare and deliver certificates for such securities in exchange for beneficial interests in the global securities. Any beneficial
interest in a global security that is exchangeable under the circumstances described in the preceding sentence will be exchangeable
for securities in definitive certificated form registered in the names that the depositary directs. It is expected that these
directions will be based upon directions received by the depositary from its participants with respect to ownership of beneficial
interests in the global securities.
We
have obtained the information in this section and elsewhere in this prospectus concerning DTC and DTC’s book-entry system
from sources that are believed to be reliable, but we take no responsibility for the accuracy of this information.
PLAN
OF DISTRIBUTION
We
may sell the securities from time to time in short or long transactions pursuant to underwritten public offerings, negotiated
transactions, block trades or a combination of these methods or through underwriters or dealers, through agents and/or directly
to one or more purchasers. The securities may be distributed from time to time in one or more transactions:
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at
a fixed price or prices, which may be changed;
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at
market prices prevailing at the time of sale;
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at
prices related to such prevailing market prices; or
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at
negotiated prices.
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Each
time that we use this prospectus to sell securities, we will also provide a prospectus supplement that contains the specific terms
of the offering. The prospectus supplement will set forth the terms of the offering of the securities, including:
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the
name or names of any underwriters, dealers or agents and the amounts of any securities
underwritten or purchased by each of them; and
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the
public offering price of the common stock and the proceeds to us and any discounts, commissions
or concessions allowed or reallowed or paid to dealers.
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Any
public offering price and any discounts or concessions allowed or reallowed or paid to dealers may be changed from time to time.
If
underwriters are used in the sale of any securities, the securities will be acquired by the underwriters for their own account
and may be resold from time to time in one or more transactions, including negotiated transactions, at a fixed public offering
price or at varying prices determined at the time of sale. The securities may be either offered to the public through underwriting
syndicates represented by managing underwriters, or directly by underwriters. Generally, the underwriters’ obligations to
purchase the securities will be subject to certain conditions precedent. The underwriters will be obligated to purchase all of
the securities if they purchase any of securities.
We
may sell the securities through agents from time to time. The prospectus supplement will name any agent involved in the offer
or sale of the securities and any commissions we pay to them. Generally, any agent will be acting on a best efforts basis for
the period of its appointment.
We
may authorize underwriters, dealers or agents to solicit offers by certain purchasers to purchase the securities from us at the
public offering price set forth in the prospectus supplement pursuant to delayed delivery contracts providing for payment and
delivery on a specified date in the future. The contracts will be subject only to those conditions set forth in the prospectus
supplement, and the prospectus supplement will set forth any commissions we pay for solicitation of these contracts.
Agents
and underwriters may be entitled to indemnification by us against certain civil liabilities, including liabilities under the Securities
Act of 1933, as amended, or to contribution with respect to payments which the agents or underwriters may be required to make
in respect thereof. Agents and underwriters may be customers of, engage in transactions with, or perform services for us in the
ordinary course of business.
All
securities we may offer, other than common stock, will be new issues of securities with no established trading market. Any underwriters
may make a market in these securities, but will not be obligated to do so and may discontinue any market making at any time without
notice. We cannot guarantee the liquidity of the trading markets for any securities.
We
may enter into derivative transactions with third parties, or sell securities not covered by this prospectus to third parties
in privately negotiated transactions. If the applicable prospectus supplement indicates, in connection with those derivatives,
the third parties may sell securities covered by this prospectus and the applicable prospectus supplement, including in short
sale transactions. If so, the third party may use securities pledged by us or borrowed from us or others to settle those sales
or to close out any related open borrowings of securities, and may use securities received from us in settlement of those derivatives
to close out any related open borrowings of securities. The third party in such sale transactions will be an underwriter and will
be identified in the applicable prospectus supplement (or a post-effective amendment).
Upon
written instruction from us, a sales agent party to a distribution agency agreement with us will use its commercially reasonable
efforts to sell on our behalf, as our agent, the securities offered as agreed upon by us and the sales agent. We will designate
the maximum amount of securities to be sold through the sales agent, on a daily basis or otherwise as we and the sales agent agree.
Subject to the terms and conditions of the applicable distribution agency agreement, the sales agent will use its commercially
reasonable efforts to sell, as our sales agent and on our behalf, all of the designated securities. We may instruct the sales
agent not to sell securities if the sales cannot be effected at or above the price designated by us in any such instruction. We
may suspend the offering of securities under any distribution agency agreement by notifying the sales agent. Likewise, the sales
agent may suspend the offering of securities under the applicable distribution agency agreement by notifying us of such suspension.
We
also may sell securities to the sales agent as principal for its own account at a price agreed upon at the time of sale. If we
sell securities to the sales agent as principal, we will enter into a separate agreement setting forth the terms of such transaction.
The
name of any such underwriter or agent involved in the offer and sale of securities, the amounts underwritten and the nature of
its obligations to take our securities will be described in the applicable prospectus supplement.
LEGAL
MATTERS
The
legality and validity of the securities offered from time to time under this prospectus will be passed upon by Goodwin Procter
LLP, New York, New York. Any underwriters will also be advised about the validity of the securities and other legal matters by
their own counsel, which will be named in the prospectus supplement.
EXPERTS
The
financial statements of Advaxis, Inc. as of October 31, 2017 and 2016, and for the years ended October 31, 2017, 2016 and 2015,
have been incorporated by reference herein and in the registration statement in reliance upon the report of Marcum LLP, independent
registered public accounting firm, and upon the authority of said firm as experts in accounting and auditing.
17,577,400
Shares of Common Stock
Pre-Funded
Warrants to Purchase up to 7,671,937 Shares of Common Stock
Warrants
to Purchase up to 11,244,135 Shares of Common Stock
PROSPECTUS
SUPPLEMENT
A.G.P.
April
12, 2021
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