Table
of Contents
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ADVAXIS,
INC.
We
are a clinical stage biotechnology company focused on the discovery, development and commercialization of proprietary
Lm
-LLO
cancer immunotherapies. These immunotherapies are based on a platform technology that utilizes live
attenuated
Listeria monocytogenes
(“
Lm
” or “Listeria” or
“
Lm
Technology
TM
”) bioengineered to secrete antigen/adjuvant fusion proteins.
These
Lm
-LLO strains are believed to be a significant advancement in immunotherapy as they integrate
multiple functions into a single immunotherapy as they access and direct antigen presenting cells to stimulate
anti-tumor T-cell immunity, stimulate and activate the immune system with the equivalent of multiple adjuvants, and
simultaneously reduce tumor protection in the tumor microenvironment to enable the T-cells to eliminate
tumors.
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 website on the Internet at www.advaxis.com. Our Internet website, and the information
contained on it, are not to be considered part of this prospectus.
THE
OFFERING
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Use
of Proceeds
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We
intend to use the net proceeds of any offering as set forth in the applicable prospectus supplement.
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NASDAQ
Symbol
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ADXS
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WHERE
YOU CAN FIND MORE INFORMATION
We
file reports with the Securities and Exchange Commission, or the SEC, on an annual basis 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 http://www.sec.gov.
You can also obtain copies of materials we file with the SEC from our Internet website found at www.advaxis.com. Our stock is
quoted on the NASDAQ Capital Market under the symbol “ADXS.”
IMPORTANT
INFORMATION ABOUT THIS PROSPECTUS
This
prospectus is part of a “shelf” registration statement that we filed with the SEC. By using a shelf registration statement,
we may sell our securities, as described in this prospectus, from time to time in one or more offerings. We may use the shelf
registration statement to offer and sell securities described in this prospectus. 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 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 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.
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, after the date of this prospectus and prior to the termination of this offering, 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, 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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(a)
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Our
Annual Report on Form 10-K for the year ended October 31, 2016 filed on January 9, 2017;
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(b)
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The
portions of our Definitive Proxy Statement on Schedule 14A filed with the SEC on February 10, 2017 that are incorporated by
reference into our Annual Report on Form 10-K for the fiscal year ended October 31, 2016;
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(c)
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Current
Reports on Form 8-K filed with the SEC on December 15, 2016; and
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(d)
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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: Sara Bonstein, or by calling (609) 452-9813.
DESCRIPTION
OF COMMON STOCK
The
following summary of the terms of our common stock may not be complete and is subject to, and qualified in its entirety by reference
to, the terms and provisions of our amended and restated certificate of incorporation and our amended and restated bylaws. You
should refer to, and read this summary together with, our amended and restated certificate of incorporation and amended and restated
bylaws to review all of the terms of our common stock that may be important to you.
Common
Stock
Under
our certificate of incorporation, we are authorized to issue a total of 65,000,000 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 February 6, 2017,
we had issued and outstanding 40,122,043 shares of our common stock. There were approximately 101 holders of record. All outstanding
shares of our common stock are fully paid and nonassessable. Our common stock is listed on the NASDAQ Capital Market under the
symbol “ADXS.”
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.
Other
Certain
of our outstanding shares of common stock, shares of common stock issuable upon conversion of our convertible notes and shares
of common stock issuable upon exercise of outstanding warrants are subject to demand or piggyback registration rights.
Anti-Takeover
Provisions
Delaware
Law
We
are subject to Section 203 of the Delaware General Corporation Law. 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.
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.
PLAN
OF DISTRIBUTION
We
may sell the securities covered in this prospectus in any of the following ways (or in any combination):
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through
underwriters or dealers;
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in
short or long transactions;
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directly
to a limited number of purchasers or to a single purchaser;
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through
agents, including via an at-the-market program; or
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through
a combination of any of these methods of sale.
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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.
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 shares of common stock offered as agreed upon by us and the sales agent. We will
designate the maximum amount of shares of common stock 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 shares of common
stock. We may instruct the sales agent not to sell shares of common stock if the sales cannot be effected at or above the price
designated by us in any such instruction. We may suspend the offering of shares of common stock under any distribution agency
agreement by notifying the sales agent. Likewise, the sales agent may suspend the offering of shares of common stock under the
applicable distribution agency agreement by notifying us of such suspension.
We
also may sell shares to the sales agent as principal for its own account at a price agreed upon at the time of sale. If we sell
shares 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 our common stock, the amounts underwritten, and the nature
of its obligations to take our common stock 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 Alston & Bird
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, 2016 and 2015, and for the years ended as of October
31, 2016, 2015 and 2014, 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.
$250,000,000
Advaxis,
Inc.
Common
Stock
PROSPECTUS
,
2017
The
information in this prospectus is not complete and may be changed. A registration statement relating to these securities has been
filed with the Securities and Exchange Commission and is effective. This prospectus is not an offer to sell these securities and
it is not soliciting an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.
Subject
to Completion – Dated February 10, 2017
PROSPECTUS
Advaxis,
Inc.
Up
to $50,000,000
Common
Stock
We
have entered into a Controlled Equity Offering
SM
sales agreement with Cantor Fitzgerald & Co. relating to
shares of our common stock offered by this prospectus. In accordance with the terms of the sales agreement, we may offer and sell
shares of our common stock having an aggregate offering price of up to $50,000,000 from time to time through Cantor Fitzgerald
& Co., acting as sales agent.
Our
common stock is traded on the NASDAQ Capital Market under the symbol “ADXS.” On February 8, 2017, the per share closing
price of our common stock as reported on the NASDAQ Capital Market was $8.98 per share.
Sales
of our common stock, if any, under this prospectus may be made in sales deemed to be an “at the market offering” as
defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended, or the Securities Act. Subject to the terms
of the sales agreement, Cantor Fitzgerald & Co. will act as sales agent and use commercially reasonable efforts to sell on
our behalf all of the shares of common stock requested to be sold by us, consistent with its normal trading and sales practices,
on mutually agreed terms between Cantor Fitzgerald & Co. and us. There is no arrangement for funds to be received in any escrow,
trust or similar arrangement.
Cantor
Fitzgerald & Co. will be entitled to compensation at a commission rate of 3.0% of the gross sales price per share sold.
In connection with the sale of shares of our common stock on our behalf, Cantor Fitzgerald & Co. will be deemed to be an “underwriter”
within the meaning of the Securities Act and the compensation of Cantor Fitzgerald & Co. will be deemed to be underwriting
commissions or discounts.
Investing
in our securities involves certain risks. See “Risk Factors” in our Annual Report on Form 10-K for the year ended
October 31, 2016, which has been filed with the Securities and Exchange Commission and are incorporated by reference into this
prospectus. You should read the entire prospectus carefully before you make your investment decision.
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 , 2017.
TABLE
OF CONTENTS
ABOUT
THIS PROSPECTUS
This
prospectus relates to part of a registration statement that we have filed with the Securities and Exchange Commission, or SEC,
utilizing a “shelf” registration process. The $50,000,000 of common stock that may be offered, issued and sold under
this prospectus is included in the $250,000,000 of securities that may be offered, issued and sold by us pursuant to our shelf
registration statement. This prospectus is deemed a prospectus supplement to the base prospectus included in the registration
statement of which this prospectus forms a part.
This
prospectus includes or incorporates by reference important information about us, our common stock, and other matters you should
know before investing. You should read this prospectus as well as additional information described under “Where You Can
Find More Information” before making an investment decision.
You
should rely only on this prospectus and the information incorporated or deemed to be incorporated by reference in this prospectus
or in any free writing prospectuses we provide you. We have not, and Cantor Fitzgerald & Co. has not, authorized anyone to
provide you with information that is in addition to, or different from, that contained or incorporated by reference in this prospectus.
If anyone provides you with different or inconsistent information, you should not rely on it. We may also file one or more prospectus
supplements to this prospectus. We are not, and Cantor Fitzgerald & Co. is not, offering to sell securities in any jurisdiction
where the offer or sale is not permitted. You should not assume that the information contained or incorporated by reference in
this prospectus is accurate as of any date other than as of the date of this prospectus or in the case of the documents incorporated
by reference, the date of such documents regardless of the time of delivery of this prospectus or any sale of our common shares.
Our business, financial condition, liquidity, results of operations, and prospects may have changed since those dates.
We
further note that the representations, warranties and covenants made by us in any agreement that is filed as an exhibit the registration
statement to which this prospectus forms a part or to any document that is incorporated by reference in this prospectus 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.
Unless
the context otherwise requires, “Advaxis,” “the Company,” “we,” “us,” “our”
and similar terms refer to Advaxis, Inc. When we refer to “you” or “yours” we mean the investors and potential
investors in the shares of common stock offered hereby.
Our
trademarks include, without limitation, our name and corporate logo. Other service marks, trademarks and trade names contained
in this prospectus, any prospectus supplement or the documents incorporated by reference herein and therein are the property of
their respective owners.
FORWARD-LOOKING
STATEMENTS
Certain
matters discussed in this prospectus may constitute forward-looking statements for purposes of the Securities Act of 1933, as
amended, or the Securities Act, and the Securities Exchange Act of 1934, as amended, or the Exchange Act, and involve known and
unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially
different from the future results, performance or achievements expressed or implied by such forward-looking statements. The words
“anticipate,” “believe,” “estimate,” “may,” “expect” and similar expressions
are generally intended to identify forward-looking statements. Our actual results may differ materially from the results anticipated
in these forward-looking statements due to a variety of factors, including, without limitation, those discussed under the captions
“Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations”
and elsewhere in this prospectus, as well as other factors which may be identified from time to time in our other filings with
the Securities and Exchange Commission, or the SEC, or in the documents where such forward-looking statements appear. All written
or oral forward-looking statements attributable to us are expressly qualified in their entirety by these cautionary statements.
Such forward-looking statements include, but are not limited to, statements about our:
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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
loss 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 foreign 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;
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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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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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The
forward-looking statements contained in this prospectus reflect our views and assumptions only as of the date of this prospectus,
respectively. Except as required by law, we assume no responsibility for updating any forward-looking statements.
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.
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PROSPECTUS
SUMMARY
The
following is a summary of what we believe to be the most important aspects of our business and the offering of our securities
under this prospectus. We urge you to read this entire prospectus, including the more detailed consolidated financial
statements, notes to the consolidated financial statements and other information incorporated by reference from our other
filings with the SEC. Investing in our securities involves risks. Therefore, carefully consider the risk factors set forth
in this prospectus of incorporated by reference herein, as well as other information in this prospectus and the documents
incorporated by reference herein, before purchasing our securities. Each of the risk factors could adversely affect our
business, operating results and financial condition, as well as adversely affect the value of an investment in our securities.
Our
Company
We
are a clinical stage biotechnology company focused on the discovery, development and commercialization of proprietary
Lm
-LLO cancer immunotherapies. These immunotherapies are based on a platform technology that utilizes live attenuated
Listeria monocytogenes,
or Listeria or
Lm
Technology
TM
, bioengineered to secrete antigen/adjuvant
fusion proteins. These
Lm
-LLO strains are believed to be a significant advancement in immunotherapy as they integrate
multiple functions into a single immunotherapy as they access and direct antigen presenting cells to stimulate anti-tumor
T-cell immunity, stimulate and activate the immune system with the equivalent of multiple adjuvants, and simultaneously
reduce tumor protection in the tumor microenvironment to enable the T-cells to eliminate tumors.
Axalimogene
filolisbac, or AXAL, is our lead
Lm
-LLO immunotherapy product candidate for the treatment of Human Papilloma Virus,
or HPV, - associated cancers. The Company completed a randomized Phase 2 study in 110 patients with recurrent cervical
cancer that was shown to have a manageable safety profile, apparent improved survival and objective tumor responses. In
addition, the Gynecologic Oncology Group, or GOG, Foundation, Inc., now part of NRG Oncology, conducted a cooperative
group / Company sponsored Phase 2 open-label clinical study of AXAL in patients with persistent or recurrent cervical
cancer with documented disease progression. The study, known as GOG-0265, has successfully completed the first and second
stages in its Simon 2-stage design. The results from both stages combined demonstrate a 38% 12-month overall survival.
Upon early closure of this study, a total of 50 patients were dosed resulting in a 12-month survival rate of 38.0% with
a manageable safety profile. The Company has initiated a registrational Phase 3 clinical trial for the adjuvant treatment
of women with high-risk locally advanced cervical cancer and is planning to initiate a registrational Phase 3 clinical
trial in 2017 in the metastatic cervical cancer setting. The Company also plans to pursue registrational opportunities
in Europe in 2017 for the metastatic cervical cancer.
AXAL
has received United States Food and Drug Administration, or FDA, orphan drug designation for three HPV-associated cancers:
cervical, head and neck, and anal cancer, and has received European Medicines Agency, or EMA, orphan drug designation
for anal cancer. AXAL has been designated by the FDA as a Fast Track product for adjuvant therapy for high-risk locally
advanced cervical cancer patients. It has also been classified as an advanced-therapy medicinal product for the treatment
of cervical cancer by the European Medicines Agency’s Committee for Advanced Therapies. AXAL is subject to an agreement
with the FDA, under the Special Protocol Assessment process, for the Phase 3 AIM2CERV trial in patients with high-risk,
locally advanced cervical cancer. It is also being evaluated in Company-sponsored trials executed under an Investigational
New Drug which include the following: (i) a Phase 1/2 clinical trial alone and in combination with MedImmune, LLC’s
investigational anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736), in patients with previously treated metastatic
cervical cancer or patients with HPV-associated head and neck cancer; and (ii) a single arm Phase 2 monotherapy study
in patients with metastatic anal cancer. In addition to the Company-sponsored trials, AXAL is also being evaluated in
two investigator-initiated clinical trials as follows: neoadjuvant treatment of HPV-positive head and neck cancer (Mount
Sinai & Baylor College of Medicine), and locally advanced high risk anal cancer (Brown University).
ADXS-PSA
is our
Lm
-LLO immunotherapy product candidate designed to target the Prostate Specific Antigen associated with
prostate cancer which is being evaluated in a Phase 1/2 clinical trial alone and in combination with KEYTRUDA® (pembrolizumab),
Merck & Co.’s humanized monoclonal antibody against PD-1, in patients with previously treated metastatic castration-resistant
prostate cancer.
ADXS-HER2
is our
Lm
-LLO immunotherapy product candidate designed for the treatment of Human Epidermal Growth Factor Receptor
2, or HER2, expressing cancers, including human and canine osteosarcoma. ADXS-HER2 is being evaluated in a Phase 1b clinical
trial in patients with metastatic HER2 expressing solid tumors. We received orphan drug designation from both the FDA
and EMA for ADXS-HER2 in osteosarcoma and have received Fast Track designation from the FDA for patients with newly-diagnosed,
non-metastatic, surgically-resectable osteosarcoma. Clinical research with ADXS-HER2 in canine osteosarcoma is being developed
by the Company’s pet therapeutic partner, Aratana Therapeutics Inc., who holds exclusive rights to develop and commercialize
ADXS-HER2 and three other
Lm
-LLO immunotherapies for pet health applications. Aratana has announced that a product
license application for use of ADXS-HER2 in the treatment of canine osteosarcoma has been filed with the United States
Department of Agriculture. Aratana received communication from the USDA in March 2015 stating that the previously submitted
efficacy data for product licensure for AT-014 (ADXS-HER2), the cancer immunotherapy for canine osteosarcoma, was accepted
and that it provides a reasonable expectation of efficacy that supports conditional licensure. While additional steps
need to be completed, including in the areas of manufacturing and safety, Aratana anticipates that AT-014 could receive
conditional licensure from the USDA in 2017.
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In
October of 2015, we received notification from the FDA that the INDs for AXAL were put on clinical hold in response to
its submission of a safety report to the FDA. The clinical hold also included the INDs for ADXS-PSA and ADXS-HER2. Following
discussions with the FDA and in accordance with their recommendations, we agreed to implement certain risk mitigation
measures, including revised study protocol inclusion / exclusion criteria, post-administration antibiotic treatment and
patient surveillance and monitoring measures. In December 2015, the FDA notified us that the hold had been lifted with
respect to our INDs.
We
have focused our development efforts on establishing a drug development pipeline that incorporates this technology into therapeutic
cancer immunotherapies, with clinical trials currently targeting HPV-associated cancers (cervical cancer, head and neck cancer,
and anal cancer), prostate cancer, and osteosarcoma. Although no immunotherapies have been commercialized to date, we continue
to invest in research and development to advance the technology and make it available to patients with many different types of
cancer. Pipeline development and the further exploration of the technology for advancement entails risk and expense. We anticipate
that our ongoing operational costs will increase significantly as we continue conducting and expanding our clinical development
programs. In addition to our existing single antigen vectors that target one tumor associated antigen, we are actively engaged
in the development of new constructs that will address multiple targets that are common to tumor types, as well as mutation-associated
epitopes that are specific to an individual patient’s tumor. We are also leveraging our
Lm
Technology
™
to
target common (public or shared) mutations (hotspots) in tumor driver genes. We are exploring a preclinical infectious disease
program as well to examine potential applications of its
Lm
Technology
™
. Lastly, we are continuing
to build-out its manufacturing capabilities at the state-of-the-art manufacturing facility in Princeton, NJ, to produce supplies
for its neoepitope and other development programs.
Corporate
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 the Company was uplisted to NASDAQ in 2014.
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 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. You may read and copy any materials we file
at the SEC’s Public Reference Room at 100 F Street, N.E., Washington, D.C. 20549 on official business days during the hours
of 10:00 a.m. to 3:00 p.m. 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 http://www.sec.gov.
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The
Offering
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Common stock offered by
us
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Shares
of our common stock having an aggregate offering price of up to $50 million.
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Common stock to
be outstanding after this offering
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40,041,047
shares of our common stock on the NASDAQ Capital Market is outstanding as of October 31, 2016. The actual number of
shares issued in connection with this offering will vary depending on how many shares of our common stock we choose to sell
and the prices at which such sales occur.
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Manner of offering
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Sales
of shares of our common stock under this prospectus may be made by any method deemed to be an “at the market offering”
as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended. Subject to the terms of the sales agreement, Cantor
Fitzgerald & Co. will make all sales using commercially reasonable efforts consistent with its normal trading and sales
practices and applicable state and federal laws, rules and regulations and the rules of The NASDAQ Capital Market, on mutually
agreeable terms between Cantor Fitzgerald & Co. and us. See “Plan of Distribution” beginning on page S-8
of this prospectus.
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Use of Proceeds
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We expect to use
the net proceeds from this offering, if any, for working capital and general corporate purposes. See “Use of Proceeds”
beginning on page S-7 of this prospectus.
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Risk Factors
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Your investment
in shares of our common stock involves substantial risks. You should consider the matters referred to under the heading “Risk
Factors” in this prospectus, including the risk factors incorporated by reference herein and therein from our filings
with the SEC.
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NASDAQ Capital Market symbol
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ADXS
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The
number of shares of common stock to be outstanding after this offering will be based
on 40,041,047 shares of our common stock outstanding as of October 31, 2016, which excludes:
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3,110,575
shares of our common stock reserved for issuance upon the exercise of outstanding warrants at a weighted average exercise
price of $5.04 per share;
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719,448
shares of our common stock reserved for issuance of unvested restricted stock units;
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3,351,795 shares
of our common stock reserved for issuance upon the exercise of outstanding stock options at a weighted average exercise price
of $13.31 per share; and
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1,145,264
shares of our common stock reserved for future awards under
our 2015 Incentive Plan.
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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 our Annual Report
on Form 10-K for the year ended October 31, 2016, as filed with the SEC on January 9, 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. 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
Associated with this Offering
We
have broad discretion in the use of the net proceeds of this offering and may not use them effectively.
We
intend to use the net proceeds from this offering for general corporate purposes and to continue clinical trials of our product
candidates. However, our management will have broad discretion in the application of the net proceeds from this offering and could
spend the proceeds in ways that do not improve our results of operations or enhance the value of our common stock. The failure
by management to apply these funds effectively could result in financial losses that could have a material adverse effect on our
business, cause the price of our common stock to decline and delay the development of our product candidates.
You
may experience future dilution as a result of future equity offerings.
In
order 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 price 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 price per share paid by investors
in this offering, and investors purchasing shares 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 price per share paid by investors in this offering.
Sales
of a significant number of shares of our common stock in the public markets, or the perception that such sales could occur, could
depress the market price of our common stock.
Sales
of a substantial number of shares of our common stock in the public markets could depress the market price of our common stock
and impair our ability to raise capital through the sale of additional equity or equity-based securities. We cannot predict the
effect that future sales of our common stock would have on the market price of our common stock.
We
have not paid dividends in the past and do not expect to pay dividends in the future on our common stock, and any return on investment
may be limited to the value of our common stock.
We
have never paid cash dividends and we currently intend to retain any future earnings and do not anticipate paying cash dividends
in the foreseeable future. We are not legally or contractually required to pay dividends and certain of our debt agreement with
our major stockholder contains restrictions on our ability to pay cash dividends. The declaration and payment of all future dividends,
if any, will be at the sole discretion our board of directors, which retains the right to change our dividend policy at any time,
and may be limited by our debt arrangements in place from time to time. The payment of dividends will depend on our earnings,
capital requirements, financial condition, prospects and other factors our board of directors may deem relevant. If we do not
pay dividends, our common stock may be less valuable because stockholders must rely on sales of their common stock after price
appreciation, which may never occur, to realize any future gains on their investment.
USE
OF PROCEEDS
We
may issue and sell shares of our common stock having aggregate sales proceeds of up to $50 million from time to time. Because
there is no minimum offering amount required as a condition to close this offering, the actual total public offering amount, commissions
and proceeds to us, if any, are not determinable at this time. We estimate that the net proceeds from the sale of the shares of
common stock that we are offering may be up to approximately $48.3 million, after deducting Cantor’s commission 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
expanding our product pipeline and for other 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.
The
timing and amounts of our actual expenditures will depend on several factors, including data results, progression of our clinical
development programs as well as our joint collaborators. 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 an offering. Accordingly, our management will have broad
discretion in the application of proceeds. Pending the uses described above, we will invest the net proceeds in short-term and
long-term, investment grade, interest-bearing securities.
PLAN
OF DISTRIBUTION
We
have entered into a Controlled Equity Offering
SM
sales agreement with Cantor Fitzgerald & Co., or Cantor, under
which we may issue and sell shares of our common stock having an aggregate gross sales price of up to $50,000,000 from time to
time through Cantor acting as agent. The sales agreement has been filed as an exhibit to our registration statement on Form S-3
of which this prospectus forms a part.
Upon
delivery of a placement notice and subject to the terms and conditions of the sales agreement, Cantor may offer and sell shares
of our common stock by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415(a)(4)
promulgated under the Securities Act. We may instruct Cantor not to sell common stock if the sales cannot be effected at or above
the price designated by us from time to time. We or Cantor may suspend the offering of common stock upon notice and subject to
other conditions.
We
will pay Cantor commissions, in cash, for its services in acting as agent in the sale of our common stock. Cantor will be entitled
to compensation at a commission rate of 3.0% of the gross sales price per share sold. Because there is no minimum offering
amount required as a condition to close this offering, the actual total public offering amount, commissions and proceeds to us,
if any, are not determinable at this time. We have also agreed to reimburse Cantor for certain specified expenses, including the
reasonable and documented fees and disbursements of its legal counsel in an amount not to exceed $50,000. We estimate that the
total expenses for the offering, excluding compensation and reimbursements payable to Cantor under the terms of the sales agreement,
will be approximately $150,000.
Settlement
for sales of shares of common stock will occur on the third business day following the date on which any sales are made, or on
some other date that is agreed upon by us and Cantor in connection with a particular transaction, in return for payment of the
net proceeds to us. Sales of our common stock as contemplated in this prospectus will be settled through the facilities of The
Depository Trust Company or by such other means as we and Cantor may agree upon. There is no arrangement for funds to be received
in an escrow, trust or similar arrangement.
Cantor
will use its commercially reasonable efforts, consistent with its sales and trading practices, to solicit offers to purchase the
shares of common stock under the terms and subject to the conditions set forth in the sales agreement. In connection with the
sale of the shares of common stock on our behalf, Cantor will be deemed to be an “underwriter” within the meaning
of the Securities Act and the compensation of Cantor will be deemed to be underwriting commissions or discounts. We have agreed
to provide indemnification and contribution to Cantor against certain civil liabilities, including liabilities under the Securities
Act.
The
offering of shares of our common stock pursuant to the sales agreement will terminate upon the termination of the sales agreement
as permitted therein. We and Cantor may each terminate the sales agreement at any time upon ten days’ prior notice.
Cantor
and its affiliates may in the future provide various investment banking, commercial banking and other financial services for us
and our affiliates, for which services they may in the future receive customary fees. To the extent required by Regulation M,
Cantor will not engage in any market making activities involving our common stock while the offering is ongoing under this prospectus.
This
prospectus in electronic format may be made available on a website maintained by Cantor and Cantor may distribute this prospectus
electronically.
LEGAL
MATTERS
The
validity of the common stock offered hereby will be passed upon by Alston & Bird LLP, New York, New York. Cantor Fitzgerald
& Co. is being represented in connection with this offering by Cooley, LLP, New York, New York.
EXPERTS
The
consolidated financial statements of Advaxis, Inc. as of October 31, 2016 and 2015 and for the years then ended,
and the cumulative period ended October 31, 2016, have been incorporated by reference herein 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.
WHERE
YOU CAN FIND MORE INFORMATION
We
file reports with the Securities and Exchange Commission, or the SEC, on an annual basis 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 http://www.sec.gov.
You can also obtain copies of materials we file with the SEC from our Internet website found at www.advaxis.com. Our stock is
quoted on the NASDAQ Capital Market under the symbol “ADXS.”
IMPORTANT
INFORMATION ABOUT THIS PROSPECTUS
This
prospectus is part of a “shelf” registration statement that we filed with the SEC. By using a shelf registration statement,
we may sell our securities, as described in this prospectus, from time to time in one or more offerings. We may use the shelf
registration statement to offer and sell securities described in this prospectus. 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 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 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.
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, after the date of this prospectus and prior to the termination of this offering, 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, 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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(a)
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Our
Annual Report on Form 10-K for the year ended October 31, 2016 filed on January 9, 2017;
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(b)
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The
portions of our Definitive Proxy Statement on Schedule 14A filed with the SEC on February 10, 2017 that are incorporated by
reference into our Annual Report on Form 10-K for the fiscal year ended October 31, 2016;
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(c)
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Current
Reports on Form 8-K filed with the SEC on December 15, 2016; and
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(d)
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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: Sara Bonstein, or by calling (609) 452-9813.
Advaxis,
Inc.
Up
to $50,000,000
Common
Stock
PROSPECTUS
SUPPLEMENT
,
2017
PART
II
INFORMATION
NOT REQUIRED IN THE PROSPECTUS
ITEM
14. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION.
The
table below itemizes the expenses payable by the Registrant in connection with the registration and issuance of the securities
being registered hereunder, other than underwriting discounts and commissions. All amounts except the Securities and Exchange
Commission registration fee are estimated.
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Securities and Exchange
Commission Registration Fee
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$
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22,191.26
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Legal Fees and Expenses
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$
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*
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Accountants’ Fees and Expenses
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$
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*
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Printing and Duplicating Expenses
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$
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*
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Transfer Agent and Registrar’s
Fees and Expense
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$
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*
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Miscellaneous
Expenses
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$
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*
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Total
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$
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*
To be filed by amendment, Form 8-K or Rule 424 filing.
ITEM
15. INDEMNIFICATION OF DIRECTORS AND OFFICERS.
Delaware
General Corporation Law
. The registrant is a Delaware corporation. Section 102(b)(7) of the Delaware General Corporation Law,
or the DGCL, enables a corporation to eliminate or limit the personal liability of a director to the corporation or its stockholders
for monetary damages for breach of the director’s fiduciary duty, except:
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for
any breach of the director’s duty of loyalty to the corporation or its stockholders;
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for
acts or omissions not in good faith or which involve intentional misconduct or a knowing violation of law;
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pursuant
to Section 174 of the DGCL (providing for liability of directors for unlawful payment of dividends or unlawful stock purchases
or redemptions); or
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for
any transaction from which the director derived an improper personal benefit
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.
In
accordance with Section 102(b)(7) of the DGCL, the registrant’s certificate of incorporation includes a provision eliminating,
to the fullest extent permitted by the DGCL, the liability of the registrant’s directors to the registrant or its stockholders
for monetary damages for breach of fiduciary as director. If the DGCL is subsequently amended to further eliminate or limit the
liability of a director, then a director of the registrant, in addition to the circumstances in which a director is not personally
liable as set forth in provision described in the preceding sentence, will not be liable to the fullest extent permitted by the
amended DGCL.
Subsection
(a) of Section 145 of the DGCL provides that a corporation may indemnify any person who was or is a party or is threatened to
be made a party to any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or
investigative (other than an action by or in the right of the corporation) by reason of the fact that he is or was a director,
officer, employee or agent of the corporation, or is or was serving at the request of the corporation as a director, officer,
employee or agent of another corporation, partnership, joint venture, trust or other enterprise, against expenses (including attorneys’
fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by him in connection with such action,
suit or proceeding if he acted in good faith and in a manner he reasonably believed to be in or not opposed to the best interests
of the corporation, and, with respect to any criminal action or proceeding, had no reasonable cause to believe his conduct was
unlawful. Section 145 of the DGCL further provides that a corporation similarly may indemnify any such person serving in any such
capacity who was or is a party or is threatened to be made a party to any threatened, pending or completed action or suit by or
in the right of the corporation to procure a judgment in its favor, against expenses (including attorneys’ fees) actually
and reasonably incurred in connection with the defense or settlement of such action or suit if he acted in good faith and in a
manner he reasonably believed to be in or not opposed to the best interests of the corporation and except that no indemnification
shall be made in respect of any claim, issue or matter as to which such person shall have been adjudged to be liable to the corporation
unless and only to the extent that the Delaware Court of Chancery or such other court in which such action or suit was brought
shall determine upon application that, despite the adjudication of liability but in view of all of the circumstances of the case,
such person is fairly and reasonably entitled to indemnity for such expenses which the Court of Chancery or such other court shall
deem proper.
Certificate
of Incorporation and Bylaws
. The registrant’s amended and restated certificate of incorporation contains provisions
which provide that the registrant will indemnify the registrant’s directors and officers in each and every situation where,
under Section 145 of the DGCL, as amended from time to time, the registrant is permitted or empowered to make such indemnification,
and to the fullest extent permitted by law. The registrant may, in the sole discretion of its Board of Directors, indemnify any
other person who may be indemnified pursuant to Section 145 of the DGCL to the extent the Board of Directors deems advisable,
as permitted by Section 145 of the DGCL.
The
registrant’s bylaws contain provisions which provide, among other things, that the registrant shall indemnify any officer
or director who was or is a party or is threatened to be made a party to any threatened, pending or completed (i) action, suit
or proceeding, whether civil, criminal, administrative or investigative (other than an action by or in the right of the registrant)
by reason of the fact that he is or was a director, officer, employee or agent of the registrant, or is or was serving at the
request of the registrant as a director, officer, employee or agent of another registrant, partnership, limited liability company,
joint venture, trust, employee benefit plan or other enterprise, against expenses (including attorneys’ fees), judgments,
fines and amounts paid in settlement actually and reasonably incurred by him in connection with such action, suit or proceeding
if he acted in good faith and in a manner he reasonably believed to be in or not opposed to the best interests of the registrant,
and, with respect to any criminal action or proceeding, had no reasonable cause to believe his conduct was unlawful and (ii) action
or suit by or in the right of the registrant to procure a judgment in its favor by reason of the fact that he is or was a director,
officer, employee or agent of the registrant, or is or was serving at the request of the registrant as a director, officer, employee
or agent of another registrant, partnership, limited liability company, joint venture, trust, employee benefit plan or other enterprise
against expenses (including attorneys’ fees) actually and reasonably incurred by him in connection with the defense or settlement
of such action or suit if he acted in good faith and in a manner he reasonably believed to be in or not opposed to the best interests
of the registrant; except that no indemnification shall be made in respect of any claim, issue or matters as to which such person
shall have been adjudged to be liable to the registrant unless and only to the extent that the Court of Chancery or the court
in which such action or suit was brought shall determine upon application that, despite the adjudication of liability but in view
of all the circumstances of the case, such person is fairly and reasonably entitled to indemnity for such expenses which the Court
of Chancery or such other court shall deem proper. Any indemnification under the provisions in the bylaws (unless ordered by a
court) shall be made by the registrant only as authorized in the specific case upon a determination that indemnification of the
director, officer, employee or agent is proper in the circumstances because he has met the applicable standard of conduct set
forth above. Such determination shall be made (i) by a majority vote of the directors who were not parties to such action, suit
or proceeding even though less than a quorum, or (ii) if there are no such directors, or, if such directors so direct, by independent
legal counsel in a written opinion, or (iii) by the stockholders. To the extent, however, that a director, officer, employee or
agent of the registrant has been successful on the merits or otherwise in defense of any action, suit or proceeding described
above, or in defense of any claim, issue or matter therein, he shall be indemnified against expenses (including attorneys’
fees) actually and reasonably incurred by him in connection therewith, without the necessity of authorization in the specific
case.
The
DGCL provides that the indemnification described above shall not be deemed exclusive of any other indemnification that may be
granted by a corporation pursuant to its by-laws, disinterested directors’ vote, stockholders’ vote, agreement or
otherwise.
Indemnification
Agreements
. In addition to the indemnification provided for in the registrant’s amended and restated certificate of
incorporation and bylaws, the registrant has entered into indemnification agreements with each of its directors and officers to
provide the directors and officers with contractual rights to indemnification and advance payment of expenses to the fullest extent
permitted by law and to further establish procedures for such indemnification.
Insurance
Policies
. The DGCL also provides corporations with the power to purchase and maintain insurance on behalf of any person who
is or was a director, officer, employee or agent of the corporation, or is or was serving at the request of the corporation in
a similar capacity for another corporation, partnership, joint venture, trust or other enterprise, against any liability asserted
against him or her in any such capacity, or arising out of his or her status as such, whether or not the corporation would have
the power to indemnify him or her against such liability as described above. The registrant has directors’ and officers’
liability insurance in an amount not less than $5 million.
Insofar
as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers, or persons
controlling the registrant pursuant to the foregoing provisions, the registrant has been informed that in the opinion of the Commission
such indemnification is against public policy as expressed in such Securities Act and is therefore unenforceable.
ITEM
16. EXHIBITS.
|
Exhibit
Number
|
|
Description
|
|
|
|
|
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1.1
|
|
Underwriting
Agreement*
|
|
|
|
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|
1.2
|
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Controlled
Equity Offering
SM
Sales Agreement, dated February 10, 2017, by and between
Advaxis, Inc. and Cantor Fitzgerald & Co.
|
|
|
|
|
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4.1
|
|
Form
of Common Stock certificate, filed as Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed with the SEC
on October 23, 2007, and incorporated herein by reference.
|
|
|
|
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5.1
|
|
Opinion
of Alston & Bird LLP
|
|
|
|
|
|
23.1
|
|
Consent
of Marcum LLP
|
|
|
|
|
|
23.2
|
|
Consent
of Alston & Bird LLP (included in Exhibit 5.1)
|
|
|
|
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24.1
|
|
Power
of Attorney (included on the signature page to this Registration Statement)
|
* To
be filed by amendment or as an exhibit to a document to be incorporated by reference herein in connection with an offering of
our securities.
ITEM
17. UNDERTAKINGS.
A. RULE
415 OFFERING
The
undersigned registrant hereby undertakes:
(1)
To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement:
|
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(i)
|
To
include any prospectus required by Section 10(a)(3) of the Securities Act of 1933;
|
|
|
|
|
|
|
(ii)
|
To
reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most
recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information
set forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered
(if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low
or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant
to Rule 424(b)) if, in the aggregate, the changes in volume and price represent no more than 20% change in the maximum aggregate
offering price set forth in the “Calculation of Registration Fee” table in the effective registration statement;
and
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|
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|
|
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(iii)
|
To
include any material information with respect to the plan of distribution not previously disclosed in the registration statement
or any material change to such information in the registration statement;
|
(2)
That, for the purpose of determining any liability under the Securities Act of 1933, each such post-effective amendment shall
be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at
that time shall be deemed to be the initial bona fide offering thereof.
(3)
To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold
at the termination of the offering.
(5)
That, for the purpose of determining liability under the Securities Act of 1933 to any purchaser:
|
|
(A)
|
Each
prospectus filed by the registrant pursuant to Rule 424(b)(3) shall be deemed to be part of the Registration Statement as
of the date the filed prospectus was deemed part of and included in the Registration Statement; and
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|
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|
|
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(B)
|
Each
prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5), or (b)(7) (§ 230.424(b)(2), (b)(5) or (b)(7) of this
chapter) as part of a Registration Statement in reliance on Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i),
(vii), or (x) (§ 230.415(a)(1)(i), (vii), or (x) of this chapter) for the purpose of providing the information required
by Section 10(a) of the Securities Act of 1933 shall be deemed to be part of and included in the Registration Statement as
of the earlier of the date such form of prospectus is first used after effectiveness or the date of the first contract of
sale of securities in the offering described in the prospectus. As provided in Rule 430B, for liability purposes of the issuer
and any person that is at that date an underwriter, such date shall be deemed to be a new effective date of the Registration
Statement relating to the securities in the Registration Statement to which that prospectus relates, and the offering of such
securities at that time shall be deemed to be the initial bona fide offering thereof. Provided, however, that no statement
made in a Registration Statement or prospectus that is part of the Registration Statement or made in a document incorporated
or deemed incorporated by reference into the Registration Statement or prospectus that is part of the Registration Statement
will, as to the purchaser with a time of contract of sale prior to such effective date, supersede or modify any statement
that was made in the Registration Statement or prospectus that was part of the Registration Statement or made in any such
document immediately prior to such effective date.
|
|
|
(6)
|
That,
for the purpose of determining liability of the registrant under the Securities Act of
1933 to any purchaser in the initial distribution of the securities:
|
|
|
|
|
|
|
|
The
undersigned registrant undertakes that in a primary offering of securities of the undersigned
registrant pursuant to this Registration Statement, regardless of the underwriting method
used to sell the securities to the purchaser, if the securities are offered or sold to
such purchaser by means of any of the following communications, the undersigned registrant
will be a seller to the purchaser and will be considered to offer or sell such securities
to such purchaser:
|
|
|
(i)
|
Any
preliminary prospectus or prospectus of the undersigned registrant relating to the offering required to be filed pursuant
to Rule 424;
|
|
|
|
|
|
|
(ii)
|
Any
free writing prospectus relating to the offering prepared by or on behalf of the undersigned registrant or used or referred
to by the undersigned registrant;
|
|
|
|
|
|
|
(iii)
|
The
portion of any other free writing prospectus relating to the offering containing material information about the undersigned
registrant or its securities provided by or on behalf of the undersigned registrant; and
|
|
|
|
|
|
|
(iv)
|
Any
other communication that is an offer in the offering made by the undersigned registrant to the purchaser.
|
B. Filings
Incorporating Subsequent Exchange Act Documents By Reference
The
undersigned registrant hereby undertakes that, for purposes of determining any liability under the Securities Act of 1933, each
filing of the registrant’s annual report pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934 (and,
where applicable, each filing of an employee benefit plan’s annual report pursuant to Section 15(d) of the Securities Exchange
Act of 1934) that is incorporated by reference in the registration statement shall be deemed to be a new registration statement
relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial
bona fide offering thereof.
H. Request
for Acceleration of Effective Date or Filing of Registration Statement Becoming Effective Upon Filing
Insofar
as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers and controlling
persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion
of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Act and is, therefore,
unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant
of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action,
suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered,
the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court
of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities
Act of 1933 and will be governed by the final adjudication of such issue.
SIGNATURES
Pursuant
to the requirements of the Securities Act of 1933, as amended, the registrant certifies that it has reasonable grounds to believe
that it meets all of the requirements for filing on Form S-3 and has duly caused this registration statement to be signed on its
behalf by the undersigned, thereunto duly authorized in the City of Princeton, State of New Jersey, on February 10, 2017.
|
|
Advaxis
,
INC.
|
|
|
|
|
|
By:
|
/s/
Daniel J. O’Connor
|
|
|
|
Daniel
J. O’Connor
|
|
|
|
President
and Chief Executive Officer
|
POWER
OF ATTORNEY
KNOW
ALL MEN BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints each of Daniel J. O’Connor
and Sara M. Bonstein, his or her true and lawful attorney-in-fact and agent, with full power of substitution and resubstitution,
for their name, place and stead, in any and all capacities, to sign any or all amendments (including pre-effective and post-effective
amendments) to this registration statement, and to file the same, with all exhibits thereto and other documents in connection
therewith, including any Registration Statement filed pursuant to Rule 462(b) under the Securities Act of 1933, with the SEC,
granting unto said attorney-in-fact and agent, full power and authority to do and perform each and every act and thing requisite
and necessary to be done in and about the premises, as fully to all intents and purposes as he might or could do in person, hereby
ratifying and confirming all that said attorney-in-fact and agent or any of his substitutes, may lawfully do or cause to be done
by virtue hereof.
Pursuant
to the requirements of the Securities Act of 1933, as amended, this registration statement has been signed by the following persons
in the capacities indicated as of February 10, 2017.
|
Signatures
|
|
Title
|
|
|
|
|
|
/s/
Daniel J. O’Connor
|
|
President
and Chief Executive Officer
|
|
Daniel
J. O’Connor
|
|
(Principal Executive
Officer) and Director
|
|
|
|
|
|
/s/
Sara M. Bonstein
|
|
Chief
Financial Officer and Executive Vice President
|
|
Sara
M. Bonstein
|
|
(Principal Financial
and Accounting Officer)
|
|
|
|
|
|
/s/
Dr. David Sidransky
|
|
Chairman
of the Board of Directors
|
|
Dr.
David Sidransky
|
|
|
|
|
|
|
|
/s/
Dr. James P. Patton
|
|
Vice
Chairman of the Board of Directors
|
|
Dr.
James P. Patton
|
|
|
|
|
|
|
|
/s/
Roni A. Appel
|
|
Director
|
|
Roni
A. Appel
|
|
|
|
|
|
|
|
/s/
Richard Berman
|
|
Director
|
|
Richard
Berman
|
|
|
|
|
|
|
|
/s/
Dr. Samir Khleif
|
|
Director
|
|
Dr.
Samir Khleif
|
|
|
|
|
|
|
|
/s/
Gregory Mayes
|
|
Director
|
|
Gregory
Mayes
|
|
|
|
|
|
|
|
/s/
Dr. Thomas McKearn
|
|
Director
|
|
Dr.
Thomas McKearn
|
|
|
|
|
|
|
|
/s/
Thomas Ridge
|
|
Director
|
|
Thomas
Ridge
|
|
|
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