Participants in the Solicitation
Ayala and Advaxis and certain of their respective directors and
executive officers may be deemed to be participants in the
solicitation of proxies in respect of the proposed transaction.
Information regarding Ayala’s directors and executive officers,
including a description of their direct or indirect interests, by
security holdings or otherwise, is contained in Ayala’s proxy
statement for its 2022 annual meeting of stockholders which was
filed with the SEC on April 27, 2022. Information regarding
Advaxis’s directors and executive officers, including a description
of their direct or indirect interests, by security holdings or
otherwise, is contained in Advaxis’s proxy statement for its 2022
annual meeting of stockholders which was filed with the SEC on
February 28, 2022. Additional information regarding the direct and
indirect interests of the participants in the solicitation of
proxies in connection with the proposed transaction, including the
interests of Ayala and Advaxis directors and executive officers in
the transaction, which may be different than those of Ayala and
Advaxis stockholders generally, will be contained in the Proxy
Statement/Prospectus and any other relevant documents that are or
will be filed with the SEC relating to the transaction. You may
obtain free copies of these documents using the sources indicated
above.
No Offer or Solicitation
This communication is not intended to and shall not constitute an
offer to sell or the solicitation of an offer to buy or sell any
securities or a solicitation of any vote or approval, nor shall
there be any sale of securities in any jurisdiction in which such
offer, solicitation or sale would be unlawful prior to registration
or qualification under the securities laws of any such
jurisdiction. No offer of securities shall be made except by means
of a prospectus meeting the requirements of Section 10 of the
Securities Act of 1933, as amended.
Forward-Looking Statements
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
All statements contained in this press release that do not relate
to matters of historical fact should be considered forward-looking
statements, including statements relating to the completion of the
our merger with Advaxis and the anticipated impact of the merger,
the timing of our communications with the FDA, our development of
AL101 and AL102, the promise and potential impact of our
preclinical or clinical trial data, the timing of and plans to
initiate additional clinical trials of AL101 and AL102, the timing
and results of any clinical trials or readouts, our participation
at scientific or medical conferences, the sufficiency of cash to
fund operations, and the anticipated impact of COVID-19, on our business. These
forward-looking statements are based on management’s current
expectations. The words ”may,” “will,” “should,” “expect,” “plan,”
“anticipate,” “could,” “intend,” “target,” “project,” “estimate,”
“believe,” “predict,” “potential” or “continue” or the negative of
these terms or other similar expressions are intended to identify
forward-looking statements, although not all forward-looking
statements contain these identifying words.
These statements are neither promises nor guarantees, but involve
known and unknown risks, uncertainties and other important factors
that may cause our actual results, performance or achievements to
be materially different from any future results, performance or
achievements expressed or implied by the forward-looking
statements, including, but not limited to, the following: the
announcement and pendency of the Merger (as defined herein) could
have an adverse effect on our business; failure to consummate the
Merger within the expected timeframe or at all could have a
material adverse impact on our business, financial condition and
results of operations; certain provisions of the Merger Agreement
(as defined herein) may discourage third parties from submitting
competing proposals, including proposals that may be superior to
the transactions contemplated by the Merger Agreement; failure to
consummate the Merger may result in the terminating party paying a
termination fee to the non-terminating party and could harm
the terminating party’s common stock price and its future business
and operations; if we do not successfully consummate the Merger
with Advaxis (as defined herein), our board of directors may
dissolve or liquidate our assets to pursue a dissolution and
liquidation; our directors and executive officers have interests in
the Merger that are different from our stockholders, and that may
influence them to support or approve the Merger without regard to
our stockholders’ interests; if the Merger is not completed, our
stock price may fluctuate significantly; the announcement and
pendency of the Merger, whether or not consummated, adversely
affected the trading price of our common stock and may continue to
adversely affect the trading price of our common stock; the failure
to successfully integrate the businesses and operations of Ayala
and Advaxis in the expected time frame may adversely affect the
combined company’s future results; we have incurred significant
losses since inception and anticipate that we will continue to
incur losses for the foreseeable future. We are not currently
profitable, and we may never achieve or sustain profitability; we
will require additional capital to fund our operations, and if we
fail to obtain necessary financing, we may not be able to complete
the development and commercialization of AL101 and AL102; we have
identified conditions and events that raise substantial doubt about
our ability to continue as a going concern; we have a limited
operating history and no history of commercializing pharmaceutical
products, which may make it difficult to evaluate the prospects for
our future viability; we are heavily dependent on the success of
AL101 and AL102, our most advanced product candidates, which are
still under clinical development, and if either AL101 or AL102 does
not receive regulatory approval or is not successfully
commercialized, our business may be harmed; due to our limited
resources and access to capital, we must prioritize development of
certain programs and product candidates; these decisions may prove
to be wrong and may adversely affect our business; the outbreak of
COVID-19, may adversely
affect our business, including our clinical trials; our ability to
use our net operating loss carry forwards to offset future taxable
income may be subject to certain limitations; our product
candidates are designed for patients with genetically defined
cancers, which is a rapidly evolving area of science, and the
approach we are taking to discover and develop product candidates
is novel and may never lead to marketable products; we were not
involved in the early development of our lead product candidates;
therefore, we are dependent on third parties having accurately
generated, collected and interpreted data from certain preclinical
studies and clinical trials for our product candidates; enrollment
and retention of patients in clinical trials is an expensive and
time-consuming process and could be made more difficult or rendered
impossible by multiple factors outside our control; if we do not
achieve our projected development and commercialization goals in
the timeframes we announce and expect, the commercialization of our
product candidates may be delayed and our business will be harmed;
our product candidates may cause serious adverse events or
undesirable side effects, which may delay or prevent marketing
approval, or, if approved, require them to be taken off the market,
require them to include safety warnings or otherwise limit their
sales; the market opportunities for AL101 and AL102, if approved,
may be smaller than we anticipate; we may not be successful in
developing, or collaborating with others to develop, diagnostic
tests to identify patients with Notch-activating mutations; we have
never obtained marketing approval for a product candidate and we
may be unable to obtain, or may be delayed in obtaining, marketing
approval for any of our product candidates; even if we obtain FDA
approval for our product candidates in the United States, we may
never obtain approval for or commercialize them in any other
jurisdiction, which would limit our ability to realize their full
market potential; we have been granted Orphan Drug Designation for
AL101 for the treatment of ACC and may seek Orphan Drug Designation
for other indications or product candidates, and we may be unable
to maintain the benefits associated with Orphan Drug Designation,
including the potential for market exclusivity, and may not receive
Orphan Drug Designation for other indications or for our other
product candidates; although we have received Fast Track
designation for AL101 and AL102, and may seek Fast Track
designation for our other product candidates, such designations may
not actually lead to a faster development timeline, regulatory
review or approval process; we face significant competition from
other biotechnology and pharmaceutical companies and our operating
results will suffer if we fail to compete effectively; we are
dependent on a small number of suppliers for some of the materials
used to manufacture our product candidates, and on one company for
the manufacture of the active pharmaceutical ingredient for each of
our product candidates; any future collaborations will be,
important to our business. If we are unable to maintain our
existing collaboration or enter into new collaborations, or if
these collaborations are not successful, our business could be
adversely affected; enacted and future healthcare legislation may
increase the difficulty and cost for us to obtain marketing
approval of and commercialize our product candidates, if approved,
and may affect the prices we may set; if we are unable to obtain,
maintain, protect and enforce patent and other intellectual
property protection for our technology and products or if the scope
of the patent or other