SPECIAL NOTE ON FORWARD
-LOOKING STATEMENTS
This prospectus supplement, including the documents incorporated
by reference in this prospectus
supplement, contains forward-looking statements within
the meaning of Section 21E of the Exchange Act
and Section 27A of the Securities Act of 1933, as amende
d
(the “Securities Act”). Forward-looking
statements are neither historical facts nor assurances of future
performance. Instead, they are based on
our current beliefs, expectations and assumptions regarding
the future of our business, future plans and
strategies and other future conditions. In some cases, you
can identify forward-looking statements
because they contain words such as “anticipate,” “believe,” “estimate,”
“expect,” “intend,” “may,”
“predict,”
“project,” “target,” “potential,” “seek,” “will,” “would,” “could,”
“should,” “continue,” “contemplate,” “plan,”
other words and terms of similar meaning and the negative
of these words or similar terms.
All forward-looking statements speak only as of the date
on which they are made. Forward-looking
statements are subject to known and unknown risks
and uncertainties, many of which may be beyond our
control. We caution you that forward-looking statements
are not guarantees of future performance or
outcomes and that actual performance and outcomes
may differ materially from those made in or
suggested by the forward-looking statements. Factors
that could cause actual results and outcomes to
differ materially from those reflected in forward-looking
statements include, among others, the following:
the prospects of our product candidates, including the
progress, number, scope, cost,
results and timing
of data from our development activities, preclinical trials
and clinical trials for our product candidates or
programs, such as the target indication(s) for development
or approval, the size, design, population,
conduct, cost, objective or endpoints of any clinical trial,
or the timing for initiation or completion of or
availability of results from any clinical trial, for submission,
review or approval of any regulatory filing, or
for meeting with regulatory authorities; the potential benefits
that may be derived from any of our product
candidates; the timing of and our ability to obtain and maintain regulatory
approval for our existing product
candidates, any product candidates that we may develop, and
any related restrictions, limitations, or
warnings in the label of any approved product candidates;
our ability to develop and commercialize new
products and product candidates; our ability to leverage our
Vaxxine Platform;
the rate and degree of
market acceptance of our products and product candidates;
estimates of our addressable market and
market growth, and expectations about market trends;
our future operations, financial position, revenue,
costs, expenses, uses of cash, including, any proceeds
from this offering, capital requirements, our needs
for additional financing or the period for which our existing
cash resources will be sufficient to meet our
operating requirements; our ability to comply with legal and regulatory
requirements relating to privacy,
tax, anti-corruption and other applicable laws; our ability
to hire and retain key personnel and to manage
our future growth effectively; our ability to access
capital on acceptable terms in a rising interest rate and
tighter credit environment; competitive companies and
technologies within our industry and our ability to
compete; our and our collaborators’, including United
Biomedical’s (“UBI”), ability and willingness to
obtain, maintain, defend and enforce our intellectual property protection
for our proprietary and
collaborative product candidates, and the scope of such protection;
the performance of third-party
suppliers and manufacturers and our ability to find additional
suppliers and manufacturers and obtain
alternative sources of raw materials; our ability and the
potential to successfully manufacture our product
candidates for pre-clinical use, for clinical trials and, if approved,
on a larger scale for commercial use; the
ability and willingness of our third-party collaborators, including
UBI, to continue research and
development activities relating to our product candidates
and our ability to attract additional collaborators
with development, regulatory and commercialization expertise;
general economic, political, demographic
and business conditions in the United States, Taiwan
and other jurisdictions where we conduct business
or clinical trials; the potential effects of government
regulation, including regulatory developments in the
United States and other jurisdictions; our ability to obtain additional
financing in future offerings or
otherwise; the effects of the Russia-Ukraine conflict
and the COVID-19 pandemic on business operations
and the initiation, development and operation of our clinical
trials, including patient enrollment of our
clinical trials; and our strategies, prospects, plans, expectations,
forecasts or objectives.
These factors should not be construed as exhaustive and should
be read in conjunction with the other
cautionary statements and information included in this prospectus
supplement, including our most recent
Annual Report on Form 10-K and subsequent Quarterly
Reports on Form 10-Q and Current Reports on
Form 8-K. New risk factors emerge from time to time, and it
is not possible to predict all such risk factors,
nor can we assess the impact of all such risk factors on
our business or the extent to which any factor or
combination of factors may cause actual results to differ
materially from those contained in any forward-
looking statement. Undue reliance should not be placed on
these forward-looking statements. We do not
undertake any obligation to make any revisions to these
forward-looking statements to reflect events or