1
SPECIAL NOTE REGARDING FORWARD
-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains forward-looking
statements. 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.
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 contained in
this Quarterly Report. In addition, even if our results
of operations, financial condition and cash flows, and the
development of the
markets in which we operate, are consistent with
the forward-looking statements contained
in this Quarterly Report, those results or
developments may not be indicative of results
or developments in subsequent periods. New factors
emerge from time to time that
may cause our business not to develop as we expect,
and it is not possible for us to predict all of them. Factors that could
cause
actual results and outcomes to differ
from those reflected in forward-looking statements
include, among others, the following:
•
the prospects of UB-612 and other product candidates,
including the timing of data from our clinical
trials for UB-612
and other product candidates and our ability
to obtain and maintain regulatory approval for our
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;
•
our status as a clinical-stage company and estimates
of our addressable market, market growth, future
revenue,
expenses, capital requirements and our
needs for additional financing;
•
our ability to comply with multiple legal and regulatory
systems 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;
•
competitive companies and technologies
and 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;
•
our ability and the potential to successfully
manufacture our product candidates for pre
-clinical use, for clinical trials
and on a larger scale for commercial
use, if approved;
•
the ability and willingness of our third-party
collaborators, including UBI, to continue research
and development
activities relating to our product candidates;
•
general economic, political, demographic
and business conditions in the United States, Taiwan
and other
jurisdictions;
•
the potential effects of government
regulation, including regulatory developments
in the United
States and other jurisdictions;
•
ability to obtain additional financing
in future offerings;
•
expectations about market trends;
and