CAUTIONARY STATEMENT REGARDING
FORWARD-LOOKING STATEMENTS
This prospectus, including the
documents that we incorporate by reference, contains
forward-looking statements within the meaning of Section 27A
of the Securities Act of 1933, as amended, or the Securities Act,
and Section 21E of the Securities Exchange Act of 1934, as
amended, or the Exchange Act. Any statements about our
expectations, beliefs, plans, objectives, assumptions or future
events or performance are not historical facts and may be
forward-looking. These statements are often, but are not always,
made through the use of words or phrases such as “may,” “will,”
“could,” “should,” “expects,” “intends,” “plans,” “anticipates,”
“believes,” “estimates,” “predicts,” “projects,” “potential,”
“continue,” and similar expressions, or the negative of these
terms, or similar expressions. Accordingly, these statements
involve estimates, assumptions, risks and uncertainties which could
cause actual results to differ materially from those expressed in
them. Any forward-looking statements are qualified in their
entirety by reference to the factors discussed throughout this
prospectus, and in particular those factors referenced in the
section “Risk Factors.”
This prospectus contains
forward-looking statements that are based on our management’s
belief and assumptions and on information currently available to
our management. These statements relate to future events or our
future financial performance, and involve known and unknown risks,
uncertainties and other factors that may cause our actual results,
levels of activity, performance or achievements to be materially
different from any future results, levels of activity, performance
or achievements expressed or implied by these forward-looking
statements. Forward-looking statements include, but are not limited
to, statements about:
•
expectations regarding the
success, cost and timing of our product development activities and
clinical trials, including statements regarding the timing of
initiation, enrollment in and completion of studies or trials and
related preparatory work, the period during which the results of
the trials will become available, and our research and development
programs;
•
plans to advance product
candidates into or successfully complete any clinical
trial;
•
beliefs about data results and
analyses, including what early data demonstrates or suggests, as
well as expectations regarding the safety and efficacy, and overall
potential and advantages, of our product candidates and our
expected timing for data;
•
beliefs that we have the
potential to significantly expand our manufacturing capabilities
and plan to stage additional investments based on future needs and
in preparation for potential pivotal trial and eventual
commercialization;
•
beliefs that we can obtain or
manufacture adequate and timely supply of our product candidates
for clinical trials or for commercial use, if
approved;
•
expectations regarding the
operation of our manufacturing facility and any plans for further
renovation or expansion;
•
beliefs regarding and plans for
our identified research priorities to advance our
technologies;
•
plans to license additional
intellectual property relating to our product candidates and
expectations that we will be able to comply with our existing
license agreements;
•
our ability to obtain funding
for our operations, including funding necessary to complete further
development, clinical trials and, if approved, commercialization of
our product candidates;
•
beliefs about the intellectual
property rights of others and our ability to commercialize our
products in light of such third-party rights;
•
beliefs about developments
relating to cellular therapies, including red blood cell
therapies;
•
expectations for competing
therapies that are or become available;
•
plans for the commercialization
of, and expectations for the market for, our product candidates, if
approved;
•
our plans to research, develop
and commercialize our product candidates;
•
our plans to attract
collaborators with development, regulatory and commercialization
expertise;