Safe
Harbor Statement Under the Private Securities Litigation Reform Act
of 1995: This Annual Report on
Form 10-K contains forward-looking statements made pursuant to the
safe harbor provisions of the Private Securities Litigation Reform
Act of 1995 under Section 27A of the Securities Act of 1933,
as amended, and Section 21E of the Securities Exchange Act of
1934, as amended. Forward-looking statements include statements
with respect to our beliefs, plans, objectives, goals,
expectations, anticipations, assumptions, estimates, intentions and
future performance, and involve known and unknown risks,
uncertainties and other factors, which may be beyond our control
and which may cause our actual results, performance or achievements
to be materially different from future results, performance or
achievements expressed or implied by such forward-looking
statements. All statements other than statements of historical fact
are statements that could be forward-looking statements. You can
identify these forward-looking statements through our use of words
such as “may,” “will,” “can,” “anticipate,” “assume,” “should,”
“indicate,” “would,” “believe,” “contemplate,” “expect,” “seek,”
“estimate,” “continue,” “plan,” “point to,” “project,” “predict,”
“could,” “intend,” “target,” “potential” and other similar words
and expressions of the future.
There are a number of important
factors that could cause the actual results to differ materially
from those expressed in any forward-looking statement made by us.
These factors include, but are not limited to:
•
our dependence on product
candidates, which are still in an early development
stage;
•
our ability to successfully
complete research and further development, including preclinical
and clinical studies, and, if we obtain regulatory approval,
commercialization of our drug candidates and the growth of the
markets for those drug candidates;
•
our anticipated timing for
preclinical development, regulatory submissions, commencement and
completion of clinical trials and product approvals;
•
the impact of the COVID-19
pandemic on our business or on the economy generally;
•
whether the COVID-19 pandemic
will affect the timing of the completion of our planned and/or
currently ongoing preclinical/clinical trials;
•
our ability to negotiate
strategic partnerships, where appropriate, for our drug
candidates;
•
our ability to manage multiple
clinical trials for a variety of drug candidates at different
stages of development;
•
the cost, timing, scope and
results of ongoing preclinical and clinical testing;
•
our expectations of the
attributes of our product and development candidates, including
pharmaceutical properties, efficacy, safety and dosing
regimens;
•
the cost, timing and
uncertainty of obtaining regulatory approvals for our drug
candidates;
•
the availability, cost,
delivery and quality of clinical management services provided by
our clinical research organization partners;
•
the availability, cost,
delivery and quality of clinical and commercial-grade materials
produced by our own manufacturing facility or supplied by contract
manufacturers, suppliers and partners;
•
our ability to develop and
commercialize products before competitors that are superior to the
alternatives developed by such competitors;
•
our ability to develop
technological capabilities, including identification of novel and
clinically important targets, exploiting our existing technology
platforms to develop new drug candidates and expand our focus to
broader markets for our existing targeted
therapeutics;
•
the cost of paying development,
regulatory approval and sales-based milestones under the merger
agreement by which we acquired Kolltan Pharmaceuticals, Inc.
(“Kolltan”), and the cost, timing, and outcome of our declaratory
judgment action against the Kolltan stockholder representative with
respect to certain of those milestones;
•
our ability to realize the
anticipated benefits from the acquisition of Kolltan;