FORWARD-LOOKING
STATEMENTS
Certain statements contained in
this prospectus, any prospectus supplement and the documents
incorporated by reference herein and therein may constitute
“forward-looking information” within the meaning of applicable
securities laws in Canada and “forward-looking statements” within
the meaning of the United States Private Securities Litigation
Reform Act of 1995, as amended (collectively, “forward-looking
statements”), which involve known and unknown risks, uncertainties
and other factors which may cause the actual results, performance
or achievements of the Company, or industry results, to be
materially different from any future results, performance or
achievements expressed or implied by such forward-looking
statements. These forward-looking statements include information
about possible or assumed future results of our business, financial
condition, results of operations, liquidity, objectives and
strategies to achieve those objectives, as well as statements with
respect to our beliefs, targets, expectations, anticipations,
estimates or intentions. In some cases, you can identify
forward-looking statements by terminology such as “believe”, “may”,
“estimate”, “continue”, “anticipate”, “intend”, “should”, “plan”,
“expect”, “predict”, “potential”, “could”, “assume”, “project”,
“guidance” or the negative of these terms or other similar
expressions, although not all forward-looking statements include
such words. The statements we make regarding the following matters
are forward-looking by their nature and are based on certain of the
assumptions noted below:
•
our aim to develop and
commercialize BLU-5937 for the treatment of hypersensitization
disorders, including refractory chronic cough (“RCC”);
•
our intention to discontinue
development of BLU-5937 in pruritic conditions and the Phase 2a
proof-of-concept BLUEPRINT trial;
•
our aim to complete additional
preclinical studies with BLU-5937;
•
our aim to complete additional
Phase 1 clinical trials with BLU-5937;
•
our aim to further explore the
potential of BLU-5937 for the treatment of other afferent
hypersensitization-related conditions;
•
our expectations with respect
to the timing and cost of the research and development activities
of BLU-5937;
•
the function, potential
benefits, tolerability profile, effectiveness and safety of our
product candidates, including BLU-5937, including with respect to
patient population, pricing and labeling, and the impact of our
enrichment strategy on labeling;
•
our expectations with respect
to pre-commercialization activities related to the commercial
launch of BLU-5937, if approved;
•
our expectations regarding the
potential development of a once-daily dosing regimen of BLU-5937
using an extended release formulation;
•
our expectations regarding our
ability to arrange for and scale up the manufacturing of BLU-5937
to reach commercial scale;
•
our estimates and assessment of
the potential markets (including size) for our product
candidates;
•
our expectations regarding
coverage, reimbursement and pricing and acceptance of our product
candidates by the market, if approved;
•
our estimates and projections
regarding potential pricing for BLU-5937 and how such pricing
compares to other P2X3 antagonists;
•
our estimates and projections
regarding the size of the total addressable global RCC market and
associated P2X3 revenue potential;
•
the benefits and risks of our
product candidates as compared to others;
•
our aim to obtain regulatory
approvals to market our product candidates;