6-K Out. Foreign Issuers Report to SEC
These statements reflect current expectations of management regarding future events and operating performance and speak only as of the date of this MD&A. 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 chronic cough and chronic pruritus;
· our aim to complete additional preclinical studies on BLU-5937;
· our aim to complete additional clinical Phase 1 trials with BLU-5937;
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· our expectations to release topline results in the fourth quarter of 2021 for our Phase 2b SOOTHE clinical trial of BLU-5937 for the treatment of patients with refractory chronic cough and conduct an interim analysis in mid-2021, the results of which we may use to initiate planning activities for Phase 3 clinical trials;
· our expectations to release topline results in the fourth quarter of 2021 for our Phase 2 BLUEPRINT clinical trial of BLU-5937 for the treatment of patients with chronic pruritus associated with atopic dermatitis;
· 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;
· our expectations regarding the potential once-daily dosing with extended-release formulation for BLU-5937 and our aim to begin prototype development of the BLU-5937 once-daily formulation in 2021;
· 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 pricing and acceptance of our product candidates by the market;
· our estimates and projections regarding potential pricing for BLU-5937 and how such pricing compares to other P2X3 inhibitors;
· our estimates and projections regarding the size of the total addressable global refractory chronic cough 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;
· our expectations with respect to the cost of preclinical studies and clinical trials and commercialization of our product candidates, including BLU-5937;
· our expectation of the continued listing of the common shares on the TSX and Nasdaq;
· our current and future capital requirements and anticipated sources of financing or revenue;
· our expectations regarding the COVID-19 pandemic and its impact on our business;
· our expectations regarding the protection of our intellectual property;
· our business strategy; and
· our development and partnership plans and objectives.
The preceding list is not intended to be an exhaustive list of all of our forward-looking statements.
Conclusions, forecasts and projections set out in forward-looking information are based on our current objectives and strategies and on expectations and estimates and other factors and assumptions that we believe to be reasonable at the time applied but may prove to be incorrect. These include, but are not limited to:
· the function, potential benefits, effectiveness and safety of BLU-5937;
· the benefits and risks of our product candidates as compared to others;
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· the accuracy of our belief that selective P2X3 inhibitors have an improved tolerability profile compared to the most advanced P2X3 receptor inhibitor in development, Merck & Co.’s gefapixant;
· progress, timing and costs related to the development, completion and potential commercialization of our product candidate;
· estimates and projections regarding our industry;
· market acceptance of our product candidate;
· future success of current research and development activities;
· achievement of development and commercial milestones, including forecasted preclinical study and clinical trial milestones within the anticipated timeframe;
· our reliance on third parties to conduct preclinical studies and clinical trials for BLU-5937;
· that the timeline and costs for our preclinical and clinical programs are not incorrectly estimated or affected by unforeseen circumstances;
· the successful development of once daily dosing with extended release formulation for BLU-5937;
· our ability to achieve intended order of market entry of BLU-5937 relative to other P2X3 inhibitors;
· accuracy of our findings of statistically significant interaction between baseline cough frequency and treatment benefit, and realization of the intended benefits of our enrichment strategy;
· accuracy of our estimates and projections regarding potential pricing for BLU-5937, including parity to other P2X3 inhibitors;
· accuracy of our estimates and projections regarding the size of the total addressable global refractory chronic cough market and associated P2X3 revenue potential;
· the capacity of our primary supply chain to produce the required clinical supplies to support a Phase 3 program in refractory chronic cough within the anticipated timeframe;
· absence of interruption or delays in the operations of our suppliers of components or raw materials, contract research organizations or other third parties with whom we engage, whether as a result of disruptions caused by the COVID-19 pandemic or otherwise;
· accuracy of our expectations regarding label indication for BLU-5937 in refractory chronic cough and the potential to expand the use of P2X3 inhibitors on all refractory chronic cough patients;
· absence of material deterioration in general business and economic conditions, including the impact on the economy and financial markets of the COVID-19 pandemic and other health risks;
· the effectiveness of COVID-19 containment efforts, including the implementation of vaccination programs and gradual recovery of global environment and global economic conditions;
· the receipt of regulatory and governmental approvals for research and development projects and timing thereof;
· the availability of tax credits and financing for research and development projects, and the availability of financing on favorable terms;
· our expectations regarding our status as a passive foreign investment company;
· the accuracy of our estimates regarding future financing and capital requirements and expenditures;
· the achievement of our forecasted cash burn rate;
· the sufficiency and validity of our intellectual property rights;
· our ability to secure, maintain and protect our intellectual property rights, and to operate without infringing on the proprietary rights of others or having third parties circumvent the rights owned or licensed by us;
· our ability to source and maintain licenses from third-party owners on acceptable terms and conditions;
· absence of significant changes in Canadian dollar-U.S. dollar and other foreign exchange rates or significant variability in interest rates;
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· the absence of material changes in market competition and accuracy of our assumptions and projections regarding profile and market dynamic amongst more selective agents;
· our ability to attract and retain skilled staff;
· our ability to maintain ongoing relations with employees and business partners, suppliers and other third parties;
· the accuracy of the market research, third-party industry data and forecasts relied upon by us; and
· the absence of adverse changes in relevant laws or regulations.
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