SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus and the documents incorporated by reference herein contain forward-looking statements. These statements are based on our management’s current beliefs, expectations and assumptions about future events, conditions and results and on information currently available to us. Discussions containing these forward-looking statements may be found, among other places, in the sections entitled “Business,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” incorporated by reference from our most recent Annual Report on Form 10-K and our most recent Quarterly Report on Form 10-Q, as well as any amendments thereto, filed with the SEC.
Any statements in this prospectus, or incorporated herein, about our expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and are forward-looking statements. Within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, these forward-looking statements include statements regarding:
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statements regarding the impact of the ongoing COVID-19 pandemic and its effects on our operations, research and development and clinical trials and potential disruption in the operations and business of third-party manufacturers, contract research organizations, or CROs, other service providers, and collaborators with whom we conduct business;
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the initiation, timing, progress and results of our preclinical studies and clinical trials, and our research and development programs;
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our ability to advance our product candidates into, and successfully complete, clinical trials;
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our reliance on the success of our product candidates in our BTC, Bicycle TICA™ and other pipeline programs;
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our ability to utilize our screening platform to identify and advance additional product candidates into clinical development;
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the timing or likelihood of regulatory filings and approvals;
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the commercialization of our product candidates, if approved;
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our ability to develop sales and marketing capabilities;
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the pricing, coverage and reimbursement of our product candidates, if approved;
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the implementation of our business model, strategic plans for our business, product candidates and technology;
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the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology;
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our ability to operate our business without infringing the intellectual property rights and proprietary technology of third parties;
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costs associated with defending intellectual property infringement, product liability and other claims;
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regulatory development in the United States, under the laws and regulations of England and Wales and in other jurisdictions;
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estimates of our expenses, future revenues, capital requirements and our needs for additional financing;
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the amount of and our ability to satisfy interest and principal payments under our debt facility with Hercules Capital, Inc.;
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the potential benefits of strategic collaboration agreements and our ability to enter into strategic arrangements;
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our ability to maintain and establish collaborations or obtain additional grant funding;
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the rate and degree of market acceptance of any approved products;