CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus and the documents incorporated by reference may contain forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities and Exchange Act of 1934, or the Exchange Act, about us and our subsidiary. These forward-looking statements are intended to be covered by the safe harbor for forward-looking statements provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact, and can be identified by the use of forward-looking terminology such as “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “will,” “would,” “could,” “should,” “potential,” “seek,” “evaluate,” “pursue,” “continue,” “design,” “impact,” “affect,” “forecast,” “target,” “outlook,” “initiative,” “objective,” “designed,” “priorities,” “goal,” or the negative thereof or comparable terminology. Forward-looking statements include, but are not limited to, statements concerning:
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our ability to raise additional capital to fund our operations and continue the development of our current and future product candidates;
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our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;
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the clinical nature of our business and our ability to successfully advance our current and future product candidates through our ongoing and future clinical trials, preclinical studies and development activities;
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our ability to generate revenue from future product sales and our ability to achieve and maintain profitability;
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the accuracy of our projections and estimates regarding our expenses, capital requirements, cash utilization, and need for additional financing;
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the expected uses of our existing cash and cash equivalents and the sufficiency of such resources to fund our planned operations;
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the extent to which health epidemics and other outbreaks of communicable diseases, including the COVID-19 pandemic, geopolitical turmoil, including the ongoing global and regional conflicts or increased trade restrictions between the United States, Russia, China, and other countries, social unrest, political instability, terrorism, or other acts of war could ultimately impact our business, including our ongoing and future clinical trials, preclinical studies and development activities;
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our dependence on the success of CT1812, our lead product candidate;
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the novelty of our approach to targeting the σ-2 (sigma-2) receptor , or S2R, complex to treat age-related degenerative diseases and disorders, and the challenges we will face due to the novel nature of such approach;
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the success of competing therapies that are, or become, available;
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the initiation, progress, success, cost, and timing of our ongoing and future clinical trials, preclinical studies and development activities;
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our ability to obtain and maintain regulatory clearance of CT1812 for clinical trials under investigational new drug, or IND, applications and any future IND applications for any of our other product candidates;
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the timing, scope and likelihood of regulatory filings and approvals, including final regulatory approval of our product candidates;
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the performance of third parties in connection with the development of our product candidates, including third parties conducting our future clinical trials as well as third-party suppliers and manufacturers;
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our ability to attract and retain strategic collaborators with development, regulatory, and commercialization expertise;
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our ability to successfully commercialize our product candidates and develop sales and marketing capabilities, if our product candidates are approved;