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These risks, uncertainties and other factors include, among others, the Company's ability to successfully engage with the FDA and satisfactorily respond to requests from the FDA for further information and data regarding the CTI-1601 clinical trial including the FDA review of data from cohort one from the Phase 2 dose escalation trial and FDA 's agreement to escalate the dosing in cohort two , the timing and outcomes of the Company's interactions with the FDA concerning the partial clinical hold, the success, cost and timing of the Company's product development activities, nonclinical studies and clinical trials, including CTI-1601 clinical milestones; that preliminary clinical trial results may differ from final clinical trial results, that earlier non-clinical and clinical data and testing of CTI-1601 may not be predictive of the results or success of later clinical trials, and assessments; the ongoing impact of the COVID-19 pandemic on the Company's future clinical trials, manufacturing, regulatory, nonclinical study timelines and operations, and the potential impact of the Russian invasion of Ukraine on the Company's ability to raise additional capital and general economic conditions; the Company's ability and the ability of third-party manufacturers the Company engages, to optimize and scale CTI-1601's manufacturing process; the Company's ability to obtain regulatory approvals for CTI-1601 and future product candidates; the Company's ability to develop sales and marketing capabilities, whether alone or with potential future collaborators, and to successfully commercialize any approved product candidates; the Company's ability to raise the necessary capital to conduct its product development activities; and other risks described in the filings made by the Company with the Securities and Exchange Commission (SEC), including but not limited to Company's periodic reports, including the annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, filed with or furnished to the SEC and available at www.sec.gov. 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