Item 1. Legal Proceedings
Item 1. Legal Proceedings
From time to time, we are subject to claims in legal proceedings arising in the normal course of business. To our knowledge, during the three months ended June 30, 2023, there were no, and as of the date of this Quarterly Report, there are no, threatened or pending legal actions that could reasonably be expected to have a material adverse effect on our business, financial condition, results of operations or cash flows.
Item 1A. Ris k Factors
You should carefully consider the risk factors described in our 2022 Annual Report under the caption “Item 1A. Risk Factors.” Except as set forth below, there have been no material changes in our risk factors disclosed in our 2022 Annual Report. The risks described in our 2022 Annual Report are not the only risks facing our company. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition or future results.
Risks Related to Our Product Development and Regulatory Approvals
Further dose escalation in our Phase 2 and OLE trials and the initiation of additional U.S. clinical trials evaluating CTI-1601 will be contingent on the FDA allowing such trials to proceed following review of data from the 50 mg cohort of our Phase 2 clinical trial; if the FDA does not allow additional trials to proceed, we may be unable to complete our CTI-1601 clinical trials without delays and our business may be adversely affected and our stock price may decline.
In July 2023, the FDA cleared our four-week, placebo-controlled, Phase 2 dose exploration trial of CTI-1601 in patients with FA to proceed to a 50 mg cohort in which participants will be dosed daily for the first 14 days, and then every other day until day 28. Additionally, the FDA cleared for initiation our OLE trial in which participants will receive 25 mg of CTI-1601 daily. Further dose escalation in the Phase 2 and OLE trials and the initiation of additional U.S. clinical trials evaluating CTI-1601 are contingent on FDA review of results from any ongoing clinical trials in accordance with a partial clinical hold. If, following completion of our Phase 2 trial’s 50 mg cohort, we are unable to reach agreement with the FDA to conduct additional clinical trials, we may be unable to complete our CTI-1601 clinical trials without delays in our clinical development plans and anticipated data milestones and additional clinical development costs, any of which could impair our ability, cost or timeline to obtain U.S. regulatory approval for CTI-1601.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Not applicable.
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