Clinical Trial Success Uncertainty: Citius Oncology's success hinges on positive results from ongoing and future clinical trials for its pipeline candidates, including Mino-Lok and I/ONTAK. Failure to meet primary endpoints, demonstrate sufficient efficacy, or prove safety would severely impact the company's viability and stock value.

Regulatory Approval Risks: Even with successful clinical trials, there is no guarantee that regulatory bodies like the FDA will grant marketing approval for any of CTOR's product candidates. Delays in the approval process, requests for additional data, or outright rejections pose significant risks to commercialization timelines and potential revenue.

Capital Raising and Dilution: As a clinical-stage biotechnology company, CTOR requires substantial additional capital to fund its research, development, and potential commercialization efforts. Inability to raise sufficient funds on acceptable terms could lead to delays, curtailment of programs, or significant shareholder dilution through equity offerings.