Clinical Trial Outcomes Uncertainty: The success of Oramed's lead candidates, especially Oravax (oral insulin), relies heavily on positive outcomes from ongoing and future clinical trials. Failure to meet endpoints or demonstrate safety and efficacy could lead to significant delays, increased costs, or complete discontinuation of development, severely impacting the company's viability.

Regulatory Approval Hurdles: Obtaining regulatory approval for new drug candidates is a complex and lengthy process. There is no guarantee that Oramed's products, even if successful in trials, will receive timely approval from regulatory authorities such as the FDA, which could delay or prevent market entry.

Intense Market Competition: The pharmaceutical industry is highly competitive, especially in the diabetes treatment space. Oramed faces significant competition from well-established companies with greater resources and existing products, potentially limiting market share and pricing power for any approved products.