Clinical Development Failure Risk: Clinical trials for Precigen's product candidates may not demonstrate sufficient efficacy or safety, leading to failure to obtain regulatory approval.

Regulatory Approval Uncertainty Risk: Precigen may not be able to secure or maintain necessary regulatory approvals from health authorities like the FDA for its investigational therapies.

Capital Requirements and Funding Risk: Precigen requires significant ongoing capital to fund its research, development, and potential commercialization efforts, which may lead to future equity financings and shareholder dilution.