Clinical Trial Failure Risk: The success of Prokidney's lead product candidate, REACT, is highly dependent on the outcomes of its ongoing Phase 3 clinical trials. Failure to demonstrate efficacy or an unacceptable safety profile would significantly harm the company's prospects.

Regulatory Approval Uncertainty Risk: Even with positive clinical trial results, Prokidney faces a complex and uncertain regulatory approval process with health authorities like the FDA. There is no guarantee that REACT or any future product candidates will receive necessary marketing approvals.

Commercialization and Market Adoption Risk: If approved, Prokidney's ability to successfully commercialize REACT depends on market acceptance, competition, pricing, and obtaining adequate reimbursement from payors. Failure to achieve broad market adoption would limit revenue generation.