Clinical Trial Failure Risk: The primary drug candidate, GP2, may fail to demonstrate sufficient efficacy or safety in ongoing or future clinical trials, including the critical Phase 3 trial, leading to significant delays or discontinuation of development.

Regulatory Approval Uncertainty Risk: Even if clinical trials are successful, there is no guarantee that regulatory authorities like the FDA will grant marketing approval for GP2, or that the approval will be broad enough for commercial viability.

Commercialization & Market Adoption Risk: Should GP2 receive regulatory approval, the company may face significant challenges in successfully manufacturing, marketing, distributing, and achieving widespread adoption among healthcare providers and patients against established competitors.