Clinical Response Variability And Execution RiskPrior studies showing a subset of nonresponders to topical statins, combined with reliance on enabling studies and regulatory alignment to advance programs, raise development and approval execution risk.
Financing And Cash RunwaySignificant cash burn and a limited cash runway increase the likelihood of near‑term fundraising, which could dilute shareholders and create heightened stock volatility if additional capital is required.
Formulation And DeliveryThe rapamycin molecule's poor solubility, instability, and limited skin penetration pose meaningful formulation hurdles that could impede achieving consistent clinical performance and complicate regulatory review.