Clinical risk is low, but regulatory and operational timing risk is now elevated due to the FDA’s OAI at a third‑party CMO, which the company expects will lead to a CRL and a 2027 launch.
Demand visibility is favorable given recurring quit attempts and documented interest in cytisine in real‑world communities, yet uptake curves in cessation are historically variable and promotion‑dependent. A future vaping indication adds upside but increases execution variability.
Until approval and early prescription trends are visible, revenue and cash conversion remain difficult to forecast.







