No Revenue / Cash BurnTrevi is a pre-revenue biotech with persistent negative operating cash flow and free cash flow, implying recurring financing needs beyond current runway if programs expand or launch costs arise. Continued burn increases dilution risk and constrains optionality for commercialization without additional capital or partners.
Trial Upsizing RiskSample-size reestimation (SSRE) mechanisms create structural execution risk: if conditional power falls, trials may need to be upsized, prolonging timelines, raising operational costs and consuming cash. This risk can materially change program economics and necessitate additional financing or partnerships to complete pivotal studies.
Competitive ReadoutsEfficacy or safety results from competing P2X3 programs are a durable competitive risk: positive competitor readouts could compress Trevi's addressable market or pricing, while negative ones could advantage Trevi. Either outcome may require strategic adjustments to labeling, positioning or market access plans over the medium term.