Trevi starts second Phase 3 OCEAN trial in IPF-related chronic cough, extends cash runway to 2030

 

Trevi starts second Phase 3 OCEAN trial in IPF-related chronic cough, extends cash runway to fund operations and trials into 2030

• Trevi progressing three Haduvio cough indications, now sole active developer after competitor failures.
• OCEAN-1 and OCEAN-2 IPF Phase III trials enrolling; guidance reaffirmed for 2027–2028 topline results.
• FDA aligned on ~120-patient non-IPF ILD Phase II, starting Q1 2027 with data expected in 1H 2028.
• Lake RCC Phase IIb uses adaptive sample-size reestimation; interim powering readout expected early Q1 2027.
• Top-line Lake RCC data still guided for 2H 2027, even at maximum upsized enrollment.
• Fiscal Q3 2026 non-GAAP EPS was -0.13, down 62% YoY, on revenue of $0, beating estimates.
• Revenue and EPS not disclosed; $299 million cash and securities fund trials into 2030.
• Company projects its cash runway will fund operations into 2030.
• Key risk: heterogeneous RCC biology, historical placebo effects and potential SSRE futility create meaningful trial outcome uncertainty.
• Severe RCC segment estimated at ~1 million U.S. patients; pulmonology outreach has already reached 93% of pulmonologists.
• New method-of-use patent for hepatic impairment and non-IPF ILD extends intellectual property protection to 2041.
• Management tone confident and execution-focused, repeatedly reaffirming trial timelines and highlighting the absence of competitors.
• Main concern remains RCC trial outcome and ability to demonstrate efficacy in a historically challenging indication.
• Strong quarter driven by clinical execution across three cough indications and maintaining a well-funded balance sheet.

https://finviz.com/stock?t=TRVI&p=d