TRVI

Trevi is a clinical-stage, single-asset biopharma with no product revenue (revenue is blank across FY2021-FY2025) and a -$42.8M FY2025 net loss; the entire investment case rides on Haduvio (oral nalbuphine ER) for chronic cough in IPF and related lung disease. The 10-K delivers the central positive: the Phase 2b CORAL trial hit its primary endpoint with statistically significant, dose-dependent 24-hour cough reductions (60.2% at 108mg BID, p<0.0001, vs 16.9% placebo), and management reports FDA alignment at an End-of-Phase 2 meeting on a path to NDA via two parallel pivotal Phase 3 trials starting Q2 2026 and 2H 2026. In a high-mortality indication with no approved cough therapy, that is a genuine, catalyst-rich setup.

The balance sheet is clean: total liabilities of just $10.2M against $183M equity (0.06x liabilities/equity) and $192M current assets, with effectively no debt. But the funding picture is tighter than the headline equity suggests — cash and equivalents fell 44.5% to $18.9M, operating cash burn was -$42.1M, and the company is about to run two simultaneous Phase 3 trials (one ~300 patients with 52 weeks of dosing, one ~130 patients). That program will cost far more than current resources can fund, so additional capital raises are near-certain; shares outstanding already grew 32.8% YoY, signaling the dilution that pre-approval funding typically requires.