Summary of Trevi Therapeutics (TRVI) Conference Call Company Overview - **Company Name**: Trevi Therapeutics (TRVI) - **Founded**: 2018 - **Focus**: Development of small molecule therapeutics targeting STAT3, a transcription factor associated with proliferative diseases and fibrosis [4][5] Financial Highlights - **Initial Funding**: Raised approximately $9.5 million in 2018 - **Series B Funding**: Raised $74 million - **Recent Financing**: Reverse merged in April 2025, raising about $50 million, providing a cash runway into Q4 2026 [5][6][78] Clinical Development - **Lead Program**: Focused on idiopathic pulmonary fibrosis (IPF) with a double-blind randomized placebo-controlled trial set to unblind in Q4 2025 [5][6] - **Oncology Trials**: Data from oncology trials showed promising pharmacokinetics (PK) and pharmacodynamics (PD) with a significant reduction in activated STAT3 [20][27] - **Next Steps**: Anticipated data readouts for both IPF and hepatocellular carcinoma (HCC) in the first half of 2026 [78][80] Mechanism of Action - **STAT3 Inhibition**: Trevi's approach involves non-covalently binding to STAT3 to inhibit its activation without affecting the protein itself, avoiding mitochondrial toxicity seen in other inhibitors [9][10] - **Importance in IPF**: STAT3 is a central mechanism in fibrosis, with high expression correlating with increased mortality in patients [13][14] Competitive Landscape - **Recent Developments**: Notable successes in the IPF space from Boehringer Ingelheim and United Therapeutics, indicating a renewed interest in the market [15][18] - **Positioning**: Trevi's STAT3 inhibitors are seen as potentially disease-modifying, with mechanisms that could complement existing therapies [18][39] Trial Design and Data - **Interim Analysis**: Conducted to assess safety and efficacy, leading to the discontinuation of the 1200 mg dose due to adverse events [35][36] - **Patient Outcomes**: Over a third of patients showed improvement in forced vital capacity (FVC), indicating potential efficacy [38] Future Directions - **Next Generation Molecule**: Development of a prodrug (TTI-109) with improved bioavailability and reduced gastrointestinal side effects, expected to enter trials if current studies yield positive results [61][68] - **Funding Strategy**: Plans to raise additional funds based on positive data from ongoing trials to support further development [78][80] Key Takeaways - Trevi Therapeutics is positioned in a promising area of drug development targeting STAT3 for fibrotic diseases, with significant upcoming data readouts that could impact its market position and funding opportunities [39][80]