Trevi Therapeutics(US:TRVI)2025-11-13 21:09Clinical Trials and Development - The Phase 2b CORAL trial for Haduvio demonstrated statistically significant reductions in 24-hour cough frequency of 60.2% (p<0.0001), 53.4% (p<0.0001), and 47.9% (p<0.01) for the 108 mg BID, 54 mg BID, and 27 mg BID dose groups, respectively, compared to a placebo reduction of 16.9%[135]. - The Phase 2a RIVER trial showed a 67% reduction in 24-hour cough frequency from baseline and a 57% placebo-adjusted reduction (p<0.0001) for Haduvio in patients with refractory chronic cough[144]. - The Phase 2 CANAL trial showed a statistically significant reduction in daytime cough frequency (p<0.0001) and positive results on patient-reported outcomes for Haduvio[141]. - The TIDAL study aims to assess the safety and tolerability of Haduvio in patients with IPF, with data expected in Q4 2025[140]. - The company is also developing Haduvio for chronic cough in patients with non-IPF interstitial lung disease (ILD) and plans to conduct a clinical trial for this indication[143]. - The company plans to conduct multiple clinical trials for Haduvio, including Phase 3 trials for chronic cough in patients with IPF and non-IPF ILD[183]. - The company plans to request an End-of-Phase 2 meeting with the FDA in Q4 2025 and initiate the Phase 3 program for Haduvio in the first half of 2026[139]. Financial Performance - As of September 30, 2025, the company reported an accumulated deficit of $321.5 million due to research and development and administrative expenses[147]. - The company had cash, cash equivalents, and marketable securities totaling $194.9 million as of September 30, 2025, expected to fund operations for at least 12 months[148]. - Research and development expenses for Q3 2025 decreased to $10.1 million from $11.2 million in Q3 2024, primarily due to reduced clinical development expenses[160]. - General and administrative expenses for Q3 2025 increased to $3.8 million from $2.9 million in Q3 2024, mainly due to higher professional fees and personnel-related costs[161]. - Total operating expenses for Q3 2025 were $13.9 million, a slight decrease from $14.1 million in Q3 2024[159]. - Net loss for Q3 2025 was $11.8 million, compared to a net loss of $13.2 million in Q3 2024, reflecting an improvement of $1.4 million[159]. - Research and development expenses for the nine months ended September 30, 2025, were $27.3 million, down from $30.0 million in the same period of 2024[164]. - General and administrative expenses for the nine months ended September 30, 2025, increased to $11.8 million from $9.2 million in the same period of 2024[165]. - Interest income for Q3 2025 was $2.1 million, up from $0.8 million in Q3 2024, driven by higher cash equivalents and marketable securities[162]. - The company raised approximately $115.1 million from the June 2025 Offering of 17.4 million shares at $5.75 per share[168]. - The company has not generated any revenue since inception and has incurred significant operating losses and negative cash flows[167]. - For the nine months ended September 30, 2025, net cash used in operating activities was $34.5 million, resulting from a net loss of $34.4 million[174]. - Net cash used in investing activities for the nine months ended September 30, 2025, was $63.5 million, primarily due to $116.3 million in purchases of available-for-sale marketable securities[176]. - Net cash provided by financing activities for the nine months ended September 30, 2025, was $120.7 million, mainly from cash proceeds of $108.2 million from common stock sales[178]. - The company reported a net increase in cash and cash equivalents of $22.8 million for the nine months ended September 30, 2025, compared to a decrease of $16.3 million in the same period of 2024[173]. - The company’s non-cash charges for the nine months ended September 30, 2025, included stock-based compensation expense of $3.8 million[174]. Future Outlook and Funding Needs - The company anticipates substantial expenditures in the future for the clinical development and commercialization of Haduvio[150]. - The company expects to incur substantial expenditures to advance Haduvio through clinical development and regulatory approval, requiring significant additional funding[181]. - The company believes existing cash, cash equivalents, and marketable securities will fund operations into 2028, but additional capital will be needed for full development and commercialization of Haduvio[186]. - The company has no committed external source of funds and will need to obtain further funding through various means, which may lead to dilution for stockholders[188]. - The company completed a Phase 1 drug-drug interaction study showing no clinically meaningful pharmacokinetic findings when Haduvio was co-administered with pirfenidone or nintedanib[146]. - The safety profile of Haduvio was consistent with previous trials, with discontinuation rates due to adverse events at 5.6% for Haduvio and 5.0% for placebo[142].