Trevi Therapeutics Q2 2024 Financial Results and Business Updates Reaffirm Clinical Trial Guidance

Trevi Therapeutics, Inc., a biopharmaceutical company based in New Haven, Connecticut, has shared its financial outcomes for the quarter which ended on June 30, 2024, along with updates on its business operations. The company is focused on developing Haduvio™, an oral nalbuphine ER therapy for chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC).

Jennifer Good, President and CEO of Trevi Therapeutics, highlighted the robust recruitment observed in their clinical trials during the recent quarter. The Phase 2a RIVER trial concerning RCC has seen about 80% of its target enrollment of 60 patients. The company anticipates revealing topline results in the fourth quarter of 2024. Additionally, the Phase 2b CORAL trial, which focuses on chronic cough in IPF patients, is making progress with the majority of its 60 planned sites now active. This trial aims to enroll around 160 patients, and the sample size re-estimation (SSRE) is expected in the fourth quarter of this year, with topline results projected for the first half of 2025.

The company has also made headway in other studies supporting Haduvio's development. The Human Abuse Potential (HAP) study is nearing completion, with 95% of participants enrolled and an anticipated data readout in the fourth quarter of 2024. Another significant study, the Phase 1b TIDAL study, is underway in both the UK and US. This study will assess Haduvio's impact on respiratory physiology in patients with varying severities of IPF. The TIDAL study, which is randomized and placebo-controlled, aims to enroll approximately 25 patients who will stay in-patient for ten days. The primary objective is to evaluate the effect of escalating Haduvio doses on respiratory function, measured by minute ventilation.

Moreover, Trevi Therapeutics has announced the appointment of Dr. Margaret Garin as Vice President of Clinical Development. Dr. Garin brings valuable experience from her previous role in clinical development at Bellus Health.

The financial highlights for the second quarter of 2024 show an increase in research and development (R&D) expenses, which rose to $10.0 million from $5.8 million in the same period in 2023. This rise is primarily attributed to the heightened clinical development activities for the Phase 2b CORAL trial, the Phase 2a RIVER trial, the HAP study, and the newly initiated Phase 1b TIDAL study. Additionally, personnel and related expenses, along with stock-based compensation, contributed to the increase. General and administrative (G&A) expenses also saw a rise, reaching $3.3 million from $2.5 million in the same quarter of 2023, due to similar reasons. Consequently, the net loss for the second quarter of 2024 was $12.4 million compared to a net loss of $7.1 million in the same period in 2023.

Trevi Therapeutics concluded the second quarter of 2024 with $69.5 million in cash, cash equivalents, and marketable securities, with an expected cash runway extending into 2026.

Trevi Therapeutics is actively participating in several upcoming industry events, including the Stifel 2024 Biotech Summer Summit, the Wells Fargo Healthcare Conference, the European Respiratory Society (ERS) Congress 2024, the H.C. Wainwright 26th Annual Global Investment Conference, the Cantor Global Healthcare Conference, and the 2024 Leerink Partners Biopharma Summit.

Trevi Therapeutics continues to advance its investigational therapy Haduvio™, a dual ĸ-opioid receptor agonist and µ-opioid receptor antagonist, which shows promise for treating chronic cough conditions affecting a significant number of patients in the U.S. Haduvio's unique mechanism could potentially offer extensive relief for patients suffering from chronic cough, a condition that significantly impacts their quality of life and currently lacks approved therapies.