8-K: Trevi Therapeutics Announces Positive Phase 2a RIVER Trial Results and Year-End 2024 Financials

Trevi Therapeutics reports positive topline data from its Phase 2a RIVER trial for refractory chronic cough and provides a business update alongside its year-end 2024 financial results.

Summary

• Trevi Therapeutics announced its fourth quarter and year-end 2024 financial results and provided business updates.
• The company reported positive topline data from the Phase 2a RIVER trial in patients with refractory chronic cough (RCC), showing that Haduvio is the first therapy in clinical development to demonstrate benefit in patients with chronic cough in idiopathic pulmonary fibrosis (IPF) and RCC.
• Enrollment in the Phase 2b CORAL trial in IPF patients with chronic cough was completed in February 2025, with topline data expected in the second quarter of 2025.
• A positive outcome was announced from the sample size re-estimation in the Phase 2b CORAL trial, resulting in no change to the study sample size.
• Trevi ended 2024 with $107.6 million in cash, cash equivalents, and marketable securities, with an expected cash runway into the second half of 2026.
• For the fourth quarter of 2024, R&D expenses increased to $9.3 million from $6.5 million in the same period in 2023.
• G&A expenses for the fourth quarter of 2024 increased to $2.9 million from $2.4 million in the same period in 2023.
• The net loss for the fourth quarter of 2024 was $11.4 million, compared to a net loss of $7.8 million in the same period in 2023.
• For the year ended December 31, 2024, R&D expenses were $39.4 million compared to $23.7 million in 2023.
• G&A expenses for the year ended December 31, 2024, were $12.1 million compared to $10.2 million in 2023.
• The net loss for the year ended December 31, 2024, was $47.9 million, compared to a net loss of $29.1 million in the same period in 2023.

Sentiment

Score: 7

Explanation: The sentiment is moderately positive due to the positive clinical trial data and sufficient cash runway, but tempered by increased losses and R&D expenses.

Positives

• The Phase 2a RIVER trial showed statistically significant reduction in cough frequency.
• The Phase 2b CORAL trial completed enrollment.
• The company has a strong cash position of $107.6 million, providing a cash runway into the second half of 2026.
• Positive topline results were achieved from the Human Abuse Potential study of oral nalbuphine.

Negatives

• The net loss for the fourth quarter of 2024 was $11.4 million, higher than the $7.8 million loss in the same period in 2023.
• The net loss for the year ended December 31, 2024, was $47.9 million, higher than the $29.1 million loss in 2023.
• R&D and G&A expenses increased in both the fourth quarter and full year 2024 compared to 2023.

Risks

• The success of Haduvio is subject to uncertainties regarding the cost and timing of clinical trials.
• Positive data from a clinical trial may not be predictive of results in later trials.
• Regulatory authorities' views on the data from Trevi's clinical trials and next steps are uncertain.
• Estimating Trevi's cash runway and future expenses involves inherent uncertainties.

Future Outlook

Trevi expects topline data from the Phase 2b CORAL trial in the second quarter of 2025 and anticipates its cash runway to extend into the second half of 2026.

Management Comments

• Jennifer Good, President and CEO of Trevi Therapeutics, stated that the company had three positive and meaningful clinical data read-outs over the past few months, validating the strategy of developing Haduvio as a potential best-in-class therapy for chronic cough conditions.
• Management believes Haduvio has the unique potential to work across various chronic cough conditions due to its central and peripheral mechanism.

Industry Context

Trevi is developing Haduvio for chronic cough in IPF and RCC, conditions with significant unmet needs as there are no approved therapies in the U.S. for RCC and limited options for IPF-related chronic cough. The company is positioning Haduvio as a potential best-in-class therapy in this space.

Comparison to Industry Standards

• Currently, there are no approved therapies for refractory chronic cough in the U.S., making Haduvio a potential first-in-class treatment if approved.
• Existing off-label treatments for chronic cough in IPF provide minimal benefit, suggesting a significant opportunity for Haduvio if it demonstrates superior efficacy.
• Companies like Bellus Health (acquired by GSK) and Merck are also developing or have developed treatments for chronic cough, but Haduvio's unique mechanism of action (KAMA) could differentiate it.

Stakeholder Impact

• Positive clinical trial results could improve the quality of life for patients with chronic cough in IPF and RCC.
• The company's financial performance impacts shareholders.
• Continued development of Haduvio provides job security for employees.

Next Steps

• The Company plans to discuss next steps and future study design with the FDA regarding the Phase 2a RIVER trial.
• Topline data from the Phase 2b CORAL trial is expected in the second quarter of 2025.
• The Company plans to participate in several upcoming healthcare conferences in April 2025.

Key Dates