8-K: Trevi Therapeutics Announces First Quarter 2025 Financial Results and Provides Business Updates

Trevi Therapeutics reports positive Phase 2a RIVER trial results and anticipates topline results from the Phase 2b CORAL trial in Q2 2025.

Summary

• Trevi Therapeutics announced its financial results for the first quarter of 2025.
• The company completed enrollment in the Phase 2b CORAL trial for IPF patients with chronic cough, with topline results expected in the second quarter of 2025.
• Positive topline results were announced from the Phase 2a RIVER trial in patients with refractory chronic cough.
• The company ended the quarter with $103.3 million in cash, cash equivalents, and marketable securities, projecting a cash runway into the fourth quarter of 2026.
• The net loss for the quarter was $10.3 million, compared to $10.9 million in the same period in 2024.
• R&D expenses decreased to $7.8 million from $8.8 million year-over-year, while G&A expenses increased to $3.7 million from $3.1 million year-over-year.

Sentiment

Score: 7

Explanation: The sentiment is moderately positive due to the positive clinical trial results, strong cash position, and anticipated topline results. However, the net loss and increased G&A expenses temper the overall sentiment.

Positives

• Positive topline results from the Phase 2a RIVER trial demonstrated a statistically significant reduction in cough frequency.
• The company has a strong cash position of $103.3 million, providing a cash runway into the fourth quarter of 2026.
• Enrollment was completed in the Phase 2b CORAL trial, with topline results expected soon.
• The net loss decreased slightly compared to the same period last year.

Negatives

• The company reported a net loss of $10.3 million for the first quarter of 2025.
• General and administrative expenses increased to $3.7 million from $3.1 million in the same period in 2024.

Risks

• The success of Haduvio is subject to the outcome of clinical trials and regulatory approvals.
• Uncertainties exist regarding regulatory authorities' views on the data from Trevi's clinical trials.
• The company's ability to fund future operations, including clinical trials, is subject to uncertainties.

Future Outlook

The company anticipates topline results from the Phase 2b CORAL trial in the second quarter of 2025 and is designing the next planned trial of Haduvio in patients with RCC.

Management Comments

• Jennifer Good, President and CEO of Trevi Therapeutics, stated that the RIVER data demonstrated the clinical significance of Haduvio's mechanism and its potential across a broad range of chronic cough patients.
• Jennifer Good noted that Trevi is at a pivotal moment with promising data, a dedicated development team, and a strong balance sheet.

Industry Context

Trevi Therapeutics is developing Haduvio for chronic cough in IPF and RCC patients, addressing a significant unmet need as there are no approved therapies for chronic cough in IPF and RCC in the U.S.

Comparison to Industry Standards

• It is difficult to compare Trevi's results directly to industry standards as Haduvio is an investigational therapy targeting a specific unmet need.
• Other companies developing cough treatments include Bellus Health (acquired by GSK), which was developing camlipixant, a P2X3 receptor antagonist, for refractory chronic cough.
• Lyra Therapeutics is developing LYR-220 for chronic rhinosinusitis, which can also cause chronic cough.
• The success of Haduvio will depend on its efficacy and safety profile compared to these and other potential treatments.

Stakeholder Impact

• Positive clinical trial results could improve the quality of life for patients with chronic cough in IPF and RCC.
• The company's strong financial position provides stability for employees and investors.
• Successful development of Haduvio could create value for shareholders.

Next Steps

• The company plans to review the full data set from the Phase 2a RIVER trial and design the next planned trial of Haduvio in patients with RCC.
• Trevi Therapeutics will participate in upcoming industry conferences, including the American Thoracic Society International Conference, the American Cough Conference, and the BIO International Convention.

Key Dates

Keywords

Haduvio, chronic cough, IPF, RCC, Trevi Therapeutics, clinical trial, nalbuphine ER, financial results