8-K: Trevi Therapeutics Q2 2025: Haduvio Success, Strong Cash

Trevi Therapeutics announced positive Phase 2b CORAL trial results for Haduvio in IPF chronic cough, reported strong Q2 2025 financials, and secured cash runway into 2029.

Summary

• Reported Q2 2025 financial results and provided business updates.
• Announced positive topline results from the Phase 2b CORAL trial evaluating Haduvio for the treatment of chronic cough in patients with Idiopathic Pulmonary Fibrosis (IPF).
• Haduvio met the primary endpoint with statistically-significant reductions in 24-hour cough frequency across all dose groups: 108 mg BID (60.2% reduction, p<0.0001), 54 mg BID (53.4% reduction, p<0.0001), and 27 mg BID (47.9% reduction, p<0.01), compared to a placebo reduction of 16.9%.
• Additional analyses from the Phase 2b CORAL trial showed positive results on the Leicester Cough Questionnaire (LCQ) Total Score for the 108 mg BID (3.4 points increase, p=0.01) and 54 mg BID (3.7 points increase, p=0.01) dose groups, with a 1.3-point increase considered clinically meaningful.
• Completed a $115 million underwritten offering in June 2025.
• Ended the second quarter of 2025 with $203.9 million in cash, cash equivalents, and marketable securities.
• Expected cash and investments to provide a cash runway into 2029.
• Reported a net loss of $12.3 million for Q2 2025, compared to a net loss of $12.4 million in Q2 2024.
• Research and development (R&D) expenses decreased to $9.4 million in Q2 2025 from $10.0 million in Q2 2024.
• General and administrative (G&A) expenses increased to $4.3 million in Q2 2025 from $3.3 million in Q2 2024.
• Other income, net, increased to $1.4 million in Q2 2025 from $0.9 million in Q2 2024.

Sentiment

Score: 8

Explanation: The filing reports highly positive clinical trial results for Haduvio in a significant unmet medical need, coupled with a strong financial position and extended cash runway, indicating substantial progress and reduced near-term financial risk.

Positives

• Positive topline results from the Phase 2b CORAL trial for Haduvio in chronic cough in IPF patients, demonstrating statistically significant and clinically meaningful reductions in 24-hour cough frequency across all dose groups (60.2% for 108mg BID, 53.4% for 54mg BID, 47.9% for 27mg BID vs 16.9% for placebo).
• Clinically meaningful improvements in quality of life as measured by the Leicester Cough Questionnaire (LCQ) Total Score (3.4 points for 108mg BID, 3.7 points for 54mg BID, where 1.3 points is clinically meaningful).
• Successful completion of a $115 million underwritten offering in June 2025.
• Strong cash position of $203.9 million in cash, cash equivalents, and marketable securities at the end of Q2 2025.
• Extended cash runway into 2029, providing financial strength for late-stage development and pre-commercial planning.
• Net loss slightly decreased to $12.3 million in Q2 2025 from $12.4 million in Q2 2024.
• Research and development expenses decreased to $9.4 million in Q2 2025 from $10.0 million in Q2 2024, primarily due to decreased clinical development expenses for trials that were actively enrolling in the prior year.
• Other income, net, increased to $1.4 million in Q2 2025 from $0.9 million in Q2 2024 due to higher invested cash balances.

Negatives

• General and administrative expenses increased to $4.3 million in Q2 2025 from $3.3 million in Q2 2024, primarily due to an increase in professional fees and personnel and related expenses.
• The company continues to report a net loss, though it slightly narrowed.

Risks

• Uncertainties regarding the success, cost, and timing of product candidate development activities and clinical trials.
• The risk that positive data from a clinical trial may not necessarily be predictive of the results of later clinical trials in the same or a different indication.
• Uncertainties regarding the ability to execute on the company's strategy.
• Uncertainties with respect to regulatory authorities' views as to the data from clinical trials and next steps in the development path for Haduvio in the United States and foreign countries.
• Uncertainties inherent in estimating cash runway, future expenses, and other financial results, including the ability to fund future operations and clinical trials.

Future Outlook

The company expects its current cash and investments to provide a cash runway into 2029, enabling the advancement of Haduvio through late-stage development, several key clinical milestones, and pre-commercial planning activities. They plan to request an End-of-Phase 2 meeting with the FDA in Q4 2025 and prepare to initiate the Phase 3 program in H1 2026.

Management Comments

• "The recently received full data set from our CORAL trial for chronic cough in patients with IPF bolsters the statistically-significant topline results presented in June. This data marks a major milestone for Trevi as it shows consistency and clinically meaningful benefit for these patients." Jennifer Good, President and CEO.
• "Chronic cough is a debilitating and underserved condition for patients with IPF, and these results, along with the positive RCC data from our RIVER trial announced earlier this year, reinforce our belief in Haduvios potential to transform care of chronic cough and the lives of these patients." Jennifer Good, President and CEO.
• "We expect our current cash and investments to provide us with cash runway into 2029, giving us the financial strength to advance Haduvio through late-stage development and several key clinical milestones, as well as enabling pre-commercial planning activities." Jennifer Good, President and CEO.

Industry Context

Chronic cough in IPF and Refractory Chronic Cough (RCC) are debilitating and underserved conditions with no approved therapies in the U.S. Haduvio is positioned as the first and only investigational therapy to show statistically significant reduction in cough frequency in these patient populations. The market for IPF patients with chronic cough is approximately 150,000 in the U.S., and RCC affects 2-3 million patients in the U.S. The positive trial results for Haduvio could represent a significant breakthrough in these areas, potentially addressing a large unmet medical need.

Stakeholder Impact

• Shareholders: Positive impact due to strong clinical trial results, extended cash runway, and potential for future drug approval and commercialization.
• Patients (IPF, non-IPF ILD, RCC): Potential for a new, effective treatment for chronic cough, addressing a significant unmet medical need and improving quality of life.
• Employees: Increased job security and potential for growth as the company advances its lead candidate.
• Regulatory Authorities: Will be engaging with the FDA for End-of-Phase 2 meeting.

Next Steps

• Request an End-of-Phase 2 meeting with the FDA in Q4 2025 to align on the Phase 3 program.
• Initiate the Phase 3 program in the first half of 2026.
• Advance Haduvio through late-stage development and several key clinical milestones.
• Engage in pre-commercial planning activities.
• Participate in upcoming investor and industry conferences in August and September 2025.

Key Dates

Recommendation

The company has achieved a major clinical milestone with statistically significant and clinically meaningful positive Phase 2b results for Haduvio in IPF chronic cough, a condition with no approved therapies. This success, combined with a recently completed $115 million capital raise extending the cash runway into 2029, significantly de-risks the company's financial position and provides a clear path to Phase 3 initiation. The potential market for Haduvio is substantial, and these results position Trevi Therapeutics as a leader in addressing a critical unmet medical need.

Keywords

Trevi Therapeutics, TRVI, Haduvio, nalbuphine ER, chronic cough, idiopathic pulmonary fibrosis, IPF, refractory chronic cough, RCC, clinical trial, Phase 2b CORAL, biopharmaceutical, drug development, Q2 2025, financial results, cash runway, FDA, Phase 3