Trevi Therapeutics Reports Fourth Quarter and Year End 2024 Financial Results and Provides Business Updates
Announced positive topline data from the Phase 2a RIVER trial in patients with refractory chronic cough (RCC), making Haduvio the first therapy in clinical development to show benefit in patients with chronic cough in idiopathic pulmonary fibrosis (IPF) and RCC
Completed enrollment in the Phase 2b CORAL trial in IPF patients with chronic cough in February 2025, with topline data expected in the second quarter of 2025
Announced positive outcome from sample size re-estimation in the Phase 2b CORAL trial, resulting in no change to study sample size
Ended 2024 with $107.6 million in cash, cash equivalents and marketable securities, with expected cash runway into the second half of 2026
Management to host a conference call and webcast today at 4:30 p.m. ET
NEW HAVEN, Conn., March 18, 2025 /PRNewswire/ -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), today announced financial results for the quarter and year ended December 31, 2024, and provided business updates.
"Trevi 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," said Jennifer Good, President and CEO of Trevi Therapeutics. "With Haduvio, we are looking to address a significant unmet need across chronic cough conditions where there are no therapies approved in the U.S. Haduvio has the unique potential to work across various chronic cough conditions due to its central and peripheral mechanism. We look forward to our expected readout of topline results for the Phase 2b CORAL trial in IPF chronic cough patients in the second quarter of this year."
Fourth Quarter and Recent Business Highlights
Positive topline data in the Phase 2a RIVER trial for the treatment of patients with RCC (N=66) in March 2025. Haduvio met the primary endpoint with a statistically-significant reduction (p<0.0001) in 24-hour cough frequency with a 57% placebo-adjusted change from baseline and showed similar effects in patients with moderate or severe cough counts. The Company plans to discuss next steps and future study design with the FDA.
Positive sample size re-estimation (SSRE) outcome for the Phase 2b CORAL trial for the treatment of chronic cough in patients with IPF in December 2024. The SSRE reaffirmed the conditional power assumptions and the original sample size (N=160). The trial completed enrollment in February 2025 and topline data is expected in the second quarter of 2025.
Positive topline results from the Human Abuse Potential study of oral nalbuphine in December 2024. Oral nalbuphine had a statistically significant lower "Drug Liking" for the clinical dose range vs. the active comparator as well as secondary endpoint results that were consistent with the primary endpoint supporting the known profile of nalbuphine and its currently unscheduled status.
Completed a $50 million underwritten offering in December 2024 to support the continued development of Haduvio.
Ended 2024 with $107.6 million in cash, cash equivalents and marketable securities, with expected cash runway into the second half of 2026.
Fourth Quarter 2024 Financial HighlightsResearch and development (R&D) expenses: R&D expenses for the fourth quarter of 2024 increased to $9.3 million from $6.5 million in the same period in 2023, primarily due to increased clinical development expenses for the Phase 2b CORAL trial, the Phase 2a RIVER trial, and the HAP study, as well as an increase in personnel-related expenses.
General and administrative (G&A) expenses: G&A expenses for the fourth quarter of 2024 increased to $2.9 million from $2.4 million in the same period in 2023, primarily due to an increase in stock-based compensation expense and personnel-related expenses.
Other income, net: Other income, net was $0.8 million in the fourth quarter of 2024 compared to $1.1 million in the same period of 2023. The decrease was primarily due to lower cash equivalent and marketable securities balances and lower interest rate yields.
Net loss: For the fourth quarter of 2024, the Company reported a net loss of $11.4 million, compared to a net loss of $7.8 million in the same period in 2023.
Full Year 2024 Financial HighlightsR&D expenses: R&D expenses for the year ended December 31, 2024, were $39.4 million compared to $23.7 million in 2023. The increase was primarily due to increased clinical development expenses for the Phase 2b CORAL trial, the Phase 2a RIVER trial, the HAP study, and the Phase 1b TIDAL study, as well as an increase in personnel-related expenses and stock-based compensation expense. These increases were partially offset by decreased clinical development expenses for our Phase 2b/3 PRISM trial.
G&A expenses: G&A expenses for the year ended December 31, 2024, were $12.1 million compared to $10.2 million in 2023. The increase was primarily due to an increase in personnel-related expenses, stock-based compensation expense, information technology service costs and market research costs.
Other income, net: Other income, net was $3.6 million for the year ended December 31, 2024, compared to $4.8 million 2023. The decrease was primarily due to a decrease in interest income due to lower cash equivalent and marketable securities balances.
Net loss: For the year ended December 31, 2024, the Company reported a net loss of $47.9 million, compared to a net loss of $29.1 million in the same period in 2023.
Conference Call/WebcastTo participate in the live conference call by phone, please dial (877) 870 4263 (domestic) or (412) 317 0790 (international) and ask to join the Trevi Therapeutics call. No code is necessary for access. A live audio webcast will be accessible from the 'Investors & News' section on the Company's website at www.TreviTherapeutics.com. An archived replay of the webcast will also be available for 30 days on the Company's website following the event.
Upcoming MeetingsThe Company plans to participate in the following events:
April 7-10: 24th Annual Needham Virtual Healthcare Conference
April 8-10: Jones 2025 Healthcare & Technology Summit
April 16-17: Piper Sandler Spring Biopharma Symposium
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