Trevi Therapeutics Reports First Quarter 2025 Financial Results and Provides Business Updates
Rhea-AI Summary
Positive
- Phase 2a RIVER trial met primary endpoint with 67% reduction in cough frequency (p<0.0001)
- Strong cash position of $103.3M providing runway into Q4 2026
- Reduced net loss to $10.3M from $10.9M year-over-year
- Phase 2b CORAL trial enrollment completed with results expected in Q2 2025
Negative
- Increased G&A expenses to $3.7M from $3.1M year-over-year
- Still operating at a significant net loss of $10.3M
Insights
Trevi's Haduvio shows impressive 67% cough reduction in Phase 2a trial; Phase 2b IPF results imminent with strong cash position.
The Phase 2a RIVER trial results for Haduvio represent a significant clinical achievement in refractory chronic cough (RCC). The drug demonstrated a
The completed enrollment and last patient visit in the Phase 2b CORAL trial positions Trevi for another potential catalyst, with topline results expected this quarter. This trial addresses a critical unmet medical need, as there are currently no approved therapies for chronic cough in IPF patients—a symptom that significantly impacts quality of life. The positive momentum from the RCC trial creates favorable expectations for the upcoming IPF results.
With two indications showing promise, Trevi is executing a strategic development approach for Haduvio. The compound's unique dual mechanism potentially provides advantages in treating cough across multiple patient populations. The company's announcement that they're designing the next planned trial for RCC indicates confidence in their clinical pathway and suggests acceleration toward later-stage development.
Trevi maintains a strong financial foundation with
The quarterly financials show disciplined expense management with R&D expenses decreasing to
The net loss of
The upcoming CORAL trial results represent a significant near-term catalyst that could impact company valuation. With positive data already secured in RCC and the potential for similarly encouraging results in IPF, Trevi could find itself in a strengthened position for partnership discussions or financing on favorable terms should additional capital be required beyond their current runway.
AI-generated analysis. How Rhea-AI works. Not financial advice.
Completed enrollment and last patient last visit in the Phase 2b CORAL trial in IPF patients with chronic cough; topline results continue to be expected in the second quarter of 2025
Announced positive topline results from the Phase 2a RIVER trial in patients with refractory chronic cough
Management to host a conference call and webcast today at 4:30 p.m. ET
"The RIVER data in patients with RCC demonstrated the clinical significance of Haduvio's centrally and peripherally acting mechanism and its potential across a broad range of chronic cough patients and cough counts," said Jennifer Good, President and CEO of Trevi Therapeutics. "Building on that positive momentum, we look forward to the topline results from the Phase 2b CORAL trial expected this quarter for the treatment of IPF patients with chronic cough. Chronic cough is a significant burden to IPF patients and there are no approved therapies. Trevi is at a pivotal moment with promising data, a dedicated development team advancing trials, and a strong balance sheet to support the continued development of Haduvio."
First Quarter 2025 Financial Results and Recent Business Highlights
- Enrollment was completed in February 2025 in the Phase 2b CORAL trial of Haduvio in chronic cough patients with IPF and the last patient last visit was completed in April 2025. Topline results for the CORAL trial remain on track for the second quarter of 2025.
- In March, Trevi announced positive topline results from its Phase 2a RIVER trial of Haduvio in patients with RCC (N=66). Haduvio met the primary endpoint with a statistically significant reduction in objective 24-hour cough frequency of
67% from baseline and57% on a placebo-adjusted basis (p<0.0001). Planned analyses of all pre-specified secondary endpoints at the end of treatment were also statistically significant. The Company is now reviewing the full data set and is in the process of designing the next planned trial of Haduvio in patients with RCC. - Ended the first quarter of 2025 with
$103.3 million
First Quarter 2025 Financial Highlights
Research and development (R&D) expenses: R&D expenses for the first quarter of 2025 decreased to
General and administrative (G&A) expenses: G&A expenses for the first quarter of 2025 increased to
Net loss: For the first quarter of 2025, the Company reported a net loss of
Conference Call/Webcast
To 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 Meetings
The Company plans to participate in the following events:
- May 16-21: American Thoracic Society 2025 International Conference
- June 6-7: 10th American Cough Conference
- June 16-19: BIO International Convention
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine extended-release) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and in patients with refractory chronic cough (RCC). Haduvio is the first and only investigational therapy to show a statistically significant reduction in cough frequency in clinical trials with IPF chronic cough patients and RCC patients. Haduvio acts on the cough reflex arc both centrally and peripherally as a kappa agonist and a mu antagonist (KAMA), targeting opioid receptors that play a key role in controlling chronic cough. Nalbuphine is not currently scheduled by the
Chronic cough is a highly prevalent condition in IPF patients, impacting up to
Refractory chronic cough has no approved therapies in the
Trevi intends to propose Haduvio as the trade name for oral nalbuphine ER. Its safety and efficacy have not been evaluated by any regulatory authority.
For more information, visit www.TreviTherapeutics.com and follow Trevi on X (formerly Twitter) and LinkedIn.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties and actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding Trevi's business plans and objectives, including future plans or expectations for Haduvio and plans and timing with respect to clinical trials and clinical data, expectations regarding Trevi's uses and sufficiency of capital, and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions. Risks that contribute to the uncertain nature of the forward-looking statements include: uncertainties regarding the success, cost and timing of Trevi's 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 Trevi's ability to execute on its strategy; uncertainties with respect to regulatory authorities' views as to the data from Trevi's clinical trials and next steps in the development path for Haduvio in
Trevi Therapeutics, Inc. | ||||||||
Selected Balance Sheet Data | ||||||||
(unaudited) | ||||||||
(amounts in thousands) | ||||||||
March 31, | December 31, | |||||||
Cash and cash equivalents | $ | 19,374 | $ | 34,097 | ||||
Marketable securities | 83,883 | 73,525 | ||||||
Working capital | 98,755 | 98,919 | ||||||
Total assets | 107,004 | 110,900 | ||||||
Stockholders' equity | 99,457 | 99,644 | ||||||
Trevi Therapeutics, Inc. | ||||||||
Selected Statement of Operations Data | ||||||||
(unaudited) | ||||||||
(amounts in thousands, except per share amounts) | ||||||||
Three Months Ended | ||||||||
2025 | 2024 | |||||||
Operating expenses: | ||||||||
Research and development | $ | 7,811 | $ | 8,804 | ||||
General and administrative | 3,659 | 3,102 | ||||||
Total operating expenses | 11,470 | 11,906 | ||||||
Loss from operations | (11,470) | (11,906) | ||||||
Other income, net | 1,119 | 996 | ||||||
Loss before income taxes | (10,351) | (10,910) | ||||||
Income tax benefit | 11 | 8 | ||||||
Net loss | $ | (10,340) | $ | (10,902) | ||||
Basic and diluted net loss per common share outstanding | $ | (0.09) | $ | (0.11) | ||||
Weighted average common shares used in net loss per share | 117,610,750 | 99,517,212 | ||||||
Investor Contact
Jonathan Carlson
Trevi Therapeutics, Inc.
(203) 654 3286
carlsonj@trevitherapeutics.com
Media Contact
Rosalia Scampoli
914-815-1465
rscampoli@marketcompr.com
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SOURCE Trevi Therapeutics, Inc.