Trevi Therapeutics, Inc. (TRVI) Q2 2025 Earnings Call Transcript
Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
Overview
The earnings call summary presents a mixed picture: strong financial metrics and consistent trial progress are positive, but uncertainties in FDA meetings and potential DEA scheduling issues pose risks. The Q&A highlights no significant changes or new hurdles, maintaining a stable outlook. Without clear market cap data, the stock reaction is likely neutral.
Key Financial Performance
Net Loss $12.3 million for Q2 2025 compared to $12.4 million for Q2 2024, a slight improvement. The change is attributed to reduced R&D expenses.
R&D Expenses $9.4 million for Q2 2025 compared to $10 million for Q2 2024, a decrease. The reduction was primarily due to decreased costs related to the Phase IIa RIVER trial, Human Abuse Potential study, and Phase IIb CORAL trial, partially offset by increased costs for a Phase I drug-drug interaction study and personnel expenses.
G&A Expenses $4.3 million for Q2 2025 compared to $3.3 million for Q2 2024, an increase. The rise was primarily due to higher professional fees, personnel expenses, and costs related to SOX Section 404(b) compliance.
Cash and Investments $204 million as of June 30, 2025, up from the prior period. The increase was primarily due to a successful public offering in June 2025, which raised approximately $115 million.
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Operating Highlights
CORAL trial results: Haduvio met the primary endpoint with a statistically significant reduction in 24-hour cough frequency across all dose groups studied. Quality of life assessment showed marked improvement with a statistically significant reduction at both the 54 and 108-milligram BID doses.
RIVER trial results: Positive data readouts for patients with refractory chronic cough (RCC).
Phase I studies: Currently conducting studies on respiratory function and safety of Haduvio on IPF patients and drug-drug interaction studies with antifibrotics.
Market expansion for non-IPF interstitial lung diseases: Planning a study for non-IPF interstitial lung diseases, which doubles the market opportunity of IPF cough. Estimated 228,000 patients with 50%-60% having uncontrolled cough.
Financial position: Raised $115 million in capital, resulting in total cash and investments of $204 million as of June 30, 2025. Cash runway extends into 2029.
R&D and G&A expenses: R&D expenses decreased to $9.4 million, while G&A expenses increased to $4.3 million due to professional fees, personnel expenses, and SOX Section 404(b) compliance.
Regulatory alignment and trial planning: Preparing for end of Phase II FDA meeting and planning Phase III trials for IPF cough, non-IPF-ILD, and RCC. Focused on aligning with regulatory authorities to ensure trial success.
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Risk or Challenges
Regulatory Alignment: The company faces challenges in aligning with the FDA on Phase III program designs for cough in IPF and non-IPF-ILD, as well as other NDA-enabling work. This could delay trial initiation and regulatory approvals.
Clinical Trial Execution: The company is managing multiple clinical trials simultaneously, including Phase III programs and Phase I studies. Any delays or issues in trial execution could impact timelines and financial resources.
Financial Sustainability: While the company has a cash runway into 2029, increased expenses related to SOX Section 404(b) compliance and other operational costs could strain financial resources if not managed effectively.
Market Expansion: The company plans to expand into non-IPF interstitial lung diseases, which doubles the market opportunity but also introduces complexities in study design and regulatory approval processes.
Operational Complexity: Managing a growing number of trials and preparing for commercialization increases operational complexity, which could lead to inefficiencies or resource allocation issues.
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Guidance & Outlook
Phase III Program for Cough and IPF: Trevi plans to initiate the Phase III program for chronic cough in IPF patients in the first half of next year. The company is preparing for an end of Phase II meeting with the FDA in Q4 2025 to gain alignment on the Phase III program and other NDA-enabling work.
Non-IPF Interstitial Lung Diseases (ILD) Study: Trevi is preparing to initiate a study for non-IPF ILD patients with lung fibrosis and cough. This population represents a market opportunity more than double that of IPF cough. The company plans to request a meeting with the FDA in 2025 to discuss the study design and protocol, with the goal of initiating the study after receiving FDA input.
Refractory Chronic Cough (RCC) Study: Trevi expects to initiate a Phase IIb parallel arm study for RCC in the first half of next year. This study will focus on dose-ranging.
Phase I Studies: Trevi is conducting two Phase I studies: the TIDAL study on respiratory function and safety of Haduvio in IPF patients, and a drug-drug interaction study examining potential PK effects of nalbuphine with pirfenidone and nintedanib. Data from these studies are expected to be available in time for the end of Phase II FDA meeting.
Financial Guidance: Trevi has a cash and investment balance of approximately $204 million as of June 30, 2025, providing a cash runway into 2029. This funding will support two Phase III trials for Haduvio, a trial for chronic cough in non-IPF ILD patients, a trial for RCC, ongoing Phase I studies, and pre-commercial planning activities.
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Shareholder Return Plan
The selected topic was not discussed during the call.
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Key Q&A
Q:Can you comment on the progress and logistics of the respiratory depression study?
A:The respiratory safety study is ongoing with 2 active sites. The protocol was modified to make it simpler and more straightforward, causing a slight delay. The study aims to assess the effects of nalbuphine (Haduvio) on respiration in patients with IPF, and data is expected for the end of Phase II meeting.
Q:Why is the DDI study a requirement despite background antifibrotic use in prior IPF studies?
A:The DDI study is a Phase I study to characterize potential metabolic PK drug interactions, especially with antifibrotics like pirfenidone and nintedanib. It is a standard FDA requirement to ensure no pharmacokinetic interactions that could affect efficacy, and it was planned as part of the development process.
Q:What are the key questions to address in the upcoming FDA meeting for Haduvio's Phase III trial in IPF cough?
A:The meeting will focus on data collected to date, especially from the CORAL study, adequacy of the program, dose selection, Phase III protocol specifics, and safety database requirements. Discussions will also include anticipated trials for registration purposes and long-term extension trials for safety and efficacy.
Q:What updates can you provide on the non-IPF ILD chronic cough trial?
A:The trial will target patients with interstitial lung disease other than IPF, defined by lung fibrosis and minimum cough. The endpoints will be similar to the IPF trial. The design has evolved to a parallel arm design to expedite the program, aligning with the IPF program.
Q:What is the rationale behind the parallel design for the non-IPF ILD study?
A:The parallel design allows for broader inclusion criteria based on fibrosis and cough, reflecting the commonality in disease mechanisms. The design builds on learnings from the CORAL study and aims to move the program forward without needing additional proof of concept.
Q:Are there any changes planned for the IPF trial based on the CORAL data?
A:No significant changes are planned. The CORAL data showed consistent findings on primary and secondary endpoints, and the tolerability and quality of life scores were strong. The specifics of the Phase III design, including dose selection, will be discussed with the FDA.
Q:Which dose or doses are being considered for the Phase III study based on the CORAL data?
A:The 54-milligram BID dose is identified as the key dose for Phase III due to its strong performance across primary and secondary endpoints. Discussions with the FDA will finalize dose selection.
Q:Can you provide more context on the LCQ data and its relation to the primary endpoint?
A:The LCQ data showed significant findings in physical, psychological, and social domains, complementing the objective cough data. It highlights the impact of cough reduction on quality of life and will be important for reimbursement and value assessments.
Q:What are the expected operating expenses for the remainder of the year?
A:Operating expenses are expected to remain relatively flat from Q2 levels until larger trials begin in 2026.
Q:Are there any implications for the RCC trial based on GSK's KALM-2 trial delays?
A:No implications are expected. The RCC trial will proceed as planned, focusing on a treatment-resistant population. The delays in GSK's trial will not impact the program.
Q:Are there plans to check for drug interactions with nerandomilast?
A:No, the focus will remain on drug-drug interaction studies with pirfenidone and nintedanib, as these are the primary antifibrotics used in IPF patients.
Q:Have there been any new trends or analyses from the CORAL data affecting dosing decisions?
A:The 54-milligram BID dose remains the key dose based on robust analysis. No surprises or new trends have emerged that would affect dosing decisions.
Q:What will be presented at the CHEST meeting for the IPF data?
A:The CHEST presentation will focus on primary data already disclosed, with no new data on FVC as it was a safety parameter in a short study.
Q:How will placebo effects be managed in the Phase III trials?
A:The CORAL study showed a large effect size with no significant placebo effect. The rapid onset of efficacy and well-controlled trial design provide confidence in managing placebo effects in Phase III.
Q:Are there any new hurdles anticipated for the Phase III trials?
A:No new hurdles are anticipated. The CORAL study provided robust data on safety and efficacy, and the team is experienced in running large trials.
Q:Are there any extra steps in manufacturing for Phase III or commercialization?
A:No extra steps are needed. The team is experienced in drug manufacturing and distribution for large trials.
Q:What are the updated thoughts on partnering for commercialization?
A:Partnering is being considered for Europe and Japan, while the U.S. commercialization will likely be handled internally. Any U.S. partnership would require acquiring the company.
Q:Review of Unclear Management Responses
A:Management avoided directly addressing the potential impact of unexpected negative findings in the respiratory depression study on DEA scheduling. They stated that the study would not directly impact scheduling but did not provide detailed reasoning or precedent.
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Earnings Word Cloud
The most frequently occurring keywords in this quarter's earning call
Alexa Rose
Ali Khurshid
Annabel Eva
Associates
BID dos
Chief Commercial
Chief Development
Commercial Officer
Development Officer
Haduvio
II meeting
III program
Inc Research
LCQ
LLC Research
Phase II
Phase III
Research Division
alignment
cough patient
end Phase
fibrosis
frequency
improvement
line result
lung
meeting FDA
milligram BID
quality life
result question
score
set trial
study design
trial update
work
TRVI Transcript
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Trevi Therapeutics, Inc. (TRVI) Q2 2025 Earnings Call Transcript
Unknown8-8
The earnings call summary presents a mixed picture: strong financial metrics and consistent trial progress are positive, but uncertainties in FDA meetings and potential DEA scheduling issues pose risks. The Q&A highlights no significant changes or new hurdles, maintaining a stable outlook. Without clear market cap data, the stock reaction is likely neutral.
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The earnings call highlights several concerns: increased net loss due to R&D expenses, ongoing cash burn, and significant competition in the chronic cough market. Although the company has a substantial cash position, the high cash burn rate and financial risks are concerning. The Q&A session did not provide reassuring insights, with management lacking clarity on key trial metrics. Despite a completed $50 million offering, the financial outlook remains challenging. These factors suggest a negative sentiment towards the stock's short-term performance.
TRVI Report
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