Trevi Therapeutics, Inc. (TRVI) Q3 2025 Earnings Call Transcript
Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
Overview
The earnings call presents a mixed sentiment. Financial performance is stable with a cash runway into 2028, but increased expenses and lack of clear guidance on critical studies raise concerns. The Q&A session highlights positive interest from the medical community and strategic planning, yet management's vague responses on potential risks and uncertainties, like orphan drug designation, dampen optimism. Given these factors, the stock price is likely to remain neutral in the short term, with no significant catalysts for a strong movement.
Key Financial Performance
Net Loss $11.8 million for Q3 2025, compared to $13.2 million for Q3 2024, a decrease due to reduced clinical trial work as trials were actively enrolling in the prior year and reported data in the first half of this year. This was partially offset by increased costs related to recently completed Phase I study and personnel expenses.
R&D Expenses $10.1 million for Q3 2025, compared to $11.2 million for Q3 2024, a decrease primarily due to reduced clinical trial work as trials were actively enrolling in the prior year and reported data in the first half of this year. This was partially offset by increased costs related to recently completed Phase I study and personnel expenses.
G&A Expenses $3.8 million for Q3 2025, compared to $2.9 million for Q3 2024, an increase primarily due to higher professional fees and personnel expenses, including costs related to compliance with SOX 404(b) regulations.
Cash and Investments $195 million as of September 30, 2025, providing cash runway into 2028, subject to finalizing the development for each indication.
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Operating Highlights
CORAL trial for chronic cough in IPF: Positive data readouts presented at CHEST conference, showing strong interest from thought leaders and pulmonologists.
RIVER trial for refractory chronic cough (RCC): Positive data readouts presented at CHEST conference, enabling further clinical studies.
Phase I studies for IPF cough program: Completed drug-drug interaction study with no clinically meaningful changes in pharmacokinetics; respiratory safety study showed no safety signals.
TIDAL study: Progressing well with no safety signals; external safety review committee approved completion of enrollment.
Expansion into non-IPF interstitial lung diseases (ILD): Preparing for a study targeting non-IPF-ILD patients with lung fibrosis and chronic cough, doubling the market opportunity of IPF chronic cough.
Financial position: Raised $115 million in June 2025, with cash and investments totaling $195 million as of September 30, 2025, providing runway into 2028.
Operational planning: Preparing to initiate multiple trials in the first half of 2026, including Phase III for IPF chronic cough, non-IPF-ILD study, and RCC Phase IIb study.
Regulatory alignment: Engaging with FDA to align on Phase III program for IPF chronic cough and other NDA-enabling work.
Focus on chronic cough indications: Strategically advancing therapies for IPF chronic cough, non-IPF-ILD chronic cough, and RCC, addressing unmet needs in these areas.
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Risk or Challenges
Regulatory Compliance: The company faces challenges in aligning with FDA requirements for Phase III program design and other NDA-enabling work. This includes ensuring compliance with SOX 404(b) regulations, which has increased professional fees and personnel expenses.
Clinical Trial Execution: The company is managing multiple clinical trials simultaneously, including Phase III trials for IPF chronic cough and non-IPF-ILD, as well as a Phase IIb trial for RCC. This requires significant planning, coordination, and resource allocation to ensure successful execution.
Financial Sustainability: Although the company has a cash runway into 2028, its ability to fund multiple trials and ongoing studies is contingent on finalizing development plans for each indication. Any delays or cost overruns could impact financial stability.
Market Expansion: The company is targeting a broader market by including non-IPF-ILD patients, which doubles the market opportunity. However, this expansion requires additional regulatory approvals and clinical studies, increasing complexity and risk.
Safety and Efficacy: The company must address safety concerns, such as respiratory depression in IPF patients, as part of its clinical trials. Any adverse findings could delay or derail development plans.
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Guidance & Outlook
Phase III program for chronic cough in IPF: The company plans to initiate the Phase III program for chronic cough in patients with idiopathic pulmonary fibrosis (IPF) in the first half of next year. Preparations include aligning with the FDA on study design and protocol, as well as identifying sites and vendors for global studies.
Study for non-IPF interstitial lung diseases (ILD): Trevi is preparing to initiate a study for chronic cough in non-IPF interstitial lung diseases (ILD) after aligning with the FDA on the IPF pivotal program. This study will target a population of approximately 228,000 patients, potentially doubling the market opportunity of IPF chronic cough.
Phase IIb study for refractory chronic cough (RCC): The company plans to initiate a Phase IIb parallel arm dose-ranging study for refractory chronic cough (RCC) in the first half of next year. Preparations include drafting the protocol and identifying study sites.
Financial outlook and funding: Trevi has cash and investments totaling approximately $195 million as of September 30, 2025, providing a cash runway into 2028. This funding is expected to support 2 Phase III trials for IPF chronic cough, a Phase IIb/III trial for non-IPF-ILD chronic cough, a trial for RCC, and ongoing Phase I supportive studies.
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Shareholder Return Plan
The selected topic was not discussed during the call.
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Key Q&A
Q:Have you narrowed down the inclusion/exclusion criteria for the non-IPF-ILD study, particularly regarding chronic cough?
A:The inclusion criteria will focus on the amount of cough (e.g., 10 coughs per hour) and lung damage/fibrosis. No specific ILDs are being excluded at this time, but this may change as the protocol is refined.
Q:Will you need to conduct more DDI studies for trials outside of IPF chronic cough and RCC?
A:Yes, additional DDI studies will be required, including one with a 2C9 inhibitor. These will be discussed with the FDA and are expected as part of Phase I studies.
Q:Do you need to complete the respiratory study before the end of Phase II meeting with the FDA?
A:No, the study does not need to be completed before the meeting. The available data will be submitted, and the intention is to have all data ready by the meeting.
Q:What feedback have you received from the CHEST meeting, and how are you targeting the market?
A:The data presented at CHEST and ERS received significant attention, with high interest from investigators and pulmonologists. The company plans to raise disease awareness, segment the market, and conduct physician and payer research to optimize targeting.
Q:Are there any specific questions or issues you want to address at the end of Phase II meeting?
A:The focus will be on protocol design, endpoints, study duration, inclusion/exclusion criteria, statistical approach, safety database size, and long-term data collection. Additional Phase I studies, including a DDI study, will also be discussed.
Q:Will Trevi need to run interaction studies in patients on other opioids?
A:No, opioids are contraindicated in the trials due to the risk of opioid withdrawal caused by the drug's mechanism as a new antagonist.
Q:What is the potential to incorporate non-IPF-ILDs into the Phase III program for IPF?
A:The company plans to focus on IPF in the end of Phase II meeting and will address non-IPF-ILDs in a subsequent Type C meeting. The strategy is to ensure clear guidance for the Phase III program first.
Q:Will you seek orphan drug designation for IPF cough?
A:Yes, the company plans to request orphan drug designation after the end of Phase II meeting, though they are cautious about expectations due to the broad nature of IPF cough.
Q:How does the evolving IPF landscape, such as United Therapeutics' TETON study, impact Haduvio's positioning?
A:Haduvio is seen as either a first- or second-line therapy for chronic cough, complementing antifibrotics. Improved therapies may increase diagnosis rates and market size, benefiting Haduvio.
Q:What are the expectations for the TIDAL study results?
A:The study aims to confirm no respiratory depression by monitoring key parameters like PO2, CO2, and respiration rate. Clean results with no findings are the ideal outcome.
Q:What is the Phase III trial design for IPF cough?
A:The trial will use a 54 mg BID dose as the top dose, with a refined titration period to mitigate side effects. Background antifibrotics will be allowed, and the trial will include U.S., Canadian, and European sites.
Q:Will the end of Phase II meeting outcomes be shared with investors?
A:Yes, the company plans to update investors after receiving the meeting minutes, likely during an earnings call or similar venue.
Q:Will future trials have broader eligibility criteria to match real-world patients?
A:Yes, the company aims to keep the Phase III population as broad and real-world as possible, refining criteria to include diverse populations.
Q:Will the RCC Phase IIb trial explore QD dosing?
A:Yes, the trial will include a 27 mg QD arm in addition to BID dosing, as the 27 mg BID dose was effective in Phase IIa.
Q:Will the respiratory safety study assess long-term effects?
A:Long-term data collection will be part of the Phase III program, with the FDA likely requiring 52 weeks of safety data.
Q:Review of Unclear Management Responses
A:Management avoided directly answering questions about the potential impact of changes in CDER leadership on the program, stating only that they have received timely and clear feedback so far. Additionally, they were vague about the likelihood of receiving orphan drug designation for IPF cough, emphasizing caution without providing specific insights.
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Earnings Word Cloud
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The earnings call presents a mixed sentiment. Financial performance is stable with a cash runway into 2028, but increased expenses and lack of clear guidance on critical studies raise concerns. The Q&A session highlights positive interest from the medical community and strategic planning, yet management's vague responses on potential risks and uncertainties, like orphan drug designation, dampen optimism. Given these factors, the stock price is likely to remain neutral in the short term, with no significant catalysts for a strong movement.
TRVI Report
Frequently Asked Questions
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