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Trevi Therapeutics Announces Q3 2025 Financial Performance and Important Updates

Trevi Therapeutics, Inc. has recently revealed its financial results for the third quarter of 2025, showcasing significant strides towards its clinical development goals. The company has reported a cash reserve of approximately $194.9 million, which is anticipated to support operations and development initiatives extending into 2028. This financial cushion is particularly critical as Trevi prepares to advance its investigational therapy Haduvio™ for chronic cough associated with idiopathic pulmonary fibrosis (IPF).

Advancements in Clinical Programs

Trevi's management expressed ongoing enthusiasm regarding their clinical trials, especially given the positive outcomes reported earlier this year regarding both chronic cough in IPF and refractory chronic cough (RCC). Jennifer Good, President and CEO, confirmed that the company is gearing up to submit a request for an End-of-Phase 2 meeting with the FDA in the current quarter, looking to facilitate the transition into a comprehensive Phase 3 program starting in the first half of 2026.

Chronic Cough in Idiopathic Pulmonary Fibrosis (IPF)

The upcoming Phase 3 program is a critical step in targeting chronic cough in patients suffering from IPF, a serious lung condition where patients are particularly vulnerable to debilitating symptoms. Clinical evaluations from the TIDAL study, which assesses respiratory function in patients with IPF, reported that the safety review committee found no concerning safety signals, thus granting approval to continue with patient enrollment. This study is anticipated to conclude within the fourth quarter of 2025.

The company has also completed a Phase 1 drug-drug interaction study that assessed the co-administration of its oral nalbuphine ER (Haduvio™) with standard antifibrotic agents, demonstrating that there were no significant pharmacokinetic interactions. Such affirmations are vital as Trevi positions Haduvio as a potentially groundbreaking treatment option for IPF patients experiencing chronic cough, a symptom for which there are currently no FDA-approved therapies.

Refractory Chronic Cough (RCC) Insights

Building upon the success of the Phase 2a RIVER trial earlier this year, Trevi is also poised to kick off a Phase 2b study for RCC, again slated for the first half of 2026. The impact of RCC, a condition marked by an unrelenting cough lasting more than eight weeks, remains profound, affecting millions of individuals. By focusing on this indication, Trevi aims to fill a significant gap in the market.

Financial Overview

Trevi's financial results for the third quarter of 2025 indicate a decrease in research and development (R&D) expenditures, which were reported at $10.1 million compared to $11.2 million from the same quarter the previous year. This decrease reflects lower clinical development expenses as some trials, such as the Phase 2a RIVER trial, had already concluded their enrollment in the prior year. However, the decrease in overall R&D spending was somewhat offset by growing costs related to new studies.

General and administrative (GA) expenses rose to $3.8 million, which represents an increase from $2.9 million in Q3 2024, largely driven by rising professional fees and personnel-related costs.

Net loss for the third quarter was reported at $11.8 million, an encouraging decline from the previous year's loss of $13.2 million, providing investors with a more optimistic outlook.

Future Directions

As Trevi Therapeutics progresses, the company continues to emphasize transparency in its development strategy, directing attention to the broader impacts of chronic cough on patient quality of life. With over 150,000 individuals in the U.S. afflicted by IPF and a substantial percentage suffering from chronic cough, Trevi’s initiatives could herald a much-needed shift in treatment paradigms.

In summary, with Haduvio aiming to bridge the therapeutic gap for chronic cough related conditions, and a solid financial foundation in place, Trevi Therapeutics is on course to expand its clinical footprint and make significant contributions to the biopharmaceutical landscape.

Conference Call

To discuss these results and updates, Trevi management will host a conference call and webcast today at 4:30 PM EST. Interested participants can join via phone or through the company's investor relations webpage for a live audio stream. An archived version will also be available online for 30 days post-event, ensuring stakeholders have continued access to this critical health update.

For further inquiries about Trevi Therapeutics and their innovative approaches, please visit www.TreviTherapeutics.com.

In conclusion, Trevi Therapeutics is making commendable strides in addressing chronic cough with their investigational therapies while ensuring financial viability and regulatory compliance at each step.