Trevi Therapeutics, Inc.

Good afternoon, and welcome to the Trevi Therapeutics first quarter 2025 earnings conference call. At this time, all participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then one on your phone. To withdraw your question, please press star, then two. Please note this event is being recorded. Various remarks that management makes during this conference call about the company's future expectations, plans, and prospects constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the risk factors section of the company's most recent quarterly report on Form 10-Q, which the company filed with the SEC this afternoon. In addition, any forward-looking statements represent the company's views only as of today and should not be relied upon as representing the company's views as of any subsequent date. While the company may elect to update these forward-looking statements at some point in the future, the company specifically disclaims any obligation to do so, even if its views change. I would now like to turn the conference call over to Jennifer Good, Trevi's president and CEO. Please go ahead.

Good afternoon, and thank you for joining us for our first quarter 2025 earnings call and business update. Joining me today on this call are my colleagues, Lisa Delfini, Trevi's chief financial officer, Dr. James Casella, our chief development officer, and Farrell Simon, our chief commercial officer. Lisa and I will make some comments on the business and financial results, and the team is happy to answer any questions that you may have. The strong momentum of 2024 at TREVI continued into the first quarter of 2025 with the positive data readout from the Phase IIa River Trial in RCC patients and the completion of enrollment in the Phase IIb Coral Trial in IPF chronic cough patients. I will discuss both of these programs in a bit more detail, but needless to say, it has been an exciting few months for us. In March, we announced the data from our Phase IIa River Trial in patients with refractory chronic cough or RCC, which includes those with unexplained chronic cough. RCC is a debilitating disease that affects approximately 2 to 3 million U.S. patients and has no approved therapies in the U.S. Importantly, there have been many drugs studied for this condition which have failed, all primarily peripherally acting agents, with only one drug still in late-stage development, GSK's Camlapixin. Our hypothesis heading into the RIVER study was that our central and peripheral mechanism could change the outcome for RCC patients by having a larger effect as well as working across a broader range of cough counts than other peripheral only therapies in development. RCC is believed to result from cough hypersensitivity at the brain level and why we believe the central activity of our mechanism is important and differentiating. In the Phase IIa RIVER study, Heduvial met the primary endpoint with a statistically significant reduction in 24-hour objective cough frequency, achieving a p-value of less than 0.0001. There was a 57% placebo-adjusted reduction in cough from baseline, and importantly, showed this same strong effect across a broad range of cough counts, including patients with moderate and severe cough frequencies. In our top line announcement, we also showed two patient-reported secondary endpoints in both cough severity and cough frequency that were highly statistically significant and corroborated the primary endpoint of the objective cough monitor. Since reporting those data, we have received the full data set and can confirm that all pre-specified secondary endpoints in the study were statistically significant at the end of treatment. The river data were important not only for potential therapeutic value to patients, but scientifically as well. Hadoobio is the first mechanism to work in both patients with RCC and in IPF patients with chronic cough. We believe this is evidence of the importance of the central mechanism underlying neurogenic chronic cough conditions and lays the groundwork for not having to do the enrichment strategies others have employed to show statistical significance in RCC. Turning now to our lead program in IPF patients who suffer from chronic cough. During the first quarter, we also completed the enrollment of the Phase 2b choral trial for the treatment of this condition. And in April, the last patient completed their last visit. This study enrolled approximately 160 patients in 10 countries and across 60 sites. The team is now cleaning the data and preparing for database log. So we remain on track for top line data this quarter. We are excited to get the data from this dose-ranging study and advance the development program in both chronic cough conditions of IPF and RCC. Speaking of the FDA, there's a lot going on there that all of us collectively are worrying about. I do want to convey our recent experiences. I think it is important for all of us to monitor the current state of this important regulatory body. We asked for guidance through a Type C request with written responses only on a technical matter in our program. I am pleased to report that the FDA met their goal date this month and provided us responses with clear guidance. We recognize the FDA staff has a lot going on and appreciate their ability to keep companies moving forward with their development programs. FDA feedback is critical during development and we hope that the new leadership will prioritize this aspect of the FDA's role. So to wrap up, all eyes here on the IPF chronic cost data. This is a patient group that has had very little innovation and treatment options over the past 10 years, especially when it comes to improving their day-to-day lives of living with IPF. As a side note, we are planning on being quite active at ATS in San Francisco in a couple weeks. I will be there with several of my colleagues, so if you plan to attend, please let me know. We are hosting a KOL panel featuring both IPF experts and an RCC doctor for investors and analysts and already have quite good attendance. We plan to share new insights from the full RCC data set, which we will release online after as well. We will also be participating in a dinner with investors and we'll be actively attending sessions at the conference. Unfortunately, our RCC data came too late to make it into the late breaker timelines for this conference. However, we plan to submit abstracts for analyses from both the river and coral studies for the European Respiratory Society meeting in September. I will now turn it over to Lisa to review our financial results, then we will open it up for any questions you may have.

Thank you, Jennifer, and good afternoon, everyone. The full financial results for the three months ended March 31, 2025 can be found in our press release issued ahead of this call and our 10-Q, which was filed with the SEC today after the market closed. For the first quarter of 2025, we reported a net loss of $10.4 million compared to a net loss of $10.9 million for the same quarter in 2024. R&D expenses were $7.8 million during the first quarter of 2025 compared to $8.8 million in the same quarter of 2024. The reduction was primarily due to decreased costs related to our human abuse potential study, which was actively enrolling in the first quarter of 2024. This was partially offset by an increase in personnel-related expenses due to increased headcount. G&A expenses increased to $3.7 million during the first quarter of 2025 compared to $3.1 million in the same period of 2024, primarily due to an increase in personnel-related expenses. As of March 31, 2025, our cash and investments totaled $103.3 million, which gives us runway into the fourth quarter of 2026. We plan to use this cash to complete our ongoing Phase IIb choral trial of Hedubio for chronic cough in patients with IPF, and based on this data, we'll determine the development path forward in our programs and the related financing needs. During the first four months of this year, we had a total of 7.9 million common stock warrant exercises. We currently have about 1.9 million common stock warrants that remain outstanding. Our current fully diluted shares outstanding are approximately 137 million, which includes 101.7 million shares outstanding, those 1.9 million common stock warrants, about 23.2 million pre-funded warrants, and approximately 10 million stock options. This concludes our prepared remarks. I will now turn the call back over to the operator for Q&A.