Trevi Therapeutics, Inc.

Good afternoon and welcome to the Trevi Therapeutics first quarter 2026 earnings conference call. At this time, all participants are in a listen-only mode. After today's presentation, there will be an opportunity to ask questions. To ask a question during the session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised that today's conference 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 annual report on Form 10-K, which the company filed with the SEC on March 17, 2026, as updated by our subsequent filings. 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 2026 earnings call and business update. Joining me today on this call are my colleagues, Dr. James Casella, our Chief Development Officer, Farrell Simon, our Chief Commercial Officer, and David Hastings, our Chief Financial Officer. Dave and I will make some initial comments, but are going to keep them brief as we have a robust presentation this Thursday at our Investor and Analyst Day. After our comments on the quarter, the team is happy to answer any questions you may have. 2026 is an important year of execution for the company, and the team is focused on delivering. Following our positive FDA meeting in the first quarter to align on our IPF-related chronic cough program, the team has finalized the study protocols for our phase three trials and has been busy identifying global sites for both pivotal studies. We expect to initiate the first of those two studies this quarter, followed by the second study in the second half of this year. After gaining alignment with the FDA and our end of phase two meeting, we now intend to submit a meeting request and protocol to the FDA to discuss our non-IPF interstitial lung disease or non-IPF-ILD related chronic cough program. We intend to propose an adaptive phase two, three study to confirm dose and powering assumptions in the Phase II study prior to rolling into one pivotal Phase III study for approval. If all goes as proposed to the FDA, we expect to initiate this trial in the second half of the year. This non-IPF ILD population will mimic the patient profile of patients in our IPF trial, as it will include patients who have established lung fibrosis and chronic cough. There are a lot of synergies with our IPF studies as these patients with non-IPF-ILD are seen in the same care centers by the same pulmonologist. So as we negotiate CDAs, contracts, and budgets for the initiation of our IPF-related chronic cough trials, we have this trial in the scope so that we can act quickly once we have alignment with the FDA on the protocol. Finally, for refractory chronic cough, we also expect to initiate a phase 2B parallel arm dose ranging trial with three doses and placebo this quarter as well. The protocol is finalized and has been submitted to regulatory authorities, and we are actively qualifying sites for this trial. This trial includes a sample size re-estimation, or SSRE, which will read out when 50% of the patients complete the trial, and is in place to confirm powering assumptions and adjust the sample size if necessary. We expect the SSRE readout in the fourth quarter of this year. One final update I would like to give is on the advancement of our intellectual property portfolio. We own the worldwide rights for our drug and are acutely focused on prosecuting incremental patent coverage in addition to the patents that have already been issued. This quarter, we had our core method of treatment patent issued for IPF-related chronic cough in Europe as well. This patent had already been issued in the U.S. and provides protection through 2039. We filed additional applications this year in the U.S., which if issued, would extend the patent coverage through 2046. We will keep you updated as incremental IP evolves. Before I close, I want to note there are two important meetings this month where we hope to see many of you. The first is our Investor and Analyst Day this Thursday, May 7th, from 10 a.m. to 12 p.m. Eastern Time, followed by an optional lunch in New York City. At this event, we plan to lay out details for the next clinical trials, the projected timelines for each of our chronic cough programs, and discuss incremental data we have developed as we continue to analyze our existing clinical trial data. We also will share commercial learnings based on recent market research and hear from KOLs on their perspective. So it should be an informative event. We will post the webcast and slides after the event for those of you that are unable to join us. Second, we will also be very active at the American Thoracic Society or ATS meeting this year with all six of our submissions being accepted for either presentations or posters. We will also be holding an investor analyst event at ATS where Jim and Dr. Philip Molyneux, the lead investigator on our CORAL trial, will summarize and share the various data being presented at the conference. This event will be a lunch meeting being held on Monday, May 18th. If you plan to attend ATS, please reach out to us as we would love to have you join. In closing, we are focused on executing against our plan of becoming the leader in chronic cough. providing therapy for these patients where there are no good options, and in the process, creating meaningful value for patients and our shareholders. I will now turn it over to Dave for his remarks, and then we are happy to answer your questions.

Dave? Thanks, Jennifer, and good afternoon, everybody. My brief remarks today will focus on our most important financial metric, which is our cash position and the runway it provides. We ended the first quarter of 2026 with approximately $172 million in cash, cash equivalents, and marketable securities. This balance does not include the $162 million in net proceeds from our underwritten common stock offering completed in April 2026. The offering was well received, and we appreciated the strong support and participation we got from our current shareholders, and we are grateful that we were able to attract new investors to Trevi. Additionally, with the completion of this offering, we accomplished two major objectives. One, we removed any financial overhang when we reach critical high-value clinical endpoints. And two, we extended our cash runway into 2030. Included in this runway guidance is the funding of our development program in patients with IPF-related chronic cough, potentially through FDA approval. And we also expect these cash resources will enable the company to fund and report top-line data from the planned Phase 2B clinical trial and potentially a subsequent Phase 3 trial for the treatment of patients with non-IPF-ILD-related chronic cough. And it funds the planned Phase 2B trial for the treatment of patients with RCC. The planned spending of these resources also include pre-commercial activities, but does not include any expenses related to the commercial launch of ADEVO or any other clinical trials. So with that, I believe we are now well positioned to execute our clinical trials with funding through critical value inflection points.