Trevi Therapeutics, Inc. Common Stock 2026 Q2 Earnings Call

Please go ahead. Good afternoon, and thank you for joining us for our second quarter 2026 earnings call and business update.

Joining me today on this call are my colleagues, Dr. James Cassella, 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, then the team is happy to answer any questions you may have. 2026 is an important year of execution for the company, the team is focused on delivering. This is the fun part of what we do. We are on track with our plans for each program initiated both the OCEAN-1 phase III 52-week trial in patients with IPF-related chronic cough, as well as the LAKE-2b trial in patients with refractory chronic cough, or RCC, both during the second quarter.

We also plan to initiate the second phase III 12-week trial in patients with IPF-related chronic cough, named OCEAN-2, in the third quarter. Things have been busy for Team Trevi through the summer. The team is focused on bringing up global sites for each of these trials, which total more than 200 sites. I have attended all of our investigator meetings to date, there is a tremendous amount of excitement and energy around the participation in our trials and the significant unmet need in chronic cough. We are early in enrollment for the two trials that have been initiated but are on track with our plans. Once we hit approximately 50% enrollment in any of our trials, we will disclose that milestone then give updates on enrollment during our quarterly earnings call after that. Look for more details as we progress.

The third piece of our story is patients with non-IPF ILD-related chronic cough. We recently submitted a meeting request to the FDA to discuss this program. We expect to hear this month if a meeting has been granted. If granted, we will submit the full protocol and briefing document for discussion of the next trial and the development plan for this indication. There are a lot of synergies with this ILD patient population and our IPF studies, as these patients with non-IPF ILD are seen in the same care centers by the same pulmonologists. As we negotiate CDAs, contracts, and budgets for our IPF-related chronic cough trials, we have this trial in the scope so that we can act quickly once we have FDA alignment. As we look forward to the rest of this year, you should expect the following key milestones from us.

One, alignment on our non-IPF ILD-related chronic cough program during the second half of this year. Two, 50% enrollment in the LAKE-2b trial for RCC also in the second half of this year. Three, results from the sample size re-estimation, or SSRE, for the LAKE trial in RCC, which will read out when 50% of the patients complete the trial and the analysis is done by an external, unblinded statistician. The SSRE was included in the protocol to confirm powering assumptions and adjust the sample size if necessary. We expect the SSRE readout in the fourth quarter of this year, which is increased focus given the recent termination of a competitive RCC program. I also wanted to comment on an important medical meeting held during the second quarter, the American Thoracic Society, or ATS, meeting.

All six of our submissions were selected for either presentations or posters and covered a range of data from our phase II trials. This included new data on the reduction of breathlessness with nalbuphine ER in patients with IPF-related chronic cough, reduction in cough bouts in both IPF chronic cough and RCC, something that is quite meaningful to the patients, as well as an analysis showing the impact of nalbuphine ER across all baseline cough counts, ranging from below 10 coughs per hour and higher, which essentially demonstrated nalbuphine ER's robust response in patients across all cough counts. These presentations can be found on our corporate website.

Finally, we were honored to see Trevi's JAMA publication of the phase II-B CORAL trial for the treatment of patients with IPF-related chronic cough highlighted at the ATS 2026 International Conference Clinical Year in Review session. Dr. Lida Hariri of Harvard Medical School highlighted the CORAL trial results among the year's key developments in ILD research. ATS was an important meeting for Trevi and shows the growing awareness of the burden of chronic cough on patients. In Q2, we also launched our unbranded campaign, raising awareness of the burden of disease of chronic cough among pulmonologists. This campaign highlights patient testimonials in IPF and non-IPF ILD and their lived experiences with chronic cough. Through our digital efforts, we reached more than 17,000 unique pulmonologists so far and saw an overwhelming engagement, supporting the eagerness of physicians for new therapies for their patients.

In closing, we are focused on executing against our plan of becoming the leader in chronic cough. With the recent competitive failure in RCC, we are essentially alone in all three of our cough indications and have the ability to be a first-in-class therapy where significant unmet need exists. We recognize the great responsibility we have to deliver nalbuphine ER and potentially help patients across these indications. There are many physicians, companies, patient advocacy groups, and patients who have provided time and resources in developing the field of chronic cough in the hopes of improving the lives of these patients. We are leaning into that responsibility and staying focused to try to get Haduvio over the finish line. We believe if we are able to execute against our current plan, we can create meaningful value for patients and in turn, significant value for our shareholders.

I will now turn it over to Dave for his remarks. Then we are happy to answer your questions.

Dave? Thanks, Jennifer, and good afternoon, everybody.

My remarks today will focus on our most important financial metric, which is our cash position and the runway it provides. We ended the second quarter of 2026 with approximately $319 million in cash equivalents, and marketable securities. Importantly, we are on track with our budgets and plans so far this year as the team continues to execute on our clinical trials. Therefore, we have not changed our cash runway guidance since our last quarterly call, which extends into 2030. Included in this runway guidance is the funding of our development program in patients with IPF-related chronic cough through potential FDA approval.

We also expect these resources will enable the company to fund the clinical development program through phase III for the treatment of patients with non-IPF ILD-related chronic cough and the ongoing phase II-B LAKE trial for the treatments of patients with RCC. The planned spending of these resources also includes pre-commercial activities, but does not include any expenses related to the commercial launch of Haduvio or a phase III clinical trial in RCC. With that, I believe we are well-positioned to execute our clinical trials with sufficient funding through critical high-value inflection points. Operator, we can now open the call for questions.