Trevi Therapeutics, Inc. (TRVI) Q1 2026 Earnings Report, Transcript and Summary

Good afternoon and welcome to the Trevi Therapeutics First Quarter 2026 Earnings Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. Various remarks that management makes during this conference call about the companys 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 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, 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 III trials and has been busy identifying global sites for both pivotal studies. We expect to initiate the first of those 2 studies this quarter, followed by the second study in the second half of this year. After gaining alignment with the FDA in our end of Phase II 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-reated chronic cough program. We intend to propose an adaptive Phase II/III study to confirm dose and powering assumptions in the Phase II study prior to rolling into 1 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 pulmonologists. 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 IIb parallel arm dose-ranging trial with 3 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 reestimation 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 2 important meetings this month where we hope to see many of you. The first is our Investor and Analyst Day this Thursday, May 7, from 10:00 a.m. to 12:00 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 time lines 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 6 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 Molyneaux, 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 18. 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 2 major objectives. One, we removed any financial overhang when we reached 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 IIb clinical trial and potentially a subsequent Phase III trial for the treatment of patients with non-IPF-ILD-reated chronic cough, and it funds the planned Phase IIb trial for the treatment of patients with RCC. Our planned spending of these resources also include pre-commercial activities but does not include any expenses related to the commercial launch of Haduvio 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. Operator, we can now open the call for questions.

[Operator Instructions] Our first question comes from the line of Roanna Ruiz of Leerink Partners.

A couple for me. First one, I was curious, what is your goal for the upcoming meeting with the FDA to talk about the protocol for your Phase IIb in non-IPF-ILD chronic cough? And if you could elaborate like anything you expect that might be up for discussion with the FDA versus more straightforward questions?

Roanna, this is Jim. Thanks for the question. So basically, that meeting is designed to discuss our intention for the ILD program. We will be submitting the full Phase IIb/III protocol with that for discussion and really talk about our intentions on using that in an sNDA strategy so that we would support approval with that adaptive Phase II/III design. So there's going to be details about our patient population, how we're going to use the Phase II for our dose selection, confirmation and defining the dose for going into Phase III and then pulling up the results from the Phase II part of that study with the interim analysis to confirm our power assumptions and for the Phase III component.

Makes sense. And then a quick follow-up. Thinking about RCC Phase IIb potentially ramping up as well and moving forward in non-IPF-ILD. Could you talk a bit about how you plan to balance resources and prioritize things as you have many really interesting things going on and moving forward?

Yes. It's -- we don't like a lot of sleep. We have things under control. I -- this is not my first time running multiple programs with a small team. We use our internal expertise. We have leveraged very experienced CRO, one that I've worked with from my last NDA, have a lot of years of experience with them. So it's a really tight team. Our vendors that we selected are really here to support us across all of our programs. So I think we're in a good position to be able to do these things. I have no questions that we have the capabilities and the intellectual horsepower to get these things done. And we have been working with [ small and ] small companies for almost 40 years now. We know how to manage the resources to get these things done.

I would add to, Jim, Roanna, we have added probably 10 people in the last -- since getting our Phase IIb results. We added a really experienced pulmonologist. We've added several clinical people. So 10 people for us is a lot of hiring. And so we have tried to scale appropriately to address the business of these trials.

Our next question comes from the line of Judah Frommer of Morgan Stanley.

Two for us. I guess, just from a competitive standpoint in RCC, we have a P2X3 readout coming midyear. Just curious how you think the landscape evolves for Haduvio kind of along the spectrum of possible outcomes for that P2X3 readout. I guess, if results are unexpectedly strong, what does that do for your opportunity in RCC? What does it do maybe for enrollment in the RCC trial?

Farrell, why don't you answer the competitive landscape and Jim can talk about enrollment?

Yes, Judah, thank you for the question. When we look at the competitive landscape, especially Camlipixant, which we'll be reading out soon in the next couple of weeks, we're hoping that they are successful here, right? This is a large unmet need patient population with no approved therapies and definitely a category that can support multiple modalities. We have strong differentiation with our central and peripheral mechanism of action. And I think what we'll take you through on Thursday in the Investor Day is exactly how that positions us for success. I'll turn it over. I'll just say, on the flip side, if Camlipixant is unsuccessful in that space, I think we'll have to take a look at what is our competitive positioning, but we have a really strong efficacy and see what the Phase IIb results say and see what the commercial opportunity lies ahead. But it's still a large unmet need patients are waiting for us. And I'll turn it to Jim.

Yes. On the enrollment side, we have our investigators signed up for that study. There's a lot of excitement. There's a lot of patients available to us. Irregardless of what happens in that environment, we're strongly supported by the investigators that we have for the study who really talk about a lot of patients being available and interested in being in our study. I think our different mechanism, the data that we've shown, the strength of the data that we have out there still is really the absolute driving force for the interest in being in our study.

And [ R2b ] will be done by the time they ever got approval. So it might be a Phase III issue to deal with. But yes, thanks for the question.

Great. And then just maybe more high-level philosophical just on the ILDs with kind of more inhaled formulation drugs kind of entering or late stage in kind of the IPF and PPF space, right? A common AE in a lot of those trials is cough. So just curious how you think the opportunity for Haduvio could be impacted by maybe more inhaled therapeutics in the PF space.

We get this question a lot. I think, obviously, we're treating more of a chronic cough that's more systemic. Now whether the hypersensitization intertwined with them taking these inhaled products and you might be able to settle that down, that's something that's going to have to be learned over time. I do think these different therapies are helpful. They'll define the market. They create options, but we can lay alongside all of these. That's why Jim has been busy doing these DDI studies. But whether we can sort of help with the cough due to their delivery system, I think that will have to be discovered.

Our next question comes from the line of Alexa Deemer of Cantor Fitzgerald.

Congrats on the great quarter. So for the guidance for the data readouts for the upcoming program, so this begins in the second half of 2027. And I just wanted to ask if there are any other data updates planned we can expect before that?

Yes. I mean we have the SSRE, the sample size reestimation, at the halfway point of the RCC trial. We should get that in by the fourth quarter of this year. We'll have to see how enrollment unfolds, but that's what we're working towards. So that's a pretty insightful readout on the RCC trial, I think. Otherwise, our current plan is second half of '27, but I want to echo what Jim said, I've been going to a lot of these investigator meetings as well. There is a lot of interest and attention on this -- on our programs. So the team is, I think, setting us up for success here. So we'll continue to update you guys as we move through the trials, but we are definitely moving along nicely.

Our next question comes from the line of Serge Belanger of Needham & Company.

This is John on for Serge today. So just a couple from us. First, I might be jumping the gun here a little bit, but on the SSRE and RCC coming up later this year. Curious what some of the key checkpoints will be that you're looking for during this analysis. I would imagine it might look somewhat similar to the IPF one done during Phase II. And in the event of requiring additional patients, just curious how you might expect that to look? And then secondly, on the IP front, I believe you have patents issued through 2039. Curious if and where you'd look to expand that portfolio ahead of the potential commercialization of Haduvio.

Yes. Jim, do you want to do the SSRE?

So the SSRE is exactly what we did with CORAL. It will be at the halfway point, looking for conditional power of 80%. If the numbers are below that, if the conditional power at that point is below 80%, we will upsize proportionately. And like we had in the CORAL design, if there's futility, it will be recognized too. That's going to be down in that 30%, 40% range. So I think conditional power. So it's really what you expected from CORAL is going to be carried over to here, and we'll be reporting whether or not we have to stay the same or upsize.

Yes. And your second question, John, about IP. So -- we are in an interesting position now. We've got the [indiscernible] base core patents issued in IPF. And now we're also -- we have a good view of what our label is going to look like. So now we are starting to prosecute the different sort of label enablement patents. So things that we're zeroing in on the label, like the final titration schedule, like how you dose adjust it with food or hepatic impairment. Jim is running a lot of different Phase I studies. Those tend to be quite rich for IP. So our goal at this point, now that we've got a nice broad sort of method of treatment patent around treating cough in these indications, now we'll start building around the label. We'll keep patent applications open. So as we complete development work and learn new things, we're able to file incremental IP around them. So our goal would be when this drug actually launches that we've got multiple patents around the original base patent.

Our next question comes from the line of Ryan Deschner of Raymond James.

You have some very interesting dyspnea data coming up at ATS later this month in Orlando. How impactful do you think dyspnea is as a quality of life metric for IPF chronic cough patients? And how relevant is potential modulation of dyspnea for the RCC and non-IPF-ILD indications? And I have a follow-up.

Yes, Ryan, this is Farrell. Thank you for the question. We've actually done a lot of research with physicians and with payers around this point. When you look at the top 3 most common complaints from these patients, whether it's IPF or ILD, dyspnea is in that top 3. It's cough, dyspnea and fatigue at the top 3. So it doesn't change our commercial thesis, but what it can do is definitely complement the speed of uptake of the product and also, I think, just the adoption from patients because it's going to be helping them across more than one of the experiences that they have at [ Impax ].

And payer conversations, right?

And payer conversations, it will help in payer conversations. It will help justify additional value.

Got it. And then how do you plan to try to minimize placebo in the RCC clinical program? And if high potential placebo is much of a concern in the IPF chronic cough and non-IPF-ILD indications?

Ryan, it's Jim. So I think we have solid data from our CORAL study in the IPF population, came in with under 20% placebo response. I think that was expected. I also think that, that's probably in the world of chronic cough, that's probably one of the more well-behaved populations and expect to see something like that going forward. I think there's precedent here in the RCC world that the placebo response could be a little bit more variable and a little bit more ranging. We are doing everything in this trial to really control for things that can contribute to a placebo response. I think a lot of it is having an extremely well-controlled trial. So we're doing our best there. I think we are incorporating at the advice of some of the experts in the RCC space, a placebo run-in period to try to mitigate any of the response there. The idea there is to look for stability around lower end of cough response. So we are incorporating those things. And of course, just sort of the rules of thumbs that I'm bringing in from my CNS background where placebo response is always a big concern is really about trial conduct and making sure that you don't set false expectations that you don't overpromise and things like that, that can help contribute to the overall placebo response.

Our next question comes from the line of Debanjana Chatterjee of Jones.

Congrats on all the progress. So looking forward to ATS, what are some of the most exciting developments we should look forward to? And I have a quick follow-up.

Jim and I will both be there. We're looking at each other. Jim, you go ahead and hear the offer on a bunch of them.

So, it's -- I think we have some exciting updates in the oral presentation that will be given by Dr. Philip Molyneaux. I mean that's going to be some new sub-analyses from our CORAL study. I think there's also going to be some interesting presentations and posters on cost-outs, our analysis of the cost-outs were both CORAL and RIVER. And it was brought up earlier, but I think our breathlessness data being presented by Don Mahler, who is really one of the key experts in this space is really going to be exciting poster to get out that initial analysis that really shows some benefit here on the breathlessness piece of things. So I think those are highlights. I think that really add some new information into the data flow for us.

Appreciate the color. And just a quick follow-up. So I know, of course, FVC is not an endpoint that you are pursuing. But like given that you'll be following the IPF patients like 52 weeks at least, right, in the Phase III program, do you expect to see some trends there? And even if that's kind of like a safety endpoint?

So we are following FVC. We have it at baseline. We have it throughout the 52-week time period. We will be able to look to see what's there. Our ends are very different than what you would expect from an IPF trial because FVC is highly variable, and I think that drives the size of those trials. But all I can promise you is that we will see what we see and report it out.

Our next question comes from the line of William Wood of B. Riley Securities.

Congrats on a nice quarter. So just curious when we're thinking about the peers P2X3 readout coming up. I was curious if there's anything specific that you might be looking for in that trial regardless of whether it's positive or negative in terms of taking forward to the FDA that you think they could really improve your learnings on your own trials?

I mean I'm just going to jump in, Jim, you add any color. Thanks for the question, William. I don't think so. P2X3s have had to kind of chase this path of the highest level of coughers and placebo run-ins and highly adjudicate the indication. We've shown data that our drug works broadly in IPF chronic cough and refractory chronic cough across different cough counts. So I think that we have to be a lot less fussy with who goes into the trial and how we get results. We'll obviously be interested in the placebo effect and how they've controlled that. But those trials were upsized. The bigger trial was upsized twice, and that's always tricky. I think they're also managing a much tighter response. So we'll look at it. We're interested. I agree with Farrell. I hope they see some results for patients. but they are guiding towards about a 15% to 20% placebo-adjusted change in their calls. We would expect much better performance of our drug. So we really are looking to be best-in-class and the most refractory patients for our drug. So it's more, as Farrell mentioned, just how we position the drug and where we go. But I would say nothing that really impacts our program. We'll learn more from our Phase IIb than we'll probably learn from their Phase III data.

Got it. That's helpful. And then one brief quick add-on. Just in terms of sort of setting our expectations for the -- for your KOL event coming up as well as at ATS, is there anything specific that the FDA may be looking for in terms of guiding for your non-IPF-ILD-related chronic cough trials that you may be highlighting at these really sort of bolster moving into this and/or certain subsets of populations as you look to meet with them in the second half.

Well, we are having an ILD expert in the U.S., Dr. Toby Maher, who runs a big ILD center. He's going to speak there. He's got to join us by Zoom because he has clinic. But one of the topics we've asked him to cover is why in his judgment, an IPF and an ILD patient is the same or not the same as it relates to cough. So you'll hear straight from one of the experts here. Toby has been involved in our program from the beginning. He knows our drug quite well. He actually sat on our FDA call with us. So you'll get some independent insights from really one of the leading voices in the ILD space on Thursday.

[Operator Instructions] our next question comes from the line of Kaveri Pohlman of Clear Street.

Just like a follow-up on the previous comments you made on the Phase IIb RCC trial design. I was wondering how you are thinking about enrolling a truly addressable patient population to fully derisk the program, particularly given the expectations that many of patients may be P2X3 antagonist experience in real world. And broadly, just like on a high level, there appears to be an increasing focus on the development progress in IPF and non-IPF-ILD. Obviously, alongside continued efforts in RCC. How do you think about the relative opportunity across these indications in the context of the evolving treatment landscape? And what key challenges in RCC will need to be addressed to fully realize its potential?

There were a lot of questions there to disentangle. So I'll just kind of start from a strategy perspective. Trevi has always been led as an IPF sort of and then adding an ILD-led strategy, primarily because of our commercial strategy, specialty, high pricing, specialty sales force. So that was always our focus. I think as the RCC competitive landscape sort of fell away and really there wasn't much left, some of the experts came to us asking us to please try our drug in RCC, we did and got very strong data. So I think definitely a commitment to RCC, but it is sort of the third leg of the stool here. With regard to the variability in the program and P2X3 responders, anything, Jim, on that?

I think are you asking there's going to be people who have experienced with P2X3 that may be entering our trial. I mean, I think the key there is if they meet the eligibility requirements and they've been off their P2X3 for an appropriate period of time, they still have the requirements to get into the study, they're fair game for coming in. I mean we want people with various experiences. We know this is a refractory condition, and people have tried a lot of different things. And they may or may not have succeeded on a P2X3, but if they meet our entry criteria, they'll be coming into the trial. So I don't think it really differentiates from any other type of therapy that they've tried in the past. They will meet the eligibility requirements for being off of the P2X3 for a certain amount of time.

I am showing no further questions at this time. This concludes our question-and-answer session. I would now like to turn the conference back to Jennifer Good for closing remarks.

We appreciate you joining us for today's call and look forward to hopefully seeing many of you later this week and this month. Thank you.

This concludes today's conference call. Thank you for attending. You may now disconnect.