Trevi Therapeutics, Inc. (TRVI) Earnings Call Transcript & Summary

Good afternoon, and welcome to the Trevi Therapeutics Second 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 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 '95. 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 Form 10-K, which the company filed with the SEC on March 17, 2026, as updated by our subsequent filings with the SEC. In addition, any forward-looking statements represents 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 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, and then 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. This is a fun part of what we do. We are on track with our plans for each program and initiated both the OCEAN-1 Phase III 52-week trial in patients with IPF-related chronic cough as well as the LAKE Phase IIb 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. So 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, and there is a tremendous amount of excitement and energy around the participation in our trial and the significant unmet need in chronic cough. We are early in enrollment for the 2 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 and then give updates on enrollment during our quarterly earnings call after that. So 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, and we expect to hear this month if the meeting has been granted. If granted, we will submit the full protocol and briefing document for a 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. So 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 Phase IIb LAKE trial for RCC also in the second half of this year; three, results from the sample size reestimation 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 has 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 6 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. And finally, we were honored to see Trevi's JAMA publication of the Phase IIb CORAL trial for the treatment of patients with IPF-related chronic cough highlighted at the ATS 2026 International Conference Clinical Year and 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 3 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, and 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, cash equivalents and marketable securities. Importantly, we are on track with our budget 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. And 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 IIb LAKE trial for the treatment of patients with RCC. Now 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. So 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.

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

So a couple from me. I was curious about the upcoming meeting with the FDA on ILD chronic cough. And what questions do you expect to get from the agency? And could you give us a little color on what some of the options are in terms of thinking about trial protocol for ILD chronic cough patients and relative to what you already have established for IPF chronic cough?

Yes. Go ahead, Jim.

Roanna, this is Jim. So thanks for the question. So really, the meeting with the FDA will be an alignment meeting. We all know that we have a solid program in IPF. We're now interested in expanding that to the non-IPF-ILD population. So a lot of what we talked about with the end of Phase II meeting for the IPF patients will be the basis and the foundation for talking to them about the non-IPF-ILD program. The protocol, as you can imagine, will follow very closely to what we're doing for the OCEAN program. Obviously, the difference being the nature of the patient population. But you can imagine everything is going to be the same in terms of endpoints and things like that. So really, it's going to be on alignment on the inclusion/exclusion criteria now looking at the non-IPF population, and we'll look at other very specific but not very different parameters for the protocol in relationship to what we already did for IPF. So it's really alignment on that and then on the pathway to an NDA filing for that indication. So really, it's going to be a meeting where we have that discussion, get finality on our approach and then execute to the plan that we come out with.

Makes sense. And I was also thinking about RCC, given one of your competitors recently terminated their program, has that changed the way that you think about the overall market landscape or any thoughts about pricing, et cetera? And as we go into the SSRE for the LAKE trial, any updated thoughts there? And how you're thinking about whether or not it will be -- it may need to be upsized or not?

Roanna, this is Farrell. I can answer your question on our RCC approach. We're an IPF-ILD-led company, and that really establishes the specialty commercial dynamics that we intend to go to the market with. Our RCC approach remains unchanged. And so we intend to target the treatment-resistant proportion of those RCC, which is still a sizable proportion, about 1 million patients in the U.S. and a large market opportunity. And that enables us to take that specialty dynamics and specialty pricing into that indication. So it remains unchanged with the recent competitive news.

And Roanna, in terms of the trial -- LAKE trial and the SSRE, the basis of that trial is from our RIVER study, the -- sorry, for the findings that we had in RCC and based on what we saw in our CORAL program. So the idea there that GSK outcome might influence us really doesn't have any impact on our trial. We power that trial based on our data and based on the assumptions that we look at for a parallel arm study where the CORAL information comes in play. So as far as we're concerned from a clinical perspective, we're driving our program from our own data. We know we have a very strong best-in-class type of efficacy in the RCC patient population. Our effect size is very strong. And that's really what's driving that trial. So we don't know what the numbers were from GSK. We don't know what their effect sizes were, but I think it really has 0 impact on our clinical program.

It is nice to protect our program a bit because I'm not sure any of us have clear line of sight to placebo at this point. So I think the nice thing about having that in there is it should protect the overall program if there's an effect there.

Our next question comes from the line of Annabel Samimy from Stifel.

Great progress. Just wanted to clarify on the SSRE for your programs, is it only going to be for the LAKE program? Or are you also doing it for the OCEAN programs as well?

It's Jim. Yes. No, it's only for LAKE. It's really the Phase II trial. OCEAN is well powered. Our effect size is known based on the CORAL study, and there's no intermediate read in that program.

Okay. Got it. And then on RCC, just to get a little bit more granular on the opportunity. So I guess the initial strategy was to go after, I guess, the most refractory patients who likely would have failed all therapy with the assumption that there would be another approved product out there. So this does seem to effectively open up the whole entire population to you. So if you could just help us understand how you, I guess, fragment this population a little bit better.

This is Farrell. Great question. So we have some optionality around RCC. We need to really understand the dose that comes out of our Phase II trial. If we end up being in the very low dose range, call it, 27 milligrams once a day or below, we may be able to really open up that market in a different way with differential pricing in a second brand. But if we're sticking -- if we get similar dose, one thing that we don't want to do is cannibalize our IPF or ILD population and revenue. And so we would stick with our current approach. This is really led by conversations we've had with payers and done deep payer research on this to make sure we're getting the patients who truly are in the highest unmet need and that have failed maybe some of these even off-label therapies.

Okay. Got it. And who might that most severe patient be if there aren't really any other therapies? Is it based on cough count?

Well, in the real world, we wouldn't really have cough counts, right? It's going to be based on mainly a cough severity NRS score, which we have as a key secondary endpoint within our trials. What it will align to is a lot of our IE criteria. So in our Phase II trial, we have RCC patients who have had that condition for greater than a year. That does start to segment this population. What we can execute well upon is also those patients that are seen by specialists, mainly by pulmonologists. So when you start to boil down what that population looks like, it's that 1 million target that we've been talking about and coining them as treatment resistant.

Yes. And Annabel, I just want to make a distinction here because you're heading this direction. Clinically, we're going to have a broad label. We could go after this whole population. Commercially, because we're leading with IPF, it's advantageous to try to keep this at a specialty prescriber level so that we can maintain pricing. So to the question you're asking, I think it's great because we have optionality [indiscernible] the low dose. So we're going to have sort of maximal flexibility here. But in the current scenario we're planning against, we are going to have to be mindful of sort of payer limitations.

Got it. Got it. And just one last question. I'm not sure you can answer this yet until your Type C meeting. But for the Phase IIb ILD study or non-IPF-ILD study, if that comes out favorable, do you have an avenue for a broad interstitial lung disease label? Or do you have to actually have another Phase III? Or how are you going to fold that in -- have you changed your ideas about how you're going to fold that into the IPF indication, given that it's functionally and pathophysiologically the same?

Yes. Annabel, this is Jim. So I think our approach to the non-IPF-ILD program is to come up with the most efficient protocol that gets us to an NDA as quickly as possible. So there are going to be things that we can discuss with the FDA. But I think you can assume that those programs will be run in parallel, and we will design and hopefully try to get agreement on the most efficient path to the NDA. So that's obviously TBD based on our conversations with the FDA. But as you mentioned, we have a solid foundation here that this is all IPF, non-IPF. This is interstitial lung disease. It's the lung disease that all the KOL believes is mediating the cough, and that's our common thread here. So we will be very interested in discussing the most efficient pathway to get that population to approval.

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

We know it's early on this front, but any thoughts on potential spend to build awareness in RCC upon the potential commercialization that maybe we could argue it would have been nice to have a large pharma help do that? Or is the market big enough that the potential lack of competition is really kind of the key takeaway here?

Judah, this is Farrell. Thanks for the question. We go back to -- we're still an IPF and ILD-led company. And what's nice about that environment is there's 90 ILD care centers in the United States. So it's a fairly focused approach. As we stated, we're kicking off this with pulmonologists as the primary call point. And that's really going to be the call point until we get to the market with the RCC indication, which they'll be familiar because we'll already be calling on them for a different indication. So yes, while they may have built the RCC awareness if they were going to market, and unfortunately, that won't be there, we have the way to really become leaders across chronic cough and shape our own narrative to make sure that this is top of mind. You asked about the spend to do so. We're taking a really efficient digital approach, and we're seeing great engagement here. We'll ramp that up as we get closer to launch, but that's all part of the pre-commercial planning.

Our next question comes from the line of Leland Gershell from Oppenheimer.

This is Tracy on for Leland. Congrats on the quarter. Recognizing that the trial designs are pretty similar across non-IPF-ILD cough and IPF chronic cough, we were wondering if you received any feedback from pulmonologists about a threshold of efficacy that they're looking for? Or are there any key differences we should keep in mind about characterizing efficacy across these conditions or indications?

This is Jim. So we've gotten very strong feedback from the KOLs that IPF and non-IPF-ILD are really interchangeable in terms of the reason for the cough, the lung disease really driving that. I think the expectation is that we will have very strong efficacy across both of those patient populations given the data that we have with IPF. So nothing special there. I think in some ways, in their mind, it's like a no-brainer. But obviously, the data will be the data, and we need to make sure that we run the right trial to really pull this out. But there's no differences in terms of what we need to look for. The endpoints are all going to be the same. So no differences really except characterizing it now in the other part of the ILD world.