Trevi Therapeutics Q2 2025 Earnings Call Transcript

Quartr
Provided by Quartr
August 7, 2025

Key Takeaways

  • Positive Sentiment: Trevy reported positive Phase II data from its CORAL trial in IPF patients and RIVER trial in refractory chronic cough, demonstrating significant reductions in cough frequency and improvements in quality of life.
  • Positive Sentiment: The company raised approximately $115 million in June, bringing total cash and investments to about $204 million and securing a runway into 2029 to fund multiple upcoming trials.
  • Positive Sentiment: Two Phase I studies—a respiratory safety assessment in IPF patients and a drug–drug interaction study with anti-fibrotics—are on track to support an end‐of‐Phase II FDA meeting planned for Q4.
  • Neutral Sentiment: Trevy expects to initiate Phase III trials for chronic cough in IPF and a parallel‐arm Phase IIb study in refractory chronic cough in H1 2026, plus a new trial in non-IPF interstitial lung diseases to more than double its target patient population.
  • Negative Sentiment: Net loss remained around $12.3 million for Q2, with R&D expenses slightly down but G&A rising by $1 million due to increased headcount and stricter internal‐control requirements, suggesting ongoing expense pressure.
AI Generated. May Contain Errors.
Earnings Conference Call
Trevi Therapeutics Q2 2025
00:00 / 00:00

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Operator

Good afternoon, and welcome to the Trevy Therapeutics Second Quarter twenty twenty five Earnings Conference Call. At this time, all participants will be in listen only mode. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then 1 on your telephone. To withdraw your question, please press star then 2.

Operator

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 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.

Operator

I would now like to turn the conference over to Jennifer Good, Trevy's President and CEO. Please go ahead.

Jennifer Good
Jennifer Good
Co-Founder, CEO, President & Director at Trevi Therapeutics Inc

Good afternoon, and thank you for joining us for our second quarter twenty twenty five earnings call and business update. Joining me today on this call are my colleagues Lisa Delfini, Trevi's Chief Financial 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, then the team is happy to answer any questions that you may have. The first half of this year has been a major inflection point for Trevy, with positive data readouts in both the CORAL trial for chronic cough in patients with idiopathic pulmonary fibrosis, or IPF, and the RIVER trial for patients with refractory chronic cough or RCC.

Jennifer Good
Jennifer Good
Co-Founder, CEO, President & Director at Trevi Therapeutics Inc

As a result of this strong data, we were able to raise approximately $115,000,000 in capital for total cash and investments at the June of approximately $2.00 $4,000,000 This gives us strong runway to execute against several important clinical milestones in each of our programs. It is an exciting place to be in our journey, and we believe we are well positioned to execute our strategy and create value. Let me provide a brief update on what we have been up to this summer. As you all know, the top line results from our CORAL trial were announced in early June with Haduvio meeting the primary endpoint with a statistically significant reduction in twenty four hour cost frequency across all dose groups studied. Since reporting our top line data, we have received the full data set from the trial and can confirm that the data across the secondary endpoints were consistent with the top line results.

Jennifer Good
Jennifer Good
Co-Founder, CEO, President & Director at Trevi Therapeutics Inc

Importantly, the quality of life assessment in our patients using the Lester Cough Questionnaire, or LCQ, showed marked improvement with a statistically significant reduction at both the fifty four and one hundred and eight milligram BID doses. ELCQ is a 21 scale with three different domains physical, social, and psychological. An increase in total score of 1.3 points is considered clinically meaningful. For the fifty four milligram and one hundred eight milligram BID doses, there was a statistically significant three point seven and three point four point increase, respectively, P equals 0.01 for the total LCQ score at week six. These are strong results for a six week study.

Jennifer Good
Jennifer Good
Co-Founder, CEO, President & Director at Trevi Therapeutics Inc

The LCQ is meaningful in patients with IPF. In fact, the publication from the large US Pulmonary Fibrosis Foundation registry demonstrated that a worse quality of life, as measured by the LCQ, correlated with the risk of worse health outcomes, such as respiratory hospitalizations and mortality. One of our key focuses at Trevy is remaining patient centric as we plan for development and commercialization. In a recent patient advisory board meeting, we reviewed the CORAL results to get patients' reactions. The two most important factors to patients when looking for a future cough treatment were seeing improvements in cough frequency and severity and quality of life, similar to what we've heard from physicians.

Jennifer Good
Jennifer Good
Co-Founder, CEO, President & Director at Trevi Therapeutics Inc

Several patients remarked that with the kind of change in cough seen in CORAL, it would be incredibly impactful and positive in their day to day lives. I was struck by how much cough controls patients' daily activities and how they isolate or compensate to avoid the embarrassment of coughing out in public. Coming off this data, Jim and his team have been very busy preparing for the end of phase II FDA meeting and the next set of trials. We will provide more detailed guidance when we initiate each trial, but let me give you a brief update on the priorities over the next few months. First, we are currently conducting a couple of important phase I studies.

Jennifer Good
Jennifer Good
Co-Founder, CEO, President & Director at Trevi Therapeutics Inc

We are working on completing our TITLE study, which is studying the respiratory function and safety of Haduvio on IPF patients, as well as conducting a drug drug interaction study looking at any potential PK effects of Nalbuphine when co administered with profanidone and nantenadib, both anti fibrotic that are taken by patients with IPF and other progressive fibrotic diseases. We expect to have the data from both of these trials in time for our end of phase two meeting with the FDA. As for the end of Phase II meeting, we expect to request that meeting in the fourth quarter of this year. The key points we are looking to discuss with the FDA are to gain alignment on the Phase III program for cough and IPF, as well as any other NDA enabling work which needs to be completed. In parallel, the team has been preparing to initiate the phase three program in the first half of next year.

Jennifer Good
Jennifer Good
Co-Founder, CEO, President & Director at Trevi Therapeutics Inc

We have also been preparing for a study in other non IPF interstitial lung diseases. This population will include non IPF patients that have lung fibrosis and cough. We estimate there approximately two hundred and twenty eight thousand of these patients, with fifty percent to sixty percent having uncontrolled cough. This more than doubles the market opportunity of IPF cough, and these patients are primarily seen by the same pulmonologists that see the IPF patients. This keeps our clinical and commercial efforts efficient and creates synergies.

Jennifer Good
Jennifer Good
Co-Founder, CEO, President & Director at Trevi Therapeutics Inc

We plan to request a meeting with the FDA this year to discuss our study design for non IPF ILD and the protocol for this indication. Once we have FDA input, we will be prepared to initiate this study. Finally, we have been working on the next study in refractory chronic cough. We expect that to be a Phase IIb parallel arm study design looking at dose ranging, and are planning to initiate that study in the first half of next year as well. So as you can see, there's a lot of clinical development planning going on at Trevy, as well as preparation work to align with the regulatory authorities.

Jennifer Good
Jennifer Good
Co-Founder, CEO, President & Director at Trevi Therapeutics Inc

This takes time to ensure that we get these next set of trials right. We will provide updates on next steps as we gain alignment and have line of sight to study starts. I will now turn it over to Lisa to review our financial results, and we will open it up for any questions you may have.

Lisa Delfini
Lisa Delfini
CFO at Trevi Therapeutics Inc

Thank you, Jennifer, and good afternoon, everyone. The full financial results for the three months ended 06/30/2025, 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 2025, we reported a net loss of $12,300,000 compared to a net loss of $12,400,000 for the same quarter in 2024. R and D expenses decreased to $9,400,000 during the 2025 compared to $10,000,000 in the same quarter in 2024. The reduction was primarily due to decreased costs related to our Phase 2a RIVOR trial, our human abuse potential study and our Phase 2b CORAL trial, all of which were actively enrolling in the prior year.

Lisa Delfini
Lisa Delfini
CFO at Trevi Therapeutics Inc

This was partially offset by increased costs related to our recently initiated Phase one drug drug interaction study and personnel and related expenses. G and A expenses increased to $4,300,000 during the 2025 compared to $3,300,000 in the same quarter of 2024, primarily due to an increase in professional fees and personnel and related expenses. The personnel and related expenses were primarily due to increased headcount. Approximately $500,000 of the $1,000,000 increase in total general and administrative expenses was due to cost to prepare for SOC Section four zero four related to our internal controls. These requirements become more rigorous as the company's market cap grows.

Lisa Delfini
Lisa Delfini
CFO at Trevi Therapeutics Inc

As we continue our readiness efforts, we expect approximately this level of expense for the 2025 and the expense may increase going forward. As of 06/30/2025, our cash and investments totaled approximately $2.00 $4,000,000 As Jennifer mentioned, the increase in our cash and investments was primarily a result of the successful public offering we completed in June 2025 after the release of the data from our Phase 2b CORAL trial that resulted in gross proceeds of approximately $115,000,000 including the full exercise of the Green Chew. Our cash and investment balance gives us cash runway into 2029 and enables us to fund two Phase III trials of Hiduvia for the treatment of chronic cough in patients with IPF, our planned trial for chronic cough in patients with non IPF ILD, our next trial in patients with RCC, the Phase I work Jennifer discussed, and it enables pre commercial planning activities. In summary, Trevy is in a strong position financially to execute our business plan. This concludes our prepared remarks.

Lisa Delfini
Lisa Delfini
CFO at Trevi Therapeutics Inc

I will now turn the call back over to the operator for Q and A.

Operator

We will now begin the question and answer session. To ask a question, you may press star then one on your touch tone phone. If you are using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star then 2. Due to the number of participants on the call, questions will be limited to one per caller and any relevant follow-up to your question.

Operator

If you have other questions, you may get back in the queue. At this time, we will pause momentarily to assemble our roster. The first question comes from Fiselle, Khorsid from Leerink Partners. Go ahead please.

Faisal Khurshid
Senior Research Analyst - Emerging Immunology at Leerink Partners

Hey, good afternoon guys. Thank you for taking the question. It kind of feels like a calm after the storm moment here. I wanted to ask on the respiratory depression study. Could you comment a little bit on the progress of this study and just what it entails in the logistics?

Faisal Khurshid
Senior Research Analyst - Emerging Immunology at Leerink Partners

And what I'm trying to get at is like for investors, should we think about this as just sort of like any risk involved in that study or how to kind of like think about the outcomes there? Thank you.

James Cassella
James Cassella
Chief Development Officer at Trevi Therapeutics Inc

Hi, Cecil. Jim here. Thanks for the question. So our respiratory safety study, as you know, is about looking at the effects potential effects of Nalbuphine, of Haduvio on respiration, looking at rate, CO2 and O2 in patients with IPF. So it is an assessment study, it's to characterize if there's any effects there in this patient population.

James Cassella
James Cassella
Chief Development Officer at Trevi Therapeutics Inc

I would say that it's an informative study. It's a study that the FDA has been looking for in order to understand the characteristics in those patient populations. So the progress is that we have this study ongoing. We have two active sites. We did do some tweaking when I arrived at the company.

James Cassella
James Cassella
Chief Development Officer at Trevi Therapeutics Inc

We modified the protocol to make it simpler and easier and a little bit more straightforward. So there was a little bit of a delay in sort of the changes that occurred there. But we are on track and our expectation is still that we will have data for the end of Phase II meeting.

Faisal Khurshid
Senior Research Analyst - Emerging Immunology at Leerink Partners

Got it. Thank you. And then just on the DDI study, could you just comment on why that's a requirement considering that you had background anti fibrotic use in your prior IPF studies?

James Cassella
James Cassella
Chief Development Officer at Trevi Therapeutics Inc

Yes. So, that's a great question. And I think it really this is one of those Phase I studies that you just need to characterize it. This is more about the potential for metabolic PK drug interactions. Our drug is metabolized through primarily CYP liver enzymes.

James Cassella
James Cassella
Chief Development Officer at Trevi Therapeutics Inc

Anti fibrotic will be used in patients, profanenone and entanenib. It's really a check the box activity based on the metabolic fate or the way the drugs are metabolized for profenadone and ententanib. There's no expected drug drug interaction. But the reason you do these studies, especially before you get to Phase three, is you want to see if when you put these drugs together if there's any change in the pharmacokinetics of our drug or the other drugs which may impact the overall efficacy of the compounds. And we know there have been some data out there where folks found out in Phase III that there was a pharmacokinetic interaction that did have a direct effect on efficacy for at least one of the doses.

James Cassella
James Cassella
Chief Development Officer at Trevi Therapeutics Inc

So this is a study that was on the books, because patients with IPF will be on these drugs and it's pretty much an activity that the FDA was expecting, so it was planned for us.

Faisal Khurshid
Senior Research Analyst - Emerging Immunology at Leerink Partners

Great, thank you for taking the questions.

Operator

The next question comes from Jason Doerr of Oppenheimer. Go ahead please.

Jason Dorr
Associate Director at Oppenheimer & Co. Inc.

Hello there. Jason here standing in for Leland Gershell. One or two questions from us, first of which is going to be, how are you thinking about the key questions to iron out in the upcoming FDA meeting as your team plans for Haduvia's Phase III trial in IPF cough? And regarding one of your other indications, what color can you provide on the soon to start trial in non IPF ILD chronic cough? Thank you.

Jennifer Good
Jennifer Good
Co-Founder, CEO, President & Director at Trevi Therapeutics Inc

Jim, you're the guy, go ahead.

James Cassella
James Cassella
Chief Development Officer at Trevi Therapeutics Inc

Happy to talk about both of those things. In the Phase II meeting is a very important meeting. It's also a very routine meeting for anybody that's going into advanced clinical development. The key thing that we'll be bringing to the FDA at the end of Phase II meeting is the data we've collected to date, especially data from CORAL, which was our definitive dose ranging study. It's about the adequacy of where we are in our program, how we establish the doses that we wanna use and primarily to talk about the Phase three program, the readiness to be into Phase three, the specifics of the protocol.

James Cassella
James Cassella
Chief Development Officer at Trevi Therapeutics Inc

Typically the protocol for the Phase three is submitted as part of the briefing document. So we'll definitely have a lot of discussion about the Phase three, get their buying on that, as well as as we look forward towards NDA, the other anticipated trials that we may we or the FDA may decide that we need to do in order to have a sufficient package for registration purposes. So things like these DDI studies that we're doing will all be part of that package. So we'll have that conversation with the FDA then as well. And one of the other things that's important to get out of the end of Phase two meeting is what the expectation is on the size of the safety database, the duration of the data that is included in that safety database.

James Cassella
James Cassella
Chief Development Officer at Trevi Therapeutics Inc

And as we've been expecting all along and talking about some kind of a long term extension trial beyond our phase three that will satisfy the FDA's requirements for longer term exposure than what we need to do to show the preliminary safety and efficacy. So that answers that part of the question. I'll pause there if you have any other question on that.

Jason Dorr
Associate Director at Oppenheimer & Co. Inc.

No, that's really great, appreciate it.

James Cassella
James Cassella
Chief Development Officer at Trevi Therapeutics Inc

On the non IPF ILD, we've had a lot of great interactions with pulmonologists and KOLs in this space. As you know, IPF is an interstitial lung disease. It's a very well defined population. As you heard from us before, there are a lot of other patient groups who have interstitial lung disease, but not IPF. So people with rheumatoid arthritis or Sjogren's or systemic sclerosis.

James Cassella
James Cassella
Chief Development Officer at Trevi Therapeutics Inc

So we'll be looking at that other population defined by a certain amount of lung fibrosis, as well as minimum cough. So, we'll be really looking at that part of the population. We expect the endpoints and everything will be the same as in the IPF because it is a continuum with the IPF population with the underlying lung fibrosis. So I think we have a pretty good handle based on our conversations with the experts here on what we need to do for the conduct of that study. So it really is expanding the patient base.

Jennifer Good
Jennifer Good
Co-Founder, CEO, President & Director at Trevi Therapeutics Inc

And Jim, think I would just add, because we I think before I talked about this next study as being sort of a Phase 2a crossover. I think after going through all the IPF data and discussing it with the KOLs, this drug works in cough. I think the whole proof of concept does this drug work here, nobody thought that added a lot of value. So we've evolved our thinking to think about doing something that's definitely a parallel arm design and maybe sort of moves this program along faster. So we want to align with the agency on that plan, and how we might lean in on that and sort of have it meet up with our IPF program somewhere along the way.

Jennifer Good
Jennifer Good
Co-Founder, CEO, President & Director at Trevi Therapeutics Inc

So I would say a little bit of evolution in our thinking as we've gotten all the data.

Jason Dorr
Associate Director at Oppenheimer & Co. Inc.

That's really helpful. Thank you again.

Jennifer Good
Jennifer Good
Co-Founder, CEO, President & Director at Trevi Therapeutics Inc

Yeah, thank you.

Operator

The next question comes from Annabel Samimy of Stifel. Go ahead, please.

Annabel Samimy
Annabel Samimy
Managing Director at Stifel Financial Corp

Hi. Thanks for taking my question. I just want to follow-up on that last point regarding the parallel design for the non IPF ILD study. So I couldn't help but remember some of the KOLs stating that the ILD patients, or non IPF patients rather, have a pretty much of a similar disease progression as well as a fibrotic mechanism or interstitial lung disease mechanism to their cough. So when you talk about a parallel design, is it possibly maybe even some kind of basket trial and, you know, guess sticking with a phase two without having to move rapidly or move into a phase three to get a label expansion?

Annabel Samimy
Annabel Samimy
Managing Director at Stifel Financial Corp

Is it just gonna be, showing, some level of proof that it works given that this seems to be a general have such a general mechanism that it works across all cough indications. So I guess that's the first convoluted question I have.

Jennifer Good
Jennifer Good
Co-Founder, CEO, President & Director at Trevi Therapeutics Inc

Question du jour. We've been debating that in here. Go ahead, Jim.

James Cassella
James Cassella
Chief Development Officer at Trevi Therapeutics Inc

Annabelle, yes. The answer is yes.

James Cassella
James Cassella
Chief Development Officer at Trevi Therapeutics Inc

Yes, would characterize it less as a basket trial and more as there's gonna be a minimum criteria for coming in that will allow these patients that may have very different kinds of comorbidities to be enrolled in the trial. So, your point is that there is a commonality here on the fibrosis and in some cases even the progression. So we'll be maybe a little bit more opened up and less specific on certain types of comorbid conditions coming in. So that's on the basic pool. So again, I think we've gotten broader in our thinking in that regard with the help of the experts who feel like the fibrosis is really the key criteria here.

Jennifer Good
Jennifer Good
Co-Founder, CEO, President & Director at Trevi Therapeutics Inc

And cough.

James Cassella
James Cassella
Chief Development Officer at Trevi Therapeutics Inc

And the cough, and obviously the cough. So the parallel group or parallel arm design study, think of what we learned from CORAL. And as Jen said, it's really good to jump to something like that. We don't really need to do the proof of concept. I think we all are believers there.

James Cassella
James Cassella
Chief Development Officer at Trevi Therapeutics Inc

I think the key is that we will be able to look at this initial phase two type study, digest the results and as appropriate and with further conversations with FDA, maybe even meld it into our IPF program as we move things in parallel down the road. I think the important point here is that things will be moving in parallel and when there's opportunity and the right kind of data sets, we will be able to have those discussions on melding.

Annabel Samimy
Annabel Samimy
Managing Director at Stifel Financial Corp

Okay, got it, got it. Okay, and then just on IPF, I guess I'm still pretty impressed with the tolerability and the low discontinuation rates that you have. I guess, you know, combine that with the strong quality of life scores that you had. I guess, you know, my question now is, you know, now that you've dug into this data and you've really gotten a chance to characterize some of these adverse events and how they, you know, were primarily on initiation regardless of dose, is there anything more that you can say about this? And do you really think you need to actually make any changes here?

Annabel Samimy
Annabel Samimy
Managing Director at Stifel Financial Corp

Because it seems like everything lined up pretty nicely for you on the tolerability side and on the quality of life side. So it goes well together. So maybe you can just comment on that.

James Cassella
James Cassella
Chief Development Officer at Trevi Therapeutics Inc

Yeah, I mean, we were so happy with the CORAL data, with the outcome of that, the consistency of the findings on the primary and the key secondary and the other secondary endpoints. So I think we learned a lot. There's no real changes that we're thinking about going forward. Obviously, we'll be discussing the specifics of the Phase III design, including the dose selection with the FDA at the end of Phase II meeting. So I think we learned so much from the CORAL study.

James Cassella
James Cassella
Chief Development Officer at Trevi Therapeutics Inc

We're in really good shape for how we plan things going forward.

Annabel Samimy
Annabel Samimy
Managing Director at Stifel Financial Corp

Okay, great. Thank you.

Jennifer Good
Jennifer Good
Co-Founder, CEO, President & Director at Trevi Therapeutics Inc

Thanks, Annabelle.

Operator

Next question comes from Josh Schimmer of Cantor Fitzgerald. Go ahead, please.

Alexa Deemer
Biotechnology Equity Research Associate at Cantor Fitzgerald

Hi. This is Alexa Demer on for Josh Schimmer, and congrats on a great quarter. So my question is, with more of the complete data for CORAL now available, how are you thinking about which dose or doses to bring forward in the Phase III study?

James Cassella
James Cassella
Chief Development Officer at Trevi Therapeutics Inc

Great question. So we know that when we look at our overall data sets, that the fifty four milligram BID dose is really a sweet spot dose. It really performed quite well. It really had broad impact across our primary and secondary endpoints. So we know that as we think about this, the fifty four milligram BID dose is going to be a key dose that we bring forward.

James Cassella
James Cassella
Chief Development Officer at Trevi Therapeutics Inc

Obviously, it will be a placebo control. We will be discussing with FDA our dose selection rationale. So we can't really talk about all the specifics there. But I think you can anticipate that fifty four is going to be a key dose bringing forward.

Alexa Deemer
Biotechnology Equity Research Associate at Cantor Fitzgerald

Okay, awesome. Thank you so much.

Operator

The next question comes from Serge Belanger of Needham and Company. Go ahead please.

Serge Belanger
Senior Analyst at Needham & Company

Hi, good afternoon. I believe you highlighted the full results of the CORAL trial that you received, I guess, the last month. Can you put maybe provide a little more context around the LCQ data, how it relates to the primary endpoint? And are there other secondary endpoints that we will see at medical meetings or in publications in the future?

James Cassella
James Cassella
Chief Development Officer at Trevi Therapeutics Inc

Sure, so the Lester cough questionnaire is a really widely used quality like questionnaire. We reported previously that we have very significant findings at the total assessment. When we look at the domain scores of physical, psychological and social domains, especially like I mentioned, the fifty four dose, we see very, very strong effects on those domains. These are looking at the impact of cough on their physical domain, social aspects of their life, psychological aspects of their life, and we see very clear significant findings, again, focusing on the fifty four dose, very, very clear findings there. So I think that really helps.

James Cassella
James Cassella
Chief Development Officer at Trevi Therapeutics Inc

It complements the objective cough data that we have. So this is objective cough is objective cough, is measured with an instrument. This is now the patient opining on how their life has been changed, their quality of life on these specific domains and rolling up into this total score. So I think it complements and puts the patient perspective in the light of the reduction in cough frequency. So that's a very, very the reason we highlight that is because it's a very common type of assessment tool, and I think a very important one when we look at quality of life.

James Cassella
James Cassella
Chief Development Officer at Trevi Therapeutics Inc

We have looked at the other patient reported outcome measures that we'll talk about at future meetings, patient global impressions, clinician global impressions, and we talked about the cost severity scores. So there will be lots of secondary endpoint patient reported outcome data to come at further meetings.

Farrell Simon
Farrell Simon
Chief Commercial Officer at Trevi Therapeutics Inc

Serge, this is Farrell. Serge, I just wanted to add something to what Jim was saying. The LCQ is a really important thing in terms of reimbursement and value, painting that overall picture in addition to the primary endpoint and the key secondary endpoints. So, I think Jennifer said upfront, the linkage also here is, if you look at the U. S.

Farrell Simon
Farrell Simon
Chief Commercial Officer at Trevi Therapeutics Inc

Pulmonary Fibrosis Foundation registry, there was a strong link and correlation between baseline LCQ and impact on health outcomes. Now that'll be seen over a much longer period of time. And I think that's something that we'll look at as we go to a pivotal program. How does this impact things like respiratory hospitalization and mortality?

Serge Belanger
Senior Analyst at Needham & Company

Thanks. And maybe a non Jim question for Lisa. Please.

Jennifer Good
Jennifer Good
Co-Founder, CEO, President & Director at Trevi Therapeutics Inc

Lisa is so happy.

Serge Belanger
Senior Analyst at Needham & Company

Should we expect OpEx to remain relatively flat from 2Q levels for the remainder of the year until some of these larger trials get underway in 2026?

Lisa Delfini
Lisa Delfini
CFO at Trevi Therapeutics Inc

Yes, that's right, Serge.

Serge Belanger
Senior Analyst at Needham & Company

All right. Perfect. Thanks.

Jennifer Good
Jennifer Good
Co-Founder, CEO, President & Director at Trevi Therapeutics Inc

Thanks, Serge.

Operator

The next question comes from Deb Chatterjee of JonesTrading. Go ahead, please.

Debanjana Chatterjee
Vice President at Jones Trading

Hi. Thanks for taking my question. So, I have one question on RCC. So, based on GSK's latest, guidance, it seems that the KARN-two will now read out potentially 2026 with KARN-one data coming together as a bundle. So, you know, I was just curious, are you aware of any particular enrollment criteria related, maybe delays?

Debanjana Chatterjee
Vice President at Jones Trading

What is actually the headwind for the trial? And are there any implications for the RCC trial you're planning? And I have a quick follow-up.

Farrell Simon
Farrell Simon
Chief Commercial Officer at Trevi Therapeutics Inc

So Deb, this is Farrell. I can talk about what we know. I mean, don't really comment on competitive reasons. We don't have any insight into what's causing some of those delays. What we know is when we look at our opportunity within RCC, we have the potential to be best in class in that indication. And I think that's the difference in approach that we're taking of going after a treatment resistant population, those who failed other therapies, there's still large patient opportunity there.

Jennifer Good
Jennifer Good
Co-Founder, CEO, President & Director at Trevi Therapeutics Inc

Yeah, and I would just add, we would have loved to have seen their data before we fired up on our trial, but we're not going to hold up and wait for it. So I think at this point with their data sort of slipping back, we're going to be ready to go before that. So it's going to have no impact on our

James Cassella
James Cassella
Chief Development Officer at Trevi Therapeutics Inc

No impact at all. And I think the strength of the data that we had from the RIVER trial, I think will have really positive impact on our ability to run the next trial as well. I think that that's also a thing that not only physicians, but the patients pay attention to as well. So I don't anticipate any problem. I don't know what the delays are related to there.

James Cassella
James Cassella
Chief Development Officer at Trevi Therapeutics Inc

I know they're running a big global trial, but our next trial is going be dose ranging, coming off of really solid data that will go a long way.

Debanjana Chatterjee
Vice President at Jones Trading

Thank you, very helpful. And a quick follow-up. This is like related to IPF. So you mentioned the drug drug interactions with nipitant and pifanidone. Any plans of checking for drug drug interactions with mirandomilized?

James Cassella
James Cassella
Chief Development Officer at Trevi Therapeutics Inc

No. There will be some other drug drug interaction studies that again relate to mechanism of metabolism. Those are very standard. They've been on our list of things to do before the NDA. But no, I think those are the two anti fibrotic that we'll be focused on.

Debanjana Chatterjee
Vice President at Jones Trading

Thank you so much.

Jennifer Good
Jennifer Good
Co-Founder, CEO, President & Director at Trevi Therapeutics Inc

Thank you.

Operator

Next question comes from Ryan Deschner of Raymond James. Go ahead, please.

Ryan Deschner
Ryan Deschner
Vice President - Equity Research at Raymond James Financial

Thanks very much. Have there been any other interesting trends or post hoc analyses coming from CORAL or RIVER that have caused your perspective on dosing to evolve in either indication? And can you also give us any additional detail on what specifically you're planning to present at ERS later this year? Thanks.

James Cassella
James Cassella
Chief Development Officer at Trevi Therapeutics Inc

We've done a very deep dive on analysis of our dose effects. We've absolutely, I think, concluded that fifty four is a very key dose for us. I don't wanna get ahead of our skis on talking about how we might approach another dose in the trial until we have that conversation with the FDA. But I think you can really see based on the all the analyses that we've done internally and had discussions with some experts and statisticians that fifty four is going be an anchor dose for us.

Jennifer Good
Jennifer Good
Co-Founder, CEO, President & Director at Trevi Therapeutics Inc

Yeah. And otherwise, Jim, I would just add, no surprises, right? AE came on early, they tend to dissipate quickly. I mean, it's the same personality that we've seen in every Obviously, sort of

James Cassella
James Cassella
Chief Development Officer at Trevi Therapeutics Inc

twenty seven will be used at a minimum as a titration dose.

Jennifer Good
Jennifer Good
Co-Founder, CEO, President & Director at Trevi Therapeutics Inc

Yeah, I think just robust. As far as your question, Ryan, on presenting at ERS, we have two abstracts that have been accepted on RCC. We're going to be putting our IPF data in a chest because we wanted that presented in The U. S, which is in October in Chicago. So those are the two medical meetings that our data will be hopefully presented at.

Jennifer Good
Jennifer Good
Co-Founder, CEO, President & Director at Trevi Therapeutics Inc

We know we've been accepted at ERS for RCC, but we don't know about CHEST yet.

Ryan Deschner
Ryan Deschner
Vice President - Equity Research at Raymond James Financial

Excellent. Congrats on the program.

Jennifer Good
Jennifer Good
Co-Founder, CEO, President & Director at Trevi Therapeutics Inc

Thank you.

Operator

The next question comes from Brandon Folkes of H. C. Wainwright. Go ahead please.

Brandon Folkes
Managing Director at H.C. Wainwright & Co.

Hi, thanks for taking my question. Maybe just coming back to a bit of an old topic here, but understanding there's not really a commercial impact on the scheduling in the IPF patient population. Have you done any commercial work or have any thoughts on scheduling impacts in the non IPF ILD indications just to in terms of prescribing habit?

Farrell Simon
Farrell Simon
Chief Commercial Officer at Trevi Therapeutics Inc

Thanks, Brandon. This is Farrell. So we've done some qual work within that space to talk to providers when you look at the overall key prescriber in that area, it's still going to be that pulmonologist. And so it really is the call point to the pulmonologist where we don't see a sensitivity to the mechanism behind the prescribing. We're going back and testing an updated TPP based on the core results.

Farrell Simon
Farrell Simon
Chief Commercial Officer at Trevi Therapeutics Inc

We'll test that across a broad range of potential patient types, But we don't anticipate an impact in non IPF ILD either.

Brandon Folkes
Managing Director at H.C. Wainwright & Co.

Great, thanks. And maybe just one follow-up. Understanding what the respiratory depression study is about here, but if we see any anomalies unexpected on the negative side, is there any obligation in terms of submitting that to the DEA in terms of scheduling? Is there any precedent that we need to keep one eye on sort of sort of the outlier event if we do see something in that data on scheduling? Or is that completely closed now?

James Cassella
James Cassella
Chief Development Officer at Trevi Therapeutics Inc

I don't think that the respiratory safety study will have any direct impact on scheduling per se. I think it really is about just establishing and showing the characteristics that we're looking at in that study. I think scheduling is really gonna be based on abuse liability and potential on that side.

Brandon Folkes
Managing Director at H.C. Wainwright & Co.

Great, thanks for taking my questions.

Jennifer Good
Jennifer Good
Co-Founder, CEO, President & Director at Trevi Therapeutics Inc

Thanks, Brandon.

Operator

The next question comes from Kaveri Pullman of Clear Street. Go ahead, please.

Kaveri Pohlman
MD & Senior Equity Research Analyst at Clear Street

Yes. Good evening. Thanks for taking my question and for the update. As we move into the Phase III trials with longer follow-up than what you had for the Phase II, how are you planning to manage this placebo effect? And also, what challenges did you address in the Phase II that give you confidence going forward?

Kaveri Pohlman
MD & Senior Equity Research Analyst at Clear Street

And additionally, based on historical data and your own experience, are there any new hurdles you anticipate in the Phase III? I guess this is more like a remedial question. And another question I have is on, as you are approaching Phase III, I would like to understand if there are any extra steps in terms of manufacturing for potential commercialization, And any updated thoughts on partnering for commercialization? Thank you.

James Cassella
James Cassella
Chief Development Officer at Trevi Therapeutics Inc

Can take the first.

Jennifer Good
Jennifer Good
Co-Founder, CEO, President & Director at Trevi Therapeutics Inc

You do all the development.

James Cassella
James Cassella
Chief Development Officer at Trevi Therapeutics Inc

I can take the first. Six parts Okay. For Thank you for the question.

Jennifer Good
Jennifer Good
Co-Founder, CEO, President & Director at Trevi Therapeutics Inc

I love the way we limit you to one question.

Lisa Delfini
Lisa Delfini
CFO at Trevi Therapeutics Inc

Five in there, I think.

James Cassella
James Cassella
Chief Development Officer at Trevi Therapeutics Inc

Yeah, think it went to AA.

Lisa Delfini
Lisa Delfini
CFO at Trevi Therapeutics Inc

Very exciting.

James Cassella
James Cassella
Chief Development Officer at Trevi Therapeutics Inc

No worries. So as far as the phase three goes, I think we learned so much in the program so far. I think CORAL was a real testing ground, proving ground for us in terms of the parallel group design. We learned a lot from that study and I think some of the things that we learned was the rapid onset of effect. Really we saw the drug effect, the efficacy coming in by that two week time point.

James Cassella
James Cassella
Chief Development Officer at Trevi Therapeutics Inc

Things pretty much stabilized from that point on. So I think we don't anticipate any changes beyond that. So in the course of that overall six week study, we saw that efficacy stabilized over from weeks two to four. I think that was fine. We didn't see anything new really popping up later on in the dosing weeks in terms of safety, so I don't think we need to anticipate that.

James Cassella
James Cassella
Chief Development Officer at Trevi Therapeutics Inc

The placebo effect, I'm not sure that we really have a placebo effect. We had a well controlled trial. I think obviously going bigger trials is something we always have to watch for, but we had a very large effect size. So I don't think we're anticipating any issues there in terms of trying to control that placebo effect when we have the kinds of delta that we have right now. I don't think we're going to see any new hurdles as we look forward into longer term dosing trials.

James Cassella
James Cassella
Chief Development Officer at Trevi Therapeutics Inc

I think we've really tested that here. We don't see anything with the history of opiates where things really pop up later. Usually things pop up earlier. I think we saw that in our trial. I think we saw that during the titration phase where we did see the adverse events that pretty much dissipated during that titration phase and really did not come back as we maintained our dose at the even at the one hundred eight level.

James Cassella
James Cassella
Chief Development Officer at Trevi Therapeutics Inc

So I don't think we have any surprises on the horizon. I think we're really good there. Just a quick response to your manufacturing question. We know how to make the drug. We know how to supply the drug for bigger trials.

James Cassella
James Cassella
Chief Development Officer at Trevi Therapeutics Inc

We've been in Europe and we've been other places. We know how to get the drug distributed. So no issues there on the Phase III front. Mean this is we've got an experienced team here that have run large trials before and we've already been to a lot of places. I don't anticipate any problems with that. So that's as far as I remember That was

Jennifer Good
Jennifer Good
Co-Founder, CEO, President & Director at Trevi Therapeutics Inc

impressive. My I'll take the partnering question. Kaveri, that's something that Sarah and I always spend time on obviously. I think what partnering is probably most relevant for us is in Europe or Japan. In The U.

Jennifer Good
Jennifer Good
Co-Founder, CEO, President & Director at Trevi Therapeutics Inc

S, Farrell is kind of all steam ahead on how this gets commercialized here. I think if somebody wanted to have those rights in The U. S, they'd have to buy the company. So, really no change for us. We would look to probably partner this, now in Europe or Japan, maybe Japan, I guess, but not Europe.

Jennifer Good
Jennifer Good
Co-Founder, CEO, President & Director at Trevi Therapeutics Inc

We're just really focused on our phase three program, how we get to the end, get good data, and obviously are in relevant conversations with strategics as it makes sense for the company.

Kaveri Pohlman
MD & Senior Equity Research Analyst at Clear Street

Appreciate the color. Thank you and congratulations.

Jennifer Good
Jennifer Good
Co-Founder, CEO, President & Director at Trevi Therapeutics Inc

Yeah. Thank you. Thanks for your excitement. Thank you.

Operator

The next question comes from Imtani from B. Riley. Go ahead please.

Mayank Mamtani
Senior MD & Group Head - Healthcare at B. Riley Securities

Hey, good afternoon team. Thanks for squeezing us in. Could you please touch on the dose levels you're exploring in the two phase one trials? Also curious if this dose finding work between IPF chronic cough and RCC helps you with the IP strategy? And just maybe my follow-up on the chest presentation for the IPF data.

Mayank Mamtani
Senior MD & Group Head - Healthcare at B. Riley Securities

Would you have any FVC data there, maybe segmented by background therapy or without background therapy? Thanks for taking my questions.

Jennifer Good
Jennifer Good
Co-Founder, CEO, President & Director at Trevi Therapeutics Inc

I'll take the chest thing, Jim, and I you can take think I got the other ones. The chest, my prep is really going to be a lot of the primary data we've already disclosed in IPF. FVC, don't plan to publish, as we've said sort of consistently. It's a safety parameter, but it's not it was too short of a study to really get at anything there. So I don't want to get anyone excited that there's something new that we're going to put out there.

Jennifer Good
Jennifer Good
Co-Founder, CEO, President & Director at Trevi Therapeutics Inc

It'll be really around our primary data. I think, Jim, I can also take the IP question, which was, I mean, we're always looking for in any study we run. After every study we complete, we meet with our IP lawyers, review all the data, and look for anything that might end up in the label that we can file claims around dosing or whatever. So that's an ongoing activity here. I think we'll have to wait and see the data if there was something that was surprising or non obvious, and we'll file dosing claims around that. So that is an ongoing activity.

James Cassella
James Cassella
Chief Development Officer at Trevi Therapeutics Inc

The Phase I studies are single dose strength studies that we compare I'm sorry, the TITLE study is a dose escalation up to the top dose that we are using in that study. And then the DI study is against profenadone and entanatib under various dosing regimens against the single dose strength of Nalbuphine.

Mayank Mamtani
Senior MD & Group Head - Healthcare at B. Riley Securities

Thank you.

Jennifer Good
Jennifer Good
Co-Founder, CEO, President & Director at Trevi Therapeutics Inc

Thank you, Mayank.

Operator

I am not showing any further questions. This concludes our question and answer session. I would like to turn the conference call back over to Jennifer Good for closing remarks.

Jennifer Good
Jennifer Good
Co-Founder, CEO, President & Director at Trevi Therapeutics Inc

We appreciate you joining us for today's call. Enjoy the rest of the summer, and we are available after the call for any follow-up questions. Just email Lisa or myself and we will get you on schedule. Thank you.

Operator

The conference call has now concluded. Thank you for attending today's

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