Q2 2025 Trevi Therapeutics Inc Earnings Call
Speaker #3: Good afternoon and welcome to the Trevi Therapeutics second quarter 2025 earnings conference call. At this time, all participants will be in listen-only mode. Should ou need assistance, please signal a conference specialist by pressing the star key followed by zero.
Speaker #3: After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone. To withdraw your question, please press star then two.
Speaker #3: 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 factor section of the company's most report on Form 10Q, which the company filed with the SEC this afternoon.
Speaker #3: 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.
Speaker #3: 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.
Speaker #3: I would now like to turn the conference over to Jennifer Good, Trevi's president and CEO. Please go ahead.
Speaker #4: Good afternoon and thank you for joining us for our second quarter 2025 earnings call and business update. Joining me today on this call are my colleagues Lisa Delfini, Trevi's chief financial officer, Dr. James Casella, ur chief development officer, and Farrell Simon, our chief commercial officer.
Speaker #4: Lisa I will make some comments on the business and financial results, then the team is happy to answer any questions that ou may have.
Speaker #4: The first half of this year has been a major inflection point for Trevi, with positive data readouts in both the quarterly trial for chronic cough in patients with idiopathic pulmonary fibrosis, or IPF, and the river trial for patients with refractory chronic cough, or RCC.
Speaker #4: As a result of this strong data, we were able to raise approximately $115 million in capital for total cash and investments at the end of June of approximately $204 million.
Speaker #4: 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.
Speaker #4: 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 quarterly trial were announced in early June, with Hiduvio meeting the primary endpoint with a statistically significant reduction in 24-hour cough frequency across all dose groups studied.
Speaker #4: 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.
Speaker #4: 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 54 and 108 milligram b.i.d.
Speaker #4: doses. The LCQ is a 21.-point scale with three different domains: physical, social, and psychological. An increase in total score of 1.3 points is considered clinically meaningful.
Speaker #4: For the 54 mg and 108 mg b.i.d. doses, there was a statistically significant 3.7 and 3.4-point increase, respectively (p = 0.01), for total LCQ score at week six.
Speaker #4: These are strong results for a six-week study. The LCQ is meaningful in patients with IPF, in fact, a 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.
Speaker #4: One of our key focuses at Trevi is remaining patient-centric as we plan for development and commercialization. In a recent patient advisory board meeting, we reviewed the quarterly results to get patients' reactions.
Speaker #4: 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.
Speaker #4: Several patients remarked that with the kind of change in cough seen in quarterly, it would be incredibly impactful and positive in their day-to-day lives.
Speaker #4: 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.
Speaker #4: Coming off this data, Jim and his team have been very busy preparing for the end-of-phase two FDA meeting and the next set of trials.
Speaker #4: 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.
Speaker #4: First, we are currently conducting a couple important phase one studies. We are working on completing our title study, which is studying the respiratory function and safety of Hiduvio on IPF patients as well as conducting a drug-drug interaction study looking at any potential PK effects of naubufen when co-administered with perphenidone and nintenidib, both anti-fibrotics that are taken by patients with IPF and other progressive fibrotic diseases.
Speaker #4: 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 two meeting, we expect to request that meeting in the fourth quarter of this year.
Speaker #4: The key points we are looking to discuss with the FDA are to gain alignment on phase three program, for cough and IPF, as well as any other NDA-enabling work which needs to be completed.
Speaker #4: In parallel, the team has been preparing to initiate the phase three program in the first half of next year. We have also been preparing for a study in other non-IPF interstitial lung diseases.
Speaker #4: This population will include non-IPF patients that have lung fibrosis and cough. We estimate there are approximately 228,000 of these patients with 50 to 60 percent having uncontrolled cough.
Speaker #4: 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.
Speaker #4: This keeps our clinical and commercial efforts efficient and creates synergies. 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.
Speaker #4: Once we have FDA input, we will be prepared to initiate this study. Finally, we have been refractory chronic cough. We expect that to be a phase two B parallel arm study design looking at dose ranging and are planning to initiate that study in first half of next year as well.
Speaker #4: So, as you can see, there is a lot of clinical development planning going on at Trevi, as well as preparation work to align with the regulatory authorities.
Speaker #4: This takes time to ensure that we get these next set of trials working on the next study in updates on next steps as we gain alignment and have line of sight to study starts.
Speaker #4: I will now turn it over to Lisa to review our financial results, then we will open it up for any questions you may have.
Speaker #5: Thank you, Jennifer, and good afternoon, everyone. The full financial results for the three-month period ending June 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.
Speaker #5: For the second quarter of 2025, we reported a net loss of 12.3 million compared to a net loss of 12.4 million for the same quarter in 2024.
Speaker #5: R&D expenses decreased to 9.4 million during the second quarter of 2025 compared to 10 million in the same quarter in 2024. The reduction was primarily due to decreased costs related to our phase two A river trial, our human abuse potential study, and our phase two B quarterly trial, all of which were actively enrolling in the prior year.
Speaker #5: This was partially offset by increased costs related to our recently initiated phase one drug-drug interaction study and personnel and related expenses. G&A expenses increased to 4.3 million during the second quarter of 2025 compared to 3.3 million in the same quarter of 2024.
Speaker #5: Primarily due to an rease 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 million increase in total general and administrative expenses was due to costs to prepare for SOC Section 404(b) related to our internal controls.
Speaker #5: These requirements become more rigorous as the company's market cap grows. As we continue our readiness efforts, we expect approximately this level of expense for second half of 2025 and the expense may increase going forward.
Speaker #5: As of June 30th, 2025, our cash and investments totaled approximately $204 million, as Jennifer mentioned, the rease 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 two B quarterly trial that resulted in gross proceeds of approximately $115 million, including the full exercise of the green shoe.
Speaker #5: Our cash and estment balance gives us cash runway into 2029 and enables us to fund two phase three trials of Hiduvio 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 one work Jennifer discussed, and it enables pre-commercial planning activities.
Speaker #5: In summary, Trevi is in a strong position financially to execute our business plan. This concludes our prepared remarks. I will now turn the call back over to the operator for Q&A.
Speaker #6: We will now begin the question and answer session. To ask a question, you may press star then one on your touchstone phone. If you are using a speakerphone, please pick up your handset before pressing the keys.
Speaker #6: To withdraw your question, please press star then two. 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.
Speaker #6: If you have other questions, you may get back in the queue. At this time, we will pause momentarily to assemble our roster.
Speaker #7: Okay. The first question comes from Faisal I'm sorry, Kurshid from Lerank Partners. Go ahead, please.
Speaker #8: Hey, good afternoon, guys. Thank you for taking the estion. good kind of feels like a, calm after the storm, moment here. wanted to k on the, h, respiratory depression, study, could you comment a little bit on the progress, of the study and just what it entails in the logistics, and what I'm trying to get at is, like, for investors, you ow, should we think about this as, you know, just sort of, like, any risk involved in that study or, or how to kind of, like, think about, the outcomes there?
Speaker #8: Thank you.
Speaker #9: Hi, Faisal. Jim here. Thanks for the question. So, our respiratory safety study, as you know, is about looking at the effects, potential effects of, of naubufen, of Hiduvio on, respiration, looking at rate, CO2 and O2, in patients with IPF.
Speaker #9: So it is, an assessment study. It's to characterize, if there's any effects there, in this patient population. I would say that it's an informative study.
Speaker #9: It's a study that the FDA has been looking for, in order to understand the characteristics in those patient populations. So, the progresses that, we have the study ongoing, and we have two active sites, we did do some tweaking when I arrived at the company.
Speaker #9: We, we modified the protocol to make it, simpler and easier, and, 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 two meeting.
Speaker #8: Got it. Thank you. And then, just on the DDI study, could you comment on, on why that's the requirement considering that ou had background anti-fibrotic use in our, prior IPF studies?
Speaker #9: Yeah. So that's a great question, and I think it really, you know, this is one of those phase one studies that you just need to characterize it.
Speaker #9: This is more about the metabolic, potential for metabolic, PK drug interactions. our drug is a metabolized, through primarily SIPP liver enzymes. anti-fibrotics will be, used in patients, for, perphenidone and nintenidib.
Speaker #9: It's a really a check-the-box activity based on the metabolic fate or the way the drugs are metabolized for perphenidone and nintenidib. There's no expected drug-drug interaction.
Speaker #9: 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.
Speaker #9: And we know that there have been some, some data out there where, you know, folks found out in phase three that there was a pharmacokinetic interaction that did have a direct effect on efficacy for at ast one of the doses.
Speaker #9: 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.
Speaker #9: So it was planned for us.
Speaker #8: Great. Thank you taking the estions.
Speaker #7: The next question comes from Jason Dorr of Oppenheimer. Go ahead, please.
Speaker #10: Hello there. Jason here standing in for Lou Lingershaw. one or two questions from us. First of which is going to be, how are you inking about the key questions to iron out in the upcoming FDA meeting as your team plans for Hiduvio's phase three trial and IPF cough?
Speaker #10: And regarding one of your other indications, what color can you provide on the soon-to-start trial and non-IPF ILD chronic cough? Thank ou.
Speaker #4: Jim here, the guy. Go ahead.
Speaker #9: Happy to, talk about both of those things. So in the phase two meeting, is, is a very important meeting. It's also, very routine meeting for anybody that's going into advanced clinical development.
Speaker #9: The key thing that we'll be bringing to the FDA at the end of phase two meeting, is the data we've collected to date, especially data from quarterly, which was our definitive dose ranging study, it's about the adequacy of where we are in our program, how we established the doses that we want to use, and primarily to talk about the phase three program, the readiness to be into phase three, the specifics of the protocol, typically the protocol for the phase three is submitted as part of the briefing document.
Speaker #9: So we'll definitely have a lot of discussion about the phase three, get their buy-in on that. As well as, as we look forward towards NDA, the other anticipated trials that we may, you ow, we or the FDA may decide that we need to do in to have a sufficient package, for registration purposes.
Speaker #9: So, you know, things like these DDI studies that we're ing, will all be part of that package. So we'll have that conversation with the FDA then as well.
Speaker #9: 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 the safety database, the duration of the the data that is included in that safety database, and as we've been expecting all along and talking about, you know, 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 ed to do to show the preliminary safety and efficacy.
Speaker #9: So that answers that part of the question. I'll pause there if you have any other question on that.
Speaker #10: No, that's really great. Appreciate it.
Speaker #9: On the, non-IPF ILD, we've had a lot of great interactions with, pulmonologists and KOLs in this space. You know, as as you ow, IPF is an interstitial lung disease.
Speaker #9: It's a very well-defined population. You know, as you heard from us before, there are a lot of other, patient groups, who have, interstitial lung disease, but not IPF.
Speaker #9: So people with rheumatoid arthritis or Sjogren's or, systemic sclerosis. So we'll be looking at that other population defined by, certain amount of lung, fibrosis as well as, minimum cough.
Speaker #9: 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.
Speaker #9: So, I think we have a pretty good handle based on our conversations with the, experts here, on, what we need do for the conduct of that study.
Speaker #9: So it really is expanding the patient base.
Speaker #4: And Jim, I think I would just add, because we, I ink before I talked about this next study as being sort a phase two A crossover, I think after going through all the IPF data and and discussing it with the KOLs, you ow, this drug works in cough.
Speaker #4: 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 move this program along faster.
Speaker #4: 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.
Speaker #4: So I would say a little bit of evolution in our thinking as we've gotten all the data.
Speaker #10: That's really helpful. Thank you in.
Speaker #4: Yeah. Thank ou.
Speaker #7: The next question comes from Annabelle Samimi of Stifel. Go ahead, please.
Speaker #11: 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.
Speaker #11: 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, you know, fibrotic mechanism or interstitial lung disease mechanism to to their cough.
Speaker #11: so when you talk about a parallel design, is it possibly maybe even some kind of basket trial and, and, you ow, I guess sticking a a phase two without having to move rapidly into a or move into a phase three to get a label expansion?
Speaker #11: Is it just going to be, showing, some level proof that it works given that this seems to be a, general, you know, have such a general mechanism that it works across all cough indications?
Speaker #11: So I guess that's the first convoluted question I have. Mm-hmm.
Speaker #10: And about.
Speaker #4: The question du jour. We've been debating that in here. Go ahead, Jim.
Speaker #10: And about, yes. The answer is yes. so yes. I I would characterize it less as a basket trial and more as, there's ing to be a minimum criteria for coming in that will allow, these patients that may have, you know, very different kinds of comorbidities, to be enrolled in the trial.
Speaker #10: So to your point is that there is a a commonality here on the, on the fibrosis and in cases even the progression, so it will be maybe a ittle bit more opened up and and less specific on certain types of, , of comorbid conditions coming in.
Speaker #10: so that that's on the basis the basic pool. So again, I think we've gotten broader in our thinking in that regard with the help of the experts.
Speaker #10: Who feel like the, you know, this is like the fibrosis is really the the key criteria here.
Speaker #7: And cough.
Speaker #10: And the cough. And obviously the cough. So the the parallel group, or parallel arm design study, think of, well, we learn from quarterly and and as Jen said, you ow, it's really good to jump to something like that now.
Speaker #10: We don't ally need to do the proof of concept. I think we all are believers there. I think the key is that we will be able to, look at this, you know, initial, you know, phase two type study, digest the results, and and as appropriate and with further conversations with a maybe even meld it into our IPF program, as we move things in parallel down the road.
Speaker #10: I ink 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.
Speaker #7: Okay. Got it. Got it. okay. And then just on IPF, I guess I'm still pretty impressed the tolerability and the low discontinuation rates that you have, and I guess, you know, combine that with the strong quality life scores that you had.
Speaker #7: I guess, you know, my question now is, you know, now that ou've dug into this data and and 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?
Speaker #7: because it seems like everything lined up pretty nicely for you. on the on the tolerability side. And on the quality of life side. so it goes well together.
Speaker #7: So, maybe you can just comment on that.
Speaker #9: Yeah. I mean, we were so happy with the quarterly data, with the outcome of that, the consistency, of the findings on the primary and the key secondary, and the and the other secondary endpoints.
Speaker #9: So I think we we learned a lot. There's no real changes, that we're thinking going forward. Obviously, we'll be discussing, you know, the specifics of the phase three design, including, you know, the dose selection, with the FDA at end of phase two meeting.
Speaker #9: So I think we learned so much from the quarterly study, we're in really good shape for how we plan things going forward.
Speaker #7: Okay. Great. Thank ou.
Speaker #4: Thanks, Annabelle.
Speaker #7: The next question comes from Josh Shimmer of Cantor Fitzgerald. Go ahead, please.
Speaker #12: Hi. This is Alexa Diemer on for Josh Shimmer and congrats on a great quarter. So my question is, with more of the complete data for quarterly now available, how are you inking about which dose or doses to bring forward in the phase three study?
Speaker #9: That's a great question. so we know that, when we look at our overall data sets, that the 54 milligram BID dose is really a sweet spot dose.
Speaker #9: It really performed quite well. It really had broad impact across our primary and secondary endpoints. So we know that as we think this, the 54 milligram BID dose is going to be a key dose that we bring forward.
Speaker #9: Obviously, there'll be a placebo control, we will be discussing with FDA, you know, our dose selection rationale. So, you ow, we can't really talk about all the specifics there, but I think you can anticipate that 54 is going to be a key dose bringing forward.
Speaker #7: Okay. Awesome. Thank you so much. The next question comes from Serge Bellinger of Needham and Company. Go ahead, please.
Speaker #13: Hi, good noon. I believe, you highlighted the the full results of the the quarterly trial that you received, I guess over the last month.
Speaker #13: can you put maybe provide a little more context around the LCQ data? How it relates to the the primary endpoint? And are there other secondary endpoints that we will see, a medical meetings or in publications in the future?
Speaker #9: Sure. So, the Lester Cough Questionnaire is a really widely used, quality-of-life questionnaire. We reported previously that we have very significant findings at the total assessment.
Speaker #9: When we look at the domain scores of physical, psychological, and social domains, you know, especially, like I mentioned, the 54 dose, we see very, very strong effects on those domains.
Speaker #9: So, you know, these are looking at the the impact of the 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 54 dose, very, very clear findings there.
Speaker #9: So I think that really helps. It complements the, the objective cough data that we have. So this is objective cough is objective cough. It's measured with an instrument.
Speaker #9: This is now the patient, you know, opining on how their life has been changed, their quality of life, on these specific domains and rolling up into this total score.
Speaker #9: So I think it complements and puts the patient perspective, in in the light of the reduction in cough frequency. So that's a very, very, the reason we highlight that is because it's it's a very common type of assessment tool, and I ink a very important one when we look at quality of life.
Speaker #9: We have looked at the other, you know, patient report outcome measures that we'll talk about at future meetings, you know, patient global impressions, clinician global impressions, and, we talked about the cough severity scores.
Speaker #9: So there will be lots of secondary endpoint, you ow, patient report outcome data to come at further meetings.
Speaker #10: Sir, this is Farrell. Oh, go ahead, sir. Sir. Oh, no. Just wanted add something to what Jim was saying. The LCQs are really important thing in terms of reimbursement and value.
Speaker #10: Painting that overall picture, in addition to the primary endpoint and the key secondary endpoints. So, you know, when I inked Jennifer said front, the linkage also here is if you look at the US Pulmonary Fibrosis Foundation registry, there was a strong link and correlation between baseline LCQ and impact on health outcomes.
Speaker #10: Now, that'll be seen over a much longer period of time. And I ink that's something that we'll look at as we go to a pivotal program.
Speaker #10: How does this impact things like respiratory hospitalization and, mortality? Thanks. And maybe a non-Jim question, for Lisa. please.
Speaker #4: Lisa, so happy.
Speaker #10: Should we expect OpEx to remain relatively flat from T2 levels for the remainder of the year until some of the some of these larger trials get underway in, or in 2026?
Speaker #5: Yeah, that's right, Sarge.
Speaker #10: All right. Perfect. Thanks.
Speaker #4: Thanks, Sarge.
Speaker #7: The next question comes from Deb Chatterjee of Jones Trading. Go ahead, please.
Speaker #12: Hi. Thanks for taking my question. So, I had one question on RCC. So, based on GSK's latest, guidance, it seems that the CON2 will now read out potentially second half of 2026 with CON1 data coming together as a bundle.
Speaker #12: So, you know, I was just curious, are ou aware of any particular, you ow, enrollment criteria related, maybe delays, what is actually the headwind for the, the trial?
Speaker #12: And are there any implications for the RCC trial you're planning? And I have a quick follow-up.
Speaker #10: So, so Deb, this is Farrell. I can talk about just just what we know. I mean, we don't really comment on on competitive reasons.
Speaker #10: We don't have any insight into what 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.
Speaker #10: And I think that's the difference in approach that we're taking of going after a treatment resistant population - those who've failed other therapies - there's still a large patient opportunity there.
Speaker #4: Yeah. And I would just add, we would have loved to have seen their data before we fired off on our trial, but we're not going to hold up and wait for it.
Speaker #4: So I think at this point with their data sort of slipping back, we're going to be ady to go before that. So it's going to have no impact on our future.
Speaker #10: No impact at all. And I think the the strength of the data that we had from the reverse trial, I think, will have really positive, impact on our ability to run the next trial as well.
Speaker #10: I think that, you know, that's also a thing that that that not only physicians but the patients pay attention to as well. So I don't anticipate any problem.
Speaker #10: I don't know what the delays are related to there. I know they're running a big global trial, but our next trial is going to be dose ranging, coming off of really solid data.
Speaker #10: That will go a long way.
Speaker #4: Thank you. Very helpful. and a quick follow-up. this is like related to IPF. so you mentioned the drug-drug interactions, with nintenidib and perphenidone. Any plans of checking for drug-drug, like interactions with niradonalized?
Speaker #9: 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, think those are the two, anti-fibrotics that we'll be focused on.
Speaker #9: I
Speaker #4: Okay. Thank you so much. Thank you.
Speaker #7: The next question comes
Speaker #13: very much. have there been any other interesting trends or post-hoc analyses coming from quarterly or but no.
Speaker #13: 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 DRS later this year?
Speaker #13: Thanks.
Speaker #9: We've done a very deep dive on analysis of our dose effects, we've absolutely, I think, concluded that 54 is a very key dose for us.
Speaker #9: I don't want to 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 the all the analyses that we've e, internally and had discussions with with, some experts and statisticians that 54 is going to an anchor dose for us.
Speaker #4: Yeah. And otherwise, Jim, I would just add no surprises, right? AE came on early. They tend dissipate quickly. I mean, 's the same personality that we've seen in every sort of trial, so.
Speaker #9: It's viously 27 will be used, at a minimum, as a titration dose.
Speaker #4: 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.
Speaker #4: we're going to be putting our IPF data in at chest because we wanted that presented in the US, which is in October in Chicago.
Speaker #4: So those are the two medical meetings that our data will be hopefully presented at. we know we've been accepted at ERS for RCC, but we don't know about chest yet.
Speaker #10: Excellent. Congrats on the .
Speaker #4: Yeah. Thank you.
Speaker #7: The next question comes from Brandon Folks of HC Wainwright. Go ahead, please.
Speaker #14: Hi. Thanks for taking my question. maybe just coming back to a bit of an old topic here, but, you know, understanding there's not really a commercial impact on the patient population, have you done any commercial work, you know, or have any thoughts on scheduling impacts in the, you know, in the non-IL, I'm sorry, in the -IPF ILD indications, just to in terms of prescribing habit?
Speaker #9: Thanks, Brandon. This is Farrell. So we we we've done some some qual work within that space to talk to providers. When we when you look at the overall, key prescriber in that area, it's still going to be that pulmonologist.
Speaker #9: And so it 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 and and testing and updated TPP based on the quarterly results.
Speaker #9: and 'll test that across a broad range of, potential patient types. But we don't anticipate an act in non-IPF ILD ither.
Speaker #10: Great. Thanks. And maybe just one follow-up. you know, understanding what the respiratory depression study is about here, but if we see any anomalies, you ow, unexpected on the negative side, is there any obligation?
Speaker #10: You know, in terms of submitting that to the DEA, in terms of scheduling, is there any precedent that, ou know, we need to keep one eye on sort of, you know, sort of the the outlier event if we do see something in that data on scheduling or, you know, is that completely closed now?
Speaker #9: I don't think that the respiratory safety study, we'll have any direct impact on scheduling per se. I think it really is about, you know, just establishing and showing, you know, the characteristics that we're looking at in that study.
Speaker #9: I think, you ow, scheduling is really going to be based on abuse liability and potential, on that side.
Speaker #10: Great. Thanks for taking my questions.
Speaker #4: Yeah. Thanks, Brandon.
Speaker #7: The next question comes from Kaveri Pullman of Clear Street. Go head, please.
Speaker #12: Yes. Good evening. thanks for taking my question and for the update. as we move into this phase three trials with, longer follow-up than, you know, what you had for the phase two, how are you planning to manage this placebo effect?
Speaker #12: and also, what challenges did you address in the phase two that give you confidence going forward? And additionally, based on historical data and your own experience, are there any new hurdles you anticipate in the phase three?
Speaker #12: I guess this is more like a a remedial question. and another question I have is on, you know, as you're approaching phase three, I, I would like understand if there are any extra steps in terms of manufacturing, you know, for potential commercialization.
Speaker #12: And any updated thoughts on partnering for commercialization? Thank you.
Speaker #9: I I can take the first.
Speaker #4: Thank you all, development was.
Speaker #10: I can take the first thing. It takes parts of the first.
Speaker #4: Okay.
Speaker #10: Thank you for the question.
Speaker #4: I love the way we limit you to one question.
Speaker #5: Five in there. I think five in there.
Speaker #10: I think we're going to double A.
Speaker #5: Yeah. Very exciting.
Speaker #10: So sorry. No worries. So as far as the phase three goes, I think, we learned so much in the program so far. I think quarterly was a real, you know, testing ground, proving ground for us in terms of the parallel group design.
Speaker #10: We learned lot from that study, and I ink some of the things that we learned was the rapid onset of effect. Really, we saw, you know, the drug effect, the efficacy coming in, by that two-week time point.
Speaker #10: It brings things pretty much stabilized from that point on. So I ink we don't anticipate any changes beyond that. So in the course of that overall six-week study, you know, we saw that efficacy stabilized over, you ow, from weeks two to four.
Speaker #10: think that was fine. We didn't see anything new really popping up later on in the dosing weeks. In terms of safety, so don't think we need to anticipate that.
Speaker #10: The placebo effect. You know, I'm not sure that we really have a placebo effect. We had a, I think, a well-controlled trial. I think, you know, obviously going bigger trials, you know, is something we always have to watch for.
Speaker #10: But we had a very large effect size. So I don't think we're anticipating any issues there in terms of of trying to control that placebo effect when we have, you know, the kinds of delta that we have right now.
Speaker #10: I don't think we're going to see any new hurdles as we look forward into longer-term dosing trials. I think we've really tested that here.
Speaker #10: 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.
Speaker #10: I think we saw that during the titration phase where we did see, you know, the adverse events that pretty much dissipated during that titration phase and really did not come back as we, you know, maintained our dose at the, even at the 108 level.
Speaker #10: So I don't think we, we have any surprises on the horizon. I think we're really od there. Just a quick response to your manufacturing question.
Speaker #10: We know how to make drug. We know how to supply the drug for bigger trials. We've been in Europe, and we've in other places.
Speaker #10: we know how to get the drug, the distributed. So no issues there on the phase three front. I mean, this is, you know, we've got an experienced team here that have run large trials before, and we've ready been to a lot of places.
Speaker #10: I don't anticipate any problems with that. So that's as far as I remember.
Speaker #4: That was impressive. I'll take over. I'll take the partnering question. Kaveri, that's something that Farrell and I always spend time on, obviously. I think we're partnering is probably most relevant for us is in Europe or Japan.
Speaker #4: in the US, you know, Farrell's kind of all steam ahead on how this gets commercialized here. I think if somebody wanted to have those rights in the US, they'd have to buy the company.
This concludes our question and answer session, I would like to turn the conference. Call back over to Jennifer good for closing remarks.
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 the call schedule. Thank you.
The conference call has now concluded. Thank you. For attending today's presentation.