Q3 2025 Trevi Therapeutics Inc Earnings Call
Speaker #1: Good morning, everyone.
Speaker #2: Good afternoon, and welcome to the Trevi Therapeutics third quarter 2025 earnings conference call. At this time, all participants will be in listen-only mode.
Speaker #2: Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions.
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Speaker #2: Various remarks that management makes during this conference call about the company's future expectations, plans, and prospects serve the purposes of the Safe Harbor Provisions under the Private Securities Litigation Reform Act of 1995.
Speaker #2: Actual results may differ materially from those indicated constitute forward-looking statements for 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-K.
Speaker #2: The company filed with the SEC this afternoon. 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 #2: While the company may elect to update these forward-looking statements, at some point in the specifically disclaims any obligation to future, the company If its views change, I conference over to Jennifer Good, Trevi's president and CEO.
Speaker #2: While the company may elect to update these forward-looking statements, at some point in the specifically disclaims any obligation to future, the company If its views change, I conference over to Jennifer Good, would now like to turn the Please go
Speaker #2: ahead. Good afternoon, and thank you for
Speaker #3: joining us for our third quarter 2025 earnings call and business update. Joining me today on this do so. call are my colleagues, Dr. James Casella, our Chief Development Officer, and Farrell Simon, our Chief Commercial Officer.
Speaker #3: I will make some results, then the team is happy to answer any questions you may have. The first half of this year, with a major positive data readouts in both the coral trial for chronic cough in patients with idiopathic pulmonary comments on the business and financial river trial for patients with refractory fibrosis, or IPF, and the chronic cough, or RCC.
Speaker #3: from leading thought leaders and community pulmonologists. As a result of these strong data, we were able to raise approximately $115 million in June, giving us cash runway into 2028 and an ability to execute It is an exciting place to be in on the next clinical studies for each indication.
Speaker #3: our journey, and we have not wasted any time in moving forward. Let me provide a brief update on what the team has indications. We have been up to in each of our chronic cough phase one studies to advance our IPF cough program.
Speaker #3: drug-drug interaction study, recently completed a couple of important requested we conduct a looking at any potential PK interactions when Nabufen is co-administered with antifibrotics and the standard of care taken by patients with perphenidone or nintenidine, which are IPF and other progressive fibrotic diseases.
Speaker #3: received the data from this study, and we The FDA We recently pharmacokinetics of any of the drug are pleased that there were no clinically meaningful changes in the combinations used in this study.
Speaker #3: We will publish these data in the future, but we did not see anything that will impact the dosing in our Phase 3 program. We also made good progress on our titled study, which is assessing respiratory function and safety of Nabufen in IPF patients.
Speaker #3: We call this a study requested by the FDA to investigate if there was any potential signs of respiratory depression in patients with IPF following dosing with Nabufen The IPF 10 days, and given increasing dose of drug while having their oxygen, carbon dioxide levels, and respiration rate assessed for periods of time.
Speaker #3: A planned review of data by an external safety patients in the study were housed in clinic for review committee in a sentinel cohort of patients concluded that there were no safety signals in the study to date.
Speaker #3: As a result, the committee gave approval to complete enrollment for this study. We will include the available data for both the DDI and respiratory safety studies in the end of phase two meeting phase two meeting, we expect to request that meeting in the fourth quarter of this year.
Speaker #3: package. The key points we are looking to As for the end of discuss with the FDA are to gain alignment on the phase three program for chronic cough in patients with IPF, get their input on the phase three study design and other parameters of the protocol, as well as agree upon any other NDA-enabling work which needs to be completed.
Speaker #3: In parallel, we will initiate the phase three program in the first half of next year. The clinical team has been preparing and is busy lining up key vendors and identifying sites for these global studies.
Speaker #3: We have also been preparing for a study in other non-IPF interstitial lung diseases, or non-IPF ILD patients that have lung fibrosis and ILD. chronic cough.
Speaker #3: We estimate there are approximately 228,000 of these patients, with 50 to 60 percent having uncontrolled cough. This more than doubles the market opportunity of IPF chronic cough, and these patients are primarily seen by the same pulmonologists as CIPF patients.
Speaker #3: This keeps our clinical and commercial efforts efficient and creates synergies. We plan to request a meeting with the FDA after we align on the IPF pivotal design and protocol for this indication as well.
Speaker #3: Once we have program to discuss our study initiate this study. Finally, we have been working on the cough. We expect that study to be a phase two B parallel arm dose FDA input, we will be prepared to next year.
Speaker #3: the protocol, and identifying sites for this study as well. So, as you can see, there is a lot of planning going We are drafting on at Trevi, as well as preparation work to align with the regulatory initiate that study in the first half of trials in the first half of next we get these trials right.
Speaker #3: We will provide updates on next authorities and initiate multiple year. steps as we gain alignment and This takes time to ensure that have line of sight to study review of the financial results for the quarter.
Speaker #3: The full financial results for the three months ended September 30, 2025, can be this call and our 10Q, which was filed with the SEC today after the market closed.
Speaker #3: For the third quarter of 2025, we reported a net loss starts. of $11.8 million compared to a net loss of $13.2 million for the same quarter in 2024.
Speaker #3: Our ND expenses I will now provide a quick decreased to $10.1 million during the third quarter of '25 from $11.2 million in the same quarter last year.
Speaker #3: The reduction was primarily due to decreased clinical trial work in which those trials were actively enrolling in the prior year and reported data in the first half of this year.
Speaker #3: This was partially offset by increased costs related to our recently completed phase one studies and personnel and related expenses. GNA expenses increased to $3.8 million during the quarter third quarter of 2025 compared to $2.9 million in the same quarter of last year.
Speaker #3: Primarily due to an increase in professional fees and expenses. The increased professional fees were primarily due to increased costs as we continue to prepare for compliance personnel related to SOX 404(b) regulations.
Speaker #3: As of September investments totaled approximately 30, 2025, our cash and $195 million. Our cash and investments give us cash runway into 2028. Subject to finalizing the development for each of our indications.
Speaker #3: We three trials of Hadoopio for the treatment of chronic cough in patients with expect to be able to fund two phase IPF, along with a long-term extension for those trials.
Speaker #3: Our planned phase two B/3 trial in chronic cough in patients with non-IPF patients with RCC, and our ILD, our next trial in ongoing phase one supportive studies.
Speaker #3: So, in closing, Trevi is positioned with strong data in two serious chronic cough conditions and is preparing to advance into the next stage of development for each of the three chronic cough indications.
Speaker #3: Chronic cough is a debilitating condition for which there are financially strong, with enough cash to complete the next stage of development work to potentially advance these patient.
Speaker #3: therapies closer to the This concludes my prepared remarks. Jim Ferrell and I are now happy to answer your questions. I will turn the call back over to the operator for
Speaker #3: We believe we are well positioned currently no FDA-approved to execute our strategy and create meaningful shareholder value over the therapies. Also, the company is next couple of years.
Speaker #2: We will now begin the
Speaker #2: question and answer session. Q&A. 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 #2: To withdraw your question, please press star, pause momentarily to assemble then two. At this time, we will our roster. The first question comes from Ryan Deschner with Raymond James.
Speaker #2: Please go ahead.
Speaker #3: Hi. Thank you very much for the question. Have you narrowed down more of what inclusion/exclusion criteria you would target for the non-IPF ILD study?
Speaker #3: Maybe in terms of, in particular, what constitutes chronic cough in those studies? And would you exclude any ILDs from an initial study in this space off the bat?
Speaker #3: Thank you.
Speaker #4: Hi, Ryan. This is Jim. Thanks for the question. We had some good discussions with our KOLs for the non-IPF ILD study.
Speaker #4: I think you can imagine that there's going to be a lot of similarity in the underlying lung disease. We'll define that in a certain way.
Speaker #4: Chronic cough. I think we're going to go in with the standard criteria. Typically, we look at some minimum amount of cough in terms of maybe 10 coughs per hour.
Speaker #4: So it'll be very consistent with what we're looking at in the rest of our program. So I think that those are narrowing down rather nicely.
Speaker #4: I think the important point to remember about that type of trial is that while there's going to be patients with lots of other comorbid conditions, we're really focusing on the entry criteria being related to the amount of cough that they have, and the amount of lung damage, lung fibrosis that they have.
Speaker #4: So those are going to be the defining features for the inclusion. And then there'll be other things to manage around their comorbid conditions.
Speaker #1: And Jim, anything we're carving
Speaker #1: And Jim, anything we're carving out? At this point in time,
Speaker #4: we're not really carving out anything. We're going to base it on those basic criteria. So, of course, it's a broad swath of conditions. And as we get closer to that inclusion or closer to defining that protocol a little bit more, in depth, we may carve out one or two.
Speaker #4: But, for the most part, it's going to be based on lung disease and the amount of cough.
Speaker #3: Excellent. Thank you very much. And
Speaker #1: Thank you.
Speaker #3: maybe quickly just on the DDI study, would you anticipate needing to do any more studies like that for a trial like this or subsequent trials outside of IPF chronic cough and RCC?
Speaker #4: Yeah. So that's great, Ryan. Thanks. So the study we got done was a DDI looking at our drug with perphenidone and intended it as the key anti-fibrotics in this space.
Speaker #4: There will be other DDI studies that will be having to do based on the mechanism of drug metabolism. We are metabolized by SIP primarily, the 2C9, 2C19 species.
Speaker #4: So there will be a DDI looking at probably a 2C9 inhibitor. These are things that we'll talk with the FDA about. But it is expected that we will have to do a couple more phase one studies and at least one more DDI study.
Speaker #3: Thank you very
Speaker #3: much. And the next question comes.
Speaker #2: from Annabelle Samimi with STEFL. Please go ahead.
Speaker #5: Hi. All thanks for taking my question. I was just wanting to clarify for the respiratory study, you had interim results from the DSMB saying that you didn't have any issues.
Speaker #5: Do you need to complete that study before you have the end of phase two meeting with FDA? And is there any other hurdle that you need to get past for that specific meeting?
Speaker #5: And then separately, if you could just share a little bit of the feedback that you've been hearing from the chest meeting at this point, how are the pulmonologists looking at this, and how do you start thinking about targeting the market that you're looking at?
Speaker #5: Thanks.
Speaker #4: Sure. Hi, Annabelle. So on title, we had a sentinel cohort of four subjects that we completed, and the plan was to have our Data Monitoring Committee review those subjects.
Speaker #4: That all went fine. There was no safety issues identified. So we continued on. To answer your question, we will have the available data when we submit the package.
Speaker #4: We don't have to complete that study before we submit for the end of phase two meeting. And our intention is that we'll have all the data by the time we have the meeting.
Speaker #1: Yeah. And I'll just jump in at the beginning of the second question, and then Ferrell, I'll have you take on how it targets the market.
Speaker #1: But thank you, Annabelle. We presented we had our data presented at both chest and ERS. It was very well attended. We had one poster at ERS.
Speaker #1: You could barely even get near the poster. A lot of interest. It was interesting. There was a lot of our investigators that were very interested in the full data.
Speaker #1: And they've got their patients coming back to them wondering when we're going to start our next trial. So I would say people understand cough's a big problem, and there's been a lot of work done in anti-fibrotics.
Speaker #1: But there really hasn't been a lot of work done on things that matter day to day to the patient. So we're getting a lot of attention in our sessions.
Speaker #1: The data's gotten a lot of attention. And we also hosted a reception one night that was very well attended by US investigators, interested in getting into our study.
Speaker #1: So really encouraging. Jim and I were both there. I'm quite busy the whole time. I think, Ferrell, I'll let you take on sort of based on the feedback how you might be thinking about targeting the market with any of the feedback.
Speaker #3: Yeah. Thanks, Annabelle, for the question. When we look at the market, we do need to raise the burden of the disease. And that's work that's undergoing.
Speaker #3: That we're continuing. And we'll launch next year. There's also just targeting in terms of how we look at segmentating this market. It's work in which we'll start next year just to make sure that we have appropriately sized our field force to target the key prescribers in this area.
Speaker #3: So that's some of the work. And then we're continuing to always do physician and payer research to understand how our new target product profile based on the positive core results are seen by physicians and payers within this space.
Speaker #1: Great. Thank you. Thanks,
Speaker #1: Annabelle. And the next question comes.
Speaker #2: from Lilian Gerschel with Oppenheimer. Please go ahead.
Speaker #6: Oh, great. Thanks for the update and for taking the questions. Just a couple—I joined a little bit late, so my apologies if you may have covered.
Speaker #6: But as you head into the end of phase two meeting, kind of are there any particular questions or issues that you would like to address or get clarity on?
Speaker #6: And then also wanted to ask on the drug-drug interaction side, is there any need for Trevi to run interaction studies in patients who may be on other opioids concomitantly?
Speaker #6: Thank you.
Speaker #4: And this is Jim. So in terms of the end of phase two meeting, our standard questions are going to be related to the protocol design, endpoints, duration of the study, really nuts and bolts around the phase three.
Speaker #4: We'll be submitting a full final draft protocol to them. So they'll have the protocol with them in hand. And we will guide some of the more important questions regarding the design, patient inclusion and exclusion criteria, our statistical approach, pretty basic things that are really important to narrow down at this meeting.
Speaker #4: So we will have absolute clarity on what we need to do for Phase 3 coming out of...
Speaker #4: that. Safety database size too is an
Speaker #4: Safety database size. We'll important one, right? be discussing the extent of any long-term data collection. And we'll also be as we've talked about the DDI study and we did talk that we may need to do some more work in the phase one world on wrapping up things for the NDA submission.
Speaker #4: We will probably do another drug-drug interaction study that encompasses our mechanism of drug metabolism, which is through SIP systems and 2C9 in particular. So we'll be asked to do a drug-drug interaction study with drugs that are inhibitors of that system to understand what the effects are on pharmacokinetics.
Speaker #4: There might be some other Phase 1 studies that we're anticipating that we will discuss with the FDA at the end of Phase.
Speaker #4: two meeting as well. I would just add, though,
Speaker #1: Lilian. I think you specifically asked about other opioids. They are contraindicated. We have excluded them because, as you know, our mechanisms immune antagonists. So if you're on other opioids, it will put you into opioid withdrawal, which is obviously super helpful from the addiction side and labeling side.
Speaker #1: But we do contraindicate that in our trials. And we'll be in our
Speaker #1: label. Right.
Speaker #4: Good.
Speaker #4: Helpful. Thanks very much. Yeah.
Speaker #1: Thank
Speaker #1: you, Lilian. And the
Speaker #2: next question comes from Judah Farmer with Morgan Stanley. Please go
Speaker #2: ahead.
Speaker #7: Yeah.
Speaker #7: Hi, guys. Thanks for taking the questions. Maybe could you help us with the latest thinking on potential to incorporate the non-IPF ILDs into the phase three program for IPF?
Speaker #7: Will you get any clarity on that at the end of phase two, do you think, or do you have to wait for that subsequent interaction?
Speaker #7: And then what are your thoughts on launching with both indications in the same label versus SNDA? And then, secondarily, obviously very high level, but any thoughts on changes in SIBO leadership and impacts of the program?
Speaker #7: Thanks.
Speaker #1: And I'm just going to comment on
Speaker #1: strategy if we could probably both do this. But I think, Judah, we made a decision that we're going to go in with sort of our strongest foot forward and do the end of phase two meeting.
Speaker #1: Jim's got a lot of data, robust data. We want the FDA to catch up with where we are, all the studies we've run, the data we've generated.
Speaker #1: And we will tease up there that our broader programming includes both RCC, but importantly, non-IPF ILD, which we think shares a common biology. So we will tee that up.
Speaker #1: But you only get one hour in this meeting. And we don't want to get distracted debating non-IPF ILD there because, to Jim's point, we need to walk out with clear guidance on our phase three program.
Speaker #1: So really trying to protect that and keep it whole as soon as we feel we have alignment with the agency, we're going to be prepared to submit a protocol in non-IPF ILD and request a type C meeting.
Speaker #1: Hopefully, that's a pretty easy ask coming off the heels of the IPF end of phase two. So that was sort of a strategy point because we could have jumped in earlier.
Speaker #1: But I felt we wanted our strongest foot forward. I mean, as far as the sort of cedar change in leadership, and I'll let Jim add any color as well.
Speaker #1: I mean, obviously, new person named this week: oncology person. I don't know how much that's really affecting the divisions we've had. I mean, baffling to me, finally feedback on time, clear communications.
Speaker #1: I don't know how the FDA is holding it together. Kudos to them. So I don't know how much those levels are affecting things when you're in a clinical trial mode.
Speaker #1: I'm sure at the point in time, they look at your NDA, it does. But it hasn't seemed to impact what we're doing. I don't know, Jim, do you have anything?
Speaker #4: No. Nothing to add to that other than I think the surprise factor of how responsive they've been is has been high on my list.
Speaker #4: It's like this is very unusual for me to get this kind of responsiveness. So very pleased about that.
Speaker #1: Yeah. Thank you,
Speaker #2: Great.
Speaker #2: And the next question comes Judah. from Serge Beylaze. With Needham & Company, please go ahead.
Speaker #8: Good Good afternoon. I think in the past, you've discussed the potential of Haduvio being eligible for orphan drug exclusivity and IPF COF, just curious if you have any updated thoughts on that.
Speaker #8: And whether that's something you will seek, like an orphan drug designation, in the upcoming end of Phase 2 meeting with the FDA. Thanks.
Speaker #1: So Jim's laughing because he made me promise. We are going to request orphan drug for IPF. I do always warn people that I don't want people to put too much in that.
Speaker #1: Although IPF has gotten orphan drug, this is COF in IPF, and COF is a broad problem. So we'll see what they have to say.
Speaker #1: So we will apply, I think it's an answer we should know. Jim made me promise that we wouldn't do that until after we went through our end of phase two meeting.
Speaker #1: He doesn't want them distracted on any other side questions. So I think on the heels of end of phase two, we'll go ahead and submit for that.
Speaker #1: And find out their views on COF and IPF.
Speaker #8: Got it. Thank
Speaker #8: you. Thank you, Serge. And the next
Speaker #2: This question comes from Rowana Ruiz with Leering Partners.
Speaker #2: ahead. Great.
Speaker #9: Good afternoon, everyone. So a couple for me. First one is, given the evolving IPF landscape with recent positive data from United Therapeutics Teton study, I was curious, how could that impact how Haduvio fits into the prescribing approach and treatment algorithm of
Speaker #9: physicians? So you want to take that or
Speaker #1: I can as well? Yeah.
Speaker #4: Happy to. Thanks, Rowana, for the question. If anything, it probably doesn't really change much for us. When you think about chronic COF, the high burden of disease among these patients, physicians look at this as either first or second-line therapy.
Speaker #4: And that could be before an anti-fibrotic or after an anti-fibrotic is initiated. When you look at the drugs and the new approvals that are already coming to market, there's still slowing the progression of the disease.
Speaker #4: And they're not having a positive impact on the COF. So there's still a very high place for a chronic COF therapy in concomitant therapy with these anti-fibrotics that are on the market or potentially coming to market.
Speaker #1: And so I would just add too. I've heard a lot of discussion about with improvements in therapies and treatments for patients, it probably just improves the diagnosis.
Speaker #1: The patient groups will start to grow. I think people are focusing on this disease a little more. Hopefully, COF comes to the forefront when we actually have something for treatment.
Speaker #1: So it's obviously great for the patient to have options. But I just think overall, it probably grows the market as well.
Speaker #9: Yep. Makes sense. And a quick follow-up about the title study. What do you hope to see in the results in terms of a best-case scenario now that you can complete enrollment?
Speaker #9: And any sort of thoughts on how that might impact the end of Phase 2 discussion with the FDA?
Speaker #4: Yeah. Hi. This is Jim. So we are looking at basic respiratory function, PO2, CO2, and respiration rate. So the FDA was interested in a study like this just to make sure that we don't have any blatant signals regarding respiratory depression.
Speaker #4: So we're taking a very fundamental approach on key respiratory parameters. And looking at those ideal outcome for this study and the data have been great so far is that there's no findings here.
Speaker #4: There would be no findings, meaning that there's no changes on any of those parameters. We are dosing at night, looking at these IPF subjects while they are asleep, which is considered a conservative way most sensitive approach to this.
Speaker #4: So that's the nature of the study to really pull out if there's anything there. So obviously, clean results and no impact on the program is the ideal outcome
Speaker #4: here. Jim, I would just add, we've obviously
Speaker #1: had this in, what, 200 people now, IPF patients, clinically. And never seen any signal. So I think this will just sort of go hand in hand with the safety database that they look at as well.
Speaker #4: Absolutely.
Speaker #9: Makes sense.
Speaker #1: Thanks, Thanks.
Speaker #1: Rowana. And the next question comes.
Speaker #2: From William Wood with Riley Securities. Please go ahead.
Speaker #8: Hi. Thanks for taking care of our questions today. So a couple from us kind of focus on the phase three. It sounds like from what I can tell you, you've essentially got your sort of phase three package sort of put together in terms of how you want it.
Speaker #8: Obviously, that's got to be discussed with the FDA and approved or at least agreed upon. But I was just curious if you could walk through sort of maybe what you're thinking at a high level in terms of doses and/or timing, titration, you're looking to take forward.
Speaker #8: And maybe just remind us, are you going to allow patients to use background anti-fibrotics in the study? And will you be looking at biomarker fibrotic biomarker improvement within the study?
Speaker #8: And then lastly, just briefly, would this be conducted in the same sites that your other phase twos were, or will you be branching out further?
Speaker #4: Sure. I think I can remember all
Speaker #4: Those. I got them down. I got it written. So, William, thanks. This is Jim. In terms of doses, we did—Coral was a great study for us because we learned a lot from it, including that it was our definitive dose-ranging study.
Speaker #4: So in terms of dose going forward, we did a lot of work over the summer. We interrogated the 54 and the 108 milligram dose group.
Speaker #4: And because of the titration up, we were able to determine in individual subjects and looking at dosing groups that the 108 really didn't add any significant value to the 54 milligram BID dose.
Speaker #4: So, 54 milligrams BID will be our top dose going forward. The 27 milligram BID dose is a titration dose. We identified that as a minimum effective dose in the Coral study.
Speaker #4: So it will not be considered a treatment dose, but it will be considered a titration dose. What we also learned from the Coral study is that when we do our titration, as we've done in all of our programs to date, we see that most of the adverse events that we see typical for this compound, which are mostly GI and CNS in nature, come on with the initiation of dosing.
Speaker #4: So what we're going to do is extend a little bit further the once-a-night dosing under the 27 milligram dose go into 27 milligrams BID and then get into our 54 milligram BID treatment dose.
Speaker #4: So we will extend that titration period a little bit to mitigate some of the earlier side effects that we see with the compound. And just a reminder about the nature of the adverse events that we see, with nabufene, is that we typically see some GI and some CNS.
Speaker #4: These are typically transient. And these are typically things that do tolerate out over time. And that's why we're going to extend that titration period.
Speaker #4: In regard to your question about allowing background anti-fibrotics, over 80% of our subjects in the Coral study were on either a tentative or Perphenidone.
Speaker #4: So yes, we are going to allow approved anti-fibrotics as background medication. In terms of biomarkers, we don't have any intention of looking at those. Well, we're not going to look at those.
Speaker #4: And in terms of the sites, if you recall, in Coral, we were running those study XUS. We will be going back to the more successful sites in that region.
Speaker #4: And we will also be bringing in the large number of US centers. The great thing about the pulmonary fibrosis foundation is that there are over 80 excellent care centers and we are talking to them about conducting our trials.
Speaker #4: So we will be bringing in in a major way US centers as well as Canada and Europe.
Speaker #8: Got it. That was very helpful. Thank you for all those quick answering all my questions. Very briefly and lastly, the end of phase two package, once you actually get that submitted and discussed, will you be relaying that to us and/or investors, the public, or is that just how will that be dispersed, I
Speaker #8: guess? Yeah.
Speaker #1: No, it's a good question, William. I think typically you do the meeting and then you wait 30 days for the minutes. Usually, you want to wait to see the minutes so that what we think we heard, we actually see in writing when we get it.
Speaker #1: When we have that information, we'll definitely give an update to the street. I mean, we probably won't put out a separate press release. I think on one of our earnings calls or some venue, we'll use it to update people.
Speaker #1: But yeah, it’s important information for sure.
Speaker #8: Got it. Helpful. Thank you very much. And I'll hop back into Q.
Speaker #1: Okay. Thanks,
Speaker #1: William. The next question comes
Speaker #2: from Kavari Pullman with Clear Street. Please go ahead.
Speaker #9: Hi. Good evening. Thanks for taking my questions. So my first question is about how well do the current trial match the real-world patients considering things like the inclusion, exclusion criteria, comorbidities, or use of other drugs?
Speaker #9: And for future trials, for both IPF and RCC, do you plan to make the eligibility criteria broader to include a more diverse population or will they stay the
Speaker #4: Yeah. Hi, this is Jim.
Speaker #4: So we will keep this population for same? the phase three as broad as possible. We are really trying not to make it strictly a clinical trial population, but we want to keep it broad.
Speaker #4: So we are working with the KOLs to really refine our inclusion and exclusion criteria to make it definitely more real-world. So we will have few restrictions.
Speaker #4: Other than they need to be diagnosed with IPF, they need to they can them relatively healthy that be have some other things that make study.
Speaker #4: it will be as broad as possible, as real life So I can promise you that
Speaker #1: Not too much different than actually be involved in the
Speaker #4: fact, we're actually refining a few things to broaden it from our 2B. We as possible. basically unless something that is going to interfere with our ability to measure cloth, where we'll have a direct impact on cloth in the trial, there are CONMEDs to, per normal, and I don't know if there's any what else?
Speaker #4: Was there anything else that you will be allowed asked? I think I covered those two things.
Speaker #9: Right. Yeah, that's helpful. And I also want to understand for the RCC phase 2B trial, do you plan to study the same dosing regimen as it was in the phase test QD options also since the drug seems pretty safe?
Speaker #4: Yeah. We're actually going to probably trial and we will
Speaker #4: QD dosing once-a-day dosing in that trial as well.
Speaker #1: As well as BID.
Speaker #4: So we'll probably add a going doses. well. I'm sorry, what was the second part?
Speaker #9: last one, so 2A, or you plan to kind of eliminate the top 108 dose in that 27 QD arm in there because respiratory safety study, it was surprising that the FDA needed that after you showed 200 patients'
Speaker #9: worth of data. But I still want to
Speaker #1: Long-term. I mean, long-term.
Speaker #4: long-term data collection in our phase We will do FDA is curious three program. The anticipation based on previous FDA experience here is safety data.
Speaker #9: Sorry.
Speaker #9: Sorry. All right. Thank you.
Speaker #9: Sorry.
Speaker #2: any further questions. This concludes our question and answer session. I would like to turn the conference back over to remarks.
Speaker #1: Thank you. We are available after the call or tomorrow for any follow-up questions that you may have. Thank you.