Q1 2025 Trevi Therapeutics Inc Earnings Call
Good afternoon, and welcome to the Chubby Therapeutics first quarter 2025 earnings conference call.
Operator: Good afternoon and welcome to the Trevi Therapeutics First Quarter 2025 Earnings Conference Call. At this time, all participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero.
This time, all participants will be in listen only mode.
Speaker Change: Need assistance. Please signal our conference specialist my question. The Starkey followed by zero. After today's presentation there'll be an opportunity to ask questions to ask a question you May Press Star then one on your phone to withdraw your question. Please press Star then two please note. This event is being recorded.
Operator: After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then one on your phone. To withdraw your question, please press star, then two.
Operator: Please note this event is being recorded.
Operator: 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.
Speaker Change: Yes 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.
Speaker Change: Under the private Securities Litigation Reform Act of 1995.
Operator: Actual results may differ materially from those indicated by these four 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.
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 FCC. This afternoon.
Operator: 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 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 it's used .
Speaker Change: 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 dates 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 it's huge change I would now like to turn the call.
Operator: I would now like to turn the conference call over to Jennifer Good, Trevi's President and CEO. Please go ahead.
Speaker Change: It's all over to Jennifer Good Chubby, President and CEO. Please go ahead.
Speaker Change: Good afternoon, and thank you for joining us for our first quarter 2025 earnings call and business update joining me today on this call are my colleagues, Lisa Delphine, Travis Chief Financial Officer, Dr. James Cassella, Our Chief Development Officer, and Simon <unk>, Our Chief Commercial Officer, Lisa and I will make some key.
Jennifer Good: Good afternoon, and thank you for joining us for our first quarter 2025 earnings call and business update.
Jennifer Good: Joining me today on this call are my colleagues Lisa Delfini, Trevi's Chief Financial Officer, Dr. James Cassella, our Chief Development Officer, and Farrell Simon, our Chief Commercial Officer. Lisa and I will make some comments on the business and financial results, and the team is happy to answer any questions that you may have. The strong momentum of 2024 at Trevi continued into the first quarter of 2025 with the positive data readout from the Phase 2a River Trial in RCC patients and the completion of enrollment in the Phase 2b Coral Trial in IPF chronic cough patients. I will discuss both of these programs in a bit more detail.
Speaker Change: On the business and financial results and the team is happy to answer any questions that you may have.
Speaker Change: The strong momentum of 'twenty 'twenty four at Trevi continued into the first quarter of 2025 with the positive data readout from the Phase Iia River trial in RCC patients and the completion of enrollment in the phase two b coral trial in IPF chronic cough patients I will discuss both of these programs in a bit more detail.
Jennifer Good: But needless to say, it has been an exciting few months for us. In March, we announced the data from our Phase 2a River Trial in patients with refractory chronic cough, or RCC, which includes those with unexplained chronic cough. RCC is a debilitating disease that affects approximately 2 to 3 million U.S. patients and has no approved therapies in the U.S. Importantly, there have been many drugs studied for this condition which have failed, all primarily peripherally acting agents, with only one drug still in late-stage development, GSK's Camlipixib. Our hypothesis heading into the RIVERS study was that our central and peripheral mechanism could change the outcome for RCC patients by having a larger effect as well as working across a broader range of cough counts than other peripheral only therapies in development.
Speaker Change: Needless to say it has been an exciting few months for us.
Speaker Change: In March we announced the data from our Phase Iia River trial in patients with refractory chronic cough or RCC, which includes those with unexplained chronic cough.
Speaker Change: RCC is a debilitating disease that affects approximately two to 3 million U S patients and has no approved therapies in the U S. Importantly, there have been many drugs studied for this condition, which have failed all primarily peripherally acting agents with only one drug still in late stage development Gsk's canola picks.
Speaker Change: Uh huh.
Speaker Change: Our hypothesis heading into the river study was that our central and peripheral mechanism could change the outcome for RCC patients by having a larger effect as well as working across a broader range of pop counts than other peripheral only therapies in development.
Jennifer Good: RCC is believed to result from cough hypersensitivity at the brain level and why we believe the central activity of our mechanism is important and differentiating. In the Phase 2a RIVERS study, Haduvial met the primary endpoint with a statistically significant reduction in 24-hour objective cough frequency, achieving a P-value of less than 0.0001. There was a 57% placebo-adjusted reduction in cough from baseline and, importantly, showed the same strong effect across a broad range of cough counts, including patients with moderate and severe cough frequencies. In our top-line announcement, we also showed two patient-reported secondary endpoints in both cough severity and cough frequency that were highly statistically significant and corroborated the primary endpoint of the objective cough monitor.
Speaker Change: RCC is believed to result from cop hypersensitivity at the brain level and why we believe the central activity of our mechanism is important and differentiating.
Speaker Change: In the phase two a river study Adobe on met the primary endpoint with a statistically significant reduction in 24 hour objective cough frequency, achieving a P value of less than 0.0001.
Speaker Change: There was a 57% placebo adjusted reduction in cost from baseline and importantly showed the same strong effect across a broad range of cough counts, including patients with moderate and severe cough frequencies.
Speaker Change: And our topline announcement, we also showed two patient reported secondary endpoints in both cost severity and cough frequency that were highly statistically significant corroborated the primary endpoint of the objective cough monitor.
Jennifer Good: Since reporting those data, we have received the full data set and can confirm that all pre-specified secondary endpoints in the study were statistically significant at the end of treatment. The RIVER data were important not only for potential therapeutic value to patients, but scientifically as well. Hadubio is the first mechanism to work in both patients with RCC and in IPF patients with chronic cough. We believe this is evidence of the importance of the central mechanism underlying neurogenic chronic cost conditions and lays the groundwork for not having to do the enrichment strategies others have employed to show statistical significance in RCC.
Speaker Change: Since reporting those data we have received the full dataset and can confirm that all prespecified secondary endpoints. In this study were statistically significant at the end of treatment.
Speaker Change: The river data were important not only for potential therapeutic value to patients, but scientifically as well how do B O is the first mechanism to work in both patients with RCC and then IPF patients with chronic cough.
Speaker Change: We believe this is evidence of the importance of the central mechanism underlying neurogenic chronic cost conditions.
Speaker Change: The groundwork, we're not having to do the enrichment strategies, others have been employed to show statistical significance in RCC.
Speaker Change: Turning now to our lead program in IPF patients, who suffer from chronic cough during the first quarter. We also completed the enrollment of the phase two be Karl trial for the treatment of this condition.
Jennifer Good: Turning now to our lead program in IPF patients who suffer from chronic cough. During the first quarter, we also completed the enrollment of the phase two B coral trial for the treatment of this condition. And in April, the last patient completed their last visit. This study enrolled approximately 160 patients in 10 countries and across 60 sites. The team is now cleaning the data and preparing for database lock. So we remain on track for top line data this quarter. We are excited to get the data from this dose ranging study and advance the development program in both chronic cough conditions of IPF and RCC.
Speaker Change: And in April the last patient completed their last visit this study enrolled approximately 160 patients in 10 countries and across 60 sites.
Speaker Change: The team is now cleaning the data and preparing for database lock. So we remain on track for top line data. This quarter. We are excited to get the data from this dose ranging study and advance the development program in both chronic cough conditions of IPF in RCC.
Jennifer Good: Speaking of the FDA, there's a lot going on there that all of us collectively are worrying about. I do want to convey our recent experiences. I think it is important for all of us to monitor the current state of this important regulatory body. We asked for guidance through a Type C request with written responses only on a technical matter in our program. I am pleased to report that the FDA met their goal date this month and provided us responses with clear guidance. We recognize the FDA staff has a lot going on and appreciate their ability to keep companies moving forward with their development programs. FDA feedback is critical during development and we hope that the new leadership will prioritize this aspect of the FDA's role.
Speaker Change: Speaking of the F D. A theres a lot going on there that all of US collectively are worrying about I do want to convey our recent experiences I think it is important for all of us to monitor the current state of this important regulatory body.
Speaker Change: We asked for guidance or a type C request with written responses only on a technical matter and our program I am pleased to report that the F. D. A met their goal date this month and provided us responses with clear guidance.
Speaker Change: We recognize the F. D. A staff has a lot going on and appreciate their ability to keep companies moving forward with their development programs F. D. A feedback is critical during development and we hope that the new leadership will prioritize this aspect of the F D as well.
Jennifer Good: So to wrap up, all eyes here on the IPF chronic cough data.
Speaker Change: So to wrap up all eyes here on the IPF chronic cough data. This is a patient group that has had very little innovation in treatment options over the past 10 years, especially when it comes to improving their day to day lives of living with IPF.
Jennifer Good: This is a patient group that has had very little innovation and treatment options over the past 10 years, especially when it comes to improving their day-to-day lives of living with IPF. As a side note, we are planning on being quite active at ATS in San Francisco in a couple weeks. I will be there with several of my colleagues, so if you plan to attend, please let me know. We are hosting a KOL panel featuring both IPF experts and an RCC doctor for investors and analysts and already have quite good attendance. We plan to share new insights from the full RCC data set, which we will release online after as well.
Speaker Change: As a side note we are planning on being quite active at a T F. In San Francisco in a couple of weeks I will be there with several of my colleagues up you plan to attend please let me know we are hosting a K O L panel featuring both IPF experts and in RCC Doctor for investors and analysts and already have quite good attendance, we plan to share new.
Speaker Change: Insights from the pole RCC dataset, which we will release online after as well we will also be participating in a dinner with investors and we'll be actively attending sessions at the conference.
Jennifer Good: We will also be participating in a dinner with investors and will be actively attending sessions at the conference. Unfortunately, our RCC data came too late to make it into the late-breaker timelines for this conference.
Speaker Change: Unfortunately, our RCC data came too late to make it into the late breaker timelines for this conference. However, we plan to submit abstracts for analyses from both the river and Coral studies for the European Respiratory Society meeting in September 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.
Jennifer Good: However, we plan to submit abstracts for analyses from both the river and coral studies for the European Respiratory Society meeting in September.
Lisa Delfini: 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 Change: Yeah.
Speaker Change: Thank you Jennifer and good afternoon, everyone. The.
Lisa Delfini: Thank you, Jennifer, and good afternoon, everyone. The full financial results for the three months ended March 31, 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 first quarter of 2025, we reported a net loss of $10.4 million compared to a net loss of $10.9 million for the same quarter in 2024. R&D expenses were $7.8 million during the first quarter of 2025, compared to $8.8 million in the same quarter of 2024. The reduction was primarily due to decreased costs related to our Human Abuse Potential Study, which was actively enrolling in the first quarter of 2024.
Speaker Change: The full financial results for the three months ended March 31, 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 first quarter of 2025, we reported a net loss of $10 4 million compared to a net loss of $10 9 million for the same quarter in 2024.
Speaker Change: R&D expenses were $7 8 million during the first quarter of 2025 as compared to $8 8 million in the same quarter of 2024.
Speaker Change: The reduction was primarily due to decreased costs related to our human abuse potential study, which was actively enrolling in the first quarter of 2024.
Lisa Delfini: This was partially offset by an increase in personnel related expenses due to increased headcount. G&A expenses increased to $3.7 million during the first quarter of 2025, compared to $3.1 million in the same period of 2024, primarily due to an increase in personnel-related expenses. As of March 31, 2025, our cash and investments totaled $103.3 million, which gives us runway into the fourth quarter of 2026. We plan to use this cash to complete our ongoing Phase IIb choral trial of Hadubio for chronic cough in patients with IPF, and based on this data, we'll determine the development path forward in our programs and the related financing needs.
Speaker Change: This was partially offset by an increase in personnel related expenses due to increased head count.
Speaker Change: G&A expenses increased to $3 7 million during the first quarter of 2025 compared to $3 1 million in the same period of 'twenty 'twenty four primarily due to an increase in personnel related expenses.
Speaker Change: As of March 31, 2025, our cash and investments totaled $103 3 million, which gives us runway into the fourth quarter of 2026, we plan to use this cash to complete our ongoing phase two b quarrelled trial of <unk> for chronic cough in patients with IPF and based on this data we will determine the development path forward in our programs and.
Speaker Change: The related financing needs.
Lisa Delfini: During the first four months of this year, we had a total of 7.9 million common stock warrant exercises. We currently have about 1.9 million common stock warrants that remain outstanding. Our current fully diluted shares outstanding are approximately $137 million, which includes $101.7 million shares outstanding, those $1.9 million common stock warrants, about $23.2 million pre-funded warrants, and approximately $10 million stock options.
Speaker Change: During the first four months of this year, we had a total of $7 9 million common stock warrant exercises. We currently have about $1 9 million common stock warrants that remain outstanding.
Speaker Change: Our current fully diluted shares outstanding are approximately $137 million, which includes the hunter and one 7 million shares outstanding those one 9 million common stock warrants about $23 2 million pre funded warrants and approximately 10 million stock options.
Speaker Change: This concludes our prepared remarks, I will now turn the call back over to the operator for Q&A.
Lisa Delfini: This concludes our prepared remarks.
Operator: I will now turn the call back over to the operator for Q&A. Thank you.
Speaker Change: Thank you.
Operator: We will now begin the question and answer session. To ask a question, you may press star, then 1 on your touch-tone phone. If you are using a speakerphone, please pick up your handset before pressing the To withdraw your question, please press star, then two.
Speaker Change: We will now begin the question and answer session to ask a question you May Press Star then one on your Touchtone phone if youre using a speakerphone. Please pick up your handset before pressing the cheese to withdraw your question. Please press Star then two.
Operator: Due to the number of participants on the call, questions will be limited to one per caller and any relevant follow-up to your... If you have any other questions, you may get back in the queue.
Speaker Change: 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 Change: If you have any other questions you may get back in the queue. At this time, we will pause momentarily to assemble our roster.
Operator: At this time, we will pause momentarily to assemble our rock.
Speaker Change: Our first question comes from with myself crush it.
Faisal Khurshid: Our first question comes from Faisal Khurshid of Lerink. Please go ahead. Hey, thank you for taking the question. Just wanted to ask, can you remind us for for the coral readout? What would you see as a kind of encouraging or positive readout, both on the efficacy side and on the safety side? And is that like meeting the statistical bar? Is there anything kind of beyond that as well?
Speaker Change: Leerink. Please go ahead.
Speaker Change: Hey, Thanks for taking the question just wanted to ask can you remind us for for the coral readout, what would you see as they can.
Speaker Change: Kind of encouraging a positive ROI.
Speaker Change: Both on the efficacy side and on the safety side and is that like meeting the statistical bar is there anything kind of beyond that as well and I have a follow up as well.
Faisal Khurshid: And then I have a follow up as well.
Speaker Change: Thanks, that's all for the question.
Jennifer Good: Thanks, Faisal, for the question. I think for this trial, because there's been so little, it's been such a difficult condition, and there's really nothing for these patients. We powered this study. And to be able to move forward. And I think unlike RCC, when there were other programs we had to consider as far as moving forward, for this program, a statistically significant positive trial, we will keep moving forward in development. So that's the bar for us for success. I think on the safety side, just continuing, no sort of unusual adverse events that we didn't see, no safety signals, which we would already know at this point, so I'm comfortable we've sort of crossed that bar.
Speaker Change: I think for this trial because theres been so little it's been such a difficult condition and there's really nothing for these patients we powered the study.
Speaker Change: SaaS and to be able to move forward and I think unlike RCC. When there were other programs we have to consider as far as moving forward for this program a statistically significant positive trial, we will keep moving forward in development and so that's the bar for US for success I think on the safety side, just continuing no sort of unusual Adler.
Speaker Change: Events that we didn't see no safety signals, which we would already know at this point, so I'm comfortable with sort of crossed that bar and we've also shared before that our discontinuation or less than 10%. So you know I think.
Jennifer Good: We've also shared before that our discontinuations are less than 10%. level perspective, I think, you know, we'll look at obviously sort of the AE profile and things, but we've seen a lot of that so far. And there's nothing jumping out as unusual here. So really, I think it's just a matter of having positive data here and what it looks like. Got it. Great.
Speaker Change: Level perspective, I think you know well, we'll look at obviously sort of the AE profile and things, but we've seen a lot of that so far and there's nothing jumping out as unusual here. So really I think it's just a matter of them, having positive data here and what it looks like.
Speaker Change: Got it great and then can you remind us like what is the next catalyst for the company looked like sort of like the year or so coming out of the coral readout.
Jennifer Good: And then can you remind us, like, what did the next catalyst for the company look like sort of in, like, the year or so, like, coming out of the coral readout? Professor, I'm going to a little bit kick that can down the road because once we get the IPF data, I think we'll be in a better position to lay out the catalyst path forward. I mean, you know, we've talked about, we've got to get to the FDA and see them based off the IPF results, assuming they're successful. Jim and Farrell are doing some work around gearing up for running a basket trial in interstitial lung disease, which we can talk more about.
Speaker Change: But that's how I'm in a little bit kicked that can down the road because once we get the IPF data I think we'll be in a better position to lay out the catalyst path forward. I mean, you know we've talked about them, we've got to get to the F. D. A N C them. They stopped the IPF results, assuming they're successful German Farrell are doing some work around gearing up for running a basket trial.
Speaker Change: All in interstitial lung disease, which we can talk more about and I think once we get the IPF data and we're clear sort of on the path forward, we'll lay out a good catalyst tracked them coming out of our IPF data.
Jennifer Good: And I think once we get the IPF data, and we're clear sort of on the path forward, we'll lay out a good catalyst track coming out of that. And I think we'll be in a better position to lay out the catalyst track coming out of that.
Speaker Change: That's great. Thank you for the taking the questions and look forward to seeing in San Francisco.
Faisal Khurshid: That's great. Thank you for taking the questions and I look forward to seeing you in terms of Great. Thanks, Faisal.
Speaker Change: Great. Thanks, that's all.
Speaker Change: Our next question comes from Annabel <unk> of Stifel. Please go ahead.
Annabel Samimy: Our next question comes from Annabel Samimy of Staples. Please go ahead. Hi, thanks for taking my question. Just following up on the discontinuation rate you mentioned, it was less than 10%. Can you just remind us what you powered for? And was this was this powering based on overall discontinuations or just discontinuations based on adverse events? And then just to follow on that, just after the positive data in canal and river and positive SSRE, what is it that in your mind still presents the biggest challenge for you or uncertainty going into this ILD study? I'm sorry, IPF study.
Annabel: Hi, Thanks for taking my question just following up on the discontinuation rate you mentioned it was less than 10% can you just remind us what your powered for and with this was powering based on overall discontinuation churches discontinuation space on adverse events and I'm just to follow on that.
Annabel: But just after the positive data and canal and river and positive SSR you what is it that in your minds still presents the biggest challenge for you or uncertainty going into this ILD study or I'm, sorry, IPF study.
Annabel: I'll, let Jim answer the statistical question.
James Cassella: I'll let Jim answer the statistical question. Yeah, so we had powered for a 30% discontinuation rate for the study, and obviously we came in a lot less than that. Yeah, and I think, Annabel, to your point, I think really, which is how much risk is left, you know, I think all of us never stop worrying about these trials. I do think we had good phase 2A results. RCC was obviously corroborating. The SSRE, I think, was comforting. But, you know, this is a complicated trial. They're tough patients. It's in 60 different sites across 10 countries. I think Jim never stops worrying about every aspect of this trial.
Jim: Yes, so we.
Speaker Change: We had powered for 30% discontinuation rate for the study and obviously, we came in a lot less than that yeah, and I think annabel to your point I think really which is how much risk is left you know I think all of US never stop worrying about these trials I do think we had good phase Iia results RCC was all obviously.
Speaker Change: We're operating the the Fsrus I think with comfort and but you know this is a complicated trial, they're tough patient sits in 60 different sites across 10 countries I think Jim never stops worrying about every aspect of this trial. So it'll be nice when we turn over the card for sure and it's such an important indication that I think we all feel that.
Jennifer Good: So it'll be nice when we turn over the card for sure. And it's such an important indication that I think we all feel the burden of that. But no, we're feeling good about it heading into the readout.
Speaker Change: And of that but but no we're feeling good about it heading into the read out.
Speaker Change: Okay, great. Thank you.
Annabel Samimy: Great, thank you. Yeah, thank you.
Speaker Change: Yeah. Thank you.
Speaker Change: Yeah.
Leland: Our next question comes from Leland <unk> of Oppenheimer. Please go ahead.
Leland Gershell: Our next question comes from Leland Gershell of Oppenheimer. Please go ahead. Hey, good afternoon. Thanks for taking our questions. I will keep myself to one question. It's been about maybe a bit over a year since you saw the publication of data from the Pacify study of low-dose controlled-release morphine and IPFs. Kroneckoff, which had shown, I think, a fairly modest 20% improvement. in cough counts. Just wondering, you know, since time has elapsed, any feedback or reflection you've had from the physician community on those data and any potential role of that substance for use in IPS chronic cough?
Leland: Hey, good afternoon question or questions.
Leland: I'll keep myself to one question.
Leland: Hmm.
Leland: It's been about maybe a bit every year since you saw the publication of data from the classify study of of logos controlled release morphine in lgs.
Leland: Chronic cough.
Leland: Could you try to get good.
Leland: Modest 20% complete.
Leland: And Costco just wondering since some of the lapsed any feedback or inflection you've had from the physician community.
Leland: And as J J, maybe potential role.
Leland: Okay substance for using clinical.
Speaker Change: Paul Thanks.
Leland: Yeah, no. It's a great question Leland so the pacify study with a single site study run in the U K by Doctor Phil Molyneux. He's also the lead investigator in our IPF trial are very well respected guy that it basically showed a 40% drag effect from a mu agonist essentially by the zero plus.
Leland: He bought a fact, which was probably artificially you know that's sort of a function of single site in his patients I think as you know in our data sets, we've seen between a 67 and 74% drag effect. So a bigger a fact I think the community feels like we do which is the capa side of our mechanism is important here clearly it's sort of.
Leland: Almost doubling the effect size I think morphine also had other issues you have to keep the dosing law, what's got respiratory depression, its got addiction potential with it and so I've heard people ask this question at various panels and I think for all these doctors any ability to move people to something that is not a scheduled to subs.
Leland: And doesn't have the issues around a respiratory depression is gonna be a better alternative for them. The fact that it's got very much better efficacy as just a bonus so I think while morphine was interesting it validates the mechanism I think that our drugs continued to perform better and Jimmy our CNS Guy anything you would want to add to that no I think that's summarized.
Leland: I think there's really maybe.
Leland: Shows maybe the limitation of that particular drug in this space and I think.
Leland: Zero percent, Cuba response always raises questions about.
Leland: The trial design or the single center in nature of the Yeah fair enough.
Leland: Thanks for the question.
Operator: Thanks for the question, Leland.
Leland: Yeah, Good West coast.
Leland: Okay.
Serge Belanger: Our next question comes from Serge Belanger of Needham & Co. Please go ahead. Hi, good afternoon.
Speaker Change: Our next question comes from Serge Belanger of Needham and co. Please go ahead.
John: Hi, Good afternoon. This is John on for search today, Thanks for taking our question.
John Gionco: This is John for Surge Today. Thanks for taking our question. Just regarding the respiratory physiology study, just curious if it's still on track to finish in the second half this year. And I believe you guys have been contemplating implementing a 108 milligram dose in the study. Just curious if any updates have been made since March.
Speaker Change: Just regarding the respiratory physiology study.
Speaker Change: Just curious if that's still on track to finish in the second half this year.
Speaker Change: And I believe.
Speaker Change: You guys have been contemplating implementing.
Speaker Change: 108 milligram dose in the study just curious if any updates have been made since March. Thanks.
Jim: Hi, This is Jim So I think we're on track to keep that timeline I think studies.
James Cassella: Hi, this is Jim. So I think we're on track to keep that timeline. I think, you know, the study is ongoing. And we should be okay with that timeline. Yeah. And we're covering our clinical doses in that, John. We're comfortable this will answer the question.
Speaker Change: Studies ongoing and and where we should be okay with that timeline yeah.
Jim: And we're covering our clinical doses and that John were comfortable this will answer the question.
Jim: Okay. Thank you and just a reminder to everyone on that point, we really need to stay down when we go to talk to F. D. A next about the program forward, so and so that's kind of what we're working against her and we felt comfortable well be able to do that.
James Cassella: Okay, thank you. And just a reminder to everyone on that point, we really need this data when we go to talk to FDA next about the program forward. So, so that's kind of what we're working against here and we feel comfortable. We'll be able to do that.
Operator: Go ahead, Ariel.
Speaker Change: Go ahead area.
Debanjana Chatterjee: Our next question comes from Debanjana of Jones Trading. Please go ahead. Hi, thanks for taking my question. So could you provide us any additional color on what data points we can expect at ADS from this additional data cut from river that we are getting? Yeah, happy to do that. Hi, Debanjana. We're still kind of finalizing the presentation, but I think we're going to talk a little bit about some of the questions we've been getting from, you know, the sell side and also investors, which is a little bit around sort of the time period. So a little more analyses around the timing of AEs, when they occurred, the discontinuations, what drove those.
Speaker Change: Our next question comes from Jeevan genre of Jones trading. Please go ahead.
Jeevan: Hi, Thanks for taking my question. So could you provide us any additional color on what data points. We can expect at E. P. S. O from this additional data from Veeva that we're getting.
Speaker Change: Yeah happy to do that high Durban John up.
Speaker Change: [laughter] finalizing the presentation, but I think we're going to talk a little bit about some of the questions. We've been getting from the sell side and also investors, which is a little bit around sort of the time period. So a little more analyses around the timing of aes when they occurred the discontinuation what drove those and we're going to show.
Jennifer Good: We're going to show a few patient vignettes from the trial. So people, you know, came in, how long they'd had cough, what happened during the trial. We're going to show data around the Leister cough questionnaire, which is a QOL questionnaire. And then I think if we can pull this together, we're going to show the treatment period effect of the crossover. So we're doing some work around that now. We know there was no treatment period effect, but we do get questions about what the effect size looked for both in each treatment period. So that's our current plan.
Speaker Change: A few patient vignettes from the trial. So people came in how long they'd had cough, what what happened during the trial, we're going to show data around the livestock cough questionnaire, which is a Q O L. Questionnaire and then I think if we can pull this together we're gonna show the treatment period effect of the crossover. So we're doing some work around that now.
Speaker Change: We know there was no treatment period of fact that we do get questions about what the effect size look for bolt in each treatment period. So that's our current plan, Jim and I don't want to take up too much at the time, we'll probably talk for 15 20 minutes, but we have an amazing panel wedge. Thank you Leland who's got a moderate it with Dr. Toby Mayer who's probably.
Jennifer Good: Jim and I don't want to take up too much of the time. We'll probably talk for 15, 20 minutes, but we have an amazing panel, which thank you, Leland, who's going to moderate it with Dr. Toby Mayer, who's probably the world's leading expert in ILD, Nazia Chowdhury, who's actually an investigator in our IPF trial, amazing woman as well. And then Dr. Juspin Engaidis, who many of you have heard speak, is sort of the leading authority in the U.S. on RCC. So we'll have a nice open discussion with them and sort of open up the room and Leland will moderate through that.
Speaker Change: The world's leading expert in ILD nausea, Chaudhuri, who is actually an investigator in our IPF trial Amazing woman as well and then Doctor just spending guide US who many of you have heard speed because it's sort of the leading authority in the U S. On RCC. So we'll have a nice open discussion with them and sort of open up the room and we let it will moderate through that.
Jennifer Good: So that's the plan for that time. And we've gotten very good response to that. So should have a nice full room for that.
Speaker Change: So that's the plan for that time, and we've gotten very good response to that so should have a nice full room for that.
Debanjana Chatterjee: Thank you so much, very helpful, and look forward to seeing you in SF. Yes, thank you, us too.
Speaker Change: Thank you so much they have full and look forward to seeing you in is it.
Speaker Change: Yes. Thank you that's too.
Speaker Change: Okay.
Speaker Change: Our next question comes from Ryan Lumb Chung.
Mayank Mamtani: Our next question comes from Mayank Mamtani. B. Reilly Securities. Please go ahead. Yes, good afternoon, Dean. Thanks for taking our question and congrats on the progress. On the river data follow-up, you know, you're trying to figure out for the next steps, additional dose exploration work.
Speaker Change: B Riley Securities. Please go ahead.
Speaker Change: Yes. Good afternoon. Thanks for taking my question and congrats on the progress on the <unk>.
Speaker Change: Indeed, a follow up.
Speaker Change: You are trying to figure it out for the next steps.
Speaker Change: Do with exploration work could you maybe talk to your latest thinking on that Jennifer and then I guess a related question on the ILD study have you.
Jennifer Good: Could you maybe talk your latest thinking on that, Jennifer? And then I guess a related question on the ILD study. Have you, you know, planned the protocol, the crossover versus parallel arm design, how that would look like? And is there anything we can learn from the IPF chronic data set that would be helpful to also think about the ILD study probability? Yeah, and Mayank, I would just add IPF is obviously a big trigger for that as well. So, assuming the IPF trial is positive, hopefully we can get a little more color around that. Yep, super helpful.
Speaker Change: The protocol.
Speaker Change: Crossover, where some parallel arm design, how that would look like and is there anything we can learn from the idea of chronic cough.
Speaker Change: Data said that would be helpful to also think about the <unk> study.
The probability of success.
Speaker Change: Yeah. So I'll take the first part and maybe you can take the second part and decide if you want a fault fairlon I think on the dose exploration. The next step for US my off we're waiting on that IPF data. It's an important dataset. It's parallel arm. We do think there are synergies between RCC and IPF. So Jim's team has been busy doing some planning and sort of.
Speaker Change: The Nazis and things like that but we're going to wait and see the IPF dataset and then decide the path forward for both programs forward I think Jim Farrell I'll turn it over to you guys talk about I L D's and sort of where you're at on thinking about that I'll talk about briefly what we're thinking about for the trial design.
Speaker Change: Rob can fill in some of the other.
Speaker Change: Commercial side of things and patient side of things, but I think the key is.
Speaker Change: There's a lot of learnings from the crossover design that had been really used in these types of cost studies and we're definitely going to take advantage of that crossover design, we're going to follow the.
Speaker Change: Food path of the IPF work that we've done and so I think you can anticipate that we're going to run a similar type of trial I think the major question here is not really about the trial design or endpoints or things like that it's really about the nature of the population.
Speaker Change: Karen and I had been looking at this from a couple of different dimensions in talking to Kols and apparel has been looking at it from the commercial side. So I'll, let him chime in on that piece too yeah. Thanks, Mike for the question when we look at the the non IPF ILD population. There is one distinction that we're making different than the anti fibrotic anti fraud products, mainly look at.
Speaker Change: This from a progressive pulmonary fibrosis, so they need to see upper crust a phenotype to see a difference in F. B C. Over time, that's different with a chronic cough therapy in this space. So we really need to measures as Jim was saying we.
Speaker Change: We need a patient with ILD with fibrosis, and we need one with chronic cough and the overlap of the two and so that does expand that population were just better defining that and we hope to provide more details on the data call for football.
Speaker Change: Oh yeah.
Speaker Change: Just to add I P. F is obviously, a big trigger for that as well so assuming the IPF trials positives hopefully we can get a little more color around that.
Speaker Change: Super helpful and just a quick follow up to your comment on the recent FDA.
Mayank Mamtani: And just a quick follow up to your comment on the recent FDA type C meeting. Are you able to share the details of what it was about? And also, obviously, if your plans for next set of FDA engagement, I believe that would be the end of phase two meeting for IPF chronic. Thank you for taking our question. Sure. On the technical matter, Mayank, it just has to do with the whole validation around the primary endpoint. Same issue everybody knows around cost counting, clarifying what we need to do. So, fortunately, the FDA thought about that and is clear.
Speaker Change: The meeting are you able to share the details of what it was about then.
Speaker Change: And also Steve yet for next instead of FDA engagement I believe that would be the end of phase two meeting for chronic cough. Thank.
Speaker Change: Thank you for taking my questions.
Speaker Change: Sure on the technical matter My I guess, just has to do with validate the whole validation around the primary endpoint famous you everybody knows around cost counting clarifying what we need to do so Fortunately the F. D. A thought about that and is clear I think Jim I'll, let you comment on sort of your thinking forward on F. D. A yeah I think it's very encouraging.
James Cassella: I think, Jim, I'll let you comment on sort of your thinking forward on FDA. Yeah. I think it's very encouraging that this was, again, a very specific question. The FDA came in on time. They gave appropriate clarifying answers for us. So, that's a very encouraging sign for us. We will plan on having the appropriate meetings. We expect that the FDA is going to be engaged with us as we need to go to them for follow-up on both the RCC and the IPF program. So fingers crossed that things remain stable there for all of us.
Speaker Change:
Speaker Change: This was again a very specific question. The FDA came in on time. He gave a appropriate answers are clarifying answers for us.
Speaker Change: So that's a very encouraging sign for US we we will plan on having the appropriate meetings, we expect that the FDA is going to be engaged with us as we need to go to them for a follow up on both the RCC in the IPF programs.
Speaker Change: So fingers crossed that things remain stable there for all of us.
Speaker Change: Yeah.
Mike: Thank you Mike.
Operator: Thank you once again. Once again, if you have a question, please press star then 1.
Speaker Change: Once again, if you have a question. Please press Star then one.
Kaveri Pullman: Our next question comes from Kaveri Pullman of Clear Street, please go ahead. Yeah, good evening. Thanks for the updates and for taking my questions. I'm curious about your thoughts on long-term patient outcomes and safety findings. You know, the current plan does not seem to include FDA-required long-term patient safety monitoring protocols, even for the Phase 3 trial. Have you received any feedback on that from the agency? Could decades of the safety data from the existing formulation serve as an acceptable proxy?
Speaker Change: Our next question comes from Caveri, Poland, a clear Street. Please go ahead.
Speaker Change: Yeah. Good evening, thanks for the update and for taking my question I'm curious about your thoughts on long term patient outcomes and safety findings you know the current plan does not seem to include FDA required long term patient safety monitoring protocols, even for the phase III.
Speaker Change: Trial have you received any feedback on that from the agency could decades off the safety data from the existing formulation served as an acceptable proxy.
Speaker Change: Hi, This is Jim so we actually have pretty good clarity around what the requirements are going to be for a long term safety.
James Cassella: Hi, this is Jim. So, we actually have pretty good clarity around what the requirements are going to be for long-term safety. The FDA has not only, you know, told others in the RCC space that 52 weeks is an important time point as far as they're concerned. So, we had planned on having 52 weeks worth of safety when we submit the NDA. There's ways to do that in the phase 3 program with, you know, separate long-term extension trials. So, our intention is to make sure that we include 52 weeks of safety. And, of course, in that trial, we're also able to look at continued effects on coughs.
Speaker Change: The FDA has not only told others in the RCC space at 52 weeks is an important time point as far as they're concerned. So we had planned on having 52 weeks or if the safety when we submit the NDA there is ways to do that in the phase III program.
Speaker Change: You know separate long term extension trial. So our intention is to make sure that we included 52 weeks of safety and of course in that trial.
Speaker Change: We're also able to look at a continued effects on on cough. So I think it's in our plans and and we'll be looking for that.
James Cassella: So, I think it's in our plans, and we'll be looking for that one.
Speaker Change: Okay. That's very helpful and maybe going forward before ahead of you know running big Phase III trials.
Kaveri Pullman: Okay, that's very helpful. And maybe going forward ahead of, you know, running big phase three trials, what are your current perspective on potential U.
Speaker Change: What are your current perspective on potential U S or ex U S partnerships.
Kaveri Pullman: S. or X U. S.
Operator: partnership? Yeah, thank you.
Speaker Change: Thanks for taking my questions.
Speaker Change: Yeah, I mean, we're always in strategic conversations I would say we are you know I think we're equipped and preparing for handling this ourselves in the U S sort of absent just a straight out by buying the company Farrell is always talking to various partners potentially for commercialization in Europe and Japan.
Speaker Change: And I think you know depending on the data and sort of timing you know that certainly on the table.
Speaker Change: Got it thank you.
Speaker Change: Thank you.
Speaker Change: Our next question comes from Ryan Deschner of Raymond James. Please go ahead.
Ryan Deschner: Our next question comes from Ryan Deschner of Raymond James, please go ahead. Hi, good afternoon.
Speaker Change: Hi, Good afternoon. This is Anthony <unk> filling in for Ryan. We wanted to ask have you seen any trends in the reverse study in terms of patient baseline characteristics, such as like background therapies or initial disease etiology.
James Cassella: This is Anthony filling in for Ryan. We wanted to ask, have you seen any trends in the RIVER study in terms of patient baseline characteristics, such as like background therapies or initial disease etiology? Jim, it's probably too early to ask that, but I'll defer to you. Yeah, we are digging in on all of the data. I can't tell you that I have an answer for that right now, but it's clearly some of the analysis that we'll be putting together and preparing for presentations at some future meeting. I mean, this drug, as you probably remember, Anthony, worked in literally everyone in a big way, so it's hard to see trends of maybe where it didn't work, but they are going sort of patient by patient trying to understand what we can see here.
Speaker Change: Yeah, it's probably too early to ask that but I'll tell you. We are digging in on all of the data I can't tell you that I have an answer for that right now it's clearly.
Speaker Change: Some of the analyses that we'll be putting together and preparing for presentations at some future meeting I mean this drag as you probably remember Anthony worked in literally every one in a big way. So it's hard to see trends of maybe where it didn't work, but they are going sort of patient by patient and trying to understand what we can see here.
Speaker Change: Alright, Thank you very much.
Ryan Deschner: All right, thank you very much. Yeah, thank you.
Speaker Change: Yeah. Thank you.
Speaker Change: Okay.
Speaker Change: I'm not showing any further questions at this time. This concludes our question and answer session I would now.
Operator: I'm not showing any further questions at this time.
Jennifer Good: This concludes our question and answer session.
Jennifer Good: I would like to turn the conference call back over to Jennifer Good for closing remarks. Thank you. We look forward to the upcoming results of our Phase 2b choral trial this quarter and appreciate all of you joining today's call. We are available after the call for any follow-up questions that you may have.
Speaker Change: Like to turn the conference call back over to Jennifer good for closing remarks.
Speaker Change: Thank you and we look forward to the upcoming results of our phase two be Karl trial. This quarter and appreciate all of you joining today's call. We are available after the call for any follow up questions that you may have thank you for joining.
Operator: Thank you for joining. This conference call has now concluded. Thank you for attending today's presentation, you may now disconnect.
Speaker Change: This conference call has now concluded.
Speaker Change: Thank you for attending today's presentation you may now disconnect.
Speaker Change: [music].
Speaker Change: Yeah.
Speaker Change: [music].
Epstiria Thanks, Jennifer
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Speaker Change: All the information in this video is based on a true story. All information about Jennifer Delfini is based on a true story. All information about Jennifer Delfini is based on a true story.
Speaker Change: [music].