Q1 2026 Trevi Therapeutics Inc Earnings Call

May 5, 2026

Speaker #1: Will be an opportunity to ask questions. To ask a question during the session, you'll need to press star 11 on your telephone, you will then hear an automated message advising your hand is raised.

Speaker #1: To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. Barriers for marks 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 #1: Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the Risk Factors section of the company's most recent annual report on Form 10-K, which the company filed with the SEC on March 17, 2026, as updated by our subsequent filings.

Speaker #1: 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 #1: 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 #1: I would now like to turn the conference call over to Jennifer Good, Trevi's president and CEO. Please go ahead.

Speaker #2: Good afternoon and thank you for joining us for our first quarter 2026 earnings call and business update. Joining me today on this call are my colleagues, Dr. James Cassella, our Chief Development Officer; Farrell Simon, our Chief Commercial Officer; and David Hastings, our Chief Financial Officer.

Speaker #2: Dave and I will make some initial comments, but are going to keep them brief as we have a robust presentation this Thursday at our investor and analyst day.

Speaker #2: After our comments on the quarter, the team is happy to answer any questions you may have. 2026 is an important year of execution for the company and the team is focused on delivering.

Speaker #2: Following our positive FDA meeting in the first quarter to align on our IPF-related chronic cough program, the team has finalized the study protocols for our phase three trials and has been busy identifying global sites for both pivotal studies.

Speaker #2: We expect to initiate the first of those two studies this quarter, followed by the second study in the second half of this year. After gaining alignment with the FDA and our end-of-phase two meeting, we now intend to submit a meeting request and protocol to the FDA to discuss our non-IPF interstitial lung disease, or non-IPF, ILD-related chronic cough program.

Speaker #2: We intend to propose an adaptive phase two, three study to confirm dose and powering assumptions in the phase two study prior to rolling into one pivotal phase three study for approval.

Speaker #2: If all goes as proposed to the FDA, we expect to initiate this trial in the second half of the year. This non-IPF ILD population will mimic the patient profile of patients in our IPF trial as it will include patients who have established lung fibrosis and chronic cough.

Speaker #2: There are a lot of synergies with our IPF studies as these patients with non-IPF ILD are seen in the same care centers by the same pulmonologist.

Speaker #2: So as we negotiate CDAs, contracts, and budgets for the initiation of our IPF-related chronic cough trials, we have this trial in the scope so that we can act quickly once we have alignment with the FDA on the protocol.

Speaker #2: Finally, for refractory chronic cough, we also expect to initiate a phase two B parallel arm dose- ranging trial with three doses and placebo this quarter as well.

Speaker #2: The protocol is finalized and has been submitted to regulatory authorities and we are actively qualifying sites for this trial. This trial includes a sample size reestimation, or SSRE, which will read out when 50% of the patients complete the trial and is in place to confirm powering assumptions and adjust the sample size if necessary.

Speaker #2: We expect the SSRE readout in the fourth quarter of this year. One final update I would like to give is on the advancement of our intellectual property portfolio.

Speaker #2: We own the worldwide rights for our drug and are acutely focused on prosecuting incremental patent coverage in addition to the patents that have already been issued.

Speaker #2: This quarter, we had our core method of treatment patent issued for IPF-related chronic cough in Europe as well. This patent had already been issued in the US and provides protection through 2039.

Speaker #2: We filed additional applications this year in the US, which if issued would extend the patent coverage through 2046. We will keep you updated as incremental IP evolves.

Speaker #2: Before I close, I want to note there are two important meetings this month where we hope to see many of you. The first is our investor and analyst day this Thursday, May 7th, from 10:00 AM to 12:00 PM Eastern Time, followed by an optional lunch in New York City.

Speaker #1: Worldwide Rights for Our Drug and our acutely focused on prosecuting incremental patent coverage in addition to the patents that have already been issued. This quarter we had our core method of treatment patent issued for IPF-related chronic cough in Europe as well.

Jennifer Good: Worldwide rights for our drug and are acutely focused on prosecuting incremental patent coverage in addition to the patents that have already been issued. This quarter, we had our core method of treatment patent issued for IPF-related chronic cough in Europe as well. This patent had already been issued in the US and provides protection through 2039. We filed additional applications this year in the US which, if issued, would extend the patent coverage through 2046. We will keep you updated as incremental IP evolve. Before I close, I wanna note there are 2 important meetings this month where we hope to see many of you. The first is our Investor and Analyst Day, this Thursday, 7 May from 10:00 AM to 12:00 PM Eastern Time, followed by an optional lunch in New York City.

Speaker #2: At this event, we plan to lay out details for the next clinical trials, the projected timelines for each of our chronic cough programs, and discuss incremental data we have developed as we continue to analyze our existing clinical trial data.

Speaker #1: This patent had already been issued in the U.S. and provides protection through 2039. We filed additional applications this year in the U.S. which, if issued, would extend the patent coverage through 2046.

Speaker #2: We also will share commercial learnings based on recent market research and hear from KOLs on their perspective. So it should be an informative event.

Speaker #1: We will keep you updated as incremental IP evolves. Before I close, I want to note there are two important meetings this month where we hope to see many of you.

Speaker #2: We will post the webcast and slides after the event for those of you that are unable to join us. Second, we will also be very active at the American Thoracic Society or ATS meeting this year.

Speaker #1: The first is our investor and analyst day this Thursday, May 7, from 10:00 a.m. to 12:00 p.m. Eastern Time, followed by an optional lunch in New York City.

Speaker #2: With all six of our submissions being accepted for either presentations or posters. We will also be holding an investor analyst event at ATS where Jim and Dr. Philip Molyneaux, the lead investigator on our coral trial, will summarize and share the various data being presented at the conference.

Speaker #1: At this event, we plan to lay out details for the next clinical trials, the projected timelines for each of our chronic cough programs, and discuss incremental data we have developed as we continue to analyze our existing clinical trial data.

Jennifer Good: At this event, we plan to lay out details for the next clinical trials, the projected timelines for each of our chronic cough programs, and discuss incremental data we have developed as we continue to analyze our existing clinical trial data. We also will share commercial learnings based on recent market research and hear from KOLs on their perspective, so it should be an informative event. We will post the webcast and slides after the event for those of you that are unable to join us. Second, we will also be very active at the American Thoracic Society, or ATS, meeting this year, with all six of our submissions being accepted for either presentations or posters.

Speaker #1: We also will share commercial learnings based on recent market research and hear from KOLs on their perspective. So it should be an informative event.

Speaker #2: This event will be a lunch meeting being held on Monday, May 18th. If you plan to attend ATS, please reach out to us as we would love to have you join.

Speaker #1: We will post the webcast and slides after the event for those of you that are unable to join us. Second, we will also be very active at the American Thoracic Society or ATS meeting this year.

Speaker #2: In closing, we are focused on executing against our plan of becoming the leader in chronic cough, providing therapy for these patients where there are no good options, and in the process creating meaningful value for patients and our shareholders.

Speaker #1: With all six of our submissions being accepted for either presentations or posters. We will also be holding an investor/analyst event at ATS where Jim and Dr. Philip Molyneux, the lead investigator on our coral trial, will summarize and share the various data being presented at the conference.

Speaker #2: I will now turn it over to Dave for his remarks and then we are happy to answer your questions. Dave?

Jennifer Good: We will also be holding an investor analyst event at ATS, where Jim and Dr. Philip Molyneaux, the lead investigator on our CORAL trial, will summarize and share the various data being presented at the conference. This event will be a lunch meeting being held on Monday, 18 May. If you plan to attend ATS, please reach out to us as we would love to have you join. In closing, we are focused on executing against our plan of becoming the leader in chronic cough, providing therapy for these patients where there are no good options, and in the process, creating meaningful value for patients and our shareholders. I will now turn it over to Dave for his remarks, and then we are happy to answer your questions. Dave?

Speaker #3: Thanks, Jennifer, and good afternoon, everybody. My brief remarks today will focus on our most important financial metric, which is our cash position and the runway it provides.

Speaker #1: This event will be a lunch meeting being held on Monday, May 18. If you plan to attend ATS, please reach out to us, as we would love to have you join.

Speaker #3: We ended the first quarter of 2026 with approximately $172 million in cash, cash equivalents and marketable securities. This balance does not include the $162 million in net proceeds from our underwritten common stock offering completed in April 2026.

Speaker #1: In closing, we are focused on executing against our plan of becoming the leader in chronic cough, providing therapy for these patients where there are no good options, and in the process creating meaningful value for patients and our shareholders.

Speaker #3: The offering was well received and we appreciated the strong support and participation we got from our current shareholders and we are grateful that we were able to attract new investors to Trevi.

Speaker #1: I will now turn it over to Dave for his remarks and then we are happy to answer your questions. Dave?

Speaker #2: Thanks, Jennifer, and good afternoon, everybody. My brief remarks today will focus on our most important financial metric, which is our cash position and the runway it provides.

David Hastings: Thanks, Jennifer, and good afternoon, everybody. My brief remarks today will focus on our most important financial metric, which is our cash position and the runway it provides. We ended Q1 2026 with approximately $172 million in cash equivalents, and marketable securities. This balance does not include the $162 million in net proceeds from our underwritten common stock offering completed in April 2026. The offering was well-received, and we appreciated the strong support and participation we got from our current shareholders, and we are grateful that we were able to attract new investors to Trevi. Additionally, with the completion of this offering, we accomplished 2 major objectives. 1, we removed any financial overhang when we reach critical high-value clinical endpoints. 2, we extended our cash runway into 2030.

Speaker #3: Additionally, with the completion of this offering, we accomplished two major objectives. One, we removed any financial overhang when we reach critical high-value clinical endpoints.

Speaker #3: And two, we extended our cash runway into 2030. Included in this runway guidance is the funding of our development program in patients with IPF-related chronic cough, potentially through FDA approval.

Speaker #2: We ended the first quarter of 2026 with approximately $172 million in cash, cash equivalents, and marketable securities. This balance does not include the $162 million in net proceeds from our underwritten common stock offering completed in April 2026.

Speaker #3: And we also expect these cash resources will enable the company to fund and report top-line data from the planned phase two B clinical trial and potentially a subsequent phase three trial for the treatment of patients with non-IPF ILD-related chronic cough.

Speaker #2: The offering was well received and we appreciated the strong support and participation we got from our current shareholders and we are grateful that we were able to attract new investors to Trevi.

Speaker #2: Additionally, with the completion of this offering, we accomplished two major objectives. One, we removed any financial overhang when we reached critical high-value clinical endpoints.

Speaker #3: And it funds the planned phase two B trial for the treatment of patients with RCC. The planned spending of these resources also include pre-commercial activities but does not include any expenses related to the commercial launch of Adivo or any other clinical trials.

Speaker #2: And two, we extended our cash runway into 2030. Included in this runway guidance is the funding of our development program in patients with IPF-related chronic cough, potentially through FDA approval.

David Hastings: Included in this runway guidance is the funding of our development program in patients with IPF-related chronic cough, potentially through FDA approval. We also expect these cash resources will enable the company to fund and report top-line data from the planned Phase 2b clinical trial and potentially a subsequent Phase 3 trial for the treatment of patients with non-IPF ILD-related chronic cough. It funds the planned Phase 2b trial for the treatment of patients with RCC. The planned spending of these resources also include pre-commercial activities, but does not include any expenses related to the commercial launch of Haduvio or any other clinical trials. With that, I believe we are now well-positioned to execute our clinical trials with funding through critical value inflection points. Operator, we can now open the call for questions.

Speaker #3: So with that, I believe we are now well positioned to execute our clinical trials with funding through critical value inflection points. Operator, we can now open the call for questions.

Speaker #2: And we also expect these cash resources will enable the company to fund and report top-line data from the planned Phase 2B clinical trial and potentially a subsequent Phase 3 trial for the treatment of patients with non-IPF ILD-related chronic cough.

Speaker #1: Thank you. We will now conduct the question-and-answer session. As a reminder to ask a question, please press star 11 on your telephone and wait for your name to be announced.

Speaker #1: To withdraw your question, please press star 11 again. At this time, we will pause momentarily to assemble our roster. Our first question comes from the line of Roanna Ruiz of Lyric Partners.

Speaker #2: And it funds the planned Phase 2B trial for the treatment of patients with RCC. The planned spending of these resources also include pre-commercial activities but does not include any expenses related to the commercial launch of Adivo or any other clinical trials.

Speaker #1: Your line is now open.

Speaker #2: So with that, I believe we are now well positioned to execute our clinical trials with funding through critical value inflection points. Operator, we can now open the call for questions.

Speaker #4: Great. Afternoon, everyone. A couple from me. First one, I was curious, what are your goals for the upcoming meeting with the FDA to talk about the protocol for your phase two B and non-IPF ILD chronic cough?

Speaker #3: Thank you. We will now conduct the question-and-answer session. As a reminder to ask a question, please press star 11 on your telephone and wait for your name to be announced.

Operator: Thank you. We will now conduct the question and answer session. As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. At this time, we will pause momentarily to assemble our roster. Our first question comes from the line of Roanna Ruiz of Leerink Partners. Your line is now open.

Speaker #4: And if you could elaborate, anything you expect that might be up for discussion with the FDA versus more straightforward questions?

Speaker #3: To withdraw your question, please press star 11 again. At this time, we will pause momentarily to assemble our roster. Our first question comes from the line of Rowanna Ruiz of Lyric Partners.

Speaker #3: Hey, Roanna. This is Jim. Thanks for the question. So basically, that meeting is designed to discuss our intention for the ILD program. We will be submitting the full phase two B three protocol with that for discussion and really talk about our intentions on using that in an SMDA strategy so that we would support approval with that adaptive phase two three design.

Speaker #3: Your line is now open.

Roanna Ruiz: Great. Afternoon, everyone. A couple from me. First one, I was curious, what are your goals for the upcoming meeting with the FDA to talk about the protocol for your Phase 2b in non-IPF ILD chronic cough? If you could elaborate, like, anything you expect that might be up for discussion with the FDA versus more straightforward questions?

Speaker #3: So there's going to be details about our patient population, how we're going to use the phase two for our dose selection confirmation and defining the dose for going into phase three, and then pulling up the results from the phase two part of that study with the interim analysis to confirm our power assumptions and for the phase three component.

Speaker #4: And if you could elaborate, anything you expect that might be up for discussion with the FDA versus more straightforward questions?

Speaker #2: Hey, Rowanna. This is Jim. Thanks for the question. So basically, that meeting is designed to discuss our intention for the ILD program. We will be submitting the full Phase 2B/3 protocol with that for discussion and really talk about our intentions on using that in an SMDA strategy so that we would support approval with that adaptive Phase 2/3 design.

James V. Cassella: Hey, Roanna. This is Jim. Thanks for the question. Basically, that meeting is designed to discuss our intention for the ILD program. We will be submitting the full Phase 2b/3 protocol with that for discussion and really talk about our intentions on using that in an sNDA strategy so that we would support approval with that adaptive Phase 2/3 design. There's gonna be details about our patient population, how we're going to use the Phase 2 for our dose selection confirmation and defining the dose for going into Phase 3 and then pulling up the, you know, the results from the Phase 2 part of that study with the interim analysis to confirm our power assumptions and for the Phase 3 component.

Speaker #4: Makes sense. And then quick follow-up. Thinking about RCC phase two B potentially ramping up as well, and moving forward in non-IPF ILD, could you talk a bit about how you plan to balance resources and prioritize things as you have many really interesting things going on?

Speaker #2: So there's going to be details about our patient population, how we're going to use the Phase 2 for our dose selection, confirmation, and defining the dose for going into Phase 3, and then pulling up the results from the Phase 2 part of that study with the interim analysis to confirm our power assumptions and for the Phase 3 component.

Speaker #4: And moving forward.

Speaker #3: Yeah. We don't like a lot of sleep. We have things under control. This is not my first time running multiple programs with a small team.

Speaker #3: We use our internal expertise. We have leveraged very experienced CRO, one that I've worked with from my last NDA, have a lot of years of experience with them.

Speaker #4: Makes sense. And then quick follow-up. Thinking about RCC Phase 2B potentially ramping up as well, and moving forward in non-IPF ILD, can you talk a bit about how you plan to balance resources and prioritize things as you have many really interesting things going on?

Roanna Ruiz: Makes sense. A quick follow-up. Thinking about RCC phase 2b potentially ramping up as well, and moving forward in non-IPF ILD, can you talk a bit about how you plan to balance resources and prioritize things, as you have, you know, many really interesting things going on and moving forward?

Speaker #3: So it's a really tight team. Our vendors that we've selected are really here to support us across all of our programs. So I think we're in a good position to be able to do these things.

Speaker #3: I have no questions that we have the capabilities in the intellectual horsepower to get these things done and we I've been working with small and small companies for almost 40 years now.

Speaker #4: And moving forward.

Speaker #2: Yeah. We don't like a lot of sleep. We have things under control. This is not my first time running multiple programs with a small team.

James V. Cassella: Yeah, it's, we don't like a lot of sleep. We have things under control. You know, this is not my first time running multiple programs with a small team. You know, we use our internal expertise. We have leveraged very experienced CRO, one that I've worked with from my last NDA, have a lot of years of experience with them. It's a really tight team. Our vendors that we've selected are really here to support us across all of our programs. I think, we're in a good position to be able to do these things. I have no questions that we have the capabilities and the intellectual horsepower to get these things done. I've been working with small companies for almost 40 years now.

Speaker #3: We know how to manage the resources to get these things done.

Speaker #5: I would add too, Jim, Roanna, we have added probably 10 people in the last since getting our phase two B results. We added a really experienced pulmonologist.

Speaker #2: We use our internal expertise. We have leveraged very experienced CRO, one that I've worked with from my last NDA, have a lot of years of experience with them.

Speaker #5: We've added several clinical people. So 10 people for us is a lot of hiring. And so we have tried to scale appropriately to address the busyness of these trials.

Speaker #2: So, it's a really tight team. Our vendors that we've selected are really here to support us across all of our programs, so I think we're in a good position to be able to do these things.

Speaker #3: Yeah.

Speaker #4: Yep. Sounds good. Thanks a lot.

Speaker #5: Thank you for the questions.

Speaker #2: I have no questions that we have the capabilities and the intellectual horsepower to get these things done and we I've been working with small and small companies for almost 40 years now.

Speaker #1: Thank you. Our next question comes from the line of Judah Frommer of Morgan Stanley. Your line is now open.

Speaker #2: We know how to manage the resources to get these things done.

James V. Cassella: We know how to manage the resources to get these things done.

Speaker #6: Yeah. Hi, guys. Thanks for the update and thanks for taking the questions. Two for us. I guess just from a competitive standpoint in RCC, we have a P2X3 readout coming mid-year.

Speaker #1: I would add too, Jim, Rowanna, we have added probably 10 people in the last since getting our Phase 2B results. We added a really experienced pulmonologist.

Jennifer Good: I would add, too, James, Roanna, we have added probably 10 people in the last since getting our Phase 2b results. We added a really experienced pulmonologist. We have added several clinical people. You know, 10 people for us is a lot of hiring. We have tried to scale appropriately to address the busyness of these trials.

Speaker #6: Just curious how you think the landscape evolves for Haduvia if kind of along the spectrum of possible outcomes for that P2X3 readout. I guess if results are unexpectedly strong, what does that do for your opportunity in RCC?

Speaker #1: We've added several clinical people. So 10 people for us is a lot of hiring. And so we have tried to scale appropriately to address the busyness of these trials.

Speaker #2: Yeah.

James V. Cassella: Yeah.

Speaker #4: Yep. Sounds good. Thanks a lot.

Roanna Ruiz: Sounds good. Thanks a lot.

Speaker #1: Thank you for the questions.

Jennifer Good: Thank you for the question.

Speaker #6: What does it do maybe for enrollment in the RCC trial? Thanks.

Speaker #3: Thank you. Our next question comes from the line of Judah Frommer of Morgan Stanley. Your line is now open.

Operator: Thank you. Our next question comes from the line of Judah Frommer of Morgan Stanley.

Speaker #5: Carol, why don't you answer the competitive landscape and Jim can talk about enrollment.

Speaker #3: Yeah. Judah, thank you for the question. When we look at the competitive landscape, especially Campbell Pixon, which we'll be reading out soon in the next couple of weeks, we're hoping that they are successful here, right?

Speaker #2: Yeah. Hi, guys. Thanks for the update and thanks for taking the questions. Two for us. I guess just from a competitive standpoint in RCC, we have a P2X3 readout coming mid-year.

Judah Frommer: Yeah. Hi, guys. Thanks for the update, and thanks for taking the questions. Two for us. I guess just from a competitive standpoint in RCC, we have a P2X3 readout coming mid-year. Just curious how you think the landscape evolves for Haduvio if kind of along the spectrum of possible outcomes for that P2X3 read. I guess if results are unexpectedly strong, what does that do for your opportunity in RCC? What does it do maybe for enrollment in the RCC trial? Thanks.

Speaker #3: This is a large, unmet need patient population. We know approved therapies and definitely a category that can support multiple modalities we have strong differentiation with our central and peripheral mechanism of action.

Speaker #2: Just curious how you think the landscape evolves for Haduvia if—kind of along the spectrum of possible outcomes for that P2X3 readout. I guess if results are unexpectedly strong, what does that do for your opportunity in RCC?

Speaker #3: And I think what we'll take you through on Thursday and the investor day is exactly how that positions us for success. I'll turn it over.

Speaker #2: What does it do maybe for enrollment in the RCC trial? Thanks.

Speaker #3: I'll just say on the flip side, if Campbell Pixon is unsuccessful, then that space, I think we'll have to take a look at what is our competitive positioning.

Speaker #1: Rowanna, why don't you answer the competitive landscape and Jim can talk about enrollment.

Jennifer Good: Farrell, why don't you answer the competitive landscape, and Jim can talk about enrollment.

Speaker #2: Yeah. Judah, thank you for the question. When we look at the competitive landscape, especially Campbell-Pickson, which we'll be reading out soon in the next couple of weeks, we're hoping that they are successful here, right?

Farrell Simon: Judah, thank you for the question. You know, when we look at the competitive landscape, especially camlipixant, which we'll be reading out soon in the next couple of weeks, you know, we're hoping that they are successful here, right? This is a large unmet need patient population with no approved therapies and definitely a category that can support multiple modalities. We have strong differentiation with our central and peripheral mechanism of action. I think what we'll take you through on Thursday in the Investor Day is exactly how that positions us for success. I'll turn it over.

Speaker #3: But we have a really strong efficacy and see what the phase two B results say and see what the commercial opportunity lies ahead. But it's still a large, unmet need patients are waiting for us.

Speaker #2: This is a large, unmet need patient population, with no approved therapies, and definitely a category that can support multiple modalities. We have strong differentiation with our central and peripheral mechanism of action.

Speaker #3: And I'll turn it to Jim.

Speaker #2: Yeah. I mean, on the enrollment side, we have our investigators lined up for that study. There's a lot of excitement. There's a lot of patients available to us.

Speaker #2: Irregardless of what happens in that environment, we're strongly supported by the investigators that we have for the study. Really talk about a lot of patients being available and interested in being in our study.

Speaker #2: And I think what we'll take you through on Thursday in the investor day is exactly how that positions us for success. Alternative I'll just say, on the flip side, if Campbell-Pickson is unsuccessful, then that space, I think we'll have to take a look at what is our competitive positioning.

James V. Cassella: You know, I'll just say on the flip side, if camlipixant is unsuccessful within that space, I think we'll have to take a look at, you know, what is our competitive positioning, but we have a really strong efficacy and see what the Phase 2b results say and see what the commercial opportunity lies ahead. It's still a large unmet need. Patients are waiting for us. I'll turn it to Jim. Yeah. I mean, on the enrollment side, you know, we have our investigators signed up for that study. There's a lot of excitement. There's a lot of patients available to us. Irregardless of what happens in that environment, we're strongly supported by the investigator study who really talk about a lot of patients being available and interested in being in our study.

Speaker #2: I think our different mechanism, the data that we've shown, the strength of the data that we have out there, still is really the absolute driving force for the interest in being in our study.

Speaker #2: But we have a really strong efficacy and see what the Phase 2B results say and see what the commercial opportunity lies ahead. But it's still a large, unmet need patients are waiting for us.

Speaker #5: And our two B will be done by the time they ever got approval. So it might be a phase three issue to deal with.

Speaker #2: And I'll turn it to Jim.

Speaker #5: Yeah. I mean, on the enrollment side, we have our investigators lined up for that study. There's a lot of excitement. There's a lot of patients available to us.

Speaker #5: But yeah, thanks for the question.

Speaker #3: Great. And then just maybe more high-level philosophical, just on the ILDs. With kind of more inhaled formulation drugs, kind of entering or late stage in kind of the IPF and PPF space, right?

Speaker #5: Irregardless of what happens in that environment, we're strongly supported by the investigators—study who really talk about a lot of patients being available and interested in being in our study.

Speaker #3: A common AE in a lot of those trials is cough. So just curious how you think the opportunity for Haduvia could be impacted by maybe more inhaled therapeutics in the PPF space.

Speaker #5: I think our different mechanism, the data that we've shown, the strength of the data that we have out there, still is really the absolute driving force for the interest in being in our study.

James V. Cassella: I think our different mechanism, the data that we've shown, the strength of the data that we have out there, still is really the absolute driving force for the interest in being in our study.

Speaker #3: Thanks.

Speaker #5: Judah, we get this question a lot. I think obviously we're treating more of a chronic cough that's more systemic. Now, whether the hypersensitizations intertwined with them taking these inhaled products and you might be able to settle that down, that's something that's going to have to be learned over time.

Jennifer Good: Our IIb will be done by the time they ever got approval.

Speaker #1: And our 2b will be done by the time they ever got approval. So it might be a Phase 3 issue to deal with. But yeah, thanks for the question.

Jennifer Good: Yeah.

Jennifer Good: It might be a phase 3 issue.

James V. Cassella: Yeah

James V. Cassella: -to deal with. yeah, thanks for the question.

Judah Frommer: Great. Then just maybe more high level philosophical, just on the ILDs. With more in inhaled formulation drugs entering or late stage in the RPF and PPF space, right? A common AE in a lot of those trials is cough. Just curious how you think, you know, the opportunity for Haduvio could be impacted by maybe more inhaled therapeutics in the PF space. Thanks.

Speaker #2: Great. And then, just maybe more high-level, philosophically, just on the ILDs. With more inhaled formulation drugs entering or in late stage in the IPF and PPF space, right?

Speaker #5: I do think these different therapies are helpful. They'll define the market. They create options. But we can lay alongside all of these. That's why Jim's been busy doing these DDI studies.

Speaker #2: A common AE in a lot of those trials is cough. So just curious how you think the opportunity for Haduvia could be impacted by maybe more inhaled therapeutics in the PPF space.

Speaker #5: But whether we can sort of help with the cough due to their delivery system, I think that'll have to be discovered.

Speaker #3: Thanks.

Speaker #5: Yeah. Thank you.

Speaker #2: Thanks.

Speaker #1: Thank you. Our next question comes from the line of Alexa Diemer of Cantor Fitzgerald. Your line is now open.

Jennifer Good: Judah, we get this question a lot. I think obviously we're treating more of a chronic cough that's more systemic. Now, whether the hypersensitization is intertwined with them taking these inhaled products and you might be able to settle that down, that's something that's gonna have to be learned over time. I do think, you know, these different therapies are helpful. They'll define the market, they create options, but we can lay alongside all of these. That's why Jim's been busy doing these DDI studies. Whether we can sort of help with the cough due to their delivery system, I think that'll have to be discovered.

Speaker #1: Judah, we get this question a lot. I think, obviously, we're treating more of a chronic cough that's more systemic. Now, whether the hypersensitizations intertwined with them taking these inhaled products and you might be able to settle that down, that's something that's going to have to be learned over time.

Speaker #5: Hi, guys. Thanks for taking my question and congrats on the great quarter. So for the guidance for the data readouts for the upcoming program, so this begins in the second half of 2027.

Speaker #1: I do think these different therapies are helpful. They'll define the market. They create options. But we can lay alongside all of these. That's why Jim's been busy doing these DDI studies.

Speaker #5: And I just wanted to ask if there are any other data updates planned that we can expect before that. Thanks.

Speaker #1: But whether we can sort of help with the cough due to their delivery system, I think that'll have to be discovered.

Speaker #4: Yeah. I mean, we have the SSRE, the sample size reestimation at the halfway point of the RCC trial. We should get that in by the fourth quarter of this year.

Judah Frommer: Thanks.

Speaker #2: Thanks.

Speaker #1: Yeah. Thank you.

Jennifer Good: Yeah. Thank you.

Speaker #4: We'll have to see how enrollment unfolds. But that's what we're working towards. So that's a pretty insightful readout on the RCC trial, I think.

Speaker #3: Thank you. Our next question comes from the line of Alexa Diemer of Cantor Fitzgerald. Your line is now open.

Operator: Thank you. Our next question comes from the line of Alexa Deemer of Cantor Fitzgerald. Your line is now open.

Speaker #4: Otherwise, our current plan is second half of '27. But I want to echo what Jim said. I've been going to a lot of these investigator meetings as well.

Alexa Deemer: Hi, guys. Thanks for taking my question and congrats on the great quarter. For the guidance for the data readouts for the upcoming program, this begins in H2 2027. I just wanted to ask if there are any other data updates planned that we can expect before that. Thanks.

Speaker #1: Hi, guys. Thanks for taking my question, and congrats on the great quarter. So, for the guidance for the data readouts for the upcoming program—so this begins in the second half of 2027.

Speaker #4: There's a lot of interest and attention on this on our programs. So the team is, I think, setting us up for success here. So we'll continue to update you guys as we move through the trials.

Speaker #1: And I just wanted to ask if there are any other data updates planned that we can expect before that. Thanks.

Speaker #4: But we are definitely moving along nicely.

Jennifer Good: Yeah. I mean, we have the SSRE, the sample size re-estimation at the halfway point of the RCC trial. We should get that in by Q4 of this year. We'll have to see how enrollment unfolds, that's what we're working towards. That's a pretty insightful readout on the RCC trial, I think. Otherwise, our current plan is H2 of 2027. I wanna echo what James said. I've been going to a lot of these investigator meetings as well. There's a lot of interest and attention on this on our programs. The team is, I think, setting us up for success here. We'll continue to update you guys as we move through the trials, we are definitely moving along nicely.

Speaker #6: Yeah, I mean, we have the SSRE, the sample size re-estimation at the halfway point of the RCC trial. We should get that in by the fourth quarter of this year.

Speaker #5: Awesome. Thank you. Thanks, Alexa.

Speaker #3: Thank you.

Speaker #1: Our next question comes from the line of Serge Belanger of Needham and Company. Your line is now open.

Speaker #6: We'll have to see how enrollment unfolds. But that's what we're working towards. So that's a pretty insightful readout on the RCC trial, I think.

Speaker #7: Hi. Good afternoon. This is John. I'm for Serge today. Thanks for taking our questions. So just a couple from us. First, I might be jumping the gun here a little bit, but on the SSRE and RCC coming up later this year, I'm curious what some of the key checkpoints will be that you're looking for during this analysis.

Speaker #6: Otherwise, our current plan is second half of '27. But I want to echo what Jim said. I've been going to a lot of these investigator meetings as well.

Speaker #6: There's a lot of interest and attention on this in our programs, so the team is, I think, setting us up for success here. We'll continue to update you all as we move through the trials.

Speaker #6: But we are definitely moving along nicely.

Speaker #7: I would imagine it might look somewhat similar to the IPF one done during phase two. And in the event of requiring additional patients, just curious how you might expect that to look.

Alexa Deemer: Awesome. Thank you.

Speaker #1: Awesome. Thank you. Thanks, Alexa.

Jennifer Good: Thanks, Alexa.

Speaker #3: Thank you. Our next question comes from the line of Serge Bellanger of Needham & Company. Your line is now open.

Operator: Our next question comes from the line of Serge Bélanger of Needham & Company. Your line is now open.

Speaker #7: And then secondly, on the IP front, I believe you have patent issued through 2039. Curious if and where you'd look to expand that portfolio ahead of the potential commercialization of Haduvia.

[Analyst] (Needham & Company): Hi, good afternoon. This is John on for Serge today. Thanks for taking our questions. Just a couple from us. First, I might be jumping the gun here a little bit, but on the SSRE and RCC coming up later this year, I'm curious what some of the key checkpoints will be that you're looking for during this analysis. Would imagine it might look somewhat similar to the IPF one done during the Phase 2. In the event of requiring additional patients, just curious how you might expect that to look. Secondly, on the IP front, I believe you have patents issued through 2039. Curious if and where you'd look to expand that portfolio ahead of the potential commercialization of Haduvio. Thanks.

Speaker #7: Hi, good afternoon. This is John on for Serge today. Thanks for taking our questions. So just a couple from us. First, I might be jumping the gun here a little bit, but on the SSRE and RCC coming up later this year, I'm curious what some of the key checkpoints will be that you're looking for during this analysis.

Speaker #7: Thanks.

Speaker #5: Yeah. Jim, you want to do the SSRE?

Speaker #3: Yeah. So the SSRE is exactly what we did with Coral. It'll be at the halfway point looking for conditional power of 80%. If the numbers are below that, if the conditional power at that point is below 80%, we will upsize proportionately and like we had in the Coral design, if there's futility it will be recognized too.

Speaker #7: I would imagine it might look somewhat similar to the IPF one done during Phase 2. And in the event of requiring additional patients, just curious how you might expect that to look.

Speaker #3: That's going to be down in that 30, 40 percent range. So I think conditional power. So it's really what you expected from Coral is going to be carried over to here.

Speaker #7: Thanks.

Jennifer Good: Yeah. Jim, you wanna do the SSRE?

Speaker #1: Yeah. Jim, you want to do the SSRE?

James V. Cassella: Yeah. The SSRE is exactly what we did with CORAL. It'll be at the halfway point, looking for conditional power of 80%. If the numbers are below that, if the conditional power at that point is below 80%, we will upsize proportionately and, like we had in the CORAL design, if there's, you know, futility, you know, it will be recognized too. That's gonna be down in that 30%, 40% range. I think, you know, conditional power. It's really what you expected from CORAL is gonna be carried over to here. We'll be reporting whether or not we have to stay the same or upsize.

Speaker #2: Yeah. So the SSRE is exactly what we did with Coral. It'll be at the halfway point, looking for conditional power of 80%. If the numbers are below that, if the conditional power at that point is below 80%, we will upsize proportionately and, like we had in the Coral design, if there's futility it will be recognized too.

Speaker #3: And we'll be reporting whether or not we have to stay the same or upsize.

Speaker #5: Yeah. And your second question, John, about IP, so we are in an interesting position now. We've got the bit of base core patents issued in IPF.

Speaker #5: And now we're also we have a good view of what our label's going to look like. So now we start we are starting to prosecute the different sort of label enablement patents.

Speaker #5: So things that were zeroing in on the label like the final titration schedule, like how you dose adjust it with food or hepatic impairment.

Speaker #2: That's going to be down in that 30-40% range. So, I think conditional power—so it's really what you expected from Coral is going to be carried over to here.

Speaker #5: Jim's running a lot of different phase one studies. Those tend to be quite rich for IP. So our goal at this point, now that we've got a nice broad sort of method of treatment patent around treating cough and these indications, now we'll start building around the label.

Speaker #2: And we'll be reporting whether or not we have to stay the same or upsize.

Jennifer Good: Yeah. Your second question, John, about IP. We are in an interesting position now. We've got the base core patents issued in IPF, and now we have a good view of what our label's gonna look like. Now we are starting to prosecute the different sort of label enablement patents. Things that we're zeroing in on the label, like the final titration schedule, like how you dose adjust it with food or hepatic impairment. Jim's running a lot of different phase 1 studies. Those tend to be quite rich for IP. Our goal at this point, now that we've got a nice, broad sort of method of treatment patent around treating cough and these indications, now we'll start building around the label.

Speaker #1: Yeah. And your second question, John, about IP: so, we are in an interesting position now. We've got a bit of base core patents issued in IPF.

Speaker #5: We'll keep patents applications open so as we complete development work and learn new things, we're able to file incremental IP around them. So our goal would be when this drug actually launches that we've got multiple patents around the original base patent.

Speaker #1: And now we're also—we have a good view of what our label's going to look like. So now we are starting to prosecute the different sort of label enablement patents.

Speaker #1: So things that were zeroing in on the label, like the final titration schedule, like how you dose adjust it with food or hepatic impairment.

Speaker #7: Great. Thanks so much for the caller.

Speaker #5: Thank you.

Speaker #1: Thank you. Our next question comes from the line of Ryan Deschner of Raymond James. Your line is now open.

Speaker #1: Jim's running a lot of different Phase 1 studies. Those tend to be quite rich for IP. So our goal at this point, now that we've got a nice broad sort of method of treatment patent around treating cough and these indications, now we'll start building around the label.

Speaker #8: Thanks for the question. You have some very interesting dyspnea data coming up at ATS later this month in Orlando. How impactful do you think dyspnea is as a quality of life metric for IPF chronic cough patients?

Jennifer Good: We'll keep patent applications open, as we complete development work and learn new things, we're able to file incremental IP around them. Our goal would be when this drug actually launches, that we've got multiple patents around the original base patent.

Speaker #1: We'll keep patents applications open. So as we complete development work and learn new things, we're able to file incremental IP around them. So our goal would be, when this drug actually launches, that we've got multiple patents around the original base patent.

Speaker #8: And how relevant is potential modulation of dyspnea for the RCC and non-IPF ILD indications? And I have a follow-up.

Speaker #3: Yeah. Ryan, this is Farrell. Thank you for the question. We've actually done a lot of research with physicians and with payers around this point.

[Analyst] (Needham & Company): Great. Thanks so much for the color.

Speaker #7: Great. Thanks so much for the caller.

Speaker #1: Thank you.

Jennifer Good: Thank you.

Speaker #3: Thank you. Our next question comes from the line of Ryan Deshner of Raymond James. Your line is now open.

Operator: Thank you. Our next question comes from the line of Ryan Deschner of Raymond James. Your line is now open.

Speaker #3: When you look at the when you look at the top three most common complaints from these patients, whether it's IPF or ILD, dyspnea is in that top three.

Ryan Deschner: Thanks for the question. You have some very interesting dyspnea data coming up at ATS later this month in Orlando. How impactful do you think dyspnea is as a quality-of-life metric for IPF chronic cough patients, and how relevant is potential modulation of dyspnea for the RCC and non-IPF ILD indications? Then I'll follow up.

Speaker #3: It's cough, dyspnea, and fatigue at the top three. So it doesn't change our commercial thesis, but what it can do is definitely complement the speed of uptake of the product and also, I think, just the adoption from patients because it's going to be helping them across more than one of the experiences that they have and impacts.

Speaker #8: And how relevant is potential modulation of dyspnea for the RCC and non-IPF ILD indications? And I have a follow-up.

Speaker #5: And payer conversations, right?

Speaker #3: And payer conversations. It will help in payer conversations. It'll help justify additional value.

Speaker #2: Yeah. Ryan, this is Ferrell. Thank you for the question. We've actually done a lot of research with physicians and with payers around this point.

James V. Cassella: Ryan, this is Farrell. Thank you for the question. We've actually done a lot of research with physicians and with payers around this point. You know, when you look at the top three most common complaints from these patients, whether it's IPF or ILD, dyspnea is in that top three. It's cough, dyspnea, and fatigue at the top three. It doesn't change our commercial thesis, but what it can do is definitely complement the speed of uptake of the product and also, I think, just the adoption from patients, 'cause it's gonna be helping them across more than one of the experiences that they have and impacts.

Speaker #8: Got it. And then how do you plan to try to minimize placebo in the RCC clinical program? And is high-potential placebo as much of a concern in the IPF chronic cough and non-IPF ILD indications?

Speaker #2: When you look at the when you look at the top three most common complaints from these patients, whether it's IPF or ILD, dyspnea is in that top three.

Speaker #2: It's cough, dyspnea, and fatigue at the top three. So it doesn't change our commercial thesis, but what it can do is definitely complement the speed of uptake, of the product, and also, I think, just the adoption from patients because it's going to be helping them across more than one of the experiences that they have and impacts.

Speaker #3: You're right, Jim. So I think we have solid data from our Coral study in the IPF population. Came in with under 20% placebo response.

Speaker #3: I think that was expected. I also think that that's probably in the world of chronic cough. That's probably one of the more well-behaved populations.

Jennifer Good: Payer conversations, right?

Speaker #6: And payer conversations, right?

James V. Cassella: Payer conversations. It will help in payer conversations. It'll help justify additional value.

Speaker #2: And payer conversations. It will help in payer conversations. It'll help justify additional value.

Speaker #3: And expect to see something like that going forward. I think there's precedent here in the RCC world that the placebo response could be a little bit more variable and a little bit more ranging.

Ryan Deschner: Got it. How do you plan to try to minimize placebo in the RCC clinical program? Is high potential placebo as much of a concern in the IPF chronic cough and non-IPF ILD indication?

Speaker #8: Got it. And then, how do you plan to try to minimize placebo in the RCC clinical program? And is high-potential placebo as much of a concern in the IPF chronic cough and non-IPF ILD indications?

Speaker #3: We are doing everything in this trial to really control for things that can contribute to a placebo response. I think a lot of it is having an extremely well-controlled trial.

Speaker #2: Yeah. Ryan, it's Jim. So I think we have solid data from our Coral study in the IPF population. Came in with under 20% placebo response.

James V. Cassella: Hey, Ryan, it's Jim. You know, I think, you know, we have solid data from our CORAL study in the IPF population. You know, came in with under 20% placebo response. I think that was expected. I also think that that's probably, in the world of chronic cough, that's probably one of the more well-behaved populations and expect to see something like that going forward. I think there's precedent here in the RCC world that the placebo response could be a little bit more variable and a little bit more ranging. We are doing everything in this trial to really control for things that can contribute to a placebo response. I think a lot of it is having an extremely well-controlled trial, so we're doing our best there.

Speaker #3: So we're doing our best there. I think we are incorporating at the advice of some of the experts in the RCC space a placebo run-in period to try to make any of the response there.

Speaker #2: I think that was expected. I also think that that's probably, in the world of chronic cough, that's probably one of the more well-behaved populations.

Speaker #3: The idea there is to look for stability around lower end of cough response. So we are incorporating those things. And of course, just sort of the rules of thumbs that I'm bringing in from my CNS background where placebo response is always a big concern is really about trial conduct and making sure that you don't set false expectations that you don't overpromise and things like that that can help contribute to the overall placebo response.

Speaker #2: And expect to see something like that going forward. I think there's precedent here in the RCC world that the placebo response could be a little bit more variable and a little bit more ranging.

Speaker #2: We are doing everything in this trial to really control for things that can contribute to a placebo response. I think a lot of it is having an extremely well-controlled trial.

Speaker #2: So we're doing our best there. I think we are incorporating at the advice of some of the experts in the RCC space a placebo run-in period to try to mitigate any of the response there.

James V. Cassella: I think, you know, we are incorporating, at the advice of some of the experts in the RCC space, you know, a placebo run-in period to try to mitigate any of the response there. The idea there is to look for, you know, stability around lower end of cough response. You know, we are incorporating those things. Of course, just sort of the rules of thumb that I'm bringing in from my CNS background, where placebo response is always a big concern, is really about, you know, trial conduct and making sure that you don't set false expectations, that you don't overpromise and things like that can help contribute to the overall placebo response.

Speaker #8: Thank you very much.

Speaker #1: Thank you. Our next question comes from the line of Devanjana Chatterjee of Jones. Your line is now open.

Speaker #2: The idea there is to look for stability around lower end of cough response. So we are incorporating those things. And of course, just sort of the rules of thumbs that I'm bringing in from my CNS background where placebo response is always a big concern is really about trial conduct and making sure that you don't set false expectations that you don't overpromise and things like that that can help contribute to the overall placebo response.

Speaker #5: Hi. Thanks for taking my question. And congrats on all the progress. So looking forward to ATS, what are some of the most exciting developments we should look forward to?

Speaker #5: And I have a quick follow-up. Jim and I will both be there. We're looking at each other. Jim, you go ahead. You're the author on a bunch of them.

Speaker #3: So hi, Dev. I think we have some exciting updates in the oral presentation that'll be given by Dr. Phil Molyneaux. I mean, that's going to be some new sub-analyses from our Coral study I think there's also going to be some interesting presentations and posters on cough bouts, our analysis of the cough bouts for both Coral and River.

Speaker #8: Thank you very much.

Ryan Deschner: Thank you very much.

Speaker #3: Thank you. Our next question comes from the line of Devanjana Chatterjee of Jones. Your line is now open.

Operator: Thank you. Our next question comes from the line of Debanjana Chatterjee of JonesTrading. Your line is now open.

Kaveri Pohlman: Hi. Thanks for taking my question and congrats on all the progress. Looking forward to ATS, what are some of the most exciting developments we should look forward to? I have a quick follow-up.

Speaker #1: Hi. Thanks for taking my question. And congrats on all the progress. So looking forward to ATS, what are some of the most exciting developments we should look forward to?

Speaker #3: And it was brought up earlier, but I think our breathlessness data being presented by Don Mailer, who is really one of the key experts in this space, is really going to be exciting poster to get out that initial analysis that really shows some benefit here on the breathlessness piece of things.

Speaker #1: And I have a quick follow-up.

Jennifer Good: Jim and I will both be there. We're looking at each other. Jim, you go ahead. You're the author on a bunch of them.

Speaker #6: Jim and I will both be there. We're looking at each other. Jim, you go ahead. You're the author on a bunch of them.

James V. Cassella: Hi, Deb. It's I think we have some exciting updates in the oral presentation that'll be given by Dr. Philip Molyneaux. I mean, that's gonna be some new sub-analyses from our CORAL study. I think there's also gonna be some interesting presentations and posters on cough bouts, our analysis of the cough bouts for both CORAL and RIVER. It was brought up earlier, but I think our breathlessness data, you know, being presented by Donald Mahler, who is really one of the key experts in this space, is really gonna be exciting poster to get out that initial analysis that really shows some benefit here on the breathlessness piece of things.

Speaker #2: So hi, Dev. I think we have some exciting updates in the oral presentation that'll be given by Dr. Phil Molyneux. I mean, there's going to be some new sub-analyses from our CORAL study. I think there's also going to be some interesting presentations and posters on cough bouts—our analysis of the cough bouts for both CORAL and RIVER.

Speaker #3: So I think those are highlights. I think that really adds some new information into the data flow for us.

Speaker #5: Appreciate the color. And just a quick follow-up. So I know, of course, FVC is not an endpoint that you are pursuing, but given that you'll be following the IPF patients like 52 weeks at least, right, in the phase three program, do you expect to see some trends there?

Speaker #2: And it was brought up earlier, but I think our breathlessness data being presented by Don Mailer, who is really one of the key experts in this space, is really going to be an exciting poster to get out—that initial analysis that really shows some benefit here on the breathlessness piece of things.

Speaker #5: And even if that's kind of a safety endpoint?

Speaker #3: So we are following FVC. We have it at baseline. We have it throughout the 52-week time period. We will be able to look to see what's there.

James V. Cassella: I think, you know, those are highlights, I think that really adds some new information into the, into the data flow for us.

Speaker #2: So I think those are highlights. I think that really adds some new information into the data flow for us.

Speaker #3: Our ends are very different than what you expect from an IPF trial because FVC is highly variable. And I think that drives the size of those trials.

Kaveri Pohlman: Appreciate the color. Just a quick follow-up. I know, of course, FVC is not an endpoint that you are pursuing, but, like, given that you'll be following the IPF patients, like, 52 weeks, at least, right, in the Phase 3 program, do you expect to see some trends there? Even if that's kind of like a safety endpoint.

Speaker #1: Appreciate the caller. And just a quick follow-up. So I know, of course, FVC is not an endpoint that you are pursuing, but given that you'll be following the IPF patients, like, 52 weeks at least, right, in the phase 3 program, do you expect to see some trends there?

Speaker #3: But all I can promise you is that we will see what we see and report it out.

Speaker #5: Thank you.

Speaker #1: Thank you. Our next question comes from the line of William Wood of B-Riley Securities. Your line is now open.

Speaker #1: And even if that's kind of a safety endpoint?

Speaker #8: Thanks for taking our questions. And congrats on a nice quarter. So just curious when we're thinking about the peers P2X3 readout coming up, I was curious if there's anything specific that you might be looking for in that trial regardless of whether it's positive or negative in terms of taking forward to the FDA that you think they could really improve your learnings on your own trials?

James V. Cassella: We are following FVC. We have it at baseline. We have it throughout the 52-week time period. We will be able to look to see what's there. Our ends are very different than what you would expect from an IPF trial because FVC is highly variable, and I think that drives the size of those trials. All I can promise you is that we will see what we see and report it out.

Speaker #2: So we are following FVC. We have it at baseline. We have it throughout the 52-week time period. We will be able to look to see what's there.

Speaker #2: Our ends are very different than what you expect from an IPF trial because FVC is highly variable. And I think that drives the size of those trials.

Speaker #2: But all I can promise you is that we will see what we see and report it out.

Speaker #1: Thank you.

Kaveri Pohlman: Thank you.

Speaker #5: I mean, I'm just going to jump in, Jim, you add any color. Thanks for the question, William. I don't think so. P2X3s have had to kind of chase this path of the highest level of coffers and placebo run-ins and highly adjudicate the indication.

Speaker #3: Thank you. Our next question comes from the line of William Wood of B. Riley Securities. Your line is now open.

Operator: Thank you. Our next question comes from the line of William Wood, B. Riley Securities. Your line is now open.

William Wood: Thanks for taking our questions and congrats on a nice quarter. Just curious, when we're thinking about the peers P2X3 readout coming up, I was curious if there's anything specific that you might be looking for in that trial, regardless of whether it's positive or negative, in terms of, you know, taking forward to the FDA that you think, you know, they could really improve your learnings on your own trials?

Speaker #5: We've shown data that our drug works broadly in IPF chronic cough and refractory chronic cough across different cough counts. So I think that we have to be a lot less fussy with who goes into the trial and how we get results.

Speaker #5: We'll obviously be interested in the placebo effect and how they've controlled that. But those trials were upsized. The bigger trial was upsized twice. And that's always tricky, I think.

Speaker #6: I mean, I'm just going to jump in, Jim, you add any color. Thanks for the question, William. I don't think so. P2X3s have had to kind of chase this path of the highest level of coffers and placebo run-ins and highly adjudicate the indication.

Jennifer Good: I mean, I'm just gonna jump in, Jim, you add any color. Thanks for the question, William. I don't think so. You know, P2X3s have had to kind of chase this path of the highest level of coughers and placebo run-ins and highly adjudicate the indication. You know, we've shown data that our drug works broadly in IPF chronic cough and refractory chronic cough across different cough counts. I think that we have to be a lot less fussy with who goes into the trial and how we get results. We'll obviously be interested in the placebo effect and how they've controlled that, but those trials were upsized. The bigger trial was upsized twice, and that's always tricky, I think. They're also managing a much tighter response. We'll look at it. We're interested. I agree with Farrell.

Speaker #5: They're also managing a much tighter response. So we'll look at it. We're interested. I agree with Farrell. I hope they see some results for patients.

Speaker #5: But they are guiding towards about a 15 to 20 percent placebo-adjusted change in their calls. We would expect much better performance of our drug.

Speaker #6: We've shown data that our drug works broadly in IPF chronic cough and refractory chronic cough across different cough counts. So I think that we have to be a lot less fussy with who goes into the trial and how we get results.

Speaker #5: So we really are looking to be best in class and the most our drug. So it's more as Farrell mentioned, just how we position the drug and where we go.

Speaker #5: But I would say nothing that really impacts our program. We'll learn more from our phase two B, then we'll probably learn from their phase three data.

Speaker #6: We'll obviously be interested in the placebo effect and how they've controlled that. But those trials were upsized. The bigger trial was upsized twice, and that's always tricky, I think.

Speaker #8: Got it. That's helpful. And then one brief quick add-on just in terms of sort of setting our expectations for the for your KOL event coming up as well as at ATS, is there anything specific that the FDA may be looking for in terms of guiding for your non-IPF ILD-related chronic cough trials that you may be highlighting at these that really sort of bolster moving into this and/or certain subsets of populations as you look to meet with them in the second half?

Speaker #6: They're also managing a much tighter response. So we'll look at it. We're interested. I agree with Ferrell. I hope they see some results for patients.

Jennifer Good: I hope they see some results for patients. They are guiding towards about a 15% to 20% placebo-adjusted change in their calls. We would expect much better performance of our drug. We really are looking to be best in class in the most refractory patients for our drug. You know, it's more, as Farrell mentioned, just how we position the drug and where we go. I would say nothing that really impacts our program. We'll learn more from our Phase 2b than we'll probably learn from their Phase 3 data.

Speaker #6: But they are guiding towards about a 15 to 20 percent placebo-adjusted change in their calls. We would expect much better performance of our drug.

Speaker #6: So we really are looking to be best in class and target the most refractory patients for our drug. So it's more, as Ferrell mentioned, just how we position the drug and where we go.

Speaker #6: But I would say nothing that really impacts our program. We'll learn more from our phase two B then. We'll probably learn from their phase three data.

Speaker #8: And thank you for taking our questions.

Speaker #5: Well, we are having an ILD expert in the US, Dr. Toby Marr, who runs a big ILD center. He's going to speak there. He's got to join us by Zoom because he has clinic.

William Wood: Got it.

Jennifer Good: Yep.

William Wood: That's helpful. One brief, quick add on. Just in terms of, you know, sort of setting our expectations for your KOL event coming up, as well as at ATS, you know, is there anything specific that the FDA may be looking for in terms of guiding for your non-IPF ILD-related chronic cough trials that you may be highlighting at these that really sort of bolster moving into this and/or certain subsets of populations as you look to meet with them in the H2? Thank you for taking our questions.

Speaker #5: But one of the topics we've asked him to cover is why in his judgment an IPF and an ILD patient is the same or not the same as it relates to cough.

Speaker #5: So you'll hear straight from one of the experts here. Toby's been involved in our program from the beginning. He knows our drug quite well.

Speaker #5: He actually sat on our FDA call with us. So you'll get some independent insights from really one of the leading voices in the ILD space on Thursday.

Speaker #8: And thank you for taking our questions.

Speaker #8: That's helpful. Thank you.

Jennifer Good: Well, we are having an ILD expert in the US, Dr. Toby Maher, who runs a big ILD center. He's gonna speak there. He's gotta join us by Zoom 'cause he has clinic. One of the topics we've asked him to cover is why, in his judgment, an IPF and an ILD patient is the same or not the same as it relates to cough. You'll hear straight from one of the experts here. Toby's been involved in our program from the beginning. He knows our drug quite well. He actually sat on our FDA call with us. You'll get some independent insights from really one of the leading voices in the ILD space on Thursday.

Speaker #6: Well, we are having an ILD expert in the US, Dr. Toby Marr, who runs a big ILD center. He's going to speak there. He's got to join us by Zoom because he has clinic.

Speaker #5: Yeah. Thank you, William.

Speaker #1: Thank you. Again, if you have questions, please press star 101. Our next question comes from the line of Kaveri Pohlman of ClearStreet. Your line is now open.

Speaker #6: But one of the topics we've asked him to cover is why in his judgment an IPF and an ILD patient is the same or not the same as it relates to cough.

Speaker #9: Okay. Yes. Good evening. Thanks for taking my questions. And just to follow up on the previous comments you made on the phase two B RCC trial design, I was wondering how you were thinking about enrolling a truly addressable patient population to fully de-risk the program, particularly given the expectations that many patients may be P2X3 antagonists experienced in real-world.

Speaker #6: So you'll hear straight from one of the experts here. Toby's been involved in our program from the beginning. He knows our drug quite well.

Speaker #6: He actually sat on our FDA call with us. So you'll get some independent insights from really one of the leading voices in the ILD space on Thursday.

William Wood: That's helpful. Thank you.

Speaker #8: That's helpful. Thank you.

Speaker #6: Yeah. Thank you, William.

Jennifer Good: Yeah. Thank you, William.

Speaker #9: And broadly, just like on a higher level, there appears to be an increasing focus on the development progress in IPF and non-IPF ILD. Obviously, alongside continued efforts in RCC, how do you think about the relative opportunity across these indications in the context of the evolving treatment landscape?

Speaker #3: Thank you. Again, if you have questions, please press star 101. Our next question comes from the line of Covaria Pullman of Clear Street. Your line is now open.

Operator: Thank you. Again, if you have questions, please press star 101. Our next question comes from the line of Kaveri Pohlman of Clear Street. Your line is now open.

Kaveri Pohlman: Okay. Yes, good evening. Thanks for taking my questions. Just like a follow-up on the previous comments you made on the Phase 2b RCC trial design, I was wondering how you are thinking about enrolling a truly addressable patient population to fully de-risk the program, particularly given the expectations that many patients may be P2X3 antagonist experience in real world. Broadly, just like on a high level, there appears to be an increasing focus on the development progress in IPF and non-IPF ILD. Obviously, alongside continued efforts in RCC, how do you think about, you know, the relative opportunity across these indications in the context of the evolving treatment landscape? What key challenges in RCC will need to be addressed to fully realize its potential? Thank you.

Speaker #1: Yes. Good evening. Thanks for taking my questions. And just to follow up on the previous comments you made on the phase two B RCC trial design, I was wondering how you were thinking about enrolling a truly addressable patient population to fully de-risk the program, particularly given the expectations that many patients may be P2X3 antagonists experience in real-world.

Speaker #9: And what key challenges in RCC will need to be addressed to fully realize its potential? Thank you.

Speaker #5: There were a lot of questions there to disentangle. So I'll just kind of start from a strategy perspective. Trevi has always been led as an IPF sort of and then adding in ILD-led strategy, primarily because of our commercial pricing, specialty Salesforce.

Speaker #1: And broadly, just like on a higher level, there appears to be an increasing focus on the development progress in IPF and non-IPF ILD. Obviously, alongside continued efforts in RCC, how do you think about the relative opportunity across these indications in the context of the evolving treatment landscape?

Speaker #5: So that was always our focus. I think as the RCC competitive landscape sort of fell away and really there wasn't much left, some of the experts came to us asking us to please try our drug in RCC.

Speaker #5: We did and got very strong data. So I think definitely a commitment to RCC, but it is sort of the third leg of the stool here.

Speaker #1: And what key challenges in RCC will need to be addressed to fully realize its potential? Thank you.

Jennifer Good: There were a lot of questions there to disentangle. I'll just kind of start from a strategy perspective. Trevi has always been led as an IPF sort of, and then adding an ILD-led strategy, primarily because of our commercial strategy. Specialty, high pricing, specialty sales force. That was always our focus. I think as the RCC competitive landscape sort of fell away and really there wasn't much left, some of the experts came to us asking us to please try our drug in RCC. We did and got very strong data. I think definitely a commitment to RCC, but it is sort of the third leg of the stool here. With regard to the variability in the program and P2X3 responders, anything, Jim, on that?

Speaker #6: There were a lot of questions there to disentangle. So I'll just kind of start from a strategy perspective. Trevi has always been led as an IPF sort of and then adding in ILD-led strategy, primarily because of our commercial strategy, specialty high pricing, specialty Salesforce.

Speaker #5: With regard to the variability in the program and P2X3 responders, anything, Jim, on that?

Speaker #3: I think are you asking there's going to be people who have experience with P2X3 that may be entering in our trial? I mean, I think the key there is if they meet the eligibility requirements and they've been off their P2X3 for an appropriate period of time, they still have the requirements to get into the study.

Speaker #6: So that was always our focus. I think as the RCC competitive landscape sort of fell away and really there wasn't much left, some of the experts came to us asking us to please try our drug in RCC.

Speaker #3: Their fair game for coming in. I mean, we want people with various experiences. We know this is a refractory condition, and people have tried a lot of different things.

Speaker #6: We did and got very strong data. So I think definitely a commitment to RCC, but it is sort of the third leg of the stool here.

Speaker #3: And they may or may not have succeeded on a P2X3, but if you meet our entry criteria, they'll be coming into the trial. So I don't think it really differentiates from any other type of therapy that they've tried in the past.

Speaker #6: With regard to the variability in the program and P2X3 responders, anything, Jim, on that?

James V. Cassella: I think, are you asking, there's gonna be people who have experience with P2X3 that may be entering in our trial? I mean, I think, you know, the key there is if they meet the eligibility requirements and they've been off their P2X3 for an appropriate period of time, they still have, you know, the requirements to get into the study, you know, they're fair game for coming in. I mean, we want people with various experiences. We know, you know, this is a refractory condition, and people have tried a lot of different things, and, they may or may not have succeeded on a P2X3, but if they meet our entry criteria, they'll be coming into the trial. I don't think it really differentiates from any other type of therapy that they've tried in the past.

Speaker #2: I think are you asking there's going to be people who have experience with P2X3 that may be entering in our trial? I mean, I think the key there is if they meet the eligibility requirements and they've been off their P2X3 for an appropriate period of time, they still have the requirements to get into the study.

Speaker #3: They will meet the eligibility requirements for being off of the P2X3 for a certain amount of time.

Speaker #5: Got it. Thank you.

Speaker #4: Thank you, Kaveri.

Speaker #1: Thank you. I am showing no further questions at this time. This concludes our question-and-answer session. I would now like to turn the conference back to Jennifer Good for closing remarks.

Speaker #2: Their fair game for coming in. I mean, we want people with various experiences. We know this is a refractory condition, and people have tried a lot of different things.

Speaker #2: And they may or may not have succeeded on a P2X3, but if you meet our entry criteria, they'll be coming into the trial. So I don't think it really differentiates from any other type of therapy that they've tried in the past.

Speaker #5: We appreciate you joining us for today's call and look forward to hopefully seeing many of you later this week and this month. Thank you.

James V. Cassella: They will meet the eligibility requirements for being off of the P2X3 for a certain amount of time.

Speaker #2: They will meet the eligibility requirements for being off of the P2X3 for a certain amount of time.

Kaveri Pohlman: Got it. Thank you.

Speaker #1: Got it. Thank you.

Jennifer Good: Thank you. Kaveri.

Speaker #6: Thank you, Coveria.

Speaker #3: Thank you. I am showing no further questions at this time. This concludes our question-and-answer session. I would now like to turn the conference back to Jennifer Good for closing remarks.

Operator: Thank you. I am showing no further questions at this time. This concludes our question and answer session. I would now like to turn the conference back to Jennifer Good for closing remarks.

Jennifer Good: We appreciate you joining us for today's call and look forward to hopefully seeing many of you later this week and this month. Thank you.

Speaker #1: We appreciate you joining us for today's call and look forward to hopefully seeing many of you later this week and this month. Thank you.

Operator: This concludes today's conference call. Thank you for attending. You may now disconnect. Good afternoon, welcome to the Trevi Therapeutics Q1 2026 earnings conference call. Please be advised that today's conference is being recorded. Various remarks that management makes during this conference call about the company's future expectations, plans, and prospects constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995.

Speaker #3: Good afternoon and welcome to the Trevi Therapeutics first quarter 2026 earnings conference call. At this time, all participants are in a listen-only mode.

Operator: Good afternoon, welcome to the Trevi Therapeutics Q1 2026 Earnings Conference Call. Please be advised that today's conference is being recorded. Various remarks that management makes during this conference call about the company's future expectations, plans, and prospects constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995.

Speaker #3: After today's presentation, there will be an opportunity to ask questions. To ask a question during the session, you'll need to press star 11 on your telephone; you will then hear an automated message advising your hand is raised.

Speaker #3: To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. Various remarks that management makes during this conference call about the company's future expectations, plans, and prospects constitute forward-looking statements for purposes of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995.

Speaker #3: Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the Risk Factors section of the company's most recent annual report on Form 10-K, which the company filed with the SEC on March 17, 2026, as updated by our subsequent filings.

Operator: Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the Risk Factors section of the company's most recent annual report on Form 10-K, which the company filed with the SEC on 17 March 2026, as updated by our subsequent filings. 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. While the company may elect to update these forward-looking statements at some point in the future, the company specifically disclaims any obligation to do so even if its views change. I would now like to turn the conference call over to Jennifer Good, Trevi's President and Chief Executive Officer. Please go ahead.

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 call over to Jennifer Good, Trevi's president and CEO. Please go ahead.

Speaker #2: Good afternoon, and thank you for joining us for our first quarter 2026 earnings call and business update. Joining me today on this call are my colleagues Dr. James Casella, our Chief Development Officer; Ferrell Simon, our Chief Commercial Officer; and David Hastings, our Chief Financial Officer.

Jennifer Good: Good afternoon, and thank you for joining us for our Q1 2026 Earnings Call and Business Update. Joining me today on this call are my colleagues, Dr. James V. Cassella, our Chief Development Officer, Farrell Simon, our Chief Commercial Officer, and David Hastings, our Chief Financial Officer. Dave and I will make some initial comments, but are going to keep them brief as we have a robust presentation this Thursday at our Investor and Analyst Day. After our comments on the quarter, the team is happy to answer any questions you may have. 2026 is an important year of execution for the company, and the team is focused on delivering.

Jennifer Good: Good afternoon, and thank you for joining us for our Q1 2026 Earnings Call and Business Update. Joining me today on this call are my colleagues, Dr. James Cassella, our Chief Development Officer, Farrell Simon, our Chief Commercial Officer, and David Hastings, our Chief Financial Officer. Dave and I will make some initial comments, but are going to keep them brief as we have a robust presentation this Thursday at our Investor and Analyst Day. After our comments on the quarter, the team is happy to answer any questions you may have. 2026 is an important year of execution for the company, and the team is focused on delivering.

Speaker #2: Dave and I will make some initial comments, but are going to keep them brief as we have a robust presentation this Thursday at our investor and analyst day.

Speaker #2: Following our positive FDA meeting in the first quarter to align on our IPF-related chronic cough program, the team has finalized the study protocols for our Phase 3 trials and has been busy identifying global sites for both pivotal studies.

Jennifer Good: Following our positive FDA meeting in Q1 to align on our IPF-related chronic cough program, the team has finalized the study protocols for our Phase 3 trials and has been busy identifying global sites for both pivotal studies. We expect to initiate the first of those 2 studies this quarter, followed by the second study in H2 of this year. After gaining alignment with the FDA in our end-of-Phase 2 meeting, we now intend to submit a meeting request and protocol to the FDA to discuss our non-IPF interstitial lung disease or non-IPF ILD-related chronic cough program. We intend to propose an adaptive Phase 2/3 study to confirm dose and powering assumptions in the Phase 2 study prior to rolling into 1 pivotal Phase 3 study for approval.

Jennifer Good: Following our positive FDA meeting in Q1 to align on our IPF-related chronic cough program, the team has finalized the study protocols for our phase III trials and has been busy identifying global sites for both pivotal studies. We expect to initiate the first of those 2 studies this quarter, followed by the second study in H2 of this year. After gaining alignment with the FDA in our end-of-phase II meeting, we now intend to submit a meeting request and protocol to the FDA to discuss our non-IPF interstitial lung disease or non-IPF ILD-related chronic cough program. We intend to propose an adaptive phase II/III study to confirm dose and powering assumptions in the phase II study prior to rolling into 1 pivotal phase III study for approval.

Speaker #2: We expect to initiate the first of those two studies this quarter, followed by the second study in the second half of this year. After gaining alignment with the FDA at our end-of-Phase 2 meeting, we now intend to submit a meeting request and protocol to the FDA to discuss our non-IPF interstitial lung disease, or non-IPF ILD-related chronic cough program.

Speaker #2: We intend to propose an adaptive Phase 2, 3 study to confirm dose and powering assumptions in the Phase 2 study prior to rolling into one pivotal Phase 3 study for approval.

Jennifer Good: If all goes as proposed to the FDA, we expect to initiate this trial in the H2 of the year. This non-IPF ILD population will mimic the patient profile of patients in our IPF trial, as it will include patients who have established lung fibrosis and chronic cough. There are a lot of synergies with our IPF studies as these patients with non-IPF ILD are seen in the same care centers by the same pulmonologist. As we negotiate CDAs, contracts, and budgets for the initiation of our IPF-related chronic cough trials, we have this trial in the scope so that we can act quickly once we have alignment with the FDA on the protocol. Finally, for refractory chronic cough, we also expect to initiate a Phase 2b parallel arm dose-ranging trial with 3 doses and placebo this quarter as well.

Jennifer Good: If all goes as proposed to the FDA, we expect to initiate this trial in the H2 of the year. This non-IPF ILD population will mimic the patient profile of patients in our IPF trial, as it will include patients who have established lung fibrosis and chronic cough. There are a lot of synergies with our IPF studies as these patients with non-IPF ILD are seen in the same care centers by the same pulmonologist. As we negotiate CDAs, contracts, and budgets for the initiation of our IPF-related chronic cough trials, we have this trial in the scope so that we can act quickly once we have alignment with the FDA on the protocol. Finally, for refractory chronic cough, we also expect to initiate a phase IIb parallel arm dose-ranging trial with 3 doses and placebo this quarter as well.

Speaker #2: There are a lot of synergies with our IPF studies as these patients with non-IPF ILD are seen in the same care centers by the same pulmonologist.

Speaker #2: Finally, for refractory chronic cough, we also expect to initiate a Phase 2B parallel arm dose-ranging trial with three doses and placebo this quarter as well.

Speaker #2: The protocol is finalized and has been submitted to regulatory authorities and we are actively qualifying sites for this trial. This trial includes a sample size reestimation or SSRE, which will read out when 50% of the patients complete the trial and is in place to confirm powering assumptions and adjust the sample size if necessary.

Jennifer Good: The protocol is finalized and has been submitted to regulatory authorities. We are actively qualifying sites for this trial. This trial includes a sample size re-estimation, or SSRE, which will read out when 50% of the patients complete the trial and is in place to confirm powering assumptions and adjust the sample size if necessary. We expect the SSRE readout in Q4 of this year. One final update I would like to give is on the advancement of our intellectual property portfolio. We own the worldwide rights for our drug and are acutely focused on prosecuting incremental patent coverage in addition to the patents that have already been issued. This quarter, we had our core method of treatment patent issued for IPF-related chronic cough in Europe as well. This patent had already been issued in the US and provides protection through 2039.

Speaker #2: We expect the SSRE readout in the fourth quarter of this year. One final update I would like to give is on the advancement of our intellectual property portfolio.

Speaker #2: We own the worldwide rights for our drug and are acutely focused on prosecuting incremental patent coverage in addition to the patents that have already been issued.

Speaker #2: We filed additional applications this year in the US, which if issued would extend the patent coverage through 2046. We will keep you updated as incremental IP evolves.

Jennifer Good: We filed additional applications this year in the US, which, if issued, would extend the patent coverage through 2046. We will keep you updated as incremental IP evolves. Before I close, I want to note there are two important meetings this month where we hope to see many of you. The first is our Investor and Analyst Day this Thursday, 7 May from 10:00 AM to 12:00 PM Eastern Time, followed by an optional lunch in New York City. At this event, we plan to lay out details for the next clinical trials, the projected timelines for each of our chronic cough programs, and discuss incremental data we have developed as we continue to analyze our existing clinical trial data. We also will share commercial learnings based on recent market research and hear from KOLs on their perspective, so it should be an informative event.

Speaker #2: We also will share commercial learnings based on recent market research and hear from KOLs on their perspective. So it should be an informative event.

Jennifer Good: We will post the webcast and slides after the event for those of you that are unable to join us. Second, we will also be very active at the American Thoracic Society, or ATS, meeting this year, with all six of our submissions being accepted for either presentations or posters. We will also be holding an investor analyst event at ATS, where Jim and Dr. Philip Molyneaux, the lead investigator on our CORAL trial, will summarize and share the various data being presented at the conference. This event will be a lunch meeting being held on Monday, 18 May. If you plan to attend ATS, please reach out to us as we would love to have you join.

Speaker #2: We will also be holding an investor analyst event at ATS where Jim and Dr. Philip Molyneux, the lead investigator on our coral trial, will presented at the conference.

Speaker #2: This event will be a lunch meeting being held on Monday, May 18th. If you plan to attend ATS, please reach out to us as we would love to have you join.

Jennifer Good: In closing, we are focused on executing against our plan of becoming the leader in chronic cough, providing therapy for these patients where there are no good options, and in the process, creating meaningful value for patients and our shareholders. I will now turn it over to Dave for his remarks, and then we are happy to answer your questions. Dave?

Speaker #2: I will now turn it over to Dave for his remarks and then we are happy to answer your questions. Dave?

Speaker #3: Thanks, Jennifer, and good afternoon, everybody. My brief remarks today will focus on our most important financial metric, which is our cash position and the runway it provides.

David Hastings: Thanks, Jennifer, and good afternoon, everybody. My brief remarks today will focus on our most important financial metric, which is our cash position and the runway it provides. We ended Q1 2026 with approximately $172 million in cash equivalents, and marketable securities. This balance does not include the $162 million in net proceeds from our underwritten common stock offering completed in April 2026. The offering was well-received, and we appreciated the strong support and participation we got from our current shareholders, and we are grateful that we were able to attract new investors to Trevi. Additionally, with the completion of this offering, we accomplished two major objectives. One, we removed any financial overhang when we reach critical high-value clinical endpoints. Two, we extended our cash runway into 2030.

Speaker #3: We ended the first quarter of 2026 with approximately $172 million in cash, cash equivalents, and marketable securities. This balance does not include the $162 million in net proceeds from our underwritten common stock offering completed in April 2026.

Speaker #3: Additionally, with the completion of this offering, we accomplished two major objectives. One, we removed any financial overhang when we reach critical high-value clinical endpoints.

David Hastings: Included in this runway guidance is the funding of our development program in patients with IPF-related chronic cough, potentially through FDA approval. We also expect these cash resources will enable the company to fund and report top-line data from the planned Phase 2b clinical trial and potentially a subsequent Phase 3 trial for the treatment of patients with non-IPF ILD-related chronic cough. It funds the planned Phase 2b trial for the treatment of patients with RCC. The planned spending of these resources also include pre-commercial activities but does not include any expenses related to the commercial launch of Haduvio or any other clinical trials. With that, I believe we are now well-positioned to execute our clinical trials with funding through critical value inflection points. Operator, we can now open the call for questions.

David Hastings: Included in this runway guidance is the funding of our development program in patients with IPF-related chronic cough, potentially through FDA approval. We also expect these cash resources will enable the company to fund and report top-line data from the planned phase IIb clinical trial and potentially a subsequent phase III trial for the treatment of patients with non-IPF ILD-related chronic cough. It funds the planned phase IIb trial for the treatment of patients with RCC. The planned spending of these resources also include pre-commercial activities but does not include any expenses related to the commercial launch of Haduvio or any other clinical trials. With that, I believe we are now well-positioned to execute our clinical trials with funding through critical value inflection points. Operator, we can now open the call for questions.

Speaker #3: And we also expect these cash resources will enable the company to fund and report top-line data from the planned Phase 2B clinical trial and potentially a subsequent Phase 3 trial for the treatment of patients with non-IPF ILD-related chronic cough.

Speaker #3: And it funds the planned Phase 2B trial for the treatment of patients with RCC. The planned spending of these resources also include pre-commercial activities but does not include any expenses related to the commercial launch of Adivo or any other clinical trials.

Speaker #1: Thank you. We will now conduct the question-and-answer session. As a reminder to ask a question, please press star 11 on your telephone and wait for your name to be announced.

Speaker #1: To withdraw your question, please press star one one again. At this time, we will pause momentarily to assemble our roster. Our first question comes from the line of Rowanna Ruiz of Lyric Partners.

Speaker #1: Your line is now open.

Speaker #4: Great. Afternoon, everyone. A couple for me. First one, I was curious, what are your goals for the upcoming meeting with the FDA to talk about the protocol for your Phase 2B and non-IPF ILD chronic cough?

Roanna Ruiz: Great. Afternoon, everyone. A couple from me. First one, I was curious, what are your goals for the upcoming meeting with the FDA to talk about the protocol for your phase IIb in non-IPF ILD chronic cough? If you could elaborate, like, anything you expect that might be up for discussion with the FDA versus more straightforward questions?

Speaker #4: And if you could elaborate, anything you expect that might be up for discussion with the FDA versus more straightforward questions?

Speaker #3: Hey, Rowanna. This is Jim. Thanks for the question. So basically, that meeting is designed to discuss our intention for the ILD program. We will be submitting the full Phase 2B/3 protocol with that for discussion and really talk about our intentions on using that in an SMDA strategy so that we would support approval with that adaptive Phase 2/3 design.

James V. Cassella: Hey, Roanna, this is Jim. Thanks for the question. Basically, that meeting is designed to discuss our intention for the ILD program. We will be submitting the full Phase 2b/3 protocol with that for discussion and really talk about our intentions on using that in an sNDA strategy so that we would support approval with that adaptive Phase 2/3 design. There's going to be details about our patient population, how we're going to use the Phase 2 for our dose selection confirmation and defining the dose for going into Phase 3 and then pulling up the, you know, the results from the Phase 2 part of that study with the interim analysis to confirm our power assumptions and for the Phase 3 component.

James Cassella: Hey, Roanna, this is Jim. Thanks for the question. Basically, that meeting is designed to discuss our intention for the ILD program. We will be submitting the full phase IIb/II protocol with that for discussion and really talk about our intentions on using that in an sNDA strategy so that we would support approval with that adaptive phase II/III design. There's going to be details about our patient population, how we're going to use the phase III for our dose selection confirmation and defining the dose for going into phase III and then pulling up the, you know, the results from the phase II part of that study with the interim analysis to confirm our power assumptions and for the phase III component.

Speaker #3: So there's going to be details about our patient population, how we're going to use the Phase 2 for our dose selection confirmation and defining the dose for going into Phase 3, and then pulling up the results from the Phase 2 part of that study with the interim analysis to confirm our power assumptions and for the Phase 3 component.

Roanna Ruiz: Makes sense. A quick follow-up. Thinking about RCC Phase 2b potentially ramping up as well, and moving forward in a non-IPF ILD, can you talk a bit about how you plan to balance resources and prioritize things, as you have, you know, many really interesting things going on and moving forward?

Roanna Ruiz: Makes sense. A quick follow-up. Thinking about RCC phase IIb potentially ramping up as well, and moving forward in a non-IPF ILD, can you talk a bit about how you plan to balance resources and prioritize things, as you have, you know, many really interesting things going on and moving forward?

Speaker #4: And moving forward.

Speaker #3: Yeah. We don't like a lot of sleep. We have things under control. This is not my first time running multiple programs with a small team.

James Cassella: Yeah, it's, we don't like a lot of sleep. We have things under control. You know, this is not my first time running multiple programs with a small team. You know, we use our internal expertise. We have leveraged very experienced CRO, one that I've worked with from my last NDA, have a lot of years of experience with them. It's a really tight team. Our vendors that we've selected are really here to support us across all of our programs. I think, we're in a good position to be able to do these things. I have no questions that we have the capabilities and the intellectual horsepower to get these things done. I've been working with small companies for almost 40 years now.

Speaker #3: We use our internal expertise. We have leveraged very experienced CRO, one that I've worked with from my last NDA, have a lot of years of experience with them.

Speaker #3: I have no questions that we have the capabilities and the intellectual horsepower to get these things done and we I've been working with small companies for almost 40 years now.

Speaker #3: We know how to manage the resources to get these things done.

James V. Cassella: We know how to manage the resources to get these things done.

James Cassella: We know how to manage the resources to get these things done.

Speaker #5: I would add too, Jim, Rowanna, we have added probably 10 people in the last since getting our Phase 2B results. We added a really experienced pulmonologist.

Jennifer Good: I would add too, Jim, Roanna, we have added probably 10 people in the last since getting our Phase 2b results. We added a really experienced pulmonologist. We've added several clinical people. You know, 10 people for us is a lot of hiring. We have tried to scale appropriately to address the busyness of these trials.

Jennifer Good: I would add too, Jim, Roanna, we have added probably 10 people in the last since getting our phase IIb results. We added a really experienced pulmonologist. We've added several clinical people. You know, 10 people for us is a lot of hiring. We have tried to scale appropriately to address the busyness of these trials.

Speaker #5: We've added several clinical people. So 10 people for us is a lot of hiring. And so we have tried to scale appropriately to address the busyness of these trials.

Speaker #3: Yeah.

James V. Cassella: Yeah.

James Cassella: Yeah.

Speaker #4: Yep. Sounds good. Thanks a lot.

Roanna Ruiz: Sounds good. Thanks a lot.

Speaker #5: Thank you for the questions.

Jennifer Good: Thank you for the question.

Speaker #1: Thank you. Our next question comes from the line of Judah Frommer of Morgan Stanley. Your line is now open.

Operator: Thank you. Our next question comes from the line of Judah Frommer of Morgan Stanley. Your line is now open.

Speaker #6: Yeah. Hi, guys. Thanks for the update and thanks for taking the questions. Two for us. I guess just from a competitive standpoint in RCC, we have a P2X3 readout coming mid-year.

Speaker #6: What does it do, maybe for enrollment in the RCC trial? Thanks.

Jennifer Good: Farrell, why don't you answer the competitive landscape, and Jim can talk about enrollment.

Speaker #5: Sarah, why don't you answer the competitive landscape and Jim can talk about enrollment.

Farrell Simon: Yeah. Judah, thank you for the question. You know, when we look at the competitive landscape, especially camlipixant, which we'll be reading out soon in the next couple of weeks, you know, we're hoping that they are successful here, right? This is a large unmet need patient population with no approved therapies and definitely a category that can support multiple modalities. We have strong differentiation with our central and peripheral mechanism of action, and I think what we'll take you through on Thursday in the Investor Day is exactly how that positions us for success. I'll turn it over.

Speaker #3: This is a large, unmet need patient population with no approved therapies and definitely a category that can support multiple modalities. We have strong differentiation with our central and peripheral mechanism of action.

Speaker #3: And I think what we'll take you through on Thursday in the investor day is exactly how that positions us for success. Alternative I'll just say, on the flip side, if Campbell Pixon is unsuccessful, then that space, I think we'll have to take a look at what is our competitive positioning.

Farrell Simon: You know, I'll just say on the flip side, if camlipixant is unsuccessful within that space, I think we'll have to take a look at, you know, what is our competitive positioning, but we have a really strong efficacy and see what the phase IIb results say and see what the commercial opportunity lies ahead. It's still a large unmet need. Patients are waiting for us. I'll turn it to Jim.

Speaker #3: But we have a really strong efficacy and see what the Phase 2B results say and see what the commercial opportunity lies ahead. But it's still a large, unmet need patients are waiting for us.

Speaker #3: An alternative, Jim.

Speaker #2: Yeah. I mean, on the enrollment side, we have our investigators lined up for that study. There's a lot of excitement. There's a lot of patients available to us.

James V. Cassella: I mean, on the enrollment side, you know, we have our investigators signed up for that study. There's a lot of excitement. There's a lot of patients available to us. Irregardless of what happens in that environment, we're strongly supported by the investigators that we have for the study who really talk about a lot of patients being available and interested in being in our study. I think our different mechanism, the data that we've shown, the strength of the data that we have out there, still is really the absolute driving force for the interest in being in our study. Our IIb will be done by the time they ever got approval.

James Cassella: I mean, on the enrollment side, you know, we have our investigators signed up for that study. There's a lot of excitement. There's a lot of patients available to us. Irregardless of what happens in that environment, we're strongly supported by the investigators that we have for the study who really talk about a lot of patients being available and interested in being in our study. I think our different mechanism, the data that we've shown, the strength of the data that we have out there, still is really the absolute driving force for the interest in being in our study.

Speaker #2: Irregardless of what happens in that environment, we're strongly supported by the investigators that we have for the study who really talk about a lot of patients being available and interested in being in our study.

Speaker #5: And our 2B will be done by the time they ever got approval. So it might be a Phase 3 issue to deal with. But yeah, thanks for the question.

Jennifer Good: Our IIb will be done by the time they ever got approval.

Jennifer Good: Yeah.

Jennifer Good: It might be a phase 3 issue.

Jennifer Good: It might be a phase III issue.

James V. Cassella: Yeah

James Cassella: Yeah

James V. Cassella: -to deal with. Yeah, thanks for the question.

Jennifer Good: To deal with. Yeah, thanks for the question.

Speaker #3: Great. And then just maybe more high-level philosophical, just on the ILDs, with kind of more inhaled formulation drugs, kind of entering or late stage in kind of the IPF and PPF space, right?

Judah Frommer: Great. Then just maybe more high-level philosophical, just on the ILDs. With kind of more inhaled formulation drugs kind of entering or late stage in kind of the IPF and PPF space, right, a common AE in a lot of those trials is cough. Just curious how you think, you know, the opportunity for Haduvio could be impacted by maybe more inhaled therapeutics in the PF space. Thanks.

Speaker #3: A common AE in a lot of those trials is cough. So, just curious how you think the opportunity for Haduvia could be impacted by maybe more inhaled therapeutics in the PF space.

Speaker #3: Thanks.

Speaker #5: Judah, we get this question a lot, I think. Obviously, we're treating more of a chronic cough that's more systemic. Now, whether the hypersensitizations intertwined with them taking these inhaled products and you might be able to settle that down, that's something that's going to have to be learned over time.

Jennifer Good: Judah, we get this question a lot. I think obviously we're treating more of a chronic cough that's more systemic. Whether the hypersensitization is intertwined with them taking these inhaled products and you might be able to settle that down, that's something that's gonna have to be learned over time. I do think, you know, these different therapies are helpful. They'll define the market, they create options, but we can lay alongside all of these. That's why Jim's been busy doing these DDI studies. Whether we can sort of help with the cough due to their delivery system, I think that'll have to be discovered.

Speaker #5: But whether we can sort of help with the cough due to their delivery system, I think that'll have to be discovered. Yeah. Thank you.

Judah Frommer: Thanks.

Jennifer Good: Yeah. Thank you.

Speaker #1: Thank you. Our next question comes from the line of Alexa Diemer of Cantor Fitzgerald. Your line is now open.

Operator: Thank you. Our next question comes from the line of Alexa Deemer of Cantor Fitzgerald. Your line is now open.

Speaker #5: Hi, guys. Thanks for taking my question, and congrats on the great quarter. So, for the guidance for the data readouts for the upcoming program, this begins in the second half of 2027.

Alexa Deemer Conzola: Hi, guys. Thanks for taking my question and congrats on the great quarter. For the guidance for the data readouts for the upcoming program, this begins in H2 2027. I just wanted to ask if there are any other data updates planned that we can expect before that. Thanks.

Speaker #5: And I just wanted to ask if there are any other data updates planned that we can expect before that. Thanks.

Speaker #4: Yeah. I mean, we have the SSRE, the sample size reestimation at the halfway point of the RCC trial. We should get that in by the fourth quarter of this year.

Speaker #4: We'll have to see how enrollment unfolds. But that's what we're working towards. So that's a pretty insightful readout on the RCC trial, I think.

Speaker #4: Otherwise, our current plan is second half of '27. But I want to echo what Jim said. I've been going to a lot of these investigator meetings as well.

Speaker #4: But we are definitely moving along nicely.

Speaker #5: Awesome. Thank you. Thanks, Alexa.

Alexa Deemer: Awesome. Thank you.

Alexa Deemer Conzola: Awesome. Thank you.

Jennifer Good: Thanks, Alexa.

Speaker #3: Thank you.

Speaker #1: Our next question comes from the line of Serge Bellinger of Needham & Company. Your line is now open.

Operator: Our next question comes from the line of Serge Belanger of Needham & Company. Your line is now open.

[Analyst] (Needham & Company): Hi, good afternoon. This is John on for Serge today. Thanks for taking our questions. Just a couple from us. First, I might be jumping the gun here a little bit, but on the SSRE and RCC coming up later this year, I'm curious what some of the key checkpoints will be that you're looking for during this analysis. Would imagine it might look somewhat similar to the IPF one done during Phase 2. In the event of requiring additional patients, just curious how you might expect that to look. Then secondly, on the IP front, I believe you have patents issued through 2039. Curious if and where you'd look to expand that portfolio ahead of the potential commercialization of Haduvio. Thanks.

[Analyst] (Needham & Company): Hi, good afternoon. This is John on for Serge today. Thanks for taking our questions. Just a couple from us. First, I might be jumping the gun here a little bit, but on the SSRE and RCC coming up later this year, I'm curious what some of the key checkpoints will be that you're looking for during this analysis. Would imagine it might look somewhat similar to the IPF one done during phase II. In the event of requiring additional patients, just curious how you might expect that to look. Then secondly, on the IP front, I believe you have patents issued through 2039. Curious if and where you'd look to expand that portfolio ahead of the potential commercialization of Haduvio. Thanks.

Speaker #7: And in the event of requiring additional patients, just curious how you might expect that to look. And then secondly, on the IP front, I believe you have patent issued through 2039.

Speaker #7: Curious if and where you'd look to expand that portfolio ahead of the potential commercialization of Haduvia. Thanks.

Speaker #5: Yeah. Jim, you want to do the SSRE?

Jennifer Good: Yeah. Jim, you wanna do the SSRE?

James Cassella: Yeah. The SSRE is exactly what we did with CORAL. It'll be at the halfway point, looking for conditional power of 80%. If the numbers are below that, if the conditional power at that point is below 80%, we will upsize proportionately and, like we had in the CORAL design, if there's, you know, futility, you know, it will be recognized too. That's gonna be down in that 30%, 40% range. I think, you know, conditional power. It's really what you expected from CORAL is gonna be carried over to here. We'll be reporting whether or not we have to stay the same or upsize.

Speaker #3: That's going to be down in that 30, 40 percent range. So I think conditional power. So it's really what you expected from Coral is going to be carried over to here.

Speaker #3: And we'll be reporting whether or not we have to stay the same or upsize.

Speaker #5: Yeah. And your second question, John, about IP, so we are in an interesting position now. We've got the bit of base core patents issued in IPF.

Jennifer Good: Yeah, your second question, John, about IP. We are in an interesting position now. We've got the base core patents issued in IPF, and now we have a good view of what our label's gonna look like. Now we are starting to prosecute the different sort of label enablement patents. Things that we're zeroing in on the label, like the final titration schedule, like how you dose adjust it with food or hepatic impairment. Jim's running a lot of different phase 1 studies. Those tend to be quite rich for IP. Our goal at this point, now that we've got a nice broad sort of method of treatment patent around treating cough and these indications, now we'll start building around the label.

Jennifer Good: Yeah, your second question, John, about IP. We are in an interesting position now. We've got the base core patents issued in IPF, and now we have a good view of what our label's gonna look like. Now we are starting to prosecute the different sort of label enablement patents. Things that we're zeroing in on the label, like the final titration schedule, like how you dose adjust it with food or hepatic impairment. Jim's running a lot of different phase I studies. Those tend to be quite rich for IP. Our goal at this point, now that we've got a nice broad sort of method of treatment patent around treating cough and these indications, now we'll start building around the label.

Speaker #5: And now we're also we have a good view of what our label's going to look like. So now we start we are starting to prosecute the different sort of label enablement patents.

Speaker #5: So things that were zeroing in on the label, like the final titration schedule, like how you dose adjust it with food or hepatic impairment.

Speaker #5: Jim's running a lot of different Phase 1 studies. Those tend to be quite rich for IP. So our goal at this point, now that we've got a nice broad sort of method of treatment patent around treating cough and these indications, now we'll start building around the label.

Speaker #5: We'll keep patents, though applications open. So as we complete development work and learn new things, we're able to file incremental IP around them. So our goal would be when this drug actually launches that we've got multiple patents around the original base patent.

Jennifer Good: We'll keep patents, applications open, so as we complete development work and learn new things, we're able to file incremental IP around them. Our goal would be when this drug actually launches, that we've got multiple patents around the original base patent.

Speaker #7: Great. Thanks so much for the caller.

[Analyst] (Needham & Company): Great. Thanks so much for the color.

Speaker #5: Thank you.

Jennifer Good: Thank you.

Speaker #1: Thank you. Our next question comes from the line of Ryan Deshner of Raymond James. Your line is now open.

Operator: Thank you. Our next question comes from the line of Ryan Deschner of Raymond James. Your line is now open.

Ryan Deschner: Thanks for the question. You have some very interesting dyspnea data coming up at ATS later this month in Orlando. How impactful do you think dyspnea is as a quality-of-life metric for IPF chronic cough patients, how relevant is potential modulation of dyspnea for the RCC and non-IPF ILD indications? A follow-up.

Speaker #8: And how relevant is potential modulation of dyspnea for the RCC and non-IPF ILD indications? And I have a follow-up.

Speaker #3: Yeah. Ryan, this is Ferrell. Thank you for the question. We've actually done a lot of research with physicians and with payers around this point.

Farrell Simon: Yeah. Ryan, this is Farrell. Thank you for the question. We've actually done a lot of research with physicians and with payers around this point. You know, when you look at the top 3 most common complaints from these patients, whether it's IPF or ILD, dyspnea is in that top 3. It's cough, dyspnea, and fatigue at the top 3. It doesn't change our commercial thesis, but what it can do is definitely complement the speed of uptake of the product and also I think just the adoption from patients, 'cause it's gonna be helping them across more than one of the experiences that they have and impacts.

Farrell Simon: Yeah. Ryan, this is Farrell. Thank you for the question. We've actually done a lot of research with physicians and with payers around this point. When you look at the top 3 most common complaints from these patients, whether it's IPF or ILD, dyspnea is in that top 3. It's cough, dyspnea, and fatigue at the top 3. It doesn't change our commercial thesis, but what it can do is definitely complement the speed of uptake of the product and also I think just the adoption from patients, 'cause it's gonna be helping them across more than one of the experiences that they have and impacts.

Speaker #3: When you look at the when you look at the top three most common complaints from these patients, whether it's IPF or ILD, dyspnea is in that top three.

Jennifer Good: Payer conversations, right?

Speaker #4: And payer conversations, right?

Jennifer Good: Payer conversations, right?

Farrell Simon: Payer conversations. It will help in payer conversations. It'll help justify additional value.

Speaker #3: And payer conversations. It will help in payer conversations. It'll help justify additional value.

Farrell Simon: Payer conversations. It will help in payer conversations. It'll help justify additional value.

Speaker #7: Got it. And then how do you plan to try to minimize placebo in the RCC clinical program? And is high-potential placebo as much of a concern in the IPF chronic cough and non-IPF ILD indications?

Ryan Deschner: Got it. How do you plan to try to minimize placebo in the RCC clinical program? Is high potential placebo as much of a concern in the IPF chronic cough and non-IPF ILD indications?

Speaker #3: You're right, Jim. So I think we have solid data from our Coral study in the IPF population. Came in with under 20% placebo response.

James Cassella: Hey, Ryan, it's Jim. We have solid data from our CORAL study in the IPF population. Came in with under 20% placebo response. I think that was expected. I also think that that's probably, in the world of chronic cough, that's probably one of the more well-behaved populations and expect to see something like that going forward. I think there's precedent here in the RCC world that the placebo response could be a little bit more variable and a little bit more ranging. We are doing everything in this trial to really control for things that can contribute to a placebo response. I think a lot of it is having an extremely well-controlled trial, we're doing our best there.

Speaker #3: I think that was expected. I also think that that's probably in the world of chronic cough. That's probably one of the more well-behaved populations.

Speaker #3: We are doing everything in this trial to really control for things that can contribute to a placebo response. I think a lot of it is having an extremely well-controlled trial.

Speaker #3: So we're doing our best there. I think we are incorporating, at the advice of some of the experts in the RCC space, a placebo run-in period to try to make any of the response there.

James V. Cassella: I think, you know, we are incorporating, at the advice of some of the experts in the RCC space, you know, a placebo run-in period to try to mitigate any of the response there. The idea there is to look for, you know, stability around lower end of cough response. You know, we are incorporating those things, and of course, just sort of the rules of thumb that I'm bringing in from my CNS background, where placebo response is always a big concern, is really about, you know, trial conduct and making sure that you don't set false expectations, that you don't overpromise and things like that that can help contribute to, the overall placebo response.

James Cassella: I think, you know, we are incorporating, at the advice of some of the experts in the RCC space, you know, a placebo run-in period to try to mitigate any of the response there. The idea there is to look for, you know, stability around lower end of cough response. You know, we are incorporating those things, and of course, just sort of the rules of thumb that I'm bringing in from my CNS background, where placebo response is always a big concern, is really about, you know, trial conduct and making sure that you don't set false expectations, that you don't overpromise and things like that that can help contribute to, the overall placebo response.

Speaker #3: The idea there is to look for stability around the lower end of cough response. So we are incorporating those things and, of course, just sort of the rules of thumb that I'm bringing in from my CNS background, where placebo response is always a big concern, is really about trial conduct and making sure that you don't set false expectations, that you don't overpromise, and things like that, that can help contribute to the overall placebo response.

Speaker #7: Thank you very much.

Ryan Deschner: Thank you very much.

Speaker #1: Thank you. Our next question comes from the line of Devanjana Chatterjee of Jones. Your line is now open.

Operator: Thank you. Our next question comes from the line of Debanjana Chatterjee of JonesTrading. Your line is now open.

Operator: Thank you. Our next question comes from the line of Debanjana Chatterjee of Jones. Your line is now open.

Speaker #5: Hi. Thanks for taking my question. And congrats on all the progress. So looking forward to ATS, what are some of the most exciting developments we should look forward to?

Debanjana Chatterjee: Hi. Thanks for taking my question, and congrats on all the progress. Looking forward to ATS, what are some of the most exciting developments we should look forward to? I have a quick follow-up.

Speaker #5: And I have a quick follow-up.

Jennifer Good: Jim and I will both be there. We're looking at each other. Jim, you go ahead. You're the author on a bunch of them.

Speaker #4: Jim and I will both be there. We're looking at each other. Jim, you go ahead. You're the author on a bunch of them.

Jennifer Good: Jim and I will both be there. We're looking at each other. Jim, you go ahead. You're the author on a bunch of them.

Speaker #3: So, hi, Dev. I think we have some exciting updates in the oral presentation that'll be given by Dr. Phil Molyneux. I mean, that's going to be some new sub-analyses from our Coral study. I think there's also going to be some interesting presentations and posters on cough bouts—our analysis of the cough bouts for both Coral and River.

James V. Cassella: Hi, Deb. I think we have some exciting updates in the oral presentation that'll be given by Dr. Philip Molyneaux. I mean, that's gonna be some new sub-analyses from our CORAL study. I think there's also gonna be some interesting presentations and posters on cough bouts, our analysis of the cough bouts for both CORAL and RIVER. It was brought up earlier, but I think our breathlessness data, you know, being presented by Donald A. Mahler, MD, who is really one of the key experts in this space, is really gonna be exciting poster to get out that initial analysis that really shows some benefit here on the breathlessness piece of things.

James Cassella: Hi, Deb. I think we have some exciting updates in the oral presentation that'll be given by Dr. Philip Molyneaux. I mean, that's gonna be some new sub-analyses from our CORAL study. I think there's also gonna be some interesting presentations and posters on cough bouts, our analysis of the cough bouts for both CORAL and RIVER. It was brought up earlier, but I think our breathlessness data, you know, being presented by Donald A. Mahler, MD, who is really one of the key experts in this space, is really gonna be exciting poster to get out that initial analysis that really shows some benefit here on the breathlessness piece of things.

Speaker #3: So, I think those are highlights. I think that really adds some new information into the data flow for us.

James V. Cassella: I think, you know, those are highlights, I think that really adds some new information into the, into the data flow for us.

James Cassella: I think, you know, those are highlights, I think that really adds some new information into the, into the data flow for us.

Debanjana Chatterjee: Appreciate the color. Just a quick follow-up. I know, of course, FVC is not an endpoint that you are pursuing, but, given that you'll be following the IPF patients, like, 52 weeks, at least, right, in the Phase 3 program, do you expect to see some trends there and, even if, that's kind of like a safety endpoint?

Debanjana Chatterjee: Appreciate the color. Just a quick follow-up. I know, of course, FVC is not an endpoint that you are pursuing, but, given that you'll be following the IPF patients, like, 52 weeks, at least, right, in the phase III program, do you expect to see some trends there and, even if, that's kind of like a safety endpoint?

Speaker #5: And even if that's kind of like a safety endpoint?

Speaker #3: So we are following FVC. We have it at baseline. We have it throughout the 52-week time period. We will be able to look to see what's there.

James Cassella: We are following FVC. We have it at baseline. We have it throughout the 52-week time period. We will be able to look to see what's there. Our ends are very different than what you would expect from an IPF trial because FVC is highly variable, and I think that drives the size of those trials. All I can promise you is that we will see what we see and report it out.

Speaker #3: Our endpoints are very different than what you expect from an IPF trial because FVC is highly variable. And I think that drives the size of those trials.

Speaker #3: But all I can promise you is that we will see what we see and report it out.

Speaker #5: Thank you.

Debanjana Chatterjee: Thank you.

Speaker #1: Thank you. Our next question comes from the line of William Wood, VRLA Securities. Your line is now open.

Operator: Thank you. Our next question comes from the line of William Wood, B. Riley Securities. Your line is now open.

Speaker #7: Thanks for taking our questions. And congrats on a nice quarter. So just curious when we're thinking about your peers' P2X3 readout coming up, I was curious if there's anything specific that you might be looking for in that trial regardless of whether it's positive or negative in terms of taking forward to the FDA that you think they could really improve your learnings on your own trials?

William Wood: Thanks for taking our questions, and congrats on a nice quarter. Just curious, when we're thinking about the peers P2X3 readout coming up, I was curious if there's anything specific that you might be looking for in that trial, regardless of whether it's positive or negative, in terms of, you know, taking forward to the FDA that you think, you know, they could really improve your learnings on your own trials.

Speaker #4: I mean, I'm just going to jump in, Jim, you add any color. Thanks for the question, William. I don't think so. P2X3s have had to kind of chase this path of the highest level of coffers and placebo run-ins and highly adjudicate the indication.

Speaker #4: We've shown data that our drug works broadly in IPF chronic cough and refractory chronic cough across different cough counts. So I think that we have to be a lot less fussy with who goes into the trial and how we get results.

Speaker #4: We'll obviously be interested in the placebo effect and how they've controlled that. But those trials were upsized. The bigger trial was upsized twice. And that's always tricky, I think.

Speaker #4: They're also managing a much tighter response. So we'll look at it. We're interested. I agree with Ferrell. I hope they see some results for patients.

Jennifer Good: I hope they see some results for patients. They are guiding towards about a 15% to 20% placebo-adjusted change in their calls. We would expect much better performance of our drug. We really are looking to be best in class in the most refractory patients for our drug. You know, it's more, as Farrell mentioned, just how we position the drug and where we go. I would say nothing that really impacts our program. We'll learn more from our phase IIb than we'll probably learn from their phase III data.

Speaker #4: But they are guiding towards about a 15 to 20 percent placebo-adjusted change in their calls. We would expect much better performance of our drug.

Speaker #4: So we really are looking to be best in class and the most refractory patients for our drug. So it's more as Ferrell mentioned, just how we position the drug and where we go.

Speaker #4: But I would say nothing that really impacts our program. We'll learn more from our phase two B than we'll probably learn from their phase three data.

Speaker #7: Got it. That's helpful. And then one brief quick add-on. Just in terms of sort of setting our expectations for the for your KOL event coming up as well as at ATS, is there anything specific that the FDA may be looking for in terms of guiding for your non-IPF ILD-related chronic cough trials that you may be highlighting at these that really sort of bolster moving into this and/or certain subsets of populations as you look to meet with them in the second half?

William Wood: Got it.

Jennifer Good: Yep.

William Wood: That's helpful. One brief, quick add-on. Just in terms of, you know, sort of setting our expectations for the, for your KOL event coming up, as well as at ATS, you know, is there anything specific that the FDA may be looking for, in terms of guiding for your non-IPF ILD-related chronic cough trials, that you may be highlighting at these that really sort of bolster moving into this and/or, certain subsets of populations as you, as you look to meet with them in the H2? Thank you for taking our questions.

Speaker #7: And thank you for taking our questions.

Speaker #4: Well, we are having an ILD expert in the US, Dr. Toby Marr, who runs a big ILD center. He's going to speak there. He's got to join us by Zoom because he has clinic.

Speaker #4: But one of the topics we've asked him to cover is why, in his judgment, an IPF and an ILD patient is the same or not the same as it relates to cough.

Speaker #4: So you'll hear straight from one of the experts here. Toby's been involved in our program from the beginning. He knows our drug quite well.

Speaker #4: He actually sat on our FDA call with us. So you'll get some independent insights from really one of the leading voices in the ILD space on Thursday.

William Wood: That's helpful. Thank you.

Speaker #7: That's helpful. Thank you.

Speaker #4: Yeah. Thank you, William.

Jennifer Good: Yeah. Thank you, William.

Speaker #1: Thank you. Again, if you have questions, please press star 101. Our next question comes from the line of Covaria Pullman of Clear Street. Your line is now open.

Operator: Thank you. Again, if you have questions, please press star 101. Our next question comes from the line of Kaveri Pohlman of Clear Street. Your line is now open.

Kaveri Pohlman: Okay. Yes, good evening. Thanks for taking my questions. Just to like a follow-up on the previous comments you made on the Phase 2b RCC trial design, I was wondering how you are thinking about enrolling a truly addressable patient population to fully de-risk the program, particularly given the expectations that many patients may be P2X3 antagonist experience in real world. Just like on a high level, there appears to be an increasing focus on the development progress in IPF and non-IPF ILD. Obviously, alongside continued efforts in RCC, how do you think about, you know, the relative opportunity across these indications in the context of the evolving treatment landscape? What key challenges in RCC will need to be addressed to fully realize its potential? Thank you.

Kaveri Pohlman: Okay. Yes, good evening. Thanks for taking my questions. Just to like a follow-up on the previous comments you made on the phase IIb RCC trial design, I was wondering how you are thinking about enrolling a truly addressable patient population to fully de-risk the program, particularly given the expectations that many patients may be P2X3 antagonist experience in real world. Just like on a high level, there appears to be an increasing focus on the development progress in IPF and non-IPF ILD. Obviously, alongside continued efforts in RCC, how do you think about, you know, the relative opportunity across these indications in the context of the evolving treatment landscape? What key challenges in RCC will need to be addressed to fully realize its potential? Thank you.

Speaker #8: Okay. Yes. Good evening. Thanks for taking my questions. And just to follow up on the previous comments you made on the Phase 2b RCC trial design, I was wondering how you were thinking about enrolling a truly addressable patient population to fully de-risk the program, particularly given the expectations that many patients may be P2X3 antagonist-experienced in the real world.

Speaker #8: And broadly, just like on a higher level, there appears to be an increasing focus on the development progress in IPF and non-IPF ILD. Obviously, alongside continued efforts in RCC, how do you think about the relative opportunity across these indications in the context of the evolving treatment landscape?

Speaker #8: And what key challenges in RCC will need to be addressed to fully realize its potential? Thank you.

Speaker #4: There were a lot of questions there to disentangle. So I'll just kind of start from a strategy perspective. Trevi has always been led as an IPF sort of and then adding in ILD-led strategy, primarily because of our commercial strategy, specialty high pricing, specialty sales force.

Speaker #4: So that was always our focus. I think as the RCC competitive landscape sort of fell away and really there wasn't much left, some of the experts came to us asking us to please try our drug in RCC.

Speaker #4: We did, and got very strong data. So I think definitely a commitment to RCC, but it is sort of the third leg of the stool here.

Speaker #4: With regard to the variability in the program and P2X3 responders, anything, Jim, on that?

James V. Cassella: I think are you asking, there's gonna be people who have experience with P2X3 that may be entering in our trial? I mean, I think, you know, the key there is if they meet the eligibility requirements and they've been off their P2X3 for an appropriate period of time, they still have, you know, the requirements to get into the study. You know, they're fair game for coming in. I mean, we want people with various experiences. We know, you know, this is a refractory condition, and people have tried a lot of different things and, they may or may not have succeeded on a P2X3, but if they meet our entry criteria, they'll be coming into the trial. I don't think it really differentiates from any other type of therapy that they've tried in the past.

James Cassella: I think are you asking, there's gonna be people who have experience with P2X3 that may be entering in our trial? I mean, I think, you know, the key there is if they meet the eligibility requirements and they've been off their P2X3 for an appropriate period of time, they still have, you know, the requirements to get into the study. You know, they're fair game for coming in. I mean, we want people with various experiences. We know, you know, this is a refractory condition, and people have tried a lot of different things and, they may or may not have succeeded on a P2X3, but if they meet our entry criteria, they'll be coming into the trial. I don't think it really differentiates from any other type of therapy that they've tried in the past.

Speaker #3: They're fair game for coming in. I mean, we want people with various experiences. We know this is a refractory condition, and people have tried a lot of different things.

James V. Cassella: They will meet the eligibility requirements for being off of the P2X3 for a certain amount of time.

Speaker #3: They will meet the eligibility requirements for being off of the P2X3 for a certain amount of time.

James Cassella: They will meet the eligibility requirements for being off of the P2X3 for a certain amount of time.

Speaker #4: Got it. Thank you.

Kaveri Pohlman: Got it. Thank you.

Speaker #8: Thank you, Coveria.

Jennifer Good: Thank you, Kaveri.

Speaker #4: We appreciate you joining us for today's call and look forward to hopefully seeing many of you later this week and this month. Thank you.

Jennifer Good: We appreciate you joining us for today's call and look forward to hopefully seeing many of you later this week and this month. Thank you.

Operator: This concludes today's conference call. Thank you for attending. You may now disconnect.