Q1 2022 Trevi Therapeutics Inc Earnings Call
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Operator: I would now like to turn the conference over to Jennifer Good, Trevi's President and CEO. Please go ahead. Good afternoon, and welcome to our first quarter 2022 earnings call and business update. Joining me today on this call are Lisa Delfini, Trevi's Chief Financial Officer, and Dr. Bill Forbes, Trevi's Chief Development Officer. Lisa and I have some prepared remarks, then the three of us will be available for questions at the end. 2022 has already been an exciting year on the clinical front for Trevi, and there is more data to come.
I would now like to turn the conference over to Jennifer Good <unk> President and CEO . Please go ahead.
Operator: On this call, we will provide an update on the continued progress we are making on advancing the development of both of our programs. However, before I do that, I want to quickly touch on the pipeline strategy at Trevi. We are focused on targeting the most debilitating aspects of the disease, where we also believe that there may be an opportunity to become disease-modifying over time. For instance, it is believed that for pruritus and PN, if you are able to break the itch-scratch cycle for the patient by reducing or suppressing the itch, and therefore the urge to scratch, then the skin and nodules will have time to heal.
Good afternoon, and welcome to our first quarter 2022 earnings call and business update joining me today on this call or at least that Delphine <unk>, Chief Financial Officer, and Dr. Bell Forbes <unk>, Chief Development Officer, Lisa and I have some prepared remarks, then the three of us will be available for questions at the.
Jennifer Good: We have seen evidence supporting that in our clinical work to date. For cough in IPF, patients may cough upwards of 1,500 times per day, and by significantly reducing cough, there is potential to decrease the mechanical trauma that coughing inflicts on the lungs, which may result in broader benefits to IPF patients. So, in both of our programs, we are exploring how providing relief for the most impactful parts of disease management may improve the underlying disease itself.
And.
2022 has already been an exciting year on the clinical front search Rabat and there is more data to come on this call. We will provide an update on the continued progress we are making on advancing the development of both of us.
Our programs however, before I do that I want to quickly touch on the pipeline and strategy at Trevi. We are focused on targeting the most debilitating aspects of disease, where we also believe that there may be an opportunity to be kind of disease modifying overtime. For instance, it is believed that for price in Pn. If you are able to.
Be it scrap cycle for the patient by reducing our suppressing the itch and therefore, the urge to scratch then the skin and nodules will have time to heal we have seen evidence supporting that in our clinical work to date for cough and IPF patients may cost upwards of 1500 times per day and by.
<unk>, reducing cost there is potential to decrease the mechanical trauma that coughing and flex on the lungs, which may result in broader benefits to IPF patients.
So in both of our programs, we are exploring how providing relief on the most impactful parts of disease management may improve the underlying disease itself Trevi was built with this strategy in mind and it is very exciting to be reading out critical data in both of our indications in the coming months, Let me now provide you with.
Jennifer Good: Trevi was built with this strategy in mind, and it is very exciting to be reading out critical data in both of our indications in the coming months. Let me now provide you with an update on both programs. Our most advanced program in clinical development is severe chronic paritis in praegonodularis, or PN, which is a serious and debilitating disease characterized by papules and nodules on the skin, as well as incessant and severe itching.
An update on both programs our most advanced program in clinical development is in severe chronic pruritus in prego and agile Arris, RPM, which is a serious and debilitating disease characterized by Pap youll have a nodule on the skin as well as an assessment and severe itching Adobe.
Jennifer Good: Haduvio is being studied in PN in our PRISM trial, which is a 14-week phase 2b3 trial. We believe PN, due to the refractory nature of the disease, is neurologically mediated and potentially aligns well with the neural mechanism of our mixed agonist antagonist drug.
<unk> is being studied in pn in our Prism trial, which is a 14 week phase <unk> three trial, we believe pn due to the refractory nature of the disease is neurologically mediated and potentially aligns well with the <unk> mechanism of our mixed agonist antagonist drug most of these patients have already.
Jennifer Good: Most of these patients have already tried and failed topical treatments, and we believe future patients will be eligible for an oral therapy like Haduvio before turning to biologics. This trial has reached several important milestones this year. At the end of January, we enrolled our last patient, and we just received word that our last patient has completed their final visit in the double-blind portion of the study. This keeps us on track to report data by the end of June. Our clinical team is cleaning the data and preparing for the database lock.
Tried and failed topical treatments and we believe future patients will be eligible for an oral therapy like <unk> before turning to biologics.
This trial has reached several important milestones this year at the end of January we enrolled our last patient and we just received word that our last patient has completed their final visits and the double blind portion of the study.
This keeps us on track to report data by the end of June .
Our clinical team is cleaning data and preparing for database lock, we look forward to seeing the results.
Jennifer Good: We look forward to seeing the results. Turning now to our other clinical program, which is in chronic cough and idiopathic pulmonary fibrosis, or IPF. During the first quarter, we were very happy to report a positive result from a pre-specified efficacy interim analysis, allowing us to end enrollment early, save money, and accelerate into the next phase of development. In this interim analysis, Hadubio showed a 77% reduction from baseline at day 22 in daytime cough frequency, as measured by an objective cough monitor, demonstrating a 52% difference from placebo.
Turning now to our other clinical program, which is in chronic cough and idiopathic pulmonary fibrosis or IPF.
During the first quarter, we were very happy to report a positive result from a pre specified efficacy interim analysis, allowing us to end enrollment early save money and accelerate into the next phase of development. In this interim analysis <unk> showed a 77% reduction from baseline at day.
<unk> 22 in daytime cough frequency as measured by an objective cost monitor demonstrating a 52% difference from placebo.
Jennifer Good: Imagine how impactful a 77% reduction in cough may be to a patient who coughs up to 1,500 times per day. The P-value on this interim analysis of 26 subjects was P less than 0.0001, and conditional power was 100%. These results were consistent regardless of baseline cough frequency or antifibrotic use.
Imagine how impactful a 77% reduction in costs may be to a patient who cough up to 1500 times per day.
The P value on this interim analysis of 26 subjects with P less than 0.0001 and conditional power with 100%. These results were consistent regardless of baseline cough frequency or anti fibrotic youth.
Jennifer Good: Patient-reported outcomes, or PROs, corroborate the impressive results found with the Objective Cough Monitor. The PRO question assessing cough frequency demonstrated separation against placebo-treated subjects starting at day one and performed better in subjects on toduvio than placebo across all time periods. Hadubio is the lead therapy and development for cough and IPF and is the only one to have shown positive results in the reduction of cough in this patient population.
Patient reported outcomes or pros corroborate the impressive results found with the objective cough monitor the pro question assessing cough frequency demonstrate separation against placebo treated subjects starting at day, one and performed better in subjects on <unk> than placebo across all time point.
<unk> is the lead therapy in development for Kaufmann IPF and is the only one to have shown positive results on the reduction of costs in this patient population.
Jennifer Good: Haduvio was well-tolerated in this study with only one SAE that was not deemed to be treatment-related, and the adverse events were consistent with what we have seen in Haduvio trials and other indications. Twenty-six subjects were included in the interim analysis, and we expect approximately 40 subjects in total to be evaluated in the final data. With the strength of the p-value reported, we would expect to see similar results in the final data set and anticipate announcing data on the full set of subjects in the third quarter of this year. Bill and his team have been busy preparing for the next IPF cost study.
<unk> was well tolerated in this study with only one S. I E that was not deemed to be treatment related and the adverse events were consistent with what we have seen in <unk> trials and other indications.
26 subjects were included in the interim analysis, and we expect approximately 40 subjects in total to be evaluated in a final data.
With the strength of the P value reported we would expect to see similar results in the final data dataset and anticipate announcing data on the full set of subjects in the third quarter of this year.
Bill and his team have been busy preparing for the next IPF cost study.
Jennifer Good: To date, the team has written a protocol synopsis, which we intend to design as an adequate and well-controlled trial, as well as requested a meeting with the FDA to discuss the design. We expect to have that FDA meeting during the third quarter of this year. This interim data is exciting and is initial validation of our hypothesis of the mechanism of Haduvio in treating cough.
To date the team has written a protocol synopsis, which we intend to design as an adequate and well controlled trial as well as requested a meeting with the FDA to discuss the design, we expect to have that FDA meeting during the third quarter of this year.
This interim data is exciting and has initial validation of our hypothesis of the mechanism of <unk> and treating costs and as a team we are determining our path forward not only in this indication, but also other chronic cough indication the global chronic cough market is estimated to be approximately $10 billion.
Jennifer Good: And as a team, we are determining our path forward, not only in this indication but also for other chronic cough indications. The global chronic cough market is estimated to be approximately $10 billion. It has been a busy start to the year at Trevi, but we still have much to do with a data-rich few months ahead of us and then a transition into the next phase of development. We look forward to getting PRISM data in June and full canal data on all subjects in the third quarter.
It has been a busy start to the year at Trevi.
We still have much to do with a data rich few months ahead of US and then a transition into the next phase of development. We look forward to getting prism data in June and full canal data on all subjects in the third quarter, we are well positioned to grow trevi based on what we know of <unk> mechanism and the strong cost data in hand.
Jennifer Good: We are well positioned to grow Trevi based on what we know of Hadoopio's mechanism and the strong cost data at hand. I will now ask Lisa to review our financial results, and then we will open it up for questions. Lisa?
I will now ask Lisa to review our financial results and then we will open it up for questions Lisa.
Lisa Delfini: Thank you, Jennifer, and good afternoon, everyone. As a reminder, the full financial results for the three months ended March 31, 2022, can be found in our press release issued ahead of this call and in our 10-Q, which was filed with the SEC today after the market closed. I'd like to begin with an update on events after the end of the quarter. On April 11th, we raised $55 million through the sale of common stock and pre-funded warrants to both new investors and NEA, a long-time investor who also chose to participate. The offering was priced at market with no warrant coverage.
Thank you Jennifer and good afternoon, everyone.
As a reminder, the full financial results for the three months ended March 31, 2022 can be found in our press release issued ahead of this call and in our 10-Q, which was filed with the SEC today after the market closed.
Lisa Delfini: The new investors were Fraser, Venrock, and Fairmont, and these funds are well-known biotech investors, and we're thrilled to have them in our corner as we advance the development of our program. We also received proceeds of $4.5 million in April related to the exercise of warrants that were originally issued in our October 2021 private placement. Together with our cash balance of $29 million at the end of March, I'm happy to report that we now have over $80 million of cash and investments on hand.
I'd like to begin with an update on events. After the end of the quarter on April 11th we raised 55 million through the sale of common stock and pre funded warrants to both new investors in any a longtime investor who also chose to participate.
The offering was priced at market with no warrant coverage, the new investors rephrase your Venrock and Fairmont and these funds are well known biotech investors and we're thrilled to have them in our corner as we advance the development of our programs.
We also received proceeds of $4 5 million in April related to the exercise of warrants that were originally issued in our October 2021 private placement together.
Together with our cash balance of $29 million at the end of March I am happy to report that we now have over $80 million of cash and investments on hand.
Lisa Delfini: These funds will be used for our ongoing operations, including completing our current PRISM trial and its open-label extension and planning for and conducting our next trial for chronic cough and IPS. This gives us cash runway into Q1 of 2024. In addition, we have approximately 15 million warrants still outstanding, which can provide up to $20 million if exercised.
These funds will be used for our ongoing operations, including completing our current prism trial and its open label extension and planning for and conducting our next trial for chronic cough and IPF.
This gives us cash runway into Q1 of 2024.
In addition, we have approximately 15 million warrants still outstanding which can provide up to $20 million of exercise.
Lisa Delfini: Now on to the first quarter results. For the first quarter of 2022, we reported a net loss of $7.3 million compared to a net loss of $8.4 million for the same quarter of 2021. R&D expenses were $4.6 million during the first quarter of 2022, compared to $5.6 million in the same period of 2021, primarily due to decreased clinical trial subject recruitment costs due to our PN trial wrapping up enrollment this year. Our consulting expenses and professional fees declined as well due to a reduction in our use of consulting services and the non-recurrence of professional recruiting fees related to hirings in the prior year period.
Now onto first quarter results for the first quarter of 2022, we reported a net loss of $7 3 million compared to a net loss of $8 4 million for the same quarter of 2021.
R&D expenses were $4 6 million during the first quarter of 2022 compared to $5 6 million in the same period of 2021, primarily due to decreased clinical trial subject recruitment costs due to our pn trial wrapping up enrollment this year.
Our consulting expenses and professional fees declined as well due to a reduction in our use of consulting services and the non recurrence of professional recruiting fees related to hirings in the prior year period.
Operator: The NA expenses were $2.4 million during the first quarter of 2022 compared to $2.5 million in the same period of 2021, primarily due to lower legal fees as a result of the timing of certain intellectual property filings. In closing, we are excited about the strategy of the company, the recently reported data and IPF costs, and the strength of our balance sheet to continue executing on our plan. This concludes our prepared remarks.
G&A expenses were $2 4 million during the first quarter of 2022 compared to $2 5 million in the same period of 2021, primarily due to lower legal fees as a result of the timing of certain intellectual property filings.
In closing we are excited about the strategy of the company. The recently reported data in IPF cough and the strength of our balance sheet to continue executing on our plan.
This concludes our prepared remarks, I will now turn the call back over to the operator for Q&A.
Operator: I will now turn the call back over to the operator for Q&A. We will now begin the question and answer session. To ask a question, you may press star and then one on your touchtone phone. If you're using a speakerphone, please pick up your handset before pressing the keys.
We will now begin the question and answer session to ask a question you May Press Star then one on your Touchtone phone if youre using a speakerphone. Please pick up your handset before pressing the keys to withdraw your question. Please press Star then two.
Operator: To withdraw your question, please press star then two. At this time, we will pause momentarily to assemble our roster. The first question comes from Serge Belanger with Needham & Company.
At this time, we will pause momentarily to assemble our roster.
The first question comes from Serge <unk>.
LNG with Needham and company. Please go ahead.
Serge Belanger: Please go ahead. Hi, good afternoon, and thanks for taking my questions. I'll start off with a couple on the PM program and more specifically the prison trial. When we get a readout at the end of June, should we expect just the top line, or will we also see the secondary endpoints, as well as the full safety results? And then secondly, maybe just give us an update on where the Open Label Extension portion of that trial stands. Yeah, thanks Serge for your questions.
Hi, good afternoon, thanks for taking my questions.
A couple on the <unk>.
The Pn program and more specifically the prism trial.
When we get a readout at the end of June .
Should we expect just a top line or should we will we also see the secondary end points as well.
Full safety results and then secondly, maybe just give us an update on where.
The open label extension.
A portion of that Charleston.
Okay.
Jennifer Good: I'll jump in here. So, as far as what to expect with the top line, I think, you know, as far as guiding you, we'll provide the information that we have. And so, I expect it to be top line, with some secondary endpoints as well as some safety overview as well. So, my hope is that we'll be able to provide all of that when we come out in June with that information. The open label continues.
Good morning.
Yeah go ahead, yeah. Thanks for your questions I'll jump in here, so as far as what to expect with the top line I think.
As far as guiding you will provide the information that we that we have and so I expect it to be topline with some secondary endpoints as well as some safety overview as well. So that's my hope is that we'll be able to provide all of that when we come out.
In June with that information.
The open label continues we ever could we have some patients that are still finishing up in that so.
Jennifer Good: We have some patients that are still finishing up on that one. So, you know, we're still collecting information on that one as well. So, that'll probably take us probably through the next six months or so. Okay, and then.
We're still collecting information on that one as well so that's.
That will take us probably through the next six months or so.
Okay.
And then.
Jennifer Good: Assuming this is positive, you'll have to conduct a second phase retrial in NPN. Can you maybe just ballpark what the cost of a phase retrial would be, and maybe? Timelines. I know it's difficult to provide those, but given that we should be in a the second trial should be conducted in a better COVID environment than the previous one, maybe just give us an idea of how the timelines could be improved. Thanks.
Assuming this is positive youll have to conduct a second phase III trial in Pn.
Can you maybe just ballpark what the cost of the phase III trial would be in.
Maybe.
Timelines I know, it's difficult to provide those but.
Given that we should be in the second trial to be conducted in the.
Better COVID-19 environment and the previous one.
Maybe just give us an idea of how the timelines could be improved.
Jennifer Good: Sure. So I'll probably pass the budget response on to Lisa. But yeah, we've been guiding towards the probable need for a second study in this indication. And so my hope is that we can do the entire rollout of that over the next couple of years. Obviously, it'll depend a lot on how large that study is.
Sure. So I'll I'll, probably pass the budget a response on the lease, but but yes, we've been guiding towards.
The probable need for a second study in this indication.
And so my hope is that we can do the <unk>.
Tire rollout of that over the next couple of years.
Obviously, it will depend a lot on how large that study is but we feel confident that we have over 60 centers that participated in prism.
Lisa Delfini: But, you know, we feel confident that we have over 60 centers that participated in prism. We'll add more patients or more centers, excuse me. And, and, hopefully, we won't have to have as many patients in this in the second study as well. So depending on a lot of hypotheticals, you know, hopefully, that'll take about two years in the in clinic phase for it to be completed. Lisa, I don't know if you want to handle the cost of the study.
We will add more patients or more centers excuse me.
And of course, hopefully we don't have to have as many patients in the second study as well so depending on a lot of hypotheticals.
Hopefully that will take about two years in the in clinic days for it to be completed.
Lisa Delfini: Yeah, on the cost of the study side, I mean, you know, we still have to do the formal RFP and all that. So we don't have an exact number, but we are estimating that it'll be in the 20 to 30 range, 20 to 30 million.
So I don't know if you want to handle the cost of the study yeah on the cost of the study side I mean, we still have to do a formal RFP and all that so we don't have an exact number but we are estimating that it will be in the 20 to 30 range $20 million to $30 million.
Okay. Thank you.
Annabel Samimy: Thank you. The next question comes from Annabel Samimy with Stifel. Please go ahead.
The next question comes from Annabel <unk> with Stifel. Please go ahead.
Jennifer Good: Hi, thanks for taking my question. So, just thinking about the size of another chronic cough trial and idiopathic in IPF, what do you think that might look like and how large? And I guess I'm asking because... You know, you could potentially have two large late-stage programs simultaneously. Do you feel like you're in a position that you would need to prioritize them based on the value of each of the different programs?
Hi, Thanks for taking my question so.
Just thinking about the size of another chronic cough trial in idiopathic and IPF.
What do you think that might look like and how large and I guess I'm asking.
Because you know.
You could potentially have two large late stage programs.
Simultaneously do you feel like you're in a position that you would need to prioritize them.
Based on the value of each of the different programs. So how do you think about running two programs simultaneously and do you have any sense of how large that next a chronic cough trial will look like.
Jennifer Good: So, how do you think about running two programs simultaneously, and do you have any sense of how large that next chronic cough trial will look? Sure, so I'll start, and maybe, Jennifer, you might want to step in on a couple of these. But, you know, what we're looking at. We've been pretty vocal about this. Right now, we estimate that we'll have about 300 patients in the next study, 100 patients per treatment group. We anticipate that the enrollment period for that will be 18 to 24 months, and we're going to try to keep it to 12 months, if possible.
Sure. So I'll start and maybe Jennifer you might want to step in on a couple of these but.
We're looking at and we've been pretty vocal about this way now we estimate that we'll have about 300 patients in the next study 100 patients per treatment group.
We anticipate that the enrollment period for that will be 18 to 24 months.
And we're going to try to do everything we can to take.
To keep it to 12 months if possible, but if we go to 18 months on enrollment than it would be six months follow up so it would be a couple of years again.
But obviously the efficacy on that will just be class counsel I'll add a few a little more color here to to this annabel, but we'll look at KOF counts, but one of the things that I've been very vocal about is that we don't need a lot of patients to show efficacy.
Jennifer Good: But if we go to 18 months on enrollment, then it would be six months follow-up, so it would be a couple of years again, but, you know, obviously, the efficacy of that would just be cough counts, so I'll add a little more color to this, Annabel, but we'll look at cough counts. But, you know, one of the things that I've been very vocal about is that we don't need a lot of patients to show efficacy, and we know, based upon our Phase II experience, that very few patients are required to drive a statistical difference.
We know based upon our phase II experience with very few patients are required to drive a statistical difference.
Jennifer Good: We're interested in following these patients for six months so that we can start to see whether or not we have an impact on their disease itself. We anticipate that when we unburden them from this kind of cough, the amount of cough that these patients have, they will do very well from a respiratory perspective, and I think that'll play into their hospitalizations and respiratory distress that they have and improvement in their respiratory exacerbations.
We're interested in following these patients for six months. So that we can start to see whether or not we have an impact on their on their disease itself. We anticipate that when we burdened them from this kind of cost is the amount of cost that these patients have that they will when they will do very well from a respiratory perspective, and I think that will play into.
Hospitalizations and respiratory distress that they have and some less attendance and an improvement in the respiratory exacerbations.
Jennifer Good: So, I think, for the most part, we'll follow them right now. We predict we'll follow them for six months, and we have to get to the FDA, and as Jennifer mentioned in her talk, we'll have a discussion with them in Q3, so I don't know, Jennifer, if I missed anything. No, I would just add on the resourcing, Annabel, you're asking. I think I feel comfortable. We've got a good development team in place.
So I think for the most part will will follow them right. Now are we predict will follow them for six months. So we have to get to the FDA and as Jennifer mentioned in her talk.
We will have a discussion with them in Q3, so I don't know Jennifer if I Miss anything.
Jennifer Good: We've got a strong clinical operations team under Bill, and we are capable of running both of these trials. There may be a couple ads or hires, but what I'm less comfortable with, and it probably plays into some of our decisions and other indications, is sort of veering off into completely new spaces. As you know, this drug, we think, has broad utility. I think as long as we stay home and sort of paritis and cough, I feel comfortable about our ability to run two trials in parallel.
No I would just add on the Resourcing Annabel, you're asking I think I feel comfortable we've got a good development team in place we've got a strong team under Bill and we are capable of running both of these trials there may be a couple add their hires but what.
What I'm less comfortable with and it probably plays into some of our decisions in other indications is sort of varying often two completely new spaces. As you know our this drug we think has broad utility I think as long as we stay home and sort of pruritus and cough I felt comfortable about our ability to run two trials in parallel.
Jennifer Good: Okay, and if I could just follow up on both the topics, actually. So when you're talking about assessing for potential disease modification, so I think PN, it's pretty easy to sort of measure healing. So for chronic cough, when you think about disease modification, are you going to be measuring things like FCC or, you know, how are you going to measure disease modification for chronic cough exactly?
Okay, and if I could just follow up on on both the topics actually so when you are talking about assessing.
Potential disease modification, so I think pn, it's pretty easy to sort of measure healing. So for chronic cough. When you think about disease modification or you're going to be measuring things like.
If you see or you know how are you going to measure disease modification for chronic cough exactly.
Jennifer Good: Yeah, well, I think the antifibrotics have done a pretty good job of, you know, trying to stake out some of this. I think we'll take a look at changes in FEC, although six months is a little bit short to be able to see anything like that, but I think we'll probably hone in around, you know, things like hospitalizations, specifically respiratory hospitalizations as a result of respiratory illness, and I think there's a few other things that we'd like to try to take a closer look at, and so we're talking about those, and I want to get over my skis on some of this, so we want to have a discussion with the FDA on it, but I think as far as exacerbation of IPF, if you could just take a look and count the, or look at the things that the antifibrotics have done to try to measure improvement in some of these things, we'll count some of those same types of things, and we'll have an open label study that we'll be able to follow these patients longer, too, so the six months on placebo will give us an event rate inside of our population.
Yes, well I think the <unk> have done a pretty good job of.
As you know trying to stake out some of that I think will take a look at changes in FCC. Although six months is a little bit short to be able to see anything like that.
I think we'll probably hone in and around.
Things like hospitalization, specifically respiratory hospitalizations as a result of <unk>.
Victoria illness.
And I think Theres a few other things that wed like to try to take a close look at and so we're talking about though is I don't want to get over my skis on some of this and we want to have a discussion with the FDA on it but I think as far as exacerbation of IPF.
If you just take a look and look.
Look at the things at the end of fibrotic have done to try to measure improvement in some of these things will come with some of those same types of things and we'll have an open label study that we'll be able to follow these patients longer too. So the six months on placebo will give us an event rate inside of our population. The open label study that we run will allow.
Jennifer Good: The open-label study that we run will allow these patients to flow into that, and we can follow them even longer, so I think we'll see over time whether or not reducing costs in about half of these patients by up to 75% reduction in their daytime costs, we'll see if that translates into better respiratory function over time. And just one last question on the sourcing side of it. Are there, I mean, you mentioned you had warrants, but are there any other... And there are potential ways to monetize some of the XUS opportunity to really give yourself an additional lift to maximize what you can do with these programs that you have right now.
These patients to flow into that and we can follow them even longer. So I think we will see over time, whether or not reducing costs in about half of these patients by up to 75% reduction in their daytime cost, we will see if that translates into into better respiratory function over time.
Okay got it and just one last question on the sourcing.
Part of it are there I mean, you mentioned you had once but are there any other.
For ways to monetize some of the ex U S opportunity to really give yourself additional lift to.
Maximize what you can do with these programs that you have right now.
Jennifer Good: Yeah, so we've been busy at that over the last year, sort of preparing for these data readouts. We are not going, obviously, to try to market this in Europe or any of the Asian countries. So we've been in active discussions with lots of partners. They're waiting for the data. I think we've got to make some decisions about the strategy there, but there is a way to monetize it. And also, to your point, I think we should bring in some development expertise in these territories. I feel comfortable in the US and Europe.
Yeah. So we've been busy at that over the last year started preparing for these data readouts, we are not going to obviously try to market. This in Europe are any of the Asian countries. So we've been in active discussions with lots of partners, they're waiting on the data I think we've got to make some decisions about the strategy there, but there is a way to monetize it and.
Also to your point I think bring on some development expertise in these territories I felt comfortable in the U S and Europe .
Jennifer Good: We've got a lot of experience, and Bill has been through all those jurisdictions getting approvals, but I do think bringing in sort of their knowledge around pricing and some of the stuff is helpful. So we will look to try to do that once we get through all the data readouts here. Great. Thank you. Thank you, Annabel. The next question comes from Nathan Weinstein with Aegis Capital. Please go ahead.
We've got a lot of experience in bell has been through all of those jurisdictions getting approval, but I do think bringing in sort of their knowledge around pricing and some of the stuff is helpful. So we will look to try to do that.
Once we get through all the data read out here.
Okay, great. Thank you.
Thank you Annabel.
The next question comes from Nathan Weinstein with Aegis capital. Please go ahead.
Nathan Weinstein: Good afternoon, Jennifer, Bill, and Lisa. Thank you for taking my questions. I had two questions.
Hi, Good afternoon, Jennifer Brian listen Thank you for taking my questions.
Jennifer Good: One was regarding the disease-modifying characteristics of Haduvio, and maybe you could share some high-level thoughts about what that profile could mean for the drug's market potential versus if it were just viewed as a palliative option. Yeah, I'll start with that. I mean, obviously, if you end up disease-modifying, I think Annabelle hit on some of the FCC's that are longer, but you know, the antifibrotics are priced annually at about $140,000 a year.
Two questions one.
Was regarding.
The disease modifying characteristics of <unk>, maybe you could share some high level thoughts about what that profile.
While it can mean for the drugs market potential versus if it were just viewed as a palliative option.
Yeah, I'll start with that.
Obviously, if you end up disease, modifying I think annabel hit on some of the FCC's that's longer but the anti fibrotic set price Daniela at about 140000 a year.
Jennifer Good: If you end up just treating sort of the severe aspect of the disease of cough, which I still think is quite meaningful, you know, it's not going to be in that disease modification category. So, you know, we've always thought about paritis pricing somewhere around biologics with some type of discount. Biologics are priced at roughly $40,000.
If you end up just treating sort of the severe aspect of the disease of cop, which I still think is quite meaningful.
Not going to be in that disease modification category. So we've always thought about the price pricing somewhere.
Around biologics with some type of discount biologics are priced at roughly 40, K. So I would sort of probably give a range somewhere between that level of pricing up to sort of disease modifying aspects I think it'll just depend on the data so huge range there and a lot of difference, but it just is going to come down to what sales able to sort of.
Jennifer Good: So I would probably give a range somewhere between that level of pricing up to sort of disease-modifying aspects, and it'll just depend on the data. So there is a huge range there and, you know, a lot of difference, but it just is going to come down to what Phil's able to sort of read out in his trial. Got it, understood. And then just one follow-up regarding the adjacent indications. You guys have been pretty vocal that there are potential large markets outside of the lead indications.
Read out and has trialed.
Got it understood.
And then just one follow up regarding the adjacent indications you guys have been pretty vocal that there are potential large markets outside of the lead indications maybe you could just speak to how you think about that embedded optionality and then strategically what are some of the pads you might take to tap into it.
Jennifer Good: Maybe you could just speak to how you think about that embedded optionality and, strategically, what are some of the paths you might take to tap into it? Yeah, so we're going to make sure we read both of these trials out and get both of these programs on their way, assuming the data supports that. Clearly, COPS does.
Yeah. So we're going to make sure we read both of these trials out and get both of these programs on their way assuming the data supports that clearly cost as well wait for PM. So our first priority is going to be moving forward. The indications we've already committed to beyond that we are doing a lot of work internally preparing for other mark.
Jennifer Good: We'll wait for PN. So our first priority is going to be moving forward with the indications we've already committed to. Beyond that, we're doing a lot of work internally preparing for other markets, pricing, sort of strategy, I think, to the question about resourcing, what can we handle. So we'll bite off maybe one or potentially two other indications along the way that could make some sense, I think, to help really grow out the company.
It's pricing sort of strategy I think to the question about Resourcing, what can we handle so won't bite off maybe one or potentially to other indications along the way that could make some sense I think to help really grow out the company. So we are doing that work and I would expect once we get all that data in hand and are able.
Jennifer Good: So we are doing that work, and I would expect once we get all the data in hand and are able to coalesce around the path forward, we'll be able to give some guidance on that. Okay, that sounds great.
Nathan Weinstein: Thanks again for taking my question. Thank you, Nathan. I am not asking any further questions.
Two called surround the path forward will be able to give some guidance on that.
Okay that sounds great. Thanks, again for taking my questions.
Thank you Nathan.
I am not showing any further questions. This concludes our question and answer session I would like to turn the conference back over to Jennifer good for closing remarks.
Operator: This concludes our question and answer session. I would like to turn the conference back over to Jennifer Good for closing remarks. We would like to thank everybody for participating in today's call. I'd also like to thank the Trevi team, our study investigators, and all the subjects who have participated in our clinical trials. Thank you. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect. Leland Gershell, David Clark, Mayank Mamtani, John Gionco, Debanjana Chatterjee, and Trevi
We would like to thank everybody for participating in today's call I'd also like to thank the <unk> team our study investigators and all of the subjects who have participated in our clinical trials. Thank you.
The conference has now concluded. Thank you for attending today's presentation you may now disconnect.
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