Q3 2020 Trevi Therapeutics Inc Earnings Call

[music].

Good afternoon, and welcome to the Trevi Therapeutics third quarter earnings Conference call.

Operator: Good afternoon, and welcome to the Trevi Therapeutics 3rd Quarter Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we'll conduct a question and answer session, and instructions will be given at that time. If anyone should require operator assistance, please press star then zero on your touchtone telephone.

At this time all participants.

So on a listen only mode.

Later, we will conduct a question and answer session and instructions will be given at that time.

If anyone should require operator assistance. Please press Star then zero on your Touchtone telephone.

Operator: As a reminder, this call may be recorded. Various remarks that management makes during this call about the company's future expectations, plans, and prospects constitute forward-looking statements for purposes of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by those forward-looking statements as a result of various important factors, including those discussed in the risk factors section of the company's most recent quarterly report on Form 10-Q, which is on file with the SEC, and subsequent filings included in the Form 10-Q that the company plans to file tomorrow. In addition, any forward-looking statements represent the company's views only as of today and should not be relied upon as representing 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 views change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to today.

As a reminder, this call may be recorded.

Various remarks that management makes during this call about.

The company's future expectations plans and prospects constitute forward looking statements for purposes of the Safe Harbor provisions under the private Securities Litigation Reform Act of 1995.

Actual results may differ materially from those indicated by those forward looking statements as a result of various them.

Important factors, including those discussed in the risk factor section of the company's most recent quarterly report on form 10-Q, which is on file with the SEC and subsequent filings included in the form 10-Q with the company plans to file tomorrow.

In addition, any forward looking statements represent the company's views only as of today and should not be relied upon as representing 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.

So even if views change.

These forward looking statements should not be relied upon as representing our views as of any date subsequent to today.

Participating on today's call from Trevi are Jennifer good President and CEO, and Chris Pitre, Chief Financial Officer.

Operator: Participating on today's call from Trevi are Jennifer Good, President and CEO, and Chris Titor, Chief Financial Officer. I would now like to turn the call over to Jennifer. Please go ahead.

I would now like.

On the call over to Jennifer. Please go ahead.

Jennifer L. Good: Thank you. Good afternoon, everyone, and welcome to our third quarter earnings call.

Thank you good afternoon, everyone and welcome to our third quarter earnings call. We continued to execute against our business plan for the quarter adapting to the challenges of the Covance pandemic. So just to step back a moment and remind everyone of the strategy for growth at track.

Jennifer L. Good: We continue to execute against our business plan for the quarter, adjusting to the challenges of the COVID pandemic. So, just to step back for a moment and remind everyone of the strategy for growth at Trevi. We are developing Hiduvio, an oral extended-release drug, to explore its potential treatment effect in various serious neurologically mediated conditions. We have focused on the clinical conditions of paritis, cough, and movement disorders as therapeutic areas of interest because of the scientific evidence that activity at both the mu and kappa receptors may play an important role in these conditions. Our lead clinical indication is severe paritis imprego nodularis, which is a serious and debilitating skin disease characterized by papules and nodules on the skin, as well as incessant and severe itching.

We are developing had to be out and are all extended release strive to explore its potential treatment effect in various areas neurologically mediated condition. We have focused on the clinical conditions that per item CCOP and movement disorders as therapeutic areas of interest because of the scientific evidence that activity.

Both immune Kappa receptors may play an important role in these conditions.

Our lead clinical indication is in severe per item in pre go Nigel areas, which is a serious and debilitating skin disease characterized by Papua nodules on the skin as well as incessant in severe itching. There are currently no approved therapies.

And this indication.

Jennifer L. Good: There are currently no approved therapies for this indication. Parigo nodularis is a chronic disease, and because of the repeated scratching, the papules and nodules spread and continue to get worse. We estimate there are approximately 250,000 PN patients in the U.S. and another 430,000 in the rest of the world. Several biologics are in clinical development for severe paritis and PM, but Hidubio is the only oral therapy in development for this condition. We believe that both biologics and oral therapies will have important and complementary roles to play in managing this serious chronic disease. We are currently conducting our first Phase 2b slash 3 trial in these subjects with pregonodularis, which we call our PRISM trial. The trial is recruiting in both the U.S. and Europe, and to date, we have more than 60 sites activated.

I go Nigel Eris is a chronic disease and because of the repeated scratching the pappy often nigel spreading continue to worsen. We estimate there are approximately 250000 pn patients in the U.S. and another 430000 in the rest of the world.

Well biologics and.

Clinical development for severe price MPN, but how do we how is the only oral therapy in development for this condition, we believe that both biologics and oral therapies will have important and complementary role to play and managing the serious chronic disease.

We are currently conducting our first phase to be last three trial.

Yeah on these subjects with Preqin agile Eric Meek.

All our present trial the trial is recruiting and both the U.S. in Europe and to date, we have more than 60 sites activated. The primary study endpoint is a responder analysis based on the reduction in its intensity as measured by the worst debts numerical rating scale or NRF.

And the changes assessed after 12 weeks of blinded fixed dosing.

We currently have randomized approximately 190 subjects into the trial more than half of the total and a 360 encouragingly greater than 95% of the subjects that have reached the end of the blinded dosing period have opted to roll into.

Open label extension portion of the study we have also had approximately 30 subjects complete the year long steady continuing to build our long term safety database as well as providing data on the potential for skin healing with longer term therapy.

Jennifer L. Good: The primary study endpoint is a responder analysis based on the reduction in itch intensity as measured by the worst itch numerical rating scale, or NRS, and the change is assessed after 12 weeks of blinded fixed dose. We have currently randomized approximately 190 subjects into the trial, more than half of the total N of 360. Encouragingly, greater than 95% of the subjects that have reached the end of the blinded dosing period have opted to roll into the open-label extension portion of this study. We have also had approximately 30 subjects complete the year-long study, continuing to build our long-term safety database as well as providing data on the potential for skin healing with longer-term therapy. Our entire team is focused on completing enrollment in this study and adapting to the changing conditions of COVID.

Our entire team is focused on completing enrollment in this study and adapting to.

To changing conditions of coated we do not currently have any of our sites in the US are you limiting screening our enrollment of subjects due to coal bed restrictions for this trial with.

With regard to enrollment we are using multiple recruitment strategies, including social media platforms to screen for potential patients as well as supporting sites defined.

Find additional patients beyond there on patient lists we.

We have also had a busy few months at medical meetings, albeit virtually we recently participated in the 2020 fall clinical dermatology conference with the virtual Booth that had over 300 interactions with our team through site visits leads live video chats and message boards.

Lord notes. We also had two posters that were presented and we participated in a shark tank style competition in which we were the runner up.

In October we attended the Pride of symposium at the virtual European Academy of Dermatology inventor allergy meeting or EA, BV and supported a presentation of our phase two trial as.

All the discussion of our present trial.

And finally this month, we will also participate in the fall clinical for Donna dermatology for physician assistants, and nurse practitioners with a virtual booth promoting our present trial. It has been instructive and a nice surprise about how effectively the world has adapted to these virtual medical conferences.

Based upon the enrollment rates, we reaffirm our guidance for the prism trial that we expect to complete enrollment in the third quarter of 2021 and report topline data in the fourth quarter of 2021, we believe in the seriousness of this condition and the importance of having an oral option for patients. We will continue to focus on getting this trial fully.

Jennifer L. Good: We do not currently have any of our sites in the U.S. or EU limiting screening or enrollment of subjects due to COVID restrictions for this trial. With regard to enrollment, we are using multiple recruitment strategies, including social media platforms to screen for potential patients, as well as supporting sites to find additional patients beyond their own patient list. We have also had a busy few months at medical meetings, albeit virtually. We recently participated in the 2020 Fall Clinical Dermatology Conference with a virtual booth that had over 300 interactions with our team through site visits, leads, live video chats, and message board notes. We also had two e-posters that were presented, and we participated in a Shark Tank-style competition in which we were the runner-up.

As world and delivering topline data roughly a year from now.

Turning now to our second clinical phase program for cost in idiopathic pulmonary fibrosis or EPS IP App is a progressive and severe condition in which they're scarring of the lung tissues, one of the leading debilitating symptoms of this disease as chronic coughing.

<unk> dollars affects approximately 70% to 85% of these patients and for which there are no approved therapies.

We are conducting a phase II double blind crossover study with a 14 day washout period. After each three week treatment arm. The primary endpoint assessment is the mean percent change in daytime cost frequency.

For each individual patient during the active treatment period versus they're on placebo period.

The daytime cost frequency is measured by digital comp monitor. This trial is currently being conducted in the UK and since this patient group is at high risk for complications from Covance due to their underlying loan impairment we pause.

Salt screening and enrollment activities in March during that time. The trial was paused, we focused on amending study procedures to enhance our ability to safely and successfully enroll within the cobot environment. We filed a protocol amendment to allow for fewer visits to the site as well as fewer overall procedures.

Jennifer L. Good: In October, we attended the Paritis Symposium at the Virtual European Academy of Dermatology and Venerology Meeting, or EADV, and supported a presentation of our Phase II trial, as well as a discussion of our PRISM trial. And finally, this month, we will also participate in the Fall Clinical Dermatology for Physician Assistants and Nurse Practitioners with a virtual booth promoting our PRISM trial. It has been instructive and a nice surprise about how effectively the world has adapted to these virtual medical conferences. Based on these enrollment rates, we reaffirm our guidance for the PRISM trial, that we expect to complete enrollment in the third quarter of 2021 and report top-line data in the fourth quarter of 2021. We believe in the seriousness of this condition and the importance of having an oral option for patients.

And lifted our screening restrictions for this trial.

The amended protocol was recently approved by the medicines and healthcare products regulatory agency or am HRS.

The UK since then some of our sites have resumed patient screening and we had our first randomization. There are several sites actively working on study started.

EPS that expect to reopen by year end. Additionally, trevi is assessing potential study sites in Germany, which could accelerate enrollment and reduce the risk inherent with the single country recruitment during the coal bed pandemic, we have completed a feasibility assessment in Germany and have had several sites expressed interest in the study we are scarce.

Scheduling qualification visits of a percent potential sites through year end as well as working through the regulatory requirements to bring on Germany for this study.

We have several other programs that are in earlier stages of development. However, the prioritization of our price and cost programs allows us to optimize both our development execution.

And company resources, I will now hand, it over to Chris Cider Treasuries, Chief Financial Officer to provide you with a financial update Chris.

Thank you Dave as a reminder, full financial results for the third quarter of 2020.

Can be found in our 10-Q, which has noted we will plan to follow the FCC tomorrow.

In the third quarter 2020, we reported a net loss of $7.4 million compared to a net loss of $7.4 million for the same quarter reporting 19.

R&D expenses were $4.8 million during the quarter third quarter 2020, compared to $5.7 million in the same period of 2018.

Jennifer L. Good: We will continue to focus on getting this trial fully enrolled and delivering top-line data roughly a year from now. Turning now to our second clinical phase program for cough and idiopathic pulmonary fibrosis, or IPF. IPF is a progressive and severe condition in which there is scarring of the lung tissues.

The decrease.

Primarily due to decreased activity in our phase two trial and call. It calls in patients with IPO due to the pausing enrollment and treatment of patients as a result of the COVID-19 pandemic as well as decreased activity with the completion of our phase one b trial in patients with chronic liver disease.

DNA expenses were $2.4 million.

Third quarter 2020, compared to $2 million in the same period of 2019.

The increase was primarily due to an increase in stock based compensation expenses and an increase in consulting fees.

Jennifer L. Good: One of the leading debilitating symptoms of this disease is chronic coughing, which affects approximately 70 to 85 percent of these patients and for which there are no approved therapies. We are conducting a Phase II double-blind crossover study with a 14-day washout period after each three-week treatment arm. The primary endpoint assessment is the mean percent change in daytime cough frequency for each individual patient during the active treatment period versus their own placebo period. The daytime cough frequency is measured by a digital cough monitor.

As of September 32020, our cash and cash equivalents totaled $53.3 million compared to 50.

$7.3 million as of December 30, Onest 2019.

During the third quarter, we have prevented funding strategies using both debt and equity to extend our cash runway during.

During the third quarter, we sold approximately two and a half million dollars of our common stock through our ATM facility.

In addition, this in the third quarter.

Steve $14 million from a term loan facility with Silicon Valley Bank the.

The proceeds from the ATM and the non dilutive term loan bolsters, our cash position and we expect will we.

We expect will extend our cash runway into the first half of 2022.

Jennifer L. Good: This trial is currently being conducted in the UK. Since this patient group is at high risk for complications from Covid due to their underlying lung impairment, we paused all screening and enrollment activities in March. During that time, the trial was paused, and we focused on amending study procedures to enhance our ability to safely and successfully enroll patients within the COVID environment. We filed a protocol amendment to allow for fewer visits to the site, as well as fewer overall procedures, and we lifted our screening restrictions for this trial. The amended protocol was recently approved by the Medicines and Healthcare Products Regulatory Agency, or MHRA, of the UK.

Yes, the anticipated topline results from the present trial, which are expected in the fourth.

The quarter of 2021.

That is all for our prepared remarks, now I will turn the call back over to the operator for culinary.

Thank you.

A question. Please press the Star then the one key on your Touchtone telephone if.

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One moment for your questions.

Our first question comes from the line of Gary Nachman with BMO capital market.

Thanks.

Hi, guys good afternoon.

You made some good progress with enrollments will trade zone Im curious how much has the pace of enrollment pick that since this summer. When you were building some momentum has it been accelerating is it flowing now at the Kogut resurgence.

Jennifer L. Good: Since then, some of our sites have resumed patient screening, and we had our first randomization. There are several sites actively working on study startup that expect to reopen by year-end. Additionally, Trevi is assessing potential study sites in Germany, which could accelerate enrollment and reduce the risk inherent with a single-country recruitment during the COVID pandemic. We have completed a feasibility assessment in Germany and have had several sites express interest in the study. We are scheduling qualification visits of potential sites through year-end, as well as working through the regulatory requirements to bring in Germany for this study. We have several other programs that are in earlier stages of development. However, the prioritization of our paritis and cough programs allows us to optimize both our development, execution, and company resources. I will now hand it over to Chris Sider, Trevi's Chief Financial Officer, to provide you with a financial update.

It sounds like you have a bunch of.

Initiatives in place that you highlighted.

Yes, and then just a follow up there Jennifer you know any scenario, where you can go higher than the 360 target if enrollment is going well or is that definitely the absolute Max you know if you guys want it to be even more certain I guess about.

The statistical significance in the study.

Yes, two good questions Hi, Gary nice to hear from you.

The pace of enrollment coming out a coded with strong definitely a good ball as the first couple of months I would say August was a bit lighter at which is not unexpected and then the follow up then good where we are heading into the holiday.

Fees and so it will be an interesting started last month and a half and half I don't you know we have good screening going on and people in screening, but this is always an interesting went off time for drug developers, but I would say on average we've been started hitting that 15 to 20 patients a month and I think if we keep clipping along at that we should be in good shape.

So that's good.

But I think your question around the 360 being the Max you have approximately 360 typically what as you know from doing that for a long time. When you have people on the queue you tend to let them work their way through so depending on just how many people are in the queue, we'll let them finished but I.

I think based on sort of our staff and our EPS.

Sorry resolve that should be a good number to tease out statistical significance. So we're not looking to try to overshoot that theyre upsize. It at the end, but if people are in the queue, obviously, let them finish.

Okay, and then if I could just squeeze in one more for chronic cough.

Chris Titor: Thank you, Jennifer. As a reminder, full financial results for the third quarter of 2020 can be found in our 10-Q, which is noted. We will plan to follow the SEC tomorrow. For the third quarter of 2020, we reported a net loss of $7.4 million compared to a net loss of $7.4 million for the same quarter of 2019. R&D expenses were $4.8 million during the third quarter of 2020 compared to $5.7 million in the same period of 2019. The decrease was primarily due to decreased activity in our Phase 2 trial and chronic cough in patients with IPF due to the pausing of enrollment and treatment of patients as a result of the COVID-19 pandemic, as well as decreased activity with the completion of our Phase 1b trial in patients with chronic liver disease.

It sounds like that's just getting started is.

Is that target still 56 patients and 44 complete or is or does it really depend on how many sites are up and running in both the UK and potentially Germany and how long you think it will take to run the study at this point.

No it has definitely changed.

So when we filed our men that within HRS we.

After the end to sit potential patients 60, and that had to do with a couple of people that we had to discontinued from the trial will meet shut it down for Covance. So we just wanted to give ourselves room to get to our 44 complete or saw that the complete or numbers still the same we just left some room of how many people you can screen it into the study.

And.

Second question, Gary with what I am sorry, Yes, just I mean timeframe for completing this study and I know, it's tough to call at this point so much depends on how many sites you get up and running but if you had to take a ballpark guess at this point.

Yeah, I know I said to Chris we're going to get this question. It is hard to get to know because we're bringing up.

Chris Titor: G&A expenses were $2.4 million during the third quarter of 2020, compared to $2 million in the same period of 2019. The increase is primarily due to an increase in stock-based compensation expenses and an increase in consulting fees. As of September 30, 2020, our cash and cash equivalents totaled $53.3 million, compared to $57.3 million as of December 31, 2019. During the third quarter, we implemented funding strategies using both debt and equity to extend our cash runway.

And your sites from the UK, we're getting them up and running we are looking at Germany to try to accelerate the EPS I mean, I am pushing I would definitely want to try to finish enrollment next year I. Just don't think we have good visibility on the timing within the year, So were investing and we've got the proper attention and resources against it.

I just don't have a good sense of runway yet weve randomized our first patient back from Covance and Oh by the way Europe sort of on Dicey ground. So it's a tough call to make.

I'd say one positive that occurred through this whole covered thing for us.

There were trials that.

Had we are fully enrolled that had to shutdown.

People have just walked away from the IP EPS base not just cost we did have one competitor on copper EPS by that whose drugs failed, leaving us sort of our frontier, which is helpful. But there is also there was a lot of activity going on in IP EPS in general, particularly in the UK and a lot of those players have not come back so we've seen a real willingness.

And for that when we went to Germany at people eager to get going on clinical trials again, so I'm, hoping that helps us, but it's got the backdrop of covered with it. So we're just not in a position yet to sort of give good guidance around that.

Operator: During the third quarter, we sold approximately $2.5 million of our common stock through our ATM facility. In addition, in the third quarter, we received $14 million from a term loan facility with Silicon Valley Bank. The proceeds from the ATM and the non-dilutive term loan bolster our cash position, and we expect we'll extend our cash runway into the first half of 2022, past the anticipated top-line results from the prison trial, which are expected in the fourth quarter of 2021. That is all for our prepared remarks. Now we'll turn the call back over to the operator for Q&A.

Okay. That's fair thanks, a lot yep.

Thank you.

Your next question comes from the line of Ami.

Audio with Leerink.

Hi, good evening, thanks for the question.

Jennifer good progress on the enrollment.

Can you give us any color on.

Sort of the.

Trapani clean for an adverse event profile.

As you have seen.

More patients come on.

Yeah, Hi, I mean nice to hear you boys.

Yes, so dropped out but as you know we always resist started getting into percentages because it's all blinded. So it's difficult to see I would say as we said before they are in and.

The expected range and I think that was sort of validated in our sample size re estimation as far as adverse events that is something we monitor and it's our obligation and it looks very much like our other trials.

Operator: Thank you. If you have a question, please press the star, then the one key on your touchtone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the pound key. We ask that you please limit yourself to one question and one follow-up. One moment for your question. Our first question comes from the line of Gary Nachman with BMO Capital Markets.

The typical sort of dizziness somnolence najera nothing has come up unexpected in the trial.

Well, we have an independent data monitoring committee met twice now in this trial and we were able to proceed as expected side.

So I would say sort of looks very typical like our other trials and the adverse events we've seen.

Got it and just on your IPO.

Gary Nachman: Hi guys, good afternoon.

Cough program.

How do you plan to move forward over the next year or so while you're completing the Pn study.

Jennifer L. Good: You made some good progress with enrollment for PRISM. I'm curious how much the pace of enrollment picked up since the summer when you were building some momentum? Has it been accelerating? Or is it slowing now with the COVID resurgence? It sounds like you have a bunch of initiatives in place that you highlighted. And then just a follow-up there, Jennifer, is there any scenario where you can go higher than a 360 target if enrollment is going well, or is that definitely the absolute max? You know, if you guys wanted to be even more certain about the statistical significance of the study, I guess you could

Yeah. So we have two different teams, we have a physician assigned to each one of our men at clinical ops team assigned to each one of them. So they're separated I mean, we're a small company. So we all Chris profit.

But I don't worry about the resources I think the challenges in both those trials are.

Recruitment enrollment you know these are both small patient populations, then certainly IPO cost has a backdrop of kobe behind it and even PM to some extent you know as we move through the winter time. So I think our focus is really around.

And.

What we can do to support both the trials and getting them enrolled because there is that we have adequate resources from the team perspective.

We have you will probably also saw I mean, we've been doing some hiring during the Colgate window. So we've added.

Strong regulatory person another pharmacology person than other commercial person.

You know that just markets strength coming in the company all around and I would say our clinical team is actually all completely built out at this point. So so I don't feel or resource constrained, it's just a matter of getting them enrolled.

Jennifer L. Good: Yep, two good questions. Hi Gary, nice to hear from you. So the pace of enrollment coming out of COVID was strong, definitely a good bullet for the first couple months. I would say August was a bit lighter, which is not unexpected. And then the fall has been good. We are heading into the holiday season.

Got it.

Okay, maybe just one last question and.

I think like you.

Given the answer to this but I'm just wondering if there was any possibility or.

How do we think about the second trial in PE and focused on a successful whether it be a similar sized trial as we sort of think about.

The time and resources that might be required for the second one.

Yeah. So the team has already started some of those discussions we want to be in a position to have a quick transition into that next trial and I think we have a lot of good ability to do that will probably stick with the same Cerro we've got a team ready to go I think its first study design, where we are talking a little bit about some different options by.

Jennifer L. Good: So it'll be an interesting sort of month and a half ish. I don't, you know, we have good screenings going on and people in screening, but this is always an interesting window of time for drug developers. But I would say, on average, we've been sort of hitting this 15 to 20 patients a month. And I think if we keep clipping along at that, we should be in good shape. So that's good.

But I think for planning purposes, probably assuming roughly the same number is a good assumption.

For the end I mean, when do we see the data obviously, we may change the powering a bit but I think sitting here today, that's probably a good assumption.

Got it okay. Thank you yeah.

Thank you Amit.

Thank you.

Jennifer L. Good: I think your question around 360 being the max, we have approximately 360. Typically, as you know, from doing this for a long time, when you have people in the queue, you tend to let them work their way through. So depending on just how many people are in the queue, we'll let them finish. But I think based on sort of our staff and our SSRE results, that should be a good number to tease out statistical significance. So we're not looking to try to overshoot this or upsize it at the end. But if people are in the queue, we'll obviously let them finish.

Our next question comes from the line of Serge Belanger with Needham and company.

Hi, good afternoon.

I guess couple of questions first on the open label trial for the full prison.

I may have missed a good are you still.

In the.

Mid 90% range of.

Level of roll over into the trial and then you also mentioned that 30 patients had completed.

The full additional 38 weeks.

Do you have an idea at this point I guess.

How many patients are.

Percentage.

<unk> patients getting to the end of that trial and are they staying on even once they reach.

Lesion healing.

Yes. So that's a good question. So yes, we did mention that it's greater than 95% are opting to roll into the open label extension, we're having good success getting paid.

Jennifer L. Good: Okay, and then if I could just squeeze in one more. For chronic cough, you know, it sounds like that's just getting started. Is the target still 56 patients and 44 completers, or does it really depend on how many sites are up and running in both the UK and potentially Germany? And how long do you think it'll take to run this study at this point, knowing that that might change?

Well to be and.

What I haven't looked at is the second part of your question, we haven't done a lot of analyzing sort of the open label data.

If I'm honest with you and where people are leaving and how their skin looks and all that so I can't really comment on that too much and it's always a little dicey to be doing that an abstract from the blinded data anyway, but.

People are staying on it they do well on the drug and clearly.

There's good durability of effect of there. It's the pressure on so I don't know I haven't sort of gone through and thought about when people leave is that because there is down to a certain level, we'll do that sort of as part of our analysis of the data.

Jennifer L. Good: So when we filed our amendment with MHRA, we upped the end to potential patients of 60, and that had to do with a couple people that we had to discontinue from the trial when we shut it down for COVID. So we just wanted to give ourselves room to get to our 44 completers. So the completer number is still the same. We just left some room for how many people you could screen into the study.

Do you need a set number.

Of patients to complete that open label extension study for.

To have.

[noise] required safety data for the year.

Yeah. So I mean, the ice age guidelines, you probably know or 100 to have one year 100 patients with one year of data we already had 25 I think from our last.

Study.

Or maybe 15, I think 15 from our prior study we already have 30 here. So we're going to make a significant data from this trial, we solve a long ways to go and there's a lot of people sort of in various stages of that so.

Jennifer L. Good: It's just, I mean, the time frame for completing this study, and I know it's tough to call at this point, so much depends on how many sites you get up and running, but... if you had to take a ballpark guess at this point,

So we're going to be in good shape I think after the study although I think with another assuming we have to run a second study.

Yes, it's always advantageous to offer that open label extension. Because then people are sure they'll get drug at least at some point so I'm not worried about our safety database here in this drug has been around a while as you know so no a lot about it at FDA recognizes that so that's all helpful. So we seem on track to hit all those numbers.

Jennifer L. Good: Yeah, no, I said to Chris, we're going to get this question. It is hard to get to know because we're bringing our sites up from the UK, and we're getting them up and running. We are looking at Germany to try to accelerate this. I mean, I'm pushing. I definitely want to try to finish enrollment next year. I just don't think we have good visibility on the timing within the year. So we're investing, and we've got the proper attention and resources for it. I just don't have a good sense of direction yet.

Okay, and then just one on the EPS.

Program.

We've seen a lot of activity in the last few months in chronic cough.

I don't know if you can talk about the main differences between rps costs in chronic confidence and if there's anything to glean from those trials in terms of response or a placebo.

Yeah, it's a fascinating world I've been following us well I sort of think of chronic cough is like a topic Durham as the PM sort of the big Gorilla here I would say first of all as you know the primary drugs being chased or P. Two X three sort of different variants of those which all started their lives as pain drugs. So I find that interesting any Nazi.

Jennifer L. Good: You know, we've randomized our first patient. And then we went back from COVID, and, oh, by the way, Europe is sort of on dicey ground. So it's a tough call to make.

Seems to be sort of the end interesting mechanism, which as you know is also sort of wear now being started its life sign that compelling I think we had chosen IP AFE cost because of the neurological mechanism of the fibrosis of the lungs, triggering the signal and sort of where the body was rich in these opioid receptors. So we felt it was.

Jennifer L. Good: I would say one positive thing that happened through this whole COVID thing for us. There were trials that were fully enrolled that had to shut down, and people just walked away from the IPF space, not just COCH. We did have one competitor in COCH, Respivant, whose drug failed, leaving us sort of, you know, out front here, which is helpful. But there's also, there was a lot of activity going on in IPF in general, particularly in the UK, and a lot of those players have not come back. So we've seen a real willingness, and we heard that when we went to Germany, of people eager to get going on clinical trials again. So I'm hoping that helps us, but it's got the backdrop of COVID with it. So we're just not in a position yet to sort of give good guidance on that.

The right place it is.

Progressive disease, it's challenging we've had experts and the cost world reach back to us.

Somewhat frequently by the way interested in studying our drug load.

Low dose morphine juice now in these patients. So this opioid mechanism is a mechanism that is known and there is interest in it.

I think we've tried to stay to areas that we think biologically make sense and are also an area that we could eventually market ourselves from us. If we wanted to chronic cost becomes a very big primary care. So not that we wouldn't be interested but I think what's interesting data here that we would figure out how to sort of springboard into doing a trial into chronic.

So I mean on following all the literature about trying to screen in and you know we have a certain severity of cough, which isn't dissimilar to PM. I think we just are going to have to get through our trial analyzes data and then start looking at it in totality with chronic cough to see what it all means there's still a lot to learn in these areas.

Yes.

Thank you.

Yes, Thank you Serge.

Thank you.

As a reminder to ask a question. Please press star and then the one key on your Touchtone telephone.

Your next question comes from the line of Annabel Samimy with Stifel.

Operator: Okay, that's fair. Thanks a lot. Yeah.

Operator: [inaudible]

Operator: And our next question comes from the line of Ami Fadia with Lyric.

Hi, Thanks for taking my question most of them have been answered at this point.

Ami Fadia: Hi, good evening. Thanks for the question. Jennifer, good progress on the enrollment. Can you give us any color on some sort of the dropout rates or adverse event profile as you have seen more patients come on?

But if I could.

Just ask you in terms of the second trial for.

Penn Obviously these studies have quite a run way to go before we start seeing completion of any any per.

Jennifer L. Good: Yeah, hi Ami, nice to hear your voice. Yeah, so dropouts, as you know, we always resist sort of getting into percentages because it's all veiled up, so it's difficult to see. I would say, as we've said before, they're in an expected range, and I think that was sort of validated in our sample size re-estimation. As far as adverse events are concerned, that is something we monitor and it's our obligation, and it looks very much like our other trials. You know, the typical sort of dizziness, somnolence, nausea; nothing has come up unexpectedly in the trial. We have an independent data monitoring committee. They've met twice now in this trial, and we were able to proceed as expected, so I would say it sort of looks very typical, like our other trials and the adverse events we've seen.

So is there any thought to starting the second study.

Before getting the results of the first study is that merely a risk.

Tranche or modify risk there or is it more about lack of resources to be able to conduct studies at the same time.

Yeah.

Now that's a good question and one we've talked about quick and I talk about a lot we've talked at the board level my feeling on that Annabel if it's not I mean, obviously, we don't have the cash to get us all the way through another pivotal study, but starting it in parallel is is not off the table, although I feel somewhat strongly that seeing.

Seeing the data from this study will help us really optimize any kind of protocol nuances and in the long run I think will actually make up time I feel a lot more comfortable that for the second study first of all some of the competitive factors, we dealt with will be sort of out of the way, which is helpful. We've also I think I understood some running.

The size of trial, how many sites you need on board, we've got relationships now with over 65, good sites between the us and Europe.

So our protocol, we sort of worked out any kinks. So I think there is a good ability to transition quickly and make up time I would be nervous about starting that trial and locked in before we can see the data from.

Jennifer L. Good: Got it. And on your IPS COF program. How do you plan to move it forward over the next year or so while you're completing the PN study?

In this trial because I do think it's about optimizing the label and the opportunity, particularly in light of its fairly clear now how the competitive landscape is going to shake out with biologics and trevi being the only oral so thinking being thoughtful about sort of how you play in that space and optimize the value of the product I think is important and I don't want to sort of jump ahead.

Jennifer L. Good: Yeah, so we have two different teams. We have a physician assigned to each one of them and a clinical operations team assigned to each one of them. So they're separated. I mean, we're a small company, so we all crisscross a bit. But I don't worry about the resources.

Out of that and lose the ability to optimize something in the final trial.

Okay got it got it and then.

Is there anything that's giving you any kind of comfort in terms of the competitor programs I realize that your mix.

No opioid targeting although.

Jennifer L. Good: I think the challenges in both those trials will be in recruitment and enrollment. You know, these are both small patient populations, and certainly IPF-COUGH has a backdrop of COVID behind it and even PN to some extent, you know, as we move through winter. So I think our focus is really around what we can do to support both the trials and get them enrolled because we have adequate resources from the team perspective. You probably also saw that, Ami, we've been doing some hiring during the COVID window. So we've added a strong regulatory person, another pharmacology person, another commercial person, you know; they're just more good strengths coming into the company all around. And I would say our clinical team is actually all completely built out at this point. So, I don't feel we're resource constrained. It's just a matter of getting them enrolled. Conant

Although carriers.

Product hosts.

What part of your your cap.

Agonists and so is there any comfort that you can take from their activity.

In various indications that could give you great.

Greater comfort around how you're going to conduct your trials.

Yeah, I mean, I think and you know weve talked about this I always think care as the best comp.

Being up here Kappa agonists, we hit both receptors I think both are important in different types of niche that.

But I do think there most like us and always had sort of stepped away from some of the other mechanisms out there I out we also get a lot of feedback from investigators that are using the drag from quite encouraging staff its encouraging for me when I see pay.

And staying on every year, we get all kinds of anecdotal stuff. So people are excited about the mechanism I am interested to get the data I think it's all about sort of getting the end right and hopefully conducting a good trial, but yes, I do think care as data is supportive of sort of our mechanism overall.

Okay and then just on the last question regarding IP, obviously, you're doing the study in the UK and possibly opening in Germany.

We know both of somewhat locked down as this is slightly different.

Locked down or they are doing here, that's not going to derail your enrollment.

Our the amendments that you've made to reduce.

Jennifer L. Good: Okay, maybe just one last question and then we'll wrap this up. I feel like you've sort of given the answer to this, but I'm just wondering if there was any possibility of... You know, how do we think about the second trial in PN if the first one is successful? Would it be a similar-sized trial, as we sort of think about? you know, the time and resources that might be required for the second one.

For visits sufficient to keep the the whole program moving forward even in that scenario.

Can you pandemic peaks and Lockdowns.

Yeah. That's a good question. So last time, when we had the paas everything they were in what's called a shield shielding environmental there were certain patients like IPO.

Patients that were told not to leave their house. They are not in that kind of locked down. They are basically it's similar to what we're seeing around here with bars and restaurants and things like that so we've been told by the sites that it doesn't impact their ability to see these patients. They all have to have the right protocols in place and we said.

Some procedures to be able to see patients. They can miss business, we dropped visit so I hope, so annabel, but if things get worse than this.

Jennifer L. Good: Yeah, so the team has already started some of those discussions. We want to be in a position to have a quick transition into that next trial, and I think we have a lot of good ability to do that. You know, we'll probably stick with the same CRO. We've got a team ready to go.

This is a tough patient population, so we're going to have to pay attention to it but their current locked down procedures do not go back to the shielding, which is what created the pause before.

Okay, great. Thank you yep.

Yep.

Thank you.

I'm not showing any further questions.

Jennifer L. Good: I think as far as study design is concerned, we are talking a little bit about some different options, but I think for planning purposes, probably assuming roughly the same number is a good assumption for the end. I mean, when we see the data, obviously we may change the powering a bit, but I think sitting here today, that's probably a good assumption. Got it. OK, thank you. Yeah, thank you, Ami.

I would now like to turn the call back to Jennifer good for any further remarks.

Chris and I 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 continue to participate in our clinical trials. During these challenging times. We look forward to continued progress in updating you soon enjoy the balance of this year and please stay healthy. Thank you.

Thank you for participating in today's conference.

This concludes today's program you may all disconnect everyone have a great day.

Jennifer L. Good: Thank you. And our next question comes from the line of Serge Belanger with Needham and Company.

[music].

Serge D. Belanger: Good afternoon. I guess I have a couple questions first on the open label trial that follows PRISM. I may have missed it, but are you still in the mid-90 percent range of level of rollover into the trial? And I think you also mentioned that 30 patients had completed the full additional 38 weeks. Do you have an idea at this point, I guess? How many patients are... or what percentage of patients are getting to the end of that trial and are they staying on even once they reach lesion healing?

Jennifer L. Good: Yeah, so Serge, that's a good question. So yes, we did mention that greater than 95% are opting to roll into the open label extension. We're having good success getting people to the end. But what I haven't looked at is the second part of your question. We haven't done a lot of analyzing sort of the open label data, you know, if I'm honest with you, and where people are leaving and how their skin looks and all that. So I can't really comment on that too much. And it's always a little dicey to be doing that and abstracting from the blinded data, anyway, but people are staying on it, and they do well on the drug. And, you know, clearly, there's good durability of the effect of their itch suppression. So I don't know, I haven't sort of gone through and thought about when people leave, is it because their itches down to a certain level? We'll do that sort of as part of our analysis of the data.

[music].

Jennifer L. Good: Do you need a set number? of patients to complete that open-label extension study to have the required safety data for the FDA?

Jennifer L. Good: Yeah, so, the ICH guidelines, you probably know, are 100 to have one year, 100 patients with one year of data. We already had 25, I think, from our last study, or maybe 15, I think, 15 from our prior study. We already have 30 here, so we're going to make a significant dent in this trial. We still have a long way to go, and there are a lot of people sort of in various stages of that. So we're going to be in good shape, I think, after this study. Although, I think, with another, assuming we have to run a second study, it's always advantageous to offer that open-label extension, because then people are sure they'll get drugged, at least at some point.

Jennifer L. Good: So I'm not worried about our safety database here. And this drug's been around a while, as you know. So we know a lot about it. FDA recognizes it, so that's all helpful. So we seem on track to hit all those numbers.

Jennifer L. Good: Okay, and then just one on the IPS COF program. We've seen a lot of activity in the last few months in chronic COF. I don't know if you can talk about the main differences between IPF cough and chronic cough and if there's anything to glean from those trials in terms of response or placebo.

Jennifer L. Good: Yeah, it's a fascinating world. I've been following it as well.

Jennifer L. Good: I sort of think of chronic cough as like atopic dermis to PN, you know, sort of the big gorilla here. I would say first of all, as you know, the primary drugs being chased are P2X3, sort of different variants of those, which all started their lives as pain drugs. So I find that interesting. I mean, that seems to be sort of an interesting mechanism, which, as you know, is also sort of where nalbuthene started its life. So I find that compelling. I think we chose IPF cough because of the neurological mechanism of the fibrosis of the lungs triggering the signal and because the body was rich in these opioid receptors. So we felt it was the right place.

Jennifer L. Good: It is a progressive disease that's challenging. We've had experts in the cough world reach back to us, somewhat frequently, by the way, interested in studying our drug, low-dose morphine juice now in these patients. So this opioid mechanism is a mechanism that's known, and there's interest in it. I think we've tried to stay to areas that we think biologically make sense and are also an area that we could eventually market ourselves in the U.S. if we wanted to.

Jennifer L. Good: Chronic cough becomes a very big primary care cell. Not that we wouldn't be interested, but I think with interesting data here, we would figure out how to sort of springboard into doing a trial for chronic cough. So, I mean, I'm following all the literature about trying to screen in and, you know, have a certain severity of cough, which isn't dissimilar to PN. I think we just are going to have to get through our trial, analyze the data, and then start looking at it in totality with chronic cough to see what it all means. There is still a lot to learn in these areas.

Jennifer L. Good: Thank you.

Jennifer L. Good: Yeah, thank you, Serge.

Operator: Thank you. And as a reminder, to ask a question, please press star and then the one key on your touchtone telephone. The next question comes from the line of Annabel Samimy with Stiefel.

Annabel Eva Samimy: Hi. Thanks for taking my questions. Most of them have been answered at this point.

Jennifer L. Good: But if I could just ask you, in terms of the second trial for PN, obviously, these studies have quite a runway to go before we start seeing completion of any programs. Is there any thought to starting the second study before getting the results of the first study? Um, you know, trying to modify risk there, or is it more about the lack of resources to be able to conduct those studies at the same time?

[music].

Jennifer L. Good: Now that's a good question, and one we've talked about a lot. Chris and I have talked about it a lot, and we've talked at the board level. My feeling on that, Annabel, is it's not, I mean, obviously we don't have the cash to get us all the way through another pivotal study, but starting it in parallel is not off the table, although I feel somewhat strongly that seeing the data from this study will help us really optimize any kind of protocol nuances and, in the long run, I think will actually make up time. I feel a lot more comfortable that for the second study, first of all, some of the competitive factors we dealt with will be sort of out of the way, which is helpful.

Jennifer L. Good: We've also, I think, understood from running this size of trial how many sites you need on board. We've got relationships now with over 65 good sites between the U.S. and Europe. You know, so our protocol, we've sort of worked out any kinks. So I think there's a good ability to transition quickly and make up for lost time. I would be nervous about starting that trial and locking in before we could see the data from this trial because I do think it's about optimizing the label and the opportunity, particularly in light of how it's fairly clear now how the competitive landscape is going to shake out with Biologics and Trevi being the only orals. So thinking, being thoughtful about sort of how you play in that space and optimize the value of the product I think is important, and I don't want to sort of jump ahead of that and lose the ability to optimize something in the final trial.

Jennifer L. Good: Okay, got it, got it. And is there anything that's giving you any kind of comfort in terms of the competitive programs? I realize that you're mixed, you know, opioid targeting, although CARES product has somewhat part of your CAPA agonism. So is there any comfort that you can take from their activity and various indications that could give you greater comfort around how you're going to conduct your trials?

Jennifer L. Good: Yeah, I mean, I think, and you know, we've talked about this. I always think care is the best compliment to us being a pure Kappa agonist.

Jennifer L. Good: We hit both receptors. I think both are important in different types of itch, but I do think they're most like us and have always sort of stepped away from some of the other mechanisms out there. We also get a lot of feedback from investigators that are using the drug, quite encouraging stuff. It's encouraging for me when I see patients staying on it for a year.

Jennifer L. Good: You know, we get all kinds of anecdotal stuff. So people are excited about the mechanism. I'm, I'm interested to get to data. I think it's all about sort of getting the end right and, you know, hopefully conducting a good trial. But yes, I do think Kara's data is supportive of our mechanism overall. Okay.

[music].

Jennifer L. Good: And then just on the last question regarding IPF, obviously you're doing the study in the UK and possibly opening it in Germany. We know both are somewhat locked down. Is this a slightly different lockdown that they're doing here that's not going to derail your enrollment, and are the amendments that you've made to reduce the number of visits sufficient to keep the whole program moving forward even in the scenario of pandemic peaks and lockdowns?

Jennifer L. Good: Yeah, that's a good question. So last time when we had to pause everything, they were in what's called a shielding environment. So there were certain patients, like IPF patients, that were told not to leave their house. But they are not in that kind of lockdown. They are basically similar to what we're seeing around here with bars and restaurants and things like that. So we've been told by the sites that it doesn't impact their ability to see these patients. They all have to have the right protocols in place.

Jennifer L. Good: And we've set up some procedures to be able to see patients. They can miss visits. We've dropped visits. So I hope so, Annabel, but, you know, if things get worse and, you know, this is a tough patient population, so we're going to have to pay attention to it. But their current lockdown procedures do not go back to the shielding, which is what created the pause before. Great, thank you.

Jennifer L. Good: Thank you.

Jennifer L. Good: And I'm not sure I'll have any further questions. I would now like to turn the call back to Jennifer Good for any further remarks.

Jennifer L. Good: Chris and I 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 continue to participate in our clinical trials during this challenging time. We look forward to continued progress and updating you soon. Enjoy the balance of this year, and please stay healthy. Thank you.

Operator: Thank you for participating in today's conference. This concludes today's program. You may all disconnect. Everyone, have a great day.

Operator: Huffman, Sarah Mullen, Greg Schultz, Leland Gershell, David Clark, Mayank Mamtani, Nathan Weinstein, Jennifer Good, David Clark, Mayank Mamtani, Nathanael Charoensook, Trevi Huffman, Sarah Mullen, Nathanael Charoensook, Trevi Huffman, Sarah Mullen, Nathanael Charoensook, Trevi ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ??