Q2 2021 Trevi Therapeutics Inc Earnings Call

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Operator: Good afternoon, and welcome to the Trevi Therapeutics Q2 2021 Earnings Conference Call. At this time, all participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press the star key, then one on your touchtone phone.

Good afternoon, and welcome to the Trevi Therapeutics Q2, 2021 earnings conference call.

At this time, all participants will be in listen only mode should you need assistance. Please signal a conference specialist by pressing the star key followed by zero.

After todays presentation, there will be an opportunity to ask questions to ask a question you May Press Star then one on your Touchtone phone to withdraw your question. Please press Star then two please note. This event may be recorded.

Operator: To withdraw your question, please press star, then two. Please note that this event 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 the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. However, actual results may differ materially from those indicated in these forward-looking statements as a result of various important factors, including those discussed in the risk factors section of the company's most recent quarterly report on Form 10-Q, which the company filed with the

Various remarks that management makes during this call about the company's future expectations plans and prospects constitute forward looking statements for the purposes of the safe Harbor.

Her provisions under the private Securities Litigation Reform Act of 1995.

Actual results may differ materially from those indicated in these forward looking statements as a result of various important factors, including those discussed in the risk factors section of the company's most recent quarterly report on Form 10-Q, which the company filed with the SEC This app.

Operator: In addition, any forward-looking statements represent the company's views only as of today and should not be relied upon as representing the company's views as of any subsequent date. While the company may elect to update these forward-looking statements at some point in the future, it may specifically disclaim any obligation to do so, even if its views change.

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

As of any subsequent date, while the company may elect to update these forward looking statements at some point in the future. The company may specifically disclaim any obligation to do so even if its changed its if even if its views change.

Operator: Participating on today's call from Trevi Therapeutics are Jennifer Good, President and CEO, Bill Forbes, Chief Development Officer, and Lisa Delfini, Chief Financial Officer. I would now like to turn the conference over to Jennifer. Please go ahead.

Participating on today's call from Trevi Therapeutics are Jennifer good President and CEO, Bill Forbes, Chief Development Officer, and Lisa Delphine, Chief Financial Officer, I would now like to turn the conference over to Jennifer. Please go ahead.

Jennifer L. Good: Good afternoon, and welcome to our second quarter 2021 earnings call and business update. As you just heard, joining me today on this call is Dr. Bill Forbes, our Chief Development Officer, who will join me for Q&A at the end of the prepared remarks, as well as Lisa Delfini, Trevi's newly appointed Chief Financial Officer. Lisa just joined us this week, and I'm very happy to welcome her to the company.

Good afternoon, and welcome to our second quarter 2021 earnings call and business update as you just heard joining me today on this call is Doctor Bill Forbes, Our Chief Development Officer, who will join me for Q&A at the end of the prepared remarks as well as we said Delphine <unk> newly appointed Chief Financial Officer Lisa.

<unk> joined US this week and I'm very happy to welcome her to the company.

Jennifer L. Good: Overall, we have been working hard on completing enrollment in both of our clinical trials. As you all know, running global clinical trials during COVID-19 has been challenging. However, we continue to make progress and believe we will report data on both of our trials in the first half of next year. Each indication represents a significant unmet medical need for patients. I will give you a bit more detail on each trial. Our most advanced program in clinical development is paritis in parigo nodularis, or PN, which is a serious and debilitating disease characterized by papules and nodules on the skin, as well as incessant and severe itchiness. There are no approved treatments for this indication. Porygonodularis is a chronic disease, and because of the repeated scratching, the papules and nodules can spread and worsen.

Overall, we have been working hard on completing enrollment in both of our clinical trials as you all know running global clinical trials. During the COVID-19 has been challenging. However, we continue to make progress and believe we will report out data on both of our trials in the first half of next year each indication represents a significant unmet medical.

Need for patients I will give you a bit more detail on each trial.

Our most advanced program in clinical development is pruritus in Prurigo, <unk>, RPM, which is a serious and debilitating disease characterized by papules and nodules on the skin as well as in surfing and severe itching.

There are no approved therapies for this indication.

<unk> is a chronic disease and because of the repeated scratching the papules and nodules can spread and Morrison.

Jennifer L. Good: We estimate the global prevalence of PN is approximately 730,000 patients, with 300,000 patients in the U.S. and 430,000 in the rest of the world. Although there are biologics also in development for PN, we are the only nonbiologic oral candidate in late stage development, which we believe potentially positions us with an important competitive advantage and provides a valuable option for patients. We are currently conducting a Phase 2b-3 trial in this condition, which we call our PRISM trial. The PRISM trial is recruiting in both the U.S. and Europe, and to date, we have more than 60 sites activated.

We estimate the global prevalence of Pn is approximately 730000 patients with 300000 patients in the U S and 430000 in the rest of the world. Although there are biologics also in development for Pn. We are the only non biologic oral candidate in late Phase development, which we believe.

<unk> potentially positions us with an important competitive advantage and provides a valuable option for patients.

We are currently conducting a phase two be slashed III trial in this condition, which we call our prism trial. The prism trial is recruiting in both the U S and Europe and to date, we have more than 60 sites activated the primary endpoint in this study as a responder analysis based on the reduction in niche intensity as measured by the worst.

Jennifer L. Good: The primary endpoint in the study is a responder analysis based on the reduction in itch intensity, as measured by the worst itch numerical rating scale after 14 weeks, 12 of which are blinded fixed doses. We currently have randomized approximately 285 of the planned 360 subjects into the trial, or approximately 80% of the targeted enrollment. We have continued to support our sites with finding new subjects for the study using various strategies.

Itch numerical rating scale. After 14 week 12 of which are blinded fixed dosing.

We currently have randomized approximately 285 of the planned 360 subjects into the trial or approximately 80% of the targeted enrollment we have continued to support our sites with finding new subjects to the study using various strategies.

Jennifer L. Good: We are encouraged by the feedback from the sites about the trial and continue to have greater than 95% of eligible subjects that complete week 14 and roll over into the open-label extension portion of this trial. This will provide not only long-term safety data but also important efficacy data around skin healing and quality of life for these subjects. We believe that by treating the symptomatic endpoint of reducing itch, an effective therapy has the potential to disrupt the itch-scratch cycle, leading to skin healing and resulting in disease modifications over time.

We are encouraged by the feedback from the sites about the trial and continue to have greater than 95% of eligible subjects that complete week 14, and rollover into the open label extension portion of this trial.

This will provide not only long term safety data, but also important efficacy data around skin healing and quality of life for these subjects.

We believe that by treating the symptomatic endpoint of reducing edge that an effective therapy has the potential to disrupt the itch scratch cycle, leading to skin healing and resulting in disease modifications over time, we are taking photographs at certain sites. In this study and continue to hear good success anecdotes from patients.

Jennifer L. Good: We are taking photographs at certain sites in the study and continuing to hear good success anecdotes from patients on long-term therapy who we know are on drugs. Regarding enrollment, the summer months are always slow for recruitment as everybody takes their vacations, and more so this year. We had strong enrollment in June, with July and August being a little lighter. We expect September enrollment figures to come back to normal levels as schools start and scheduled vacations lighten.

On long term therapy, who we know are on drug.

Regarding enrollment this summer months are always slow in recruitment as everybody takes their vacations and more so this year, we had strong enrollment in June with July and August being a little lighter we expect September enrollment figures to come back to normal levels at schools start and scheduled vacations lighten up.

Jennifer L. Good: Turning now to our second clinical program for Chronic Cough and Idiopathic Pulmonary Fibrosis, or IPF. IPF is a progressive and severe condition in which there is scarring of the lung. 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.

Turning now to our second clinical program for chronic cough, and idiopathic pulmonary fibrosis or IPF.

IPF is a progressive and severe condition in which there is scarring of the lung tissues.

The leading debilitating symptoms of this disease is chronic coughing, which affects approximately 70% to 85% of these patients and for which there are no approved therapies in the U S. We estimate that there are approximately 130000 patients with IPF and an equal amount in Europe.

Jennifer L. Good: In the U.S., we estimate that there are approximately 130,000 patients with IPF and an equal amount in Europe. Worldwide, it is estimated that there are in excess of a million patients that suffer from IPF. Due to the high five-year mortality associated with IPF, prescribers and patients are not only looking to slow the progression of the disease but also improve their quality of life.

Worldwide. It is estimated there in excess of a million patients that suffer from IPF dude.

Due to the high five year mortality associated with IPF prescribers and patients are not only looking to slow the progression of the disease, but also improve their quality of life.

Jennifer L. Good: We are conducting a Phase II double-blind crossover study with a 14-day washout period between each three-week treatment arm. The primary endpoint assessment is the mean percent change in daytime cough frequency from baseline. The daytime cough frequency is measured by a digital cough monitor between the treatment and placebo arms.

We are conducting a phase two double blind crossover study with a 14 day washout period between each three week treatment arm.

Primary endpoint assessment is the mean percent change in daytime cough frequency from baseline the daytime cough frequency as measured by a digital cost monitor between the treatment and placebo arms. This trial is currently being conducted in the U K and because of the lung impairment associated with this disease. This trial has been more <unk>.

Jennifer L. Good: This trial is currently being conducted in the UK, and because of the lung impairment associated with this disease, this trial has been more significantly impacted by COVID-19 restrictions than our PN study. The shelter-in-place restrictions for these patients in the UK were lifted at the end of March, and additional broader country restrictions were lifted in July. We have reopened about half of our 15 sites in the UK coming out of the COVID restrictions, and we were pleased to see screening and enrollment activity resume at those sites.

<unk> impacted by COVID-19 restrictions then our Pn study.

The shelter in place restrictions for these patients in the U K were lifted at the end of March and additional broader country restrictions were lifted in July we have reopened about half of our 15 sites in the U K coming out of the Covid restrictions and we were pleased to see in those sites screening and enrollment activity resume we.

Jennifer L. Good: We have helped conduct constructive advisory board meetings with our sites to solicit feedback on timing and how to support their enrollment to complete the trial. We continue to monitor the COVID situation in the UK, but fortunately, IPF patients were prioritized for COVID vaccination. We estimate that most of these patients are now fully vaccinated. We will continue to work closely with all of our remaining qualified sites in the U.K. to get the study fully up and enrolling. As a reminder, this study is designed to enroll approximately 60 subjects with a goal of getting 44 completers. Once enrolled, it takes a subject about 70 days to complete the full study.

<unk> held constructive advisory board meetings with our sites to solicit feedback on timing and how to support their enrollment to complete the trial.

We continue to monitor the COVID-19 situation in the U K, but Fortunately IPF patients were prioritized for Covid vaccination, we estimate that most of these patients are now fully vaccinated. We will continue to work closely with all of our remaining qualified sites in the U K to get this study fully up and enrolling.

As a reminder, this study is designed to enroll approximately 60 subjects with a goal of getting 44 completed once enrolled it takes a subject about 70 days to complete the full study.

Jennifer L. Good: Based on the reopening activity this quarter and discussions with our sites, we have established guidance for this trial to report top-line data in the first half of next year. In addition to the focus on completing our trials, the team has also been active preparing for the next stage of development for both of these indications, as well as evaluating other potential indications for development. We are also actively publishing our data and participating in conferences, as well as conducting market research to understand the potential positioning of our product as it may inform additional clinical work.

Based on the reopening activity this quarter and discussions with our sites. We have established guidance for this trial to report topline data in the first half of next year.

In addition to the focus on completing our trials. The team has also been active preparing for the next stage of development for both of these indications as well as evaluating other potential indications for development. We are also actively publishing our data and participating in conferences as well as conducting market research to understand the potential.

Positioning of our product as it may inform additional clinical work.

Jennifer L. Good: In the past quarter, we attended the Biodigital Conference in June, where we met with over 30 companies about potential ex-U.S. partnership opportunities. We also recently attended the summer meeting for AAD, where we continue to gain support from KOLs who believe in this mechanism for pruritic conditions.

In the past quarter, we attended the bio digital conference in June where we met with over 30 companies on potential ex U S partnership opportunities. We also recently attended the summer meeting for AAD, where we continue to gain support from Kols, who believe in this mechanism for predict conditions. So lots of activity in the company.

Jennifer L. Good: So lots of activity in the company as we prepare for top-line data in both of these trials. I will now quickly review our financial results for the second quarter of 2021, and I look forward to turning this financial review over to Lisa next quarter. As a reminder, the full financial results for the second quarter of 2021 can be found in our press release issued ahead of this call and our 10-Q, which was filed with the SEC today after the market closed.

As we prepare for topline data in both of these trials.

I will now quickly review our financial results for the second quarter of 2021, and I look forward to turning this financial review over to Lisa next corner.

As a reminder, the full financial results for the second quarter of 2021 can be found within our press release issued ahead of this call and our 10-Q, which was filed with the SEC today. After the market closed for the second quarter of 2021, we reported a net loss of $9.8 million compared to a net loss of $7.4 million for the same quarter.

Jennifer L. Good: For the second quarter of 2021, we reported a net loss of $9.8 million, compared to a net loss of $7.4 million for the same quarter of 2020. R&D expenses were $6.5 million during the second quarter of 2021, compared to $4.9 million in the same period of 2020. The increase was primarily due to increases in personnel-related expenses, increased enrollment in our ongoing Phase 2B3 PRISM trial, purchases of clinical trial supplies, and increases in consulting and professional fees.

A 2020 R&D expenses were $6.5 million during the second quarter of 2021 compared to $4.9 million in the same period of 2020. The increase was primarily due to increases in personnel related expenses increased enrollment in our ongoing phase II <unk> III prism trial purchases of clinical trial.

Slides and increases in consulting and professional fees. These increases were partially offset by decreased expenses, reflecting the completion of our phase <unk> clinical trial in patients with chronic liver disease in the first half of 2020.

Jennifer L. Good: These increases were partially offset by decreased expenses reflecting the completion of our Phase 1B clinical trial in patients with chronic liver disease in the first half of 2020. G&A expenses were $2.7 million during the second quarter of 2021, compared to $2.5 million in the same period of 2020. The increase was primarily due to increased legal and professional fees, partially offset by a reduction in personnel-related expenses.

G&A expenses were $2.7 million during the second quarter of 2021 compared to $2.5 million in the same period of 2020. The increase was primarily due to increased legal and professional fees, partially offset by a reduction in personnel related expenses.

Jennifer L. Good: Other expenses also increased by approximately $600,000, representing interest expense on our term loan with SVD, which was executed in August of last year, as well as a commitment fee paid to Lincoln Park Capital for a purchase agreement put in place in which the company has the right, but not the obligation, to sell to Lincoln Park up to 15 million shares of our common stock. Such sales of common stock, if any, will be subject to certain limitations and may occur from time to time over a 24-month period.

Other expenses also increased by approximately $600000 representing interest expense on our term loan with SBB, which was executed in August of last year as well as the commitment fee paid to Lincoln Park capital for a purchase agreement put in place in which the company has the right, but not the obligation to sell to Lincoln Park up to <unk>.

$15 million of shares of our common stock.

Sales of common stock if any will be subject to certain limitations and may occur from time to time over a 24 month period, we have not yet sold any stock under that agreement.

Jennifer L. Good: We have not yet sold any stock under that agreement. As of June 30, 2021, our cash and cash equivalents totaled $36.4 million, compared to $45 million as of December 31, 2020. That is all I have for our prepared remarks. I will now turn the call back over to our operator for Q&A.

As of June 32021, our cash and cash equivalents totaled $36.4 million compared to $45 million as of December 31, 2020.

That is all I have for our prepared remarks, I will now turn the call back over to our operator for Q&A.

Operator: We will now begin the question and answer session. To ask a question, you may press star then one on your touch-tone phone. If you are using a speakerphone, please pick up your handset before pressing the key. To withdraw your question, please press star then 2. At this time, we'll pause momentarily to assemble our roster. The first question comes from Serge Belanger with Needham and Company. Please go ahead.

We will now begin the question and answer session.

To ask a question you May press Star then one on your Touchtone phone. If you were using a speakerphone. Please pick up your handset before pressing the keys to withdraw your question. Please press Star then two at this time, we'll pause momentarily to assemble our roster.

Yeah.

The first question comes from Serge Belanger.

Wenger with Needham and company. Please go ahead.

Serge D. Belanger: Hey, good afternoon, and thanks for taking my questions. The first one is just on enrollment in the PRISM trial. It looks like the expected summer seasonal slowdown has materialized. Just curious what kind of enrollment you're seeing through the summer. I know your prior steady state of enrollment was about 20 to 30 patients per month. Curious how that has dropped, and are you feeling any impact from it?

Hey, good afternoon, thanks for taking my questions.

First one is just on the enrollment of the prism trial, it looks like the VIX, but.

The summer seasonal slowdown has materialized just curious what kind of enrollment you see through the summer I know.

Your prior steady state of enrollment is about 20% to 30 months, 20% to 30 patients per month.

Chris.

That's dropped them or are you feeling any impact from the.

Operator: [inaudible]

Bill Forbes: Bill, I'll let you take that. You're on the ground dealing with it. All right. Yeah. Hi, Serge.

Resurgence of Covid.

Sure.

So I'll, let you take that you're on the ground dealing with it.

Bill Forbes: Thanks for your question. So, yeah, it has been slower. And the summer months have been particularly difficult. We anticipated that there'd be a fair amount of vacations that were being taken. So, there's kind of an interesting dynamic that has gone on through COVID. I mean, obviously, everybody was sequestered and wasn't so interested in coming out. And we moved through that portion of it. But I'm not sure that the Delta variant is necessarily playing a role in this.

Alright, Yes, hi, Serge Thanks for your question.

So yeah. It has been slower in the summer months have been particularly difficult week, we anticipated that there would be a fair amount of vacations that were being taken so there's there's kind of a interesting dynamic that has gone on to Covid I mean, obviously everybody was sequestered and.

Wasn't it wasn't so interested in coming out and we move to that portion of it I'm not sure that the Delta variant.

Bill Forbes: I feel more like as we look at it center by center, what we see are just a lot of staff and even patients taking a lot of vacation through these summer months. I guess everybody lost it last summer. And so, it was expected. We had a heads up on this going into it. That's why we made a comment on the last call. Obviously, we're looking for the rest of August into September and the rest of the year to really be our prime enrollment months to finish this off. So, I hope that answers your question.

Necessarily playing a role in this I feel more like as we look at it by center by Center. What we see are just a lot of staff and even patients taken a lot of vacation through the summer months, I guess, everybody lawsuit last summer and so it.

It was expected we had a heads up on this going to do it while we made a comment on the last call. So obviously, we're looking for you know the.

The the rest of August into September and the rest of the year to really be our prime enrollment months to finish this off so I hope that answers your question.

Bill Forbes: And then on IPF costs, it looks like your UK sites are coming back online. I think in the past, you had talked about potentially adding some sites in Germany. Is that off the table now? Do you think the number of UK sites will be adequate to recruit the number of patients you're looking for? We do, actually.

Yeah and then.

IPF costs it looks like Youre your UK sites are coming back online.

I think in the past you had talked about potentially adding some some sites in Germany.

Is that off the table now.

The number of UK sites will be adequate to recruit the number of patients who are looking for.

Bill Forbes: We pulled Germany off the table because we felt like the resources were best spent in the UK, and the way that these patients are seen within the trust within the UK health system really afforded us the best opportunity to enroll this small study. We've had three screens this week alone, so, I mean, it's really picked up quite a bit, and so we anticipate, again, as we get out of these, this summer month of August, particularly, we anticipate this to go.

We do actually we pulled Germany off the table because we felt like the resources were best bank in the U K that that the way that these patients are seen within the trust within the UK health system.

It afforded us the best opportunity to enroll this small study.

We've had three screens. This week alone. So I mean, it's it's really picked up quite a bit and so we anticipate again as we get out of these this summer month of August, particularly we anticipate this to go in as Jennifer noted earlier, I mean half the sites are up and running.

Bill Forbes: And as Jennifer noted earlier, half the sites are up and searching for patients. We hope to have the rest of them up soon. So, I think at this point that the sites that we have are the ones that we can go with here, and the hope is that we can complete enrollment through this year and report out in the first half of next year. Thank you. We're up on the progress.

Searching for patients we hope to have the rest of them up soon so I think at this point, we feel like the sites that we have are the ones that we can go with here and the hope is that we can complete enrollment through this year and report out in the first half of next year.

Great. Thank you on the progress.

Thank you Serge.

Operator: I am not showing any further questions, so this concludes our question and answer session. I would like to turn the conference back over to Jennifer Good for closing remarks.

I am not showing any further questions. So this concludes our question and answer session I would like to turn the conference back over to Jennifer good for closing remarks.

Jennifer L. Good: We would like to thank everybody for dialing in and participating on today's call. I'd also like to thank the Trevi team, our study investigators, and all of the subjects who continue to participate in our clinical trials. I hope you all enjoy the rest of summer, and we look forward to sharing our progress with you in the fall. Thank you.

We would like to thank everybody for dialing in and participating on today's call I'd also like to thank the travel team our study investigators and all of the subjects, who continue to participate in our clinical trials I Hope you all enjoy the rest of the summer and we look forward to sharing our progress with you in the fall. Thank you.

Operator: The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

The conference has now concluded.

You for attending today's presentation you may now disconnect.

Yeah.