Good afternoon and welcome to the Trevi Therapeutics Q2 2021 Earnings Conference Call. At this time, all participants will be in listen-only mode. [Operator Instructions] After today's presentation, there will be an opportunity to ask questions. [Operator Instructions] Please note, 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.

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 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 it's changed - even if its views change.

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..

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. 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 our 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 Pruritis in prurigo nodularis or PN, which is a serious and debilitating disease characterized by papules and nodules on the skin as well as incessant and severe itching. There are no approved therapies for this indication.

Prurigo nodularis is a chronic disease and because of the repeated scratching, the papules and nodules can spread and worsen. We estimate the global prevalence of PN is approximately 730,000 patients with 300,000 patients in the US and 430,000 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 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 US and Europe. And today, we have more than 60 sites activated. 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 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 of finding new subjects for the study using various strategies.

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, 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 the study and continue 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 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 as schools start and scheduled vacations lighten up. Turning now to our second clinical program for chronic cough in idiopathic pulmonary fibrosis or IPF.

IPF is a progressive and severe condition in which there is scarring of the lung tissues. One of 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 US, we estimate that there are approximately 130,000 patients with IPF and an equal amount in Europe. Worldwide it is estimated there are in excess of 1 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. We are conducting a Phase 2, double-blind crossover study with a 14-day washout period between each 3-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.

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 in those sites screening and enrollment activity resume.

We have 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 situation in the UK. But fortunately, IPF patients were prioritized for COVID vaccinations. 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 UK 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.

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.

In the past quarter, we attended the BIO Digital Conference in June where we met with over 30 companies on potential ex-US 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.

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. 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 2b/3 PRISM trial, purchases of clinical trial supplies and increases in consulting and professional fees.

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.

Other expenses also increased by approximately $600,000, representing interest expense on our term loan with SVB, 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 15 million of 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. 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..

We will now begin the question-and-answer session. [Operator Instructions] The first question comes from Serge Belanger with Needham & Company. Please go ahead..

Hi. Good afternoon and thanks for taking my questions. First one is just on the enrollment of the PRISM trial.

It looks like the - expect - like do you expected summer seasonal slowdown as 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 month - 20 to 30 patients per month.

Just how that has dropped? And are you feeling any impact from the resurgence of COVID so far?.

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

All right, yeah. Hi, Serge, thanks for your question. So yeah, it has been slower and in the summer months have been particularly difficult. We anticipated that there would be a fair amount of vacations that were being taken. So there's kind of an interesting dynamic that has gone on to COVID.

I mean, obviously everybody was sequestered and wasn't so interested in coming out and we moved through that portion of it. I'm not sure that the Delta variant is 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 lost it last summer. And so it's - it was expected we had a heads up on this going into it. It's why we made a comment on the last call.

So obviously we're looking for you know, the rest of August into September and the rest of the year to really be our prime enrollment months to finish this off. So, and I hope that answers your question..

Yeah. And then on IPF cough, it looks like your UK sites are coming back online.

I think in the past you have 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. We pulled Germany off the table, because we felt like the resources were best spent in the UK that, that the way that these patients are seen within the Trust within the UK health system that really had 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, and we anticipate this to go. And as Jennifer noted earlier, I mean, half the sites are up and running and searching for patients. We hope to have the rest of them walk 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. Congrats on the progress..

Thank you, Serge..

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..

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 in all of the subjects who continue to participate in our clinical trials. I hope you all enjoyed the rest of summer and we look forward to sharing our progress with you in the fall. Thank you..

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