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…

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.