Trevi Therapeutics, Inc.

Good afternoon and welcome to the Trevi Therapeutics third 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. 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 10Q, which is on file with the SEC and subsequent filings included in the form 10Q 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 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 Heider, Chief Financial Officer. I would now like to turn the call over to Jennifer. Please go ahead.

Thank you. Good afternoon, everyone, and welcome to our third quarter earnings call. We continue to execute against our business plan for the quarter, adapting to the challenges of the COVID pandemic. So just to step back a moment and remind everyone of the strategy for growth at Trevi. We are developing Heduvio, 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 pruritus, 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 in severe pruritus in prurigo nodularis, which is a serious and debilitating skin disease characterized by papules and nodules on the skin, as well as incessant and severe itching. There are currently no approved therapies for this indication. Parigonodularis is a chronic disease, and because of the repeated scratching, the papules and nodules spread and continue to worsen. 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 PN, but Heduvio 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 Prigo nodularis, 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. 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 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 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. We do not currently have any of our sites in the US 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. 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 for 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 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 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. 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. 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. 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. This trial is currently being conducted in the UK, and 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, we focused on amending study procedures to enhance our ability to safely and successfully enroll within the COVID environment. We filed a protocol amendment to allow for fewer visits to the site, as well as fewer overall procedures, and 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. 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 the 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 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. Chris?

Thank you, Jennifer. As a reminder, the full financial results for the third quarter of 2020 can be found in our 10Q, which is noted we will plan to file with 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 II trial in 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 Ib trial in patients with chronic liver disease. 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 was 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. During the third quarter, we sold approximately $2.5 million of our common stocks 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 bolsters 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.