Trevi Therapeutics, Inc.

Good afternoon and welcome to the Travi Therapeutics second quarter 2022 earnings conference call. At this time, all participants will be in listen-only mode. Should you need assistance, please signal conference specials 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 star, then one on your touchstone phone. To withdraw your question, please press star, then two. Please note this event is being 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 by 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 10Q, 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 specifically disclaims any obligation to do so even if its views change. I would now like to turn the conference over to Jennifer Goode. Trevi's President and CEO, please go ahead.

Good afternoon and thank you for joining our second quarter earnings call and business update. Joining me today on this call are Lisa Delfini, Trevi's Chief Financial Officer, and Dr. Bill Forbes, Trevi's Chief Development Officer. Lisa and I have some prepared remarks, then the three of us will be available for questions at the end. This has been an exciting year for Trevi and the second quarter with no exception. After reporting out positive interim cough data in the first quarter, in the second quarter we read out our parigonodularis trial, or PN, which was also statistically significant. We believe this was important validation of the unique mechanism of Heduvia, which works both centrally and peripherally and is important in the conditions we have targeted. Cough and idiopathic pulmonary fibrosis, or IPF, and pruritus and PN represent some of the most severe aspects of these diseases. And we believe there's a potential opportunity to affect the underlying disease in both of these conditions. For example, we were able to show the healing of the excoriations in the PN trial with 55% of Hadovio subjects showing at least a one category improvement in the five-point Prigo activity scale versus 38% on placebo with a p-value of 0.006 at week 14. Let me now provide you with an update on both development programs. Beginning with chronic cough and IPF, we are very excited to be moving forward in this indication. Hedubio is the lead therapy in development for cough and IPF and is the only one to have shown positive results in a blinded study. Cough represents a significant unmet need for IPF patients as the majority of these patients report cough as one of their most bothersome aspects of their disease. In the next study, we also plan to assess other elements of the underlying disease to see if cough reduction has an impact on health outcomes. As I mentioned, we reported highly statistically significant results in the first quarter in the interim analysis of this trial. Since proof of concept was established, we worked with our sites to close enrollment early and finish the study. At the interim analysis, we reported data on the 26 subjects who had completed at least treatment period one, the full analysis set, and 18 subjects who had completed the full crossover of both treatment periods in the trial. For the complete trial, we ended up with 38 subjects enrolled. We are waiting for the full data set on all subjects in the trial, as well as the unblinded safety results, and expect to announce results on the full set of subjects this quarter. We will also be presenting data from both the interim and full data set for cost at medical meetings this fall. beginning with the European Respiratory Society meeting in Barcelona in September, where our interim data was selected for oral presentation. We have also been actively planning and preparing for the next study in COFF. We have engaged our CRO partner, are identifying countries and sites, and are working on a protocol that we intend to discuss with the FDA at a meeting scheduled this quarter. We will keep you informed when the study design is finalized, and provide guidance to you on timing for the trial and results. Our other target indication is for the treatment of prigonodularis, which is a serious and debilitating disease characterized by papules and nodules on the skin, as well as incessant and severe itching. We believe PN, due to the refractory nature of the disease, is neurologically mediated and potentially aligns well with the neuronal mechanism of Hadubio. Most of these patients have already tried and failed topical treatments, and we believe future patients will be eligible for an oral therapy like Heduvio before turning to biologics. As previously mentioned, we reported out positive data at the end of the second quarter in the Phase 2B-3 PRISM trial in PN. The trial achieved statistical significance on the primary and all key secondary endpoints. At the time we reported out the top line data, we did not yet have the final key secondary endpoint, which was the PROMIS sleep scale. We are pleased to report that the PROMIS sleep scale also supported the overall positive results, with Heduvia subjects experiencing significantly greater improvements in the PROMIS scale versus placebo with a p-value of 0.0002 at week 14. The first assessment of PROMIS was made at week six of the trial, which also showed a statistically significant improvement. So we are pleased that the primary and all the key secondary endpoints were positive and that Hedubio demonstrated an early response. This data has been accepted for oral presentation at the European Academy of Dermatology and Venerology in September, which I plan to attend if any of you will be there. The next steps for the PN program include completing the one year open label extension study. The last patient is scheduled to complete one year in January of 2023. In parallel, we will continue analyzing the blinded data and preparing a request for an end of phase two meeting with the FDA. It has been a busy year at Trevi and the trial data has positioned us well for potential growth in these two important indications, along with other potential lifecycle management opportunities. As a reminder, this quarter we will have the full canal data for COFF and IPF, FDA meeting on COFF and IPF, and an R&D day later in the quarter to outline the going forward strategy and development plans. I will now ask Lisa to review our financial results, and then we will open it up for questions.

Thank you, Jennifer, and good afternoon, everyone. As a reminder, the full financial results for the three and six months ended June 30th, 2022 can be found in our press release issued ahead of this call and in our 10Q, which was filed with the SEC today after the market closed. In the second quarter of 2022, we reported a net loss of 8.1 million compared to a net loss of 9.8 million for the same quarter of 2021. R&D expenses were $5.1 million during the second quarter of 22 compared to $6.5 million in the same period of 2021. The decrease was primarily due to reduced purchases of clinical trial supplies and clinical trial subject recruitment costs, a reduction in our use of consulting services, and the non-recurrence of professional recruiting fees related to hirings in the prior year period. G&A expenses were $2.7 million during the second quarter of 2022, which was flat compared to the same period of 2021. As I discussed on last quarter's call, in early April, we raised approximately $55 million through the sale of common stock and pre-funded warrants. The offering was priced at the market with no warrant coverage. With more cash on hand and interest rates rising, we are now investing our cash in a portfolio of high-credit quality marketable securities to provide interest incomes. We also received proceeds of $5.9 million in the second quarter related to the exercise of warrants that were originally issued in our October 2021 private placement. Our cash, cash equivalents and marketable securities balance at the end of June was $78.9 million. We received another $4.1 million in proceeds also from the exercise of warrants that were issued in our October 2021 private placement in July. So we end July with cash, cash equivalents, and marketable securities balance of approximately $79.8 million. This gives us cash runway into Q4 of 2023 to fund our ongoing operations, including completing the open-label extension of the PRISM trial, like Jennifer referred to, and preparing for the end-of-Phase II meeting with the FDA, and planning for and conducting our next trial for chronic cough and IPF. In addition, we currently have approximately 11 million warrants still outstanding, which can provide us up to 15 million in proceeds if exercised. With the $55 million raise in April, our cap table has gotten a little more complicated, so I wanted to lay it out for you. As of today, we have 42.8 million shares outstanding. In the April private placement, we also issued 24.4 million pre-funded warrants. They are called pre-funded warrants because substantially all of the strike prices paid at the time they are issued. So while they're not legally outstanding, they're required to be included in our calculation of weighted average shares outstanding and basic and diluted loss per share. Also, as I mentioned before, we have approximately $11 million in warrants outstanding from our October 2021 private placement and $4.1 million stock options outstanding. So our fully diluted shares outstanding is a little over $82 million. We continue to pay down our term loan and the principal balance is now under $11 million. In closing, we're excited about the recently reported data in PN and the strength of our balance sheet to continue executing on our plan. This concludes our prepared remarks. I will now turn the call back over to the operator for Q&A.