Trevi Therapeutics, Inc.

Good afternoon and welcome to the Trevi Therapeutics Q3 2022 earnings conference call. At this time, all participants will be in a listen-only mode. Should you need any assistance during today's call, please signal for 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 star then one on your telephone. To withdraw your question, please press star then two. Please note, today's event is being recorded. Various remarks that management makes during this conference 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 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 specifically disclaims any obligation to do so, even if its views do change. I would now like to turn the conference over to Jennifer Good, Trevi's President and CEO. Please go ahead.

Good afternoon, and thank you for joining our third quarter earnings call and business update. Joining me today on this call is Lisa Delfini, Trevi's Chief Financial Officer. Lisa and I have some short prepared remarks, then we will be available for questions at the end of the call. This has been an exciting year for Trevi with regard to delivering against our business plan and the third quarter with no exception. As expected, the full trial results for our canal trial in chronic cough and idiopathic pulmonary fibrosis, or IPS, were reported in September and confirmed the positive interim results previously reported, showing a significant reduction in the frequency of cough from baseline and were highly statistically significant on both the primary and several key secondary endpoints. This included objective measures of cough, patient-reported outcomes on cough frequency and severity, along with investigator-reported improvements in cough. In mid-September, we hosted an R&D day to review these results in detail, along with the PN results and heard from prominent KOLs in cough and itch. Instead of re-reviewing all of the information, I would like to provide you with an update on our activities since our R&D day. Chronic cough in IPF has emerged as our lead indication, and we are busy developing protocols for the next phase of development and interacting with both the FDA and preparing for interactions with European regulatory authorities. Hadubio is the lead therapy in development for cough and IPF and is the only one to have shown positive results in a blinded study in this indication. IPF is a serious end-of-life disease, and chronic cough is a major cause of morbidity, significantly impacting the patient's quality of life. Although there are many learnings we can take from the development that is ongoing in the refractory chronic cough space, there are unique aspects in the IPF patient population related not only to the potential effect in the underlying disease, but also safety as it relates to this frail patient population. So as we prepare for this next step in development, we want to make sure we are aligned with the regulators. In parallel, the clinical teams are preparing for the study. so that we can initiate once we have agency agreement on the protocol and an open IND. We expect to initiate the next study in the first half of 2023, and we will provide guidance on the overall design as well as the timing for the trial and results when we begin the study. Our data in COP and IPF has been presented by Dr. Toby Mayer as a late breaker at the European Respiratory Society and also was presented at ICLAS. Dr. Philip Molyneux will present the full data this month at the British Thoracic Society meeting. We are also currently preparing a manuscript to publish the trial results. The IPF cough data has gained the attention and support from KOLs and pulmonologists globally. The other program where we have ongoing work is for the treatment of parigonodularis, or PN. which is a serious and debilitating disease characterized by papules and nodules on the skin, as well as incessant and severe itching. In June, we also reported positive data in the Phase IIb-III PRISM trial in PN. The trial achieved statistical significance on the primary and all key secondary endpoints. We still have several patients in the one-year open-label extension study, with the last patient forecasted to complete in February 2023. In parallel, we are completing all the various clinical reports and documents and preparing to request an end-of-Phase II meeting with the FDA, which we expect to hold in the first half of 2023. Our PN data was presented orally at the European Academy of Dermatology and Venerology by Dr. Sonja Stander in September, and we are currently working on a manuscript to publish the full study results as well as abstracts at several other dermatology meetings. It is a busy time at TREVI preparing for upcoming regulatory meetings across indications, designing the protocols for the next phase of development, and identifying sites for our next study. We are making good progress and look forward to updating you with more details as we get ready to initiate the next studies. As I look back on 2022, I am extremely proud of the execution by our team and the positive trial results in both of our lead indications. The trial data and subsequent financings have positioned us well to continue the development of Hadovio in not only IPF chronic cough, but also other serious chronic cough conditions. For PN, we are in discussions with potential partners to advance that program into the next stage of clinical development. I will now turn it over to Lisa to review our financial results, and 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 nine months ended September 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 third quarter of 2022, we reported a net loss of 8.3 million compared to a net loss of 7.3 million for the same quarter of 2021. R&D expenses were $5.8 million during the third quarter of 2022 compared to $4.7 million in the same period of 2021. This was primarily due to startup activities for our planned trials, including purchases of clinical trial supplies and increased expense related to the timing of activity in our Phase 2 canal trial as compared to the third quarter of 2021. These increases were offset by decreased expenses for activities in our PRISM trial to the completion of the blinded portion of the trial in the second quarter of 2022. dna expenses were 2.6 million during the third quarter of 2022 compared to 2.2 million in the same period of 2021. the increase was primarily due to higher legal fees related to intellectual property and increased market research costs during the quarter after the announcement of the positive results for the full data in our canal trial We raised gross proceeds of approximately $55 million from both new and existing investors through a public offering. We also received proceeds of $5.9 million in the quarter related to the exercise of previously issued warrants. Subsequent to quarter end, we received another $3.1 million in proceeds from the underwriter's option for the green shoe related to the September offering. So we end October with a cash and investments balance of approximately $125.7 million in which we have invested in a portfolio of high credit quality marketable securities and is providing us with healthy interest income in today's higher interest rate environment. This gives us cash runway into 2026 to execute the plans that Jennifer laid out today and to pay off our term loan in accordance with its terms between now and February 1st, 2024. In closing, I'm happy to welcome our new investors to Trevi and I am thankful for our existing investors, including those who participated in this latest funding round. I look forward to supporting our TREVI team with financial discipline as we negotiate agreements and execute the next phase of development for Heduvia. This concludes our prepared remarks. I will now turn the call back over to the operator for Q&A.