Lexicon Pharmaceuticals, Inc.

Good day, ladies and gentlemen. Welcome to the Lexicon Pharmaceuticals, Inc., third quarter 2022 earnings conference call. At this time, all minds are in a listen-only mode. Following the presentation, we will conduct a question-and-answer session. If at any time during the call you require immediate assistance, please press the star zero for the operator. This call is being recorded on November 9, 2022. I would now like to turn the conference over to Mike Kelly. Please go ahead, sir.

Thank you, Michelle. Good afternoon and welcome to the Lexicon Pharmaceuticals Third Quarter 2022 Financial Results Conference Call. Joining me today are Lynelle Coates, Lexicon's Chief Executive Officer, Jeff Wade, Lexicon's President and Chief Financial Officer, and Dr. Craig Granowitz, Lexicon's Senior Vice President and Chief Medical Officer. Earlier this afternoon, LexCon issued a press release announcing our financial results for the third quarter of 2022, which is available on our website at www.lexpharma.com and through our SEC filings. A webcast of this call, along with a slide presentation, is available on our website. During this call, we will review the information provided in the release, provide a corporate update, and then use the remainder of our time to answer your questions. Before we begin, let me remind you that we will be making forward-looking statements, including statements relating to the safety, efficacy, regulatory status and therapeutic and commercial potential of Sotagliflozin, LX9211 and other drug candidates. These statements may include characterizations of the expected timing and results of clinical trials of Sotagliflozin, LX92211 and our other drug candidates and the regulatory status and market opportunity for those programs. This call may also contain forward-looking statements relating to our growth and future operating results, discovery and development of our drug candidates, launch and commercialization plans for any approved products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. Various risks may cause our actual results to differ materially from those expressed or implied in such forward-looking statements. These risks include uncertainties related to our NDA for Sotagliflozin and heart failure and our discussions with the FDA regarding Sotagliflozin relating to heart failure and type 1 diabetes. Success of our commercialization efforts with respect to any approved products the timing and results of clinical trials and preclinical studies of Sotagliflozin LX9211 and our other drug candidates, our dependence upon strategic alliances and other third-party relationships, our ability to obtain patent protection for our discoveries, the limitations imposed by patents owned or controlled by third parties, and the requirements of substantial funding to conduct our planned research, development, and commercialization activities. for a list and a description of the risks and uncertainties that we face. Please see the reports we have filed with the Securities and Exchange Commission. I would now like to turn the call over to Lynell Coates.

Thank you, Mike. Good afternoon, everyone, and thank you for joining us. As expected, the third quarter of 2022 was an active period for both of our lead programs, Sotocliflozin, our dual SCOT1 and 2 inhibitor that we're developing for heart failure. and LX9211, our AAK1 inhibitor that we are developing for neuropathic pain. Let me jump in and tell you that I'm very pleased to report we had our mid-cycle review meeting with the FDA earlier this week for NDA for Sotagliflozin for the treatment of heart failure. The agency indicated that there were no significant review issues that may impact approvability of the NDA. that it had identified no major safety concerns and that it has no plans to hold an advisory committee meeting. So everything remains on track for an anticipated PDUFA target action date in May of 2023. We continue to believe the unique data from our soloist WHF trial and recent and worsening heart failure may provide a point of differentiation and strong entry and to the heart failure market, if approved. Just this past weekend, unique new data from the Soloist WHF trial was presented at the American Heart Association Scientific Sessions demonstrating Sotica flows have significant effects in reducing cardiovascular mortality and the risk of hospital readmission at 30 and 90 days following discharge after an initial event. This is a significant finding that we believe could provide tremendous benefit to patients, physicians, hospitals, and payers, and help differentiate Sotocoflozin within the current heart failure treatment paradigm. We look forward to continuing to work with FDA throughout the remainder of the review period, and if approved for marketing, we are expected to commercially launch Sotocoflozin in the U.S. in the first half of next year and preparations for which are already well underway. Moving to our LX9211 program for neuropathic pain. As you know, we announced positive top line results from our phase two proof of concept study of LX9211 in painful diabetic neuropathy earlier this year. Final data from this successful trial will be presented this coming Monday at the 16th Annual Pain Therapeutic Summit in Washington, D.C., which will be followed by a conference call discussing the final results in detail and their importance in this area of significant unmet medical need. Also, we completed enrollment in a second phase two proof of concept study of LX9211 in post-herpetic neuralgia earlier this quarter with top line results anticipated to read out before the end of this year. We believe LX9211 represents an innovative approach to treating neuropathic pain and, if approved, could provide a significant improvement to the treatment landscape for the benefit of patients. Now I will turn the call over to Jeff to put into context some of the recent analysis from the Sotagliflozin program.