Lexicon Pharmaceuticals, Inc.

Welcome to the Lexicon Pharmaceutical 3rd Quarter 2025 Financial Results Conference Call. At this time, all participants are in listen-in mode. Following the management's prepared remarks, we will hold a brief question and answer session. As a reminder, this call is being recorded today, November 6, 2025. I will now turn the call over to Lisa DeFrancesco, Senior Vice President for Investor Relations and Corporate Communications for Lexicon. Please go ahead, Lisa.

Thank you, Mila. Good morning and welcome to our third quarter 2025 conference call. Joining me today are Dr. Mike Exton, Lexicon's Chief Executive Officer and Director, Dr. Craig Granowitz, Senior Vice President and Chief Medical Officer, and Scott Chianti, Senior Vice President and Chief Financial Officer. This morning Lexicon issued a press release announcing our financial results for the third quarter of 2025, which is available on our website at www.lexpharma.com and through our SEC filing. A webcast of this call along with a slide presentation is also available on our website. During the call we will also review the information provided in the press 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 related to the safety, efficacy, clinical development, regulatory status, and therapeutic and commercial potential of pilobapidin, LX9851, Sotagliflozin, and our other drug programs, as well as our business generally. These statements may include characterizations and projections relating to the clinical development, regulatory status, and market opportunity for our drug programs, and the commercial performance of Impefa for heart failure. This call may also contain forward-looking statements relating to our growth and future operating results, discovery and development of our drug candidates, 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. And we refer you to our most recent annual report on Form 10-K and our other SEC filings for detailed information describing such risks. I would now like to turn the call over to Mike Exton. Mike?

Okay, great. Thank you, Lisa, and good day, everyone. Great to have you all with us this morning. We're really excited to give you updates on this quarter and all the great work that's going on here at Lexicon. Now, as we approach the final weeks of the year, I wanted to really begin by regrounding you on the ambitious set of strategic imperatives that we set out at the start of this year, which were designed to drive long-term value for the company. Now, these goals were firstly to progress pillavapidin to be ready for phase three registrational trials. Secondly, submit an IND for LX9851, our novel non-incretin candidate in obesity. Thirdly, to recruit patients and accelerate recruitment into our ongoing phase three clinical trial in hypertrophic cardiomyopathy, or HCM, named Sonata. continue the ongoing discussions with FDA on Zynquista and establish a path forward in type 1 diabetes, and finally to add targeted partnerships to maximize the value of our R&D programs. Now, throughout the past three quarters, we've made really excellent progress, not only against these goals, but within our pipeline and across our organization. In addition, we've continued to make strategic decisions to further advance our position across cardiometabolic disease with high unmet need. In so doing, we've successfully repositioned the company to really focus on R&D. We've achieved this focus by developing our innovative pipeline, maximizing operational efficiency, and elevating the focus on targeted partnering. So allow me to outline the substantial progress in R&D. For Pilavapidin, we recently presented a post hoc analysis of the aggregated results of our phase two program in diabetic peripheral neuropathic pain, or DPNP. All of our findings to date reinforce the broad clinical potential for this novel molecule, as well as its phase three readiness. And we're working with the FDA on next steps, as well as engaging with potential partners. For LX9851, I'm really pleased to say that we've completed our IND enabling studies. And as you know, earlier this year, we entered into an exclusive agreement with a strong partner who have the capabilities to develop this asset as quickly and as broadly as possible. And finally, for Sotica Flows and all 130 plus sites are now active in our phase three Sonata study in HCM, which is the only phase three HCM program enrolling both obstructive and non-obstructive subtypes. Now operationally, we are very mindful of resource utilization here at Lexicon across all parts of the business. This has enabled us to significantly reduce our operating expenses while preserving investment in areas where we believe we have the highest probability of value creation. Embedding an efficiency mindset has also resulted in us implementing innovative ways to drive our business forward. For example, as many of you are aware, a substantial proportion of the current evidence generation for soda is conducted and funded by third parties. On the commercial side of our business, we've recently introduced an innovative virtual sales support system for IMPEFA here in the US as we look to move IMPEFA from a stable break-even business to a growing profitable revenue stream for Lexicon in 2026 and beyond. Now, before Craig takes us through specific updates on the pipeline, I'd like to take a few moments to talk about some other internal and external pillars that we believe will continue to positively shape our business moving forward. First of all, as we continue to advance the science and explore the clinical potential of our assets, strategic and thoughtful partnering is vital to increasing the likelihood of our potential products reaching patients. Now, we've demonstrated our ability to partner with strong organizations, and I'm really impressed, not only by the capability and drive our partners are demonstrating, but how seamlessly and effectively our teams are really working together. And we can already see our strategy in action. Firstly, we're working closely with Beatrice on expanding the reach of soda for heart failure in major markets and territories outside of the US and Europe, and they're making really excellent progress. Really, really happy with that partnership with Beatrice. Secondly, we aim to maximize the potential of LX-9851 with our licensee, Nova Nordisk, who, as you know, are a global expert in obesity and related conditions. And our recent completion of IND enabling studies of LX9851 obesity means that we may earn up to $30 million in near-term milestone payments as 9851 enters future phases of development. Lastly, partnership discussions are ongoing with Pillavapidin, where we aim to collaborate with a high-quality partner to unlock the pipeline and appeal potential of this asset globally and across multiple indications. So our approach to partnership remains flexible as we aim to stay focused internally on our core cardiometabolic expertise. Second, I'd like to turn your attention to Zynqvista as our engagement with the FDA has progressed significantly. In September, we shared that we've submitted additional data to the FDA supporting the benefit-risk profile of Zynqvista as an adjunct to insulin for glycemic control in adults with type 1 diabetes. These data were from an ongoing, third-party-funded, investigator-sponsored trials of Zynqvista and were submitted as part of a Type D process to address the concerns the FDA had raised in its December 2024 complete response letter. Now, we feel that these data support a positive benefit risk of Zynqvista and address the concerns raised. And we're committed to working with the FDA on a path forward. In fact, the agency confirmed that they expect to provide written feedback by the end of this year. And following alignment with the FDA, Lexicon would target a resubmission as early as possible in 2026. And finally, with healthcare on the political agenda in DC and beyond, we see positive shifts and opportunities in this environment for our portfolio. Now, one area where this is particularly apparent is neuropathic pain management. Neuropathic pain is a type of chronic pain in which there's been little advancement in treatments for over two decades, despite its significant impact on patients' quality of life. For those with chronic pain, many are prescribed oral opioids despite the known serious risks of misuse. Better, safer options are not only needed, but in fact being demanded. And there have been three major developments this quarter that I want to update you on. Firstly, as a part of our advocacy efforts this year, Lexicon convened the first ever chronic pain roundtable in D.C. with representatives across clinical, patient, and payer communities. We're really inspired by this discussion with all of these experts, all of whom are actively advocating for recognition of chronic pain in legislation and the need for new innovation and access to non-opioid treatment options. Second and most recently, just a few days ago, A new bill, the Relief of Chronic Pain Act, was introduced into the US Senate to increase access to non-opioid therapies for Medicare patients with chronic pain. And finally, the FDA recently issued new draft guidance to expand non-opioid options for chronic pain management. So these three factors, together with additional legislative efforts that are currently making their way through Congress, really underscore the critical bipartisan demand for opioid alternatives in pain management. So overall, we're encouraged to see that not only these signals from the broader legislative environment, but also other important catalysts for change. From regulatory openness, evolving access dynamics, AI exploration, and overall changes in clinical care, all of these changes are huge opportunities for our company. And so with that, I'll turn it over to Craig to further update you on our assets under development. Thank you, Mike.