Lexicon Pharmaceuticals, Inc.

Welcome to the Lexicon Pharmaceuticals fourth quarter and full year 2025 financial results conference call. At this time, all participants are in a listen-only mode. Following management's prepared remarks, we will hold a brief question and answer session. As a reminder, this call is being recorded today, March 5th, 2026. I would now like to turn the call over to Lisa DeFrancesco, SVP Investor Relations and Corporate Communications for Lexicon. Please go ahead, Lisa.

Thank you, Michelle. Good morning and welcome to our Q4 and full year 2025 earnings 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 fourth quarter and full year of 2025, 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 also 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 related to the safety, efficacy, clinical development, regulatory status, and therapeutic and commercial potential of Sotocliflozin, Pilavapidin, LX9851, and our other drug programs, as well as our business generally. These statements may include characterizations and projections related to the clinical development, regulatory status, market opportunity for our drug programs, 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 other SEC filings for detailed information describing such risks. I would now like to turn the call over to Mike Exton. Mike?

Yeah, thanks, Lisa. Good day, everyone. Thanks for joining us today. So I reflect back on this year, my first full year as CEO at Lexicon. I'm enormously proud of all the progress we've made. In addition to all we've accomplished in 2025, we've had a tremendously productive start to this year. So we're excited to give you some updates on our recent progress and discuss the many important milestones ahead of us in 2026. By way of a high-level overview, Lexicon is advancing three very strong, novel, late-stage programs in the therapeutic areas of cardiometabolic disease and chronic pain. In cardiometabolic, we have Sotocliflozin, which is currently in late-stage development in hypertrophic cardiomyopathy. Also planning an NDA submission for Sotocliflozin in type 1 diabetes and collaborating with our licensee, Beatrice, on making Sotocliflozin available in patients outside the US and Europe. We also have our novel, oral, early stage program in obesity, LX9851, which is being advanced by Novo Nordisk. Within chronic pain, we have pilavapidin, a phase three ready drug candidate for diabetic peripheral neuropathic pain. Each of these programs have key potential catalysts upcoming, which we'll cover shortly. Any one of these programs alone would represent a significant opportunity and scientific achievement to be excited about. But taken together, they comprise a portfolio that we're quite proud of. Now, before I jump into the details and next steps for each of these programs, I want to emphasize that in addition to the R&D excellence behind this pipeline, we've also been diligent about driving operational excellence, as well as improving our financial position and cost structure to sustainably support our core programs going forward. So looking ahead, we've set clear goals for what we need to achieve in 2026. The Sonata HCM phase three trial of SOTA for obstructive and non-obstructive HCM is enrolling well, and we expect to complete enrollment in the middle of this year. We received feedback from FDA that data from the third-party Stena 1 study can support an NDA resubmission for Zinclista for glycemic control in type 1 diabetes, if supported by patient exposure and safety data from the study. Now, based on the data we've seen thus far, We expect to resubmit in 2026 with potential approval later this year. Our partnership strategy continues as we support our existing licensees, Navinordisk and Beatrice, while also exploring new partnerships where appropriate to augment our capabilities, including seeking a partner for Phase 3 development of Pillar Bafferton. And last but not least, we're financially well-positioned following our recent capital raise. We plan to maintain our operational discipline to support long-term growth with diligent expense management and continued focus on deploying capital towards the highest value, highest impact opportunities. Collectively, this truly demonstrates our lead to succeed strategy in action. Now, we entered 2026 with significant momentum, and that has really continued in the first few months of the year. In January and February alone, we announced a successful end of phase two meeting with Kilobapidin in DPNP with no objections raised by the FDA to advancement into phase three development. We strengthened our financial position with more than $100 million in additional cash from our recent capital raise as well as the Novo Nordisk milestone payment. We continued enrollment in the ongoing Sonata HCM phase three study of Sotoclosen for HCM, surpassing 50% enrollment completion earlier this quarter and progressed our work towards a potential resubmission of our NDA for Zynclista in type 1 diabetes later this year, if the Steno 1 patient exposure and safety data requirements identified by the FDA are achieved. So as you can see, we're very much off and running, and so much more to come. With that, I'll ask Craig to provide a deeper dive on our lead programs. Craig?