speaker
Tricia
Conference Call Operator

Welcome to the Lexicon for Missouri Coast First Quarter 2026 Financial Results Conference Call. At this time, all participants are in listen-only mode. Following management's preferred remarks, we will hold a brief question-and-answer session. As a reminder, this call is being recorded today, May 7, 2026. I will now turn the call over to Lisa DeFrancesco, SBP Investor Relations and Corporate Communications for Lexicon. Please go ahead, Lisa.

speaker
Lisa DeFrancesco
SVP Investor Relations and Corporate Communications

Thank you, Tricia. Good morning, and welcome to our first quarter 2026 earnings 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 first quarter of 2026, which is available on our website at www.lexfarmer.com and through our RCC 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 Sotocloplozin, Pilavapidin, LX9851, and our other drug programs, as well as our business generally. These statements may also include characterizations and projections relating to the clinical development, regulatory status, and market opportunity for our drug programs and the commercial performance of Inpepa 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 Epson, our CEO.

speaker
Dr. Mike Exton
Chief Executive Officer and Director

Yeah, thanks, Lisa, and good day, everyone. Thanks for joining us this morning. Look, we began this year with an ambitious set of 2026 objectives, which are to, firstly, advance our late-stage regulatory programs, both of which have major potential milestones mid-year. Second, expand our internationally through both existing collaborations with Beatrice and Nova Nordisk and a new collaboration for Pilaf Abaddon. And third, to remain operationally disciplined and focused, which is the foundation to support long-term growth and value creation. And I'm really excited that we've executed on all of these fronts. Now, as I reflect back at where we were last year around this time, it's truly incredible to look at the evolution of Lexicon across the board. Our strong R&D execution has resulted in significant progress across each one of our late-stage programs. And through our focus on operational excellence, including lowering our expenses, executing a successful capital raise earlier this year and establishing a new debt facility, which we just announced this quarter, we've taken the steps to ensure we're financially solid. We're on the precipice of a number of pivotal milestones in the coming months, with the potential to completely reshape the future of this company, as well as the treatment landscape for the patients we serve. We couldn't be more excited for what's to come. Now, to summarise our year to date highlights in a bit more detail, Lexicon is advancing a portfolio of novel targeted therapies in two main therapeutic areas, cardiometabolic diseases and chronic pain. We've made meaningful progress across each of these programs, Now, starting with Sotoclozin, in hypertrophic cardiomyopathy, or HCM, we are on track to complete enrolment in the Sonata Phase 3 study mid-year. Sonata continues to enrol well, and we're seeing strong execution as we approach enrolment completion. Type 1 diabetes, we remain on track to resubmit our application for approval of Zynquista with the FDA by mid-year, putting us in the position of a potential approval as early as this year. As a reminder, this resubmission will leverage investigator-initiated study data from the Steno 1 study, and the data we've seen thus far continue to support a favourable benefit-risk profile. On the global front, our licensee, Beatrice, has submitted regulatory applications for soda in heart failure across an increasing number of markets outside the US and Europe, with a launch underway in the United Arab Emirates. With LX9851, a first-in-class ACSL5 inhibitor for obesity, a Lycan-C NovoNordisk initiated the Phase 1 study in March, marking the program's entry into clinical development and triggering a second $10 million milestone payment. We're incredibly pleased with the progress and applaud the NovoNordisk team for how swiftly they advanced this novel treatment candidate to the clinic. We're excited to see the continued progress. And within chronic pain, we continue to deepen our understanding of the profile and potential of pilavaptin. We've met our regulatory objectives and remain in discussions with third parties regarding next steps for the program. Now, our initial objective in securing a partner for pilavaptin was really to secure non-diluted capital to support the important late-stage cardiometabolic opportunities in HCM and T1D. While we currently have no plans to fund the Phase III development for this program, The steps taken to strengthen our financial position, including our recent capital raise and refinancing of our land facility, provide us with the financial flexibility to find the right partner and explore structures that reflect the value of this novel asset, which we believe is significant. Lastly, in addition to the strong progress on our pipeline, the team has continued to deliver on our commitment to operational excellence and strengthening our balance sheet. So lots going on, lots to look forward to. With that, I'll ask Craig Granowitz, our Chief Medical Officer, to provide additional color on these pipeline updates. Craig? Thank you, Mike, and good morning, everyone.

Disclaimer

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