Welcome to the Lexicon Pharmaceuticals third quarter 2026 financial results conference call. At this time, all participants are in 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, November 5th, 2026. I will now turn the call over to Lisa DeFrancesco. SVP, Investor Relations, and Corporate Communications for Lexicon. Please go ahead, Lisa.

Thank you, Operator.

Good morning and welcome to our third 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 Coiante, Senior Vice President and Chief Financial Officer. This morning, Lexicon issued a press release announcing our financial results for the third quarter of 2026, 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 use the remainder of the 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, clinical development, regulatory status, and therapeutic and commercial potential of Sotocliflozin, Filavapidin, LX9851, and our other drug programs, as well as our business generally. This call may 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?

Thank you, Lisa. Good day, everyone, and thanks for joining us. As we approach the end of 2026, a year of tremendous focus and strategic evolution for Lexicon, I want to highlight the significant progress we've made across the business. First and foremost, in HCM, we completed patient enrollment in our Phase 3 Sonata HCM study. The baseline characteristics reflect the broad spectrum of patients being treated for HCM today, which we believe positions the study to evaluate SOTA across both non-obstructive HCM, where significant unmet need remains, and obstructive HCM, where many patients continue to experience symptoms despite available treatment options. Importantly, the baseline case CQ score of 59, reflects a highly symptomatic patient population with substantial room for symptomatic improvement. We're very pleased with the overall enrollment profile of Sonata HCM and look forward to reporting top-line results in the first quarter of 2027. Now, moving to Zynqvista, we continue to make strong progress towards the resubmission of our NDA in type 1 diabetes, supported by new prospective safety data from the investigator-initiated Steno 1 study. We are extremely pleased with the Steno-1 safety data, with rates of DKA that were low and comparable to standard of care, as well as the background rate among T1D patients in Denmark. It's worth remembering why this matters. Insulin remains the only glucose-lowering therapy for people with type 1 diabetes, and even with today's pumps and sensors, only about 1 in 5 adults reaches the A1C goal of 7%. and while much of our recent focus has understandably been on providing the additional safety data requested by the FDA, we don't want to lose sight of the strong efficacy results demonstrated in our phase three in tandem program. Those results are equally important to evaluating the overall profile of Zynqvista. And taken together, we believe the in tandem efficacy results and the new steno one safety data provide a compelling benefit risk profile for Zynqvista and a strong foundation for our NDA resubmission. We are now preparing that resubmission. And because Steno 1 is an investigator-initiated study and was not designed for regulatory purposes, significant work has been required to analyze, format, and prepare the data for submission and review. What remains is bringing this academic data set up to an agreed upon regulatory submission standards. We are completing that work in parallel with ongoing discussions with FDA, with the goal of submitting the highest quality package possible and maximizing the probability of a successful review. While this process is taking longer than we originally anticipated, we expect to complete the resubmission in the first quarter of 2027. We've been unwavering in our commitment to people living with type 1 diabetes and to making Sotagliflozin available as a new treatment option. I'm incredibly proud of the work our team has done to get us to this point. and grateful to the StenoOne investigators for their collaboration in helping us pursue an innovative regulatory path forward. Now, in heart failure, our licensee, Beatrice, continues to expand the global regulatory footprint for Sotoclosen with regulatory submissions across a growing number of markets outside the US and Europe. To date, Beatrice has obtained regulatory approvals in the United Arab Emirates and Bahrain and submitted applications in more than a dozen additional countries, including Saudi Arabia, Canada and Australia. Turning to LX9851, our first in class ACSL5 inhibitor for obesity, the phase one study being conducted by our licensee Novo Nordisk is progressing nicely. During the third quarter, we received our third $10 million milestone payment of the year from Novo with the potential to receive additional milestone payments as the program advances. We're very pleased with the progress of this promising compound and excited to see Novo continue to move the program forward. And finally, turning to Pilavapidin, our conviction in the potential of this agent and its novel AAK1 inhibition mechanism continues to grow. Last quarter, I mentioned that we had exciting work underway exploring its potential in additional high-value indications. And today, I'm pleased to share some of that work, particularly in obesity and weight management. In preclinical studies, pilavapidin has produced significant reductions in body weight both as a monotherapy and in combination with semaglutide. While this work remains early, we are encouraged by what we've seen and believe it points to an intriguing new opportunity for this program. We look forward to sharing more on this and additional preclinical programs with pilavapidin. Lastly and importantly, we've remained steadfast in our commitment to operational excellence and disciplined investment as we advance our programs and prepare for the opportunities ahead. To that end, we recently appointed Rachel Martens as Chief Commercial Officer and added new leaders in marketing and market access to advance our pre-commercial planning in HCM and T1D. I'm extremely pleased with the caliber of talent that we have and continue to attract at Lexicon, which I believe speaks to the strength of our programs and the opportunities ahead of us. Now before I turn the call over to Craig, I'd like to return to HCM and spend a few minutes on why we believe this represents such a compelling opportunity for Lexicon and why sotagliflozin may be uniquely positioned to address the significant unmet need across the disease. HCM is a genetic disease characterized by adverse cardiac remodeling, including myocardial hypertrophy, diastolic dysfunction, and fibrosis. Importantly, this underlying biology is the fundamental pathology across both non-obstructive and obstructive HCM. And while today much of the innovation in HCM is centered on cardiac myosin inhibitors, which target the contraction mechanism of the heart, Sotagliflozin takes a fundamentally different approach. Through its dual SGLT1 and SGLT2 inhibition, we believe Sotagliflozin may influence the metabolic and other biological processes that contribute to diastolic dysfunction in HCM. That distinction is important because the underlying abnormalities in cardiac structure, function, and metabolism extend across both forms of HCM. And we believe this gives SOTA the potential to deliver meaningful benefits in both obstructive and non-obstructive disease, something Sonata HCM is specifically designed to evaluate. Now the HCM market is a large and rapidly growing opportunity for a novel agent like soda. Awareness and treatment of HCM is accelerating in the US and around the world, but patients continue to experience significant symptom burden that impacts their life. Today in the US, more than 800,000 patients have been diagnosed with either obstructive or non-obstructive disease, but there are many more remaining undiagnosed currently. In NHCM in particular, a treatment gap remains with no disease-specific therapies currently approved despite a patient population growing quickly with rising levels of obesity and diabetes. And there's strong support for an option that is simple, safe, and easy to use for the busy and growing cardiology practices. We believe Sotocliflozin's once-daily oral profile together with its differentiated mechanism and potential Applicability across both obstructive and non-obstructive HCM could provide an attractive option for physicians and patients. With that, Craig Granowitz, our Chief Medical Officer, will provide additional color on our pipeline. Craig?

Thank you, Mike, and good morning, everyone. As Mike mentioned, Sonata HCM is the ongoing Phase III study for patients with symptomatic HCM, the top-line results of which are expected in the first quarter of next year. Sonata HCM was designed to evaluate SOTA in a broad HCM population reflective of real-world clinical practice. With the baseline characteristics of the study now available, we are very pleased that the final study population met that objective. Importantly, the demographic and clinical characteristics of both the non-obstructive and obstructive HCM cohorts are generally consistent with those reported in previous clinical studies of other agents in those respective patient populations. The overall study population had a mean baseline KCCQ score of 59. The primary efficacy endpoint of the pivotal study is improvement in symptoms compared to placebo as measured by the change in baseline KCCQ at week 26. In total, Sonata HCM enrolled 542 patients with 440 classified as non-obstructive at baseline and 102 as obstructive. The trial also includes patients on stable background therapies, including cardiac myosin inhibitors. The scientific evidence for sodaglifosin continues to accumulate, strengthening the rationale for its effectiveness and mechanisms in HCM and providing important insights into the potential differentiation of dual SGLT1 and SGLT2 inhibition. In a preclinical murine model of HCM, SOTA improved baseline measures of cardiac structure and function, including diastolic function, hypertrophy, and fibrosis. Separate research has also demonstrated SOTA's inhibition of platelet activation and thrombus formation, which were greater than those observed with the SGLT2 inhibitor empaglifosin, highlighting the importance of the SGLT1 effects in impacting thrombotic events. New investigator-led research being presented at the upcoming AHA meeting this weekend includes work in living human HCM heart tissue where SGLT1 inhibition directly reduced myocardial work with soda showing greater potency at higher afterloads compared to empagliposin. A separate study in healthy adults treated with empa or soda found a significant reduction in thrombus formation from baseline with soda while the reduction with EMPA did not reach significance. We believe that body of evidence will continue to grow. The investigator-initiated SOTA cross study being conducted at the University of Pennsylvania is evaluating SOTA in patients with nonobstructive HCM, including its effects on cardiac function, exercise performance, and quality of life, with completion now expected in 2027. We believe these findings provide increased scientific and clinical support for the differences between the dual SGLT1-2 inhibitor SOTA from SGLT2 inhibitors. Additionally, the HCM-specific data reinforce our excitement as we approach the expected Sonata HCM top-line readout in the first quarter of 2027. Moving to Synqüista, to expand upon what Mike highlighted earlier, The In Tandem Program demonstrated important benefits for people with type 1 diabetes, including a reduction in HbA1c of about 0.4 percentage points, roughly 3 hours per day of time and range, fewer hypoglycemic events, reduced body weight, and lower blood pressure. The FDA requested additional prospective data characterizing the risk of DKA as a precondition for resubmission of the NDA. We have subsequently worked with the agency on a path forward using data from the Steno-1 trial. The FDA agreed that Steno-1 could provide the prospective data needed to assess DKA rates in a large Sotaglifosin-treated population, provided the study achieved sufficient patient exposure comparable to the approximate 200 patient years of SOTA treatment in the in tandem clinical program. Indeed, we have now met the criteria outlined by the FDA, including the required level of patient exposure and have received that data from Steno needed to support our resubmission. The in tandem efficacy results, together with the new Steno safety data, give us increased confidence in the overall profile of Zynqvista as we prepare to resubmit our NDA. Looking at the Ceno data in more detail, we are encouraged by the safety results observed in the trial. As shown on this slide, the rate of DKA amongst patients receiving soda glyphosate was approximately one DKA event per 100 patient years of soda exposure. This was comparable both to the standard of care group in the Ceno 1 trial and the historic rates in Denmark in people with type 1 diabetes. The rate of DKA is well below that of the rates observed in the SOTA arms of the in tandem studies. Importantly, as of the end of August 2026, which we are using as the cutoff date being used to support the FDA resubmission, the study included 496 patients randomized to SOTA and 708 patients receiving the standard of care, which provides the level of patient exposure agreed with the FDA. As Mike mentioned, significant work is ongoing with Steno in conjunction with alignment from the FDA on analysis parameters to properly prepare the data for FDA submission and review. While the administrative process is taking longer than initially projected, we remain confident in the robustness of the data set and we are encouraged by our progress towards resubmission, which we now expect will occur in the first quarter of 2027. Turning now to pilavapidin, the selective AK1 inhibitor, we continue to explore the program's potential beyond its established development path in neuropathic pain. We have been investigating the potential application of pilavapidin in additional indications based on its ability to affect biological pathways involved in several processes, including nerve transmission involved in gastrointestinal motility. The results shown here provide encouraging early evidence of that potential in obesity and weight management. In this preclinical study, 10 milligrams per kilogram of pilavapidin reduced body weight by 14% after 28 days of treatment. When pilavapidin was combined with semaglutide, the mice experienced a reduction of 31% of body weight, greater than the 25% body weight reduction observed for semaglutide alone. Although these are early findings, these results suggest that pilavapidin may have activity as a standalone agent and may also provide incremental benefit when combined with a GLP-1 therapy. We believe that this potential is particularly interesting as the obesity treatment landscape continues to evolve and the need remains for differentiated mechanisms and combination approaches. We are continuing to evaluate these findings and advance additional work needed to better define the opportunity, and we look forward to providing further updates as this program progresses. I'll now turn it over to Scott to discuss our financial results.

Thank you, Craig, and good morning. I'll begin with a review of our financial results for the quarter. Total revenues were $11.3 million for the quarter ended September 30, 2026. compared to $14.2 million for the corresponding period in 2025. Revenues for the third quarter of 2026 included $10 million in milestone revenue recognized from the Novo Nordisk Licensing Agreement and net sales of MPEFA of $1.2 million. Revenues for the third quarter of 2025 included $13.2 million of licensing revenue from the Novo Agreement and net sales of MPEFA of $1.0 million. Research and development expenses for the third quarter of 2026 were $16.2 million compared to $18.8 million in the corresponding period of 2025, reflecting lower external clinical trial expenses as a result of the completion of our Progress Phase 2B clinical trial in 2025, partially offset by higher Sonata HCM Phase 3 clinical trial expense in 2026. Selling general and administrative expenses for the third quarter of 2026 were $9.5 million compared to $7.6 million in the corresponding period of 2025, reflecting increased employee benefit costs and increased pre-commercialization expenses. Net loss for the third quarter of 2026 was $14.0 million, or $0.03 per share, compared to a net loss of $12.8 million, or $0.04 per share, in the corresponding period in 2025. Net loss for the third quarters of 2026 and 2025 includes non-cash stock-based compensation expense of $3.4 million for each of these periods. As of September 30, 2026, Lexicon had $183.2 million in cash, cash equivalents, and short-term investments as compared to $125.2 million of cash, cash equivalents, short-term investments, and restricted cash as of December 31, 2025. As previously noted, third quarter revenue included the third $10 million milestone payment received this year from Novo Nordisk following the achievement of a phase one development milestone for LX9851. We continue to maintain our operating expense guidance for 2026 of between 100 and 110 million, with R&D expected to be between 63 and 68 million and SG&A expected to be between 37 and 42 million. which includes targeted investments and pre-commercial activities. We remain incredibly pleased with our financial accomplishments thus far in 2026. As we prepare for several important milestones across our portfolio, we remain focused on maintaining the financial flexibility needed to support execution and advance our key strategic priorities while continuing to evaluate opportunities to unlock additional value across the portfolio. I will now turn it back to Mike for closing remarks.

Thanks, Scott. Now, stepping back, we believe Lexicon is entering a potentially transformational 12-month period, supported by multiple opportunities across our cardiometabolic portfolio. For Sotagliflozin and HCM, we are approaching the pivotal Phase III Sonata HCM top-line data readout expected in the first quarter of 2027, while continuing our pre-commercial planning and readiness activities. In type 1 diabetes, we're working towards the resubmission of the Zynquista NDA, supported by additional safety data from Steno 1, with resubmission expected in the first quarter of 2027. Beyond these near-term priorities, the Phase 1 program for LX9851 continues to advance with the potential to create additional development milestone opportunities. With Pilavapidin, we have a Phase 3 ready pain program, as well as an emerging opportunity in obesity that we are actively investigating. Taken together, these programs provide multiple potential paths of value creation. We believe our progress reflects the strength of our science, the breadth of our portfolio, and most importantly, the commitment to creating new opportunities for people living with serious cardiometabolic diseases to live longer, healthier lives. Thank you again for joining today. We now look forward to taking your questions. Operator, back to you.