LXRX

Findings presented at ESC Congress 2026 and simultaneously published in JACC: Heart Failure THE WOODLANDS, Texas, Aug. 31, 2026 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced results from a post hoc analysis of the Phase 3 SOLOIST-WHF trial evaluating the efficacy and safety of sotagliflozin across the spectrum of baseline systolic blood pressure in patients recently hospitalized for worsening heart failure. The data, which were presented yesterday at ESC Congress 2026 in Munich, Germany and simultaneously published in JACC: Heart Failure1, demonstrated that the results of sotagliflozin treatment were maintained regardless of baseline systolic blood pressure. Among patients with baseline systolic blood pressure as low as 100 mmHg, treatment with sotagliflozin was associated with a reduction in cardiovascular death and heart failure-related events, without an increase in hypotension or acute kidney injury (AKI). “Patients hospitalized for recent worsening heart failure and lower systolic blood pressure are often considered among the most clinically vulnerable,” said Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer. “We were encouraged to see that the results of sotagliflozin treatment remained consistent across the spectrum of baseline blood pressure in SOLOIST-WHF, providing additional insight into the potential utility of sotagliflozin in a particularly high-risk heart failure population.” The SOLOIST-WHF trial randomized 1,222 patients with type 2 diabetes admitted for worsening heart failure to treatment with the dual SGLT 1 and 2 inhibitor sotagliflozin or placebo. The analysis demonstrated that the effect of sotagliflozin was consistent across the spectrum of baseline systolic blood pressure (SBP), with no evidence that treatment effect varied by baseline blood pressure. Among patients with a baseline SBP <110 mmHg (n=201), those randomized to sotagliflozin experienced a reduction in total occurrences of cardiovascular deaths and HF-related events (HR 0.56 (95% CI 0.33-0.95), p=0.03). These data suggest efficacy of sotagliflozin in even the lowest SBP stratum. There was no difference in the incidence of adverse events of hypotension between treatment groups (p=0.34) or AKI (p=0.69). Additionally, patients with a baseline SBP ≥ 110 mmHg (n=1175) also experienced a reduction in total occurrences of cardiovascular deaths and HF-related events (HR 0.69 (95%CI 0.53-0.91), p=0.01). About SotagliflozinDiscovered using Lexicon’s unique approach to gene science, sotagliflozin is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1). SGLT2 is responsible for glucose and sodium reabsorption by the kidney and SGLT1 is responsible for glucose and sodium absorption in the gastrointestinal tract. Sotagliflozin has been studied in multiple patient populations encompassing heart failure, diabetes, and chronic kidney disease in clinical studies involving approximately 20,000 patients. Sotagliflozin is also currently under investigation for another cardiac condition, hypertrophic cardiomyopathy (HCM). About Lexicon PharmaceuticalsLexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Lexicon has a pipeline of drug candidates in discovery, preclinical, and clinical development in neuropathic pain, hypertrophic cardiomyopathy (HCM), obesity and metabolic disorders, and other cardiometabolic indications. For additional information, please visit www.lexpharma.com. Safe Harbor Statement This press release contains “forward-looking statements,” including statements relating to the research, development and therapeutic and commercial potential of sotagliflozin. In addition, this press release may also contain forward-looking statements relating to Lexicon’s financial position and long-term outlook on its business, including the commercialization of its approved products and the clinical development of, regulatory filings for, and potential therapeutic and commercial potential of its other drug candidates. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicon’s ability to meet its capital requirements, successfully commercialize its approved products, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of its other drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its approved products and other drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2025, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise. For Media Inquiries: Dave Belian Lexicon Pharmaceuticals, Inc. [email protected]   For Investor Inquiries: Lisa DeFrancesco Lexicon Pharmaceuticals, Inc. [email protected] 1 Zitelny E, et al. Benefit of Sotagliflozin Across the Full Range of Baseline Blood Pressure in the SOLOIST-WHF Trial. JACC: Heart Failure. Published online August 2026. DOI: 10.1016/j.jchf.2026.103368.

Image source: The Motley Fool. Thursday, Aug. 6, 2026 at 8:30 a.m. ET Chief Executive Officer and Director - Mike Exton Senior Vice President and Chief Medical Officer - Craig Granowitz Senior Vice President and Chief Financial Officer - Scott Coiante SVP, Investor Relations and Corporate Communications - Lisa DeFrancesco Operator: Welcome to the Lexicon Pharmaceuticals Second Quarter 2026 Financial Results Conference Call. [Operator Instructions] As a reminder, this call is being recorded today, August 6, 2026. I will now turn the call over to Lisa DeFrancesco, SVP, Investor Relations and Corporate Communications for Lexicon. Please go ahead, Lisa. Lisa DeFrancesco: Thank you, Therese. Good morning, and welcome to our Second 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 second 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 the slide presentation is also available on our website. During this call, we will review the information provided in our 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, clinical development, regulatory status and therapeutic and commercial potential of sotagliflozin, pilavapadin, LX9851 and our other drug programs as well as our business generally. 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 the 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? Michael Exton: Yes. Thank you, Lisa, and good day, everyone. Thanks for joining us. Look, I want to begin by focusing on our most recent and major accomplishment, the completion of enrollment in SONATA-HCM, our Phase III study of sotagliflozin in hypertrophic cardiomyopathy or HCM. This study is the largest Phase III study to date in both obstructive and nonobstructive HCM. This marks an important milestone for patients living with the symptoms of HCM as SOTA would be a completely novel and complementary treatment for their disease as compared to all approved treatments currently available and other agents in development. We're thrilled with the outcome of our enrollment efforts, which resulted in the study being significantly over-enrolled. I couldn't be more pleased with the accomplishment of this critical milestone, and we eagerly await the top line data, which we expect to announce in Q1 of next year. In addition to the completion of enrollment in SONATA, we've also made other important progress across our portfolio. I'll start by providing an update on Zynquista, where we are at an important and exciting moment for the program. If you recall, the FDA asked for 3 things to support a resubmission of our new drug application: a prospective study, adequate patient exposure and DKA rates below those observed in our previous clinical trials. I'll ask Craig to take over here. Craig Granowitz: The FDA has previously confirmed that STENO1, an open-label investigator-initiated study of sotagliflozin being conducted by the STENO Diabetes Center in Denmark may serve as that prospective study. STENO1 is on the verge of achieving the exposure levels previously identified by FDA as necessary to support a resubmission and the DKA rates observed to date in the study in patients treated with SOTA are similar to patients on the standard of care in the trial and below those observed in our earlier trials. As a result, we believe that each of the FDA's criteria for resubmission of the NDA will soon be satisfied. We expect that STENO1 will achieve adequate exposure levels by the end of August and following, we will quickly move to finalize the administrative aspects of patient level data collection and transfer from Denmark. We currently anticipate that we will complete a resubmission of our NDA during the fourth quarter of this year. While this is a slight delay from our previous time line, we cannot be more pleased with the data we've received to date. This is a huge step forward for Zynquista, for Lexicon and for patients with type 1 diabetes who for many years have pleaded for another option besides insulin to manage their blood sugar. Furthermore, in heart failure, our licensee Viatris has also continued to submit regulatory applications for sotagliflozin across an increasing number of markets outside the U.S. and Europe. To date, Viatris has obtained regulatory approval in the United Arab Emirates and in Bahrain and has submitted applications for regulatory approval in more than a dozen other countries, including Saudi Arabia, Canada and Australia. Viatris anticipates regulatory decisions in Australia and Canada and additional regulatory submissions in other markets this year. Turning to 9851, a first-in-class ACSL5 inhibitor for obesity, a Phase I study is underway and being conducted by our licensee, Novo Nordisk. We have previously received 2 $10 million milestone payments under our license agreement with Novo and have the potential to receive a third $10 million milestone payment later this year. We are excited to see the continued progress on this promising compound. Finally, turning to pilavapadin. Our belief in the potential of this agent and its novel AAK1 inhibition mechanism of action only continues to grow. We have exciting work underway exploring its utility in other potentially high-value indications, and we look forward to sharing data from these preclinical studies as early as later this year. Michael Exton: Yes. Sorry about that, everyone. Thanks, Craig, for taking that on. But really, I couldn't be more pleased with where we're at, both for HCM and importantly, for Zynquista. This is a really important milestone for us in this program. As many of you know, we've been working with the FDA very constructively and are now on the precipice of having all the requirements needed to move forward with the NDA. So with that, I'll ask Craig to continue and give you the pipeline update. Craig Granowitz: Thank you, Mike, and good morning, everyone. I'll start with sotagliflozin, our novel oral SGLT1 and SGLT2 inhibitor, which is in late-stage development in both HCM and type 1 diabetes. I'd like to begin by discussing the underlying pathology of HCM and why we at Lexicon believe that sotagliflozin is uniquely positioned to address the tremendous unmet need in this space. Hypertrophic cardiomyopathy, or HCM, is a genetic disease characterized by adverse cardiac remodeling associated with myocardial hypertrophy, diastolic dysfunction and fibrosis. This fundamental biology is present across both non-obstructive and obstructive HCM, which I'll refer to as nHCM and oHCM independent of underlying anatomy. It is important to note that even in oHCM, symptoms and progression are not explained by left ventricular outflow tract obstruction alone. It is noteworthy that in oHCM, patients in which the outflow tract obstruction has been eliminated through surgery or other means, patients may still remain symptomatic due to the underlying disease process. Diastolic dysfunction is the underlying disease process observed in both nHCM and oHCM. This dysfunction is characterized by an abnormally thick and stiff left ventricle and impaired diastolic relaxation. These metabolic and anatomical changes negatively impact cardiac function. Both types of HCM are characterized by a thick and left ventricle associated with fibrosis, which results in a less pliable and improperly functioning left ventricle. These changes in cardiac structure and function result in the physical manifestations of shortness of breath and exercise intolerance that often impact patient quality of life. SOTA's unique dual SGLT1 and SGLT2 inhibition directly addresses the underlying diastolic dysfunction that characterizes HCM. By improving how the heart uses energy and other mechanisms, we believe that SOTA has the potential to demonstrate similar benefits in both nHCM and oHCM. SGLT1 is expressed by cardiac myocytes and the level of expression is increased in cardiac diseases such as HCM and other cardiomyopathies. And as a reminder, SGLT2 is not routinely expressed in the myocardium. By inhibiting SGLT1, SOTA improves cardiac cell function in the heart through mechanisms such as enhanced calcium flux, improved energy utilization, reduced inflammatory and fibrosis markers and reduced epicardial fat. In addition to the cardiac benefits of SGLT1 inhibition, SGLT2 inhibition also has a positive effect on the cardiorenal dysfunction that is a hallmark of all patients with heart failure. As a result, SOTA is the only agent that works both inside and outside the heart to reduce the symptoms of HCM. As Mike highlighted earlier, we are excited to have completed enrollment in the SONATA-HCM trial, which is evaluating the effects on symptoms, function and other patient-reported outcomes as well as safety in patients with symptomatic HCM. We are pleased that the trial was significantly overenrolled and as such, should positively impact the overall study powering. The study included a substantial majority of patients with nHCM, providing a robust opportunity to evaluate SOTA in a patient group for whom effective treatment options remain limited as well as a meaningful cohort of patients with oHCM. As a reminder, the primary efficacy endpoint is improvement in symptoms as measured by the change from baseline to week 26 in the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score or KCCQ CSS for the overall patient population. Patients with symptomatic HCM on a stable dose of guideline-directed HCM therapy, including cardiac myosin inhibitors were permitted to enroll in the trial. Our objective was to conduct a pragmatic study where the enrolled patients truly reflect the treatment paradigm for this disease. We believe that the final study population will enable a thorough assessment of SOTA's potential across the spectrum of symptomatic HCM, and we look forward to sharing top line results in the first quarter of 2027. Moving to Zynquista. I'd like to elaborate a bit on where we are in the resubmission process for our new drug application. By the end of August, we expect that the STENO1 study will have achieved the number of patient years of sotagliflozin exposure that FDA had previously identified as being necessary to support refiling. The DKA rates observed in the STENO trial amongst patients treated with SOTA remain similar to those observed in the standard of care group in the study and well below that observed in our previous inTandem studies. Based on our previous discussions with FDA, we believe that these levels of exposure and DKA rates support a resubmission of the NDA. We have been providing these data along with additional information from the study to the FDA on an ongoing basis, excluding and most recently as this week. Concurrent with our FDA discussions, we have been in continuous dialogue with the STENO group to ensure the appropriate collection and formatting of the necessary data fields and analysis parameters for NDA resubmission, which we believe could occur at the end of October 2026 based on our current estimates. Turning to our earlier-stage pipeline, LX9851, a first-in-class non-incretin oral small molecule inhibitor of ACSL5 is currently in Phase I development by our licensee, Novo Nordisk. We could not be more pleased with the continued collaboration with Novo on this promising compound, and we look forward to future results. I'll now turn it over to Scott to provide an update on the company's financials. Scott Coiante: Thank you, Craig, and good morning, everyone. I'll begin with a review of our financial results for the quarter. Total revenues were $0.7 million for the quarter ended June 30, 2026, compared to $28.9 million for the corresponding period in 2025. Revenues for the second quarter of 2026 represented net sales of INPEFA, and revenues for the second quarter of 2025 included $27.5 million in licensing revenue recognized from the Novo Nordisk licensing agreement in addition to net sales of INPEFA. Research and development expenses for the second quarter of 2026 were $17.4 million compared to $15.7 million in the corresponding period of 2025, reflecting higher external costs in 2026 related to our ongoing SONATA-HCM Phase III clinical trial. Selling, general and administrative expenses for the second quarter of 2026 were $9.8 million compared to $9.4 million in the corresponding period of 2025. Net loss for the second quarter of 2026 was $31.8 million, or $0.07 per share compared to net income of $3.3 million or $0.01 per share in the corresponding period in 2025. Net loss for the second quarter of 2026 and net income for the second quarter of 2025 included noncash stock-based compensation expense of $3.3 million and $3.2 million, respectively. Net loss for the second quarter of 2026 also includes a loss on the early extinguishment of debt of $4.3 million, or $0.01 per share resulting from the early repayment of the company's term loans with Oxford Finance. The company replaced its debt facility in May of this year, which I will expand on momentarily. As of June 30, 2026, Lexicon had $190.6 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, we have taken steps to improve our balance sheet and enhance our financial flexibility. And in May of this year, announced a $100 million debt facility with Hercules Capital. Under the terms of this agreement, an initial $55 million tranche was funded at closing and was utilized to repay our previous loan facility with Oxford Finance. A second $20 million tranche is available for draw Lexicon's option, subject to the achievement of certain clinical, regulatory and financial milestones and specified timing requirements. A third $25 million tranche is available for draw at Lexicon's option, subject to Hercules consent and specified timing requirements. The loan facility provides for an initial interest-only period of 18 months with the potential for 2 6-month extensions. We are also reiterating our operating expense guidance for 2026 of between $100 million and $110 million and continue to anticipate R&D to be between $63 million and $68 million and SG&A to be between $37 million and $42 million. During the second quarter, we initiated targeted investments in precommercial activities focused primarily on medical education and marketing preparation. These investments will also include market access activities as we approach the late-stage development of our assets, which is included in our estimates. We are incredibly pleased with our financial accomplishments thus far in 2026, including our capital raise in February and the new loan facility with Hercules. We have strengthened our balance sheet and improved our financial flexibility while remaining prudent with our expenses ahead of our important milestones expected in the coming months. I will now turn it back to Mike for closing remarks. Michael Exton: Yes. Thanks, Scott. Look, this quarter, we're really starting to see the output of the Lead to Succeed strategy, which we put in place 1.5 years ago. We're focused on driving opportunities that have the highest probability of impact where we believe we can truly make a difference and have the greatest chance for success. Indeed, using Lead to Succeed as our guiding principle, we believe the next 12 months have the potential to be one of the most transformational periods in Lexicon's history. We have significant opportunities ahead of us that could meaningfully expand the reach of SOTA and the impact we can have for patients. First and foremost is our opportunity for SOTA in HCM, where it has the potential to be the first and only medicine indicated to treat patients across the spectrum of disease. As Craig explained, SOTA's unique mechanism of action, which includes not only SGLT2 but also SGLT1 inhibition, differentiates it as a hemodynamic and metabolic agent and sets it apart from all other agents in HCM. SOTA also offers what we believe will be an ease of adoption for patients and prescribers, supporting its potential as a first-line treatment with broad use. At the same time, we've reached an instrumental point in the development of Zynquista in type 1 diabetes. Over the last 12 months, we've actively engaged with FDA and received clear feedback on their requirements for submission of our NDA. In addition to these late-stage opportunities, we're also making progress across our entire portfolio and continuing our commitment to operational excellence. Together, these priorities position Lexicon to drive value and growth while staying focused on areas of meaningful patient impact. Thanks again for joining today. We now look forward to taking your questions. Operator? Operator: [Operator Instructions] Our first question today is from Yigal with Citigroup. Joohwan Kim: This is Joohwan Kim on for Yigal. On SONATA, given that there's a substantial majority of nHCM patients with a meaningful oHCM cohort as well, how should we think about that mix in terms of the commercial and regulatory value of the study if overall population is positive? And is directionality across both phenotypes more important in your view than the exact magnitude in each group? Craig Granowitz: Yes. Thank you for the question. It's Craig Granowitz. I'll start, and I'll turn it over to Mike to answer the commercial element. From the standpoint of the trial enrollment, this is really where the need is. As I mentioned during the prepared remarks, we're really looking at a pragmatic study that reflects the population that is currently available and in greatest need. And that really is a large number of nonobstructive patients where there really are no options that are available. With obstructive, there are both surgical and other options as well as medical options available. As I've mentioned in past calls, and I hope I was able to communicate, the trial was powered on the overall population. That was what we had discussed with the FDA that includes both obstructive and nonobstructive, and particularly with the significant over enrollment, this gives us even more confidence in the primary endpoint that we selected in our power to observe that primary endpoint. And also to reinforce, while there are more nonobstructive patients in the trial, we believe that there's a significant number -- a significant enough number in the -- of the obstructive patients that gives us great confidence that we'll be able to observe and find meaningful results in both the obstructive and nonobstructive groups. Michael Exton: Yes. And from a commercial perspective, we see that there's opportunity across the spectrum of disease, both in obstructive and nonobstructive, obstructive clearly where there are already approved agents, but still a significant number of patients remain symptomatic and nonobstructive where there are currently no approved agents. And this mechanism allows us to work in a space where we are the one and only SGLT inhibitor in HCM. And that provides applicability across the broad spectrum of disease either as a solo treatment for HCM or in combination with the other CMIs. Joohwan Kim: Got it. And if I could just ask one more question. On LX9851, I was curious how we should think about the bar for continued development coming out of the Phase I. What would constitute a supportive data package for Novo to move the program forward? Michael Exton: Yes. Look, for 9851 in terms of the bar for development, that really is a question now for Novo. What we can say is that we're incredibly pleased with how the partnership has progressed to date. Novo is very enthusiastic about this mechanism and the trial -- Phase I trial is progressing extremely well. So we have always thought that the combination of different mechanisms of oral medicines will probably be an important player, an important therapeutic option in obesity. And clearly, Novo being the leader of oral weight loss medicines is taking that approach with LX9851 as well. So we're really excited to see the continued development and progress that Novo is making. Operator: Our next question is from Andrew Tsai with Jefferies. Brian Balchin: It's Brian Balchin here for Andrew Tsai. Just on type 1 diabetes, you're resubmitting that now in Q4 versus I think it was around mid-'26 before. So is it fair to assume approval could be closer to mid-'27, assuming a Class II resubmission? Can you just talk a little bit about why that's taking longer to accrue data? Craig Granowitz: Yes. It's a great question. And we've been working very hard with both the FDA and STENO. And I hope I've been effective at communicating over time that STENO is an investigator-initiated trial that was never designed for regulatory purpose. And we've been continuously work with STENO to pull all of the data together. We had a certain regulatory path that we were considering, but just based on the ability of STENO to pull the data together in a timely way in the manner that the FDA wanted, it's just taking them more time. I think as both Mike and I reinforced, the most important aspects is that the trial has now achieved the exposure required by the FDA for sotagliflozin patients as well as the control group because FDA wanted to see the control group in the study as well and extraordinarily encouraging the rates of DKA that we're seeing. And as a reminder, this is an open-label trial. So we're getting monthly or even more frequent updates from STENO on the exposure data. The rates of diabetic ketoacidosis in the SOTA-treated group seems to be similar on an exposure basis to that in the standard of care. And that's certainly well below that, which was observed in the inTandem trial. So to me, it's just a matter of how long is it going to take to pull the details together from STENO in the format and the way that we have agreed with the FDA to submit, not do we have a drug that has met the requirements that FDA set out in the outset of this process of a favorable risk benefit. Michael Exton: And I think the other thing to keep in mind here regarding the timing, we expect and as we outlined, we think that the submission could be as early as the end of October, which with a 6-month review would put us nicely in Q2, but not at the end of Q2. But having said that, this is an unusual review because clearly, the FDA has seen a lot of the information that they'll see in this submission. And the actual data that they'll be reviewing from STENO is not as comprehensive as a normal review. So we will work with them very proactively as we have done in the past to see if there is possibility for a review quicker than the statutory time line. Operator: Our next question is from Roanna Ruiz with Leerink Partners. Roanna Clarissa Ruiz: A couple from me. I wanted to ask a question about SONATA and if you're able to share the proportion of patients on CMIs? And how you think that might impact the -- both the overall results and informing future prescribing because I noticed that you're talking about majority of patients are nHCM. So what does that mean for the oHCM proportion of patients in the trial? Craig Granowitz: Yes. Thanks, Roanna. Great question. We haven't broken out and we probably won't until we share the baseline characteristics of the study at an upcoming medical meeting. But I can say that there are a fair number of patients on a CMI. But as you would expect, the availability of CMIs in the trial was rather limited. We included 20 countries in the study. And while the U.S. was the largest -- single largest enrolling country, was certainly not a majority of the patients. So I think sort of taking that into account and the protocol required patients to be on a stable dose of any of their underlying CMI -- underlying HCM medication for at least 6 months. But I can say that we do have patients in the trial that are on a CMI and both patients that the baseline were considered obstructive by the criteria and nonobstructive by the criteria. So what I would infer from that is that all of the patients are put on a CMI because they were obstructive at some point. So it is interesting to note, and as we were referencing repeatedly through our prepared comments, that even if you remove the outflow tract obstruction, patients are still symptomatic. So we have, in a sense, all different options. We have patients who are obstructive and nonobstructive in the trial and patients that are on CMI that are also at the baseline of enrollment in our trial that have either an obstruction by the definition of obstruction in the trial or nonobstructive. The single unifying characteristic of the trial is they all have a baseline KCCQ score of less than 85. And I think that really is the gold standard today is managing symptomatic relief of these patients. Roanna Clarissa Ruiz: Super helpful. And a follow-up question. Could you give us your updated thoughts about where you believe SOTA fits into the HCM landscape? We've been following a couple of biotechs that are gearing up to start Phase III trials and could potentially enter after SOTA as well in the market. How do you see prescribers making decisions between these different programs? Michael Exton: Yes. I think overall, the important thing is that this is a complementary mechanism to the currently approved agents and potentially newer agents as well. So this is really the way we've approached it with Lead to Succeed is that we can play in a way our own game and have the potential to be prescribed either as a stand-alone or combination therapy with other agents. Now there are a few unique attributes to SOTA in this market that really augur well for a first-line treatment option. The first is that it's an oral once-a-day medicine that's extremely well tolerated and very safe. And so that really has the propensity to be prescribed very easily with broad access for patients. And so we would see this naturally as an option that a broad range of prescribing physicians could turn to immediately for symptomatic HCM with the possibility of currently, if they have an obstruction, then looking to add the CMI if they are still symptomatic. Operator: Our next question is from Yasmeen Rahimi from Piper Sandler. Yasmeen Rahimi: Thank you so much for all the great updates and again, congrats on SONATA. Excited to look forward to the data. Craig, question for you is obviously, the population contains both obstructive and nonobstructive and the study is powered for a KCCQ in both populations. How do you envision between now and the top line data to maybe potentially explore the optionality if there is a path forward if you see statistical separation in one population versus another? Is that something that you guys would evaluate? What work goes into it? And how much flexibility do you have until you lock the database and provide that update? So if you could talk about sort of the statistical protocol, how you're thinking, whether you want to change it or not? And then the second question is, I'm sorry if it has already been answered, but maybe just the type of data that were generated by the PI for Zynquista as well as in-house to correlate together to make -- to ensure a filing to be near complete and the timing around that? And I'll jump back in the queue. Craig Granowitz: Yes. Thanks, Yas. Great questions. It's a really good question about the statistical analysis plan. And good clinical practice, normally, you want to finalize your SAP before you close your database. So we have a number of months theoretically that we can do that. In light of as we're completing enrollment, we are certainly taking a really another good hard look at the SAP. I don't think there's really probably going to be any changes to the primary endpoint. The primary endpoint is the KCCQ score at week 26 in the overall population between placebo and the treated group. And as I said previously and Mike has said, that includes both the obstructive and nonobstructive. I think depending upon market, how the market unfolds and as other piece of information come into the market over the next several months as this is a dynamic market, there might be some shifting in the order that we do the hierarchy in the statistical plan right now. The key secondary is New York Heart. I think there are potential things that we could think about in the hierarchy of the statistical plan. But I think right now, we're very much aligned internally and with our external Scientific Advisory Board and co-PIs that the primary endpoint of week 26 placebo-adjusted KCCQ score is not going to change. I think on the -- I hope that answers the first. I'll answer -- move to the second question on STENO. The amount of interaction we've had with STENO is extensive. And as I think I mentioned, we get monthly updates from STENO on patient enrollment, patient enrollment by group, number of cases of DKA. We have the detailed narratives of every single patient that's developed DKA. They've been translated. We've been in continuous dialogue with the PIs of that group. We've looked at their database. We've looked at their electronic medical records. We've looked at the ability of that electronic medical record, which is in a certain format to be downloaded into SAS, which is the format that FDA database requires for submission. We've looked at the programming of SAS. I mean we have really extensively looked at this from both a data quantity and quality standpoint. We've agreed on the key variables that FDA wants to see as baseline characteristics, the exposure of DKA. We -- as I said, we have the detailed narratives of the DKA cases. So we feel comfortable that we understand each individual patient that's developed a DKA event, whether or not they are on SOTA or not. So I feel that we've really detailed gone through this in a really extensive fashion. Michael Exton: Let me just pile on that quickly there, Craig. I just want to take a moment to really recognize the scope of this data and the scope of the study as well because what we have been able to collect in collaboration with the FDA is now an exposure on SOTA that really is just a little less than what we saw in the entire inTandem program. So inTandem program was the largest trial in type 1 diabetes for glycemic control. So this is a significant amount of data, a significant amount of exposure. And as we mentioned in the prepared remarks, what we're seeing in the DKA rates between SOTA and the standard of care is similar, exactly no more than standard of care. And so this is really compelling data that we've engaged with FDA over a number of months now. And we're at the precipice of being able to really have all that together and submit the NDA. And really, it's a pretty significant moment for this program, which has a history both with Lexicon and the FDA, as you know. So I'm really, really delighted that we've reached this milestone. Operator: [Operator Instructions] I'm showing no other questions at this time. So I would now like to turn it back to Mike Exton, Chief Executive Officer of Lexicon. Michael Exton: Thanks, everyone. Look, thanks for joining us today. This has been a really important call and a really important point for Lexicon as we really execute lead to succeed. We've got a lot going on over the next 12 months, a lot to execute, but many milestones and potential catalysts ahead of us. And so I really want to thank the Lexicon team for all the effort that they've put in, in particularly progressing these 2 very important late-stage programs for sotagliflozin in type 1 diabetes and HCM and look forward to updating you further as we go throughout the rest of 2026. Thanks a lot, and have a great day. Operator: Thank you for your participation in today's conference. This does conclude the program. You may now disconnect. Before you buy stock in Lexicon Pharmaceuticals, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Lexicon Pharmaceuticals wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $400,209!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,375,393!* Now, it’s worth noting Stock Advisor’s total average return is 964% — a market-crushing outperformance compared to 215% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of August 13, 2026. This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Lexicon (LXRX) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool

Enrollment complete in Phase 3 SONATA-HCM study; top-line data expected Q1 2027 NDA resubmission activities for ZYNQUISTA® in type 1 diabetes nearing completion Phase 1 clinical development of LX9851 ongoing by Novo Nordisk Conference call and webcast at 8:30 am ET THE WOODLANDS, Texas, Aug. 06, 2026 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today reported financial results for the three months ended June 30, 2026, and provided an update on key corporate milestones and accomplishments. “Lexicon continued to make strong progress during the second quarter, with the refinement of our strategy and sharpening of our focus beginning to bear fruit across our business,” said Mike Exton, Ph.D., Lexicon’s chief executive officer and director. “Among all the accomplishments, I’m particularly pleased that we have completed enrollment of our SONATA-HCM study on time, reflecting strong clinical interest for a novel class of medicine to treat HCM. Overall, I could not be more confident in how these opportunities are poised to shape the company over the coming months.” “We remain very focused on disciplined, targeted capital allocation as we continue to advance our clinical programs,” said Scott Coiante, Lexicon’s chief financial officer. “With early commercial planning now underway for our late-state pipeline, we are committed to maximizing the value of these opportunities to create long-term shareholder value.” Second Quarter 2026 Business and Pipeline Highlights Cardiometabolic Sotagliflozin Sotagliflozin is a unique oral inhibitor of sodium-glucose cotransporter types 1 and 2 (SGLT1 and SGLT2) and has been studied in approximately 20,000 patients across multiple cardiometabolic indications. Sotagliflozin is commercially available in the U.S. for heart failure as INPEFA®. Hypertrophic Cardiomyopathy (HCM) Enrollment has been completed in SONATA-HCM, a pivotal Phase 3 placebo-controlled study, substantially exceeding its enrollment target of 500 patients across both non-obstructive (nHCM) or obstructive HCM (oHCM). The primary efficacy endpoint will assess improvement in symptoms for the entire population (nHCM and oHCM). The final study population included a substantial majority of patients with nHCM, providing a robust opportunity to evaluate sotagliflozin in a patient group for whom effective treatment options remain limited, as well as a meaningful cohort of patients with oHCM. Lexicon continues to expect topline results in the first quarter of 2027. Type 1 Diabetes (T1D) (ZYNQUISTA®) Lexicon remains focused on bringing ZYNQUISTA to market for glycemic control in adults with T1D, a patient population for which there are no treatment options beyond insulin. STENO1, a third-party funded, investigator-initiated study of sotagliflozin being conducted by the STENO Diabetes Center (Denmark) is approaching the patient exposure and safety data requirements previously identified by the U.S. Food and Drug Administration (FDA) as being adequate to support a resubmission of the company's New Drug Application (NDA), which Lexicon anticipates will occur in the fourth quarter of 2026 based on current estimated timing of data collection. The safety data received to date from this open-label trial continue to support the resubmission. Viatris License for All Indications Ex-U.S. and Ex-Europe Lexicon continues to support licensee Viatris in its regulatory filing and commercial strategy for sotagliflozin outside of the U.S. and Europe. Viatris has obtained regulatory approval for heart failure in the United Arab Emirates and Bahrain and has submitted applications for regulatory approval for heart failure in several other markets, including Saudi Arabia, Canada, Australia, New Zealand, Mexico, Singapore, Oman, Thailand, Turkey, Malaysia, Philippines, and Kuwait. Viatris anticipates regulatory decisions in Australia and Canada and regulatory submissions in other markets in 2026. LX9851 LX9851 is a first-in-class, non-incretin, oral, small molecule inhibitor of acyl-CoA synthetase 5 (ACSL5) in development by licensee Novo Nordisk for obesity and associated metabolic disorders. Obesity and Associated Cardiometabolic Disorders In March 2026, Novo Nordisk initiated a Phase 1 study investigating single and multiple ascending doses of LX9851 compared to placebo in overweight or obese people. The Phase 1 program is expected to be completed in the first quarter of 2027. Under the terms of Lexicon’s exclusive license agreement with Novo Nordisk, Lexicon received an upfront payment of $45 million and two $10 million payments related to clinical development. Lexicon is eligible to receive a third $10 million milestone payment as early as later this year and up to an aggregate of $1 billion in upfront and development, regulatory and sales milestone payments. Lexicon is also eligible for tiered royalties on net sales of LX9851. Pilavapadin (LX9211) Discovered using Lexicon’s unique approach to gene science and target identification, pilavapadin is a potent, once-daily, orally delivered, selective, investigational small molecule inhibitor of AAK1. Lexicon identified AAK1 in its target discovery efforts as a promising approach for the treatment of neuropathic pain and is exploring its potential in other indications. Diabetic Peripheral Neuropathic Pain (DPNP) Pilavapadin has the potential to be the first oral, non-opioid drug therapy approved in neuropathic pain in more than 20 years. Lexicon continues to explore strategic opportunities to maximize the global potential of this investigative therapy. Second Quarter 2026 Financial Highlights Revenues: Total revenues were $0.7 million for the second quarter of 2026, consisting of net sales of INPEFA. Total revenues for the second quarter of 2025 were $28.9 million, consisting of $27.6 million in licensing revenue recognized from the Novo Nordisk licensing agreement and $1.3 million from net sales of INPEFA. Research and Development (R&D) Expenses: Research and development expenses for the second quarter of 2026 increased to $17.4 million from $15.7 million for the corresponding period in 2025, reflecting higher external research expense in 2026 related to the Company’s ongoing SONATA-HCM Phase 3 clinical trial. Selling, General and Administrative (SG&A) Expenses: Selling, general and administrative expenses for the second quarter of 2026 increased to $9.8 million from $9.4 million for the corresponding period in 2025. The increase in 2026 reflects higher professional and consulting costs. Net Loss: Net loss for the second quarter of 2026 was $31.8 million, or $0.07 per share, as compared to net income of $3.3 million, or $0.01 per share, in the corresponding period in 2025. Net loss for the second quarter of 2026 and net income for the second quarter of 2025 included non-cash, stock-based compensation expense of $3.3 million and $3.2 million, respectively. Cash, Investments and Restricted Cash: As of June 30, 2026, Lexicon had $190.6 million in cash and investments, as compared to $125.2 million in cash, investments, and restricted cash as of December 31, 2025. The increase in cash and investments reflects net proceeds of $96.2 million from the sale of common and preferred stock in February 2026. Hercules Capital Loan FacilityIn May 2026, Lexicon entered into a $100 million loan facility with Hercules Capital. An initial $55 million tranche was funded at closing and used to repay Lexicon’s previous loan facility with Oxford Finance. The second $20 million tranche is available for draw at Lexicon’s option subject to the achievement of certain clinical, regulatory and financial milestones and specified timing requirements. The third $25 million tranche is available for draw at Lexicon’s option subject to Hercules’ consent and specified timing requirements. Conference Call and Webcast Information  Lexicon management will hold a live conference call and webcast today at 8:30 am ET / 7:30 am CT to review its financial and operating results and to provide a general business update. A live audio webcast of the call can be accessed by visiting the Events page of the Company’s investor relations website at https://investors.lexpharma.com/. Participants who wish to ask a question may join by phone at 800-715-9871 and use passcode 9826247. An archived version of the webcast will be available on the website for 30 days. About Lexicon Pharmaceuticals Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Lexicon has a pipeline of drug candidates in discovery, preclinical, and clinical development in neuropathic pain, hypertrophic cardiomyopathy (HCM), obesity and metabolic disorders, and other cardiometabolic indications. For additional information, please visit www.lexpharma.com. Safe Harbor Statement This press release contains “forward-looking statements,” including statements relating to Lexicon’s financial position and long-term outlook on its business, including the commercialization of its approved products and the clinical development of regulatory filings for, and potential therapeutic and commercial potential of its other drug candidates. In addition, this press release also contains forward looking statements relating to Lexicon’s growth and future operating results, discovery, development and commercialization of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicon’s ability to meet its capital requirements, successfully commercialize its approved products, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of its other drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its approved products and other drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2025, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise. For Media Inquiries:Dave BelianLexicon Pharmaceuticals, [email protected] For Investor Inquiries:Lisa DeFrancescoLexicon Pharmaceuticals, [email protected]

This article first appeared on GuruFocus. Total Revenue: $0.7 million for Q2 2026, compared to $28.9 million in Q2 2025. Licensing Revenue: Q2 2025 included $27.5 million in licensing revenue from the Novo Nordisk agreement; no comparable revenue was recognized in Q2 2026. R&D Expenses: $17.4 million in Q2 2026, up from $15.7 million in Q2 2025, driven by higher external costs for the SONATA HCM Phase III trial. SG&A Expenses: $9.8 million in Q2 2026, compared to $9.4 million in Q2 2025. Net Loss: $31.8 million, or $0.07 per share, in Q2 2026, versus net income of $3.3 million, or $0.01 per share, in Q2 2025. Non-Cash Stock-Based Compensation: $3.3 million in Q2 2026 and $3.2 million in Q2 2025. Loss on Early Extinguishment of Debt: $4.3 million, or $0.01 per share, in Q2 2026 from early repayment of term loans with Oxford Finance. Cash Position: $190.6 million in cash equivalents and short-term investments as of June 30, 2026, versus $125.2 million in cash equivalents, short-term investments, and restricted cash as of December 31, 2025. 2026 Operating Expense Guidance: Reiterated at $100 million to $110 million, with R&D between $63 million and $68 million and SG&A between $37 million and $42 million. Warning! GuruFocus has detected 5 Warning Signs with LXRX. Is LXRX fairly valued? Test your thesis with our free DCF calculator. Release Date: August 06, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Lexicon Pharmaceuticals Inc (NASDAQ:LXRX) completed enrollment in its Phase 3 SONATA HCM trial, which was significantly over-enrolled, potentially improving the study's statistical power. The company expects to meet all FDA criteria for resubmitting the Zynquista NDA, with DKA rates in the STENA-1 study similar to standard of care and below those seen in prior trials. Lexicon Pharmaceuticals Inc (NASDAQ:LXRX) anticipates completing the Zynquista NDA resubmission in Q4 2026, with potential for a faster-than-standard FDA review. The company strengthened its balance sheet with a new $100 million debt facility from Hercules Capital, improving financial flexibility. Lexicon Pharmaceuticals Inc (NASDAQ:LXRX) is advancing its pipeline, including LX-9851 for obesity with licensee Novo Nordisk, and has potential to receive a third $10 million milestone payment later this year. The company is exploring new high-value indications for pilavapidin, with preclinical data expected later this year. Lexicon Pharmaceuticals Inc (NASDAQ:LXRX) reported a net loss of $31.8 million for Q2 2026, a significant decline from net income of $3.3 million in the same period of 2025. Total revenues dropped sharply to $0.7 million in Q2 2026 from $28.9 million in Q2 2025, primarily due to the absence of a one-time licensing fee from Novo Nordisk. The Zynquista NDA resubmission timeline was delayed to Q4 2026, slightly later than previously anticipated. The company incurred a $4.3 million loss on the early extinguishment of debt related to repaying its Oxford Finance term loans. Lexicon Pharmaceuticals Inc (NASDAQ:LXRX) faces uncertainty regarding the commercial potential of sotagliflozin in HCM, as the trial includes a mix of obstructive and non-obstructive patients, and the exact patient breakdown on cardiac myosin inhibitors has not been disclosed. The company's cash position of $190.6 million may be insufficient to fund all operations and milestones without additional financing or successful commercialization. Q: On SONATA, given the substantial majority of NHCM patients with a meaningful OHCM cohort, how should we think about the mix in terms of commercial and regulatory value if the overall population is positive? Is directionality across both phenotypes more important than the exact magnitude in each group?A: Craig Granowitz (CMO): The trial is powered on the overall population, which was discussed with the FDA and includes both obstructive and non-obstructive patients. The significant over-enrollment gives us even more confidence in the primary endpoint. While there are more non-obstructive patients, there is a significant enough number of obstructive patients to find meaningful results in both groups. Mike Exton (CEO) added that commercially, there is opportunity across the spectrum, as obstructive patients remain symptomatic despite approved agents, and non-obstructive patients have no approved options. Sotagliflozin is the only SGLT inhibitor in HCM, applicable as a solo treatment or in combination with cardiac myosin inhibitors. Q: On type 1 diabetes, you're resubmitting in Q4 versus mid-26 before. Can you talk about why it's taking longer to accrue data?A: Craig Granowitz (CMO): STENA-1 is an investigator-initiated trial never designed for regulatory purposes. We've been working continuously with Steno to pull data together in the format the FDA requires, which is taking more time. The most important aspect is that the trial has achieved the exposure required by the FDA for both sotagliflozin and the control group. The rates of diabetic ketoacidosis (DKA) in the SOTA-treated group are similar to standard of care and well below those observed in the In Tandem trials. Mike Exton (CEO) added that submission could be as early as end of October, which with a six-month review would put approval in Q2 2027, though they will work proactively with the FDA to potentially expedite the review. Q: On SONATA, are you able to share the proportion of patients on cardiac myosin inhibitors (CMIs) and how that might impact overall results and future prescribing? What does the majority NHCM mean for the OHCM proportion?A: Craig Granowitz (CMO): We haven't broken out the proportions and probably won't until we share baseline characteristics at an upcoming medical meeting. There are a fair number of patients on a CMI, but availability was limited since the trial included 20 countries and the US, while the largest single enrolling country, was not a majority. The protocol required patients to be on a stable dose of underlying HCM medications for at least six months. The single unifying characteristic of the trial is that all patients have a baseline KCCQ score of less than 85, which is the gold standard for managing symptomatic relief. Q: Could you give us your updated thoughts on where sotagliflozin fits into the HCM landscape, given other biotechs are gearing up for Phase 3 trials? How do you see prescribers making decisions between programs?A: Mike Exton (CEO): Sotagliflozin is a complementary mechanism to currently approved and newer agents. It has unique attributes that support first-line use: it's an oral, once-a-day medicine that is extremely well tolerated and safe, with broad access for patients. We see it naturally as an option that a broad range of physicians could turn to immediately for symptomatic HCM, with the possibility of adding a CMI if patients remain symptomatic. Q: The population contains both obstructive and non-obstructive, and the study is powered for KCCQ in both. How do you envision exploring optionality if there is statistical separation in one population versus another? What work goes into that, and how much flexibility do you have before locking the database?A: Craig Granowitz (CMO): We are taking a hard look at the statistical analysis plan (SAP) as we complete enrollment. The primary endpoint of KCCQ score at week 26 in the overall population will not change. However, depending on how the market unfolds, there might be shifts in the order of the hierarchy in the statistical plan. We are aligned internally and with our external scientific advisory board that the primary endpoint remains unchanged. Q: What type of data were generated by the PI for Zynquista as well as in-house to correlate together to ensure a near-complete filing, and what is the timing around that?A: Craig Granowitz (CMO): The interaction with Steno has been extensive. We receive monthly updates on patient enrollment and DKA cases, have detailed narratives of every DKA patient, and have been in continuous dialogue with the PIs. We've examined their database, electronic medical records, and the ability to download data into SAS format for FDA submission. We've agreed on key variables for baseline characteristics and exposure. Mike Exton (CEO) added that the exposure on sotagliflozin is now just a little less than the entire In Tandem program, and DKA rates are similar to standard of care, making this compelling data as they approach NDA submission. Q: On LX-9851, how should we think about the bar for continued development coming around Phase 1? What would constitute a supportive data package for Novo to move the program forward?A: Mike Exton (CEO): The bar for development is now a question for Novo Nordisk. We're incredibly pleased with how the partnership has progressed. Novo is very enthusiastic about the mechanism, and the Phase 1 trial is progressing extremely well. We've always thought that combinations of different mechanisms of oral medicines will be important in obesity, and Novo, as the leader in oral weight loss medicines, is taking that approach with LX-9851. Q: Can you elaborate on the financial results for the quarter and the company's balance sheet position?A: Scott Coiante (CFO): Total revenues were $0.7 million for Q2 2026, compared to $28.9 million in Q2 2025, which included $27.5 million in licensing revenue from Novo Nordisk. R&D expenses were $17.4 million, reflecting higher external costs for the SONATA HCM Phase 3 trial. Net loss was $31.8 million, or $0.07 per share, including a $4.3 million loss on early extinguishment of debt. As of June 30, 2026, the company had $190.6 million in cash and short-term investments. In May, the company announced a $100 million debt facility with Hercules Capital, with an initial $55 million tranche funded to repay the Oxford Finance loan. The company reiter For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Interested in Lexicon Pharmaceuticals, Inc.? Here are five stocks we like better. Revenue fell sharply to $0.7 million from $28.9 million a year earlier, while Lexicon reported a $31.8 million net loss versus $3.3 million in net income in Q2 2025. Lexicon completed enrollment in the Phase III SONATA-HCM trial of sotagliflozin, which was significantly over-enrolled; top-line results are expected in the first quarter of 2027. The company expects to resubmit ZYNQUISTA’s NDA for type 1 diabetes by the fourth quarter, potentially leading to an FDA decision in Q2 2027, while ending June with $190.6 million in cash and short-term investments. Lexicon Pharmaceuticals (NASDAQ:LXRX) reported a wider second-quarter loss as revenue declined sharply from the prior-year period, while the company highlighted completed enrollment in its Phase III SONATA-HCM trial and outlined plans to resubmit a new drug application for ZYNQUISTA in type 1 diabetes during the fourth quarter. Total revenue for the quarter ended June 30 was $0.7 million, compared with $28.9 million a year earlier. Second-quarter 2026 revenue represented net sales of INPEFA, while the prior-year quarter included $27.5 million of licensing revenue related to the company’s agreement with Novo Nordisk, in addition to INPEFA sales. → 3 Drone Stocks That Should Soar After the Summer Slump Lexicon recorded a net loss of $31.8 million, or $0.07 per share, compared with net income of $3.3 million, or $0.01 per share, in the second quarter of 2025. The 2026 loss included a $4.3 million loss on early debt extinguishment associated with the repayment of term loans from Oxford Finance. Non-cash stock-based compensation expense was $3.3 million, compared with $3.2 million a year earlier. Chief Executive Officer Mike Exton said Lexicon completed enrollment in SONATA-HCM, a Phase III study evaluating sotagliflozin in patients with hypertrophic cardiomyopathy, or HCM. The company said the study was significantly over-enrolled and described it as the largest Phase III study to date involving both obstructive and non-obstructive HCM. → Meta’s Earnings Drop Shows Wall Street Wants More Than Ad Growth Lexicon expects to report top-line results from the trial in the first quarter of 2027. The study’s primary efficacy endpoint is the change from baseline to week 26 in the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score, or KCCQ-CSS, across the overall study population. Chief Medical Officer Craig Granowitz said the trial enrolled a substantial majority of patients with non-obstructive HCM, a population for which the company said treatment options remain limited, along with a meaningful cohort of obstructive HCM patients. Patients receiving stable guideline-directed HCM therapy, including cardiac myosin inhibitors, were permitted to enroll. → Jersey Mike's Serves Fresh Gains After IPO Stumble During the question-and-answer session, Granowitz said the trial is powered for the combined obstructive and non-obstructive population. He added that the over-enrollment increased management’s confidence in the study’s ability to assess the primary endpoint and that the company expects sufficient obstructive-HCM enrollment to evaluate results in both groups. Exton said Lexicon views sotagliflozin as potentially usable either alone or alongside cardiac myosin inhibitors, though any future commercial positioning would depend on clinical and regulatory outcomes. Lexicon said the STENO-1 study, an open-label investigator-initiated study being conducted by the Steno Diabetes Center in Denmark, is expected to reach the patient-exposure level requested by the U.S. Food and Drug Administration by the end of August. The FDA had requested a prospective study, adequate patient exposure and diabetic ketoacidosis, or DKA, rates below those seen in Lexicon’s earlier clinical trials to support resubmission of the ZYNQUISTA new drug application. Granowitz said DKA rates among sotagliflozin-treated patients in STENO-1 have been similar to the study’s standard-of-care group and below rates observed in Lexicon’s prior inTandem studies. The company expects to complete the administrative work needed to collect and transfer patient-level data after the exposure threshold is reached. Lexicon currently anticipates an NDA resubmission during the fourth quarter, with Granowitz citing the end of October as the company’s current estimate. In response to an analyst question on potential review timing, Exton said a six-month review following an end-of-October filing could place a decision in the second quarter of 2027. He noted, however, that the company intends to discuss whether a quicker review may be possible because the FDA has already received much of the information expected in the filing. Outside the U.S. and Europe, Lexicon licensee Viatris has secured regulatory approvals for sotagliflozin in the United Arab Emirates and Bahrain. Viatris has also submitted applications in more than a dozen additional markets, including Saudi Arabia, Canada and Australia. Regulatory decisions in Canada and Australia are anticipated this year, according to Lexicon. Lexicon said LX9851, an oral small-molecule inhibitor of ACSL5 being developed for obesity, is in a Phase I study being conducted by Novo Nordisk. Lexicon has received two $10 million milestone payments under its license agreement with Novo Nordisk and said it could receive a third $10 million milestone later this year. The company also said it is conducting preclinical work to explore additional potential indications for pilavapadin, which uses an AAK1 inhibition mechanism. Lexicon said it expects to share preclinical data as early as later this year. Research and development expense rose to $17.4 million from $15.7 million a year earlier, driven by higher external costs related to the SONATA-HCM trial. Selling, general and administrative expense increased to $9.8 million from $9.4 million. As of June 30, Lexicon had $190.6 million in cash equivalents and short-term investments, compared with $125.2 million in cash equivalents, short-term investments and restricted cash at the end of 2025. In May, the company announced a $100 million debt facility with Hercules Capital. An initial $55 million tranche was funded at closing and used to repay the Oxford Finance facility. Lexicon may access an additional $20 million subject to clinical, regulatory and financial milestones, while a further $25 million tranche would require Hercules’ consent and meet specified timing requirements. Lexicon reiterated its 2026 operating expense guidance of $100 million to $110 million, including expected research and development spending of $63 million to $68 million and selling, general and administrative spending of $37 million to $42 million. The company said it began targeted pre-commercial investments during the second quarter, including medical education, marketing preparation and market-access activities. Lexicon Pharmaceuticals, Inc is a biopharmaceutical company focused on the discovery and development of novel medicines through its proprietary genome biology platform. By leveraging large-scale gene knockout libraries, the company identifies potential therapeutic targets and advances them through preclinical and clinical development. Lexicon's approach emphasizes the translation of genetic insights into targeted therapies for a range of human diseases. The company's most advanced product is telotristat ethyl (sold under the brand name XERMELO), an oral treatment approved for the management of carcinoid syndrome diarrhea in patients inadequately controlled by somatostatin analog therapy. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Lexicon Pharmaceuticals Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Image source: The Motley Fool. Thursday, May 7, 2026 at 8:30 a.m. ET Chief Executive Officer and Director — Dr. Mike Exton Senior Vice President and Chief Medical Officer — Dr. Craig Granowitz Senior Vice President and Chief Financial Officer — Scott Coiante Vice President, Investor Relations and Corporate Communications — Lisa DeFrancesco Need a quote from a Motley Fool analyst? Email [email protected] Lisa DeFrancesco: 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 Coiante, 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.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 sotagliflozin, pilavapadin, 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 INPEFA 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, our CEO. Michael Exton: Yes. 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 midyear; second, expand our internationally through both existing collaborations with Viatris and Novo Nordisk and the new collaboration for pilavapadin; 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 summarize our year-to-date highlights in a bit more detail. Lexicon is advancing a portfolio of novel targeted therapies in 2 main therapeutic areas, cardiometabolic diseases and chronic pain. We've made meaningful progress across each of these programs. Now starting with sotagliflozin. In hypertrophic cardiomyopathy, or HCM, we are on track to complete enrollment in the SONATA Phase III study midyear. SONATA continues to enroll well, and we're seeing strong execution as we approach enrollment completion. Type 1 diabetes, we remain on track to resubmit our application for approval of Zynquista with the FDA by midyear, 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 STENO1 study, and the data we've seen thus far continue to support a favorable benefit risk profile. On the global front, our licensee, Viatris has submitted regulatory applications for SOTA in heart failure across an increasing number of markets outside the U.S. and Europe with a launch underway in the United Arab Emirates. With LX9851, a first-in-class ACSL5 inhibitor for obesity, our licensee, Novo Nordisk initiated the Phase I 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 Novo Nordisk 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 pilavapadin. 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 pilavapadin was really to secure nondilutive 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 loan 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. And with that, I'll ask Craig Granowitz, our Chief Medical Officer, to provide additional color on these pipeline updates. Craig? Craig Granowitz: Thank you, Mike, and good morning, everyone. I'll start with sotagliflozin, our novel oral SGLT1 and SGLT2 inhibitor, which is in late-stage development in both HCM and type 1 diabetes. I want to take a moment and remind everyone of the important and unique effects of sotagliflozin's mechanism of action. Sotagliflozin is the only dual inhibitor of both SGLT1 and SGLT2, and I want to emphasize the importance of the SGLT1 effects. While SGLT2 is expressed primarily in the kidney, SGLT1 is expressed in the kidney, but also in other tissues, particularly the GI tract and the heart as well as the endothelial. Inhibition of SGLT1 in the GI tract is important in postprandial glycemic control in people with T1D. And we believe the inhibition of SGLT1 in the heart has important effects on myocardial health, particularly in disease states like HCM. It is also noteworthy that SGLT1 expression is upregulated in patients with ischemic heart conditions and in patients with hypertrophic cardiomyopathy. Lexicon continues to study and publish the biology of inhibition of the dual effects of both SGLT1 and SGLT2. As Mike mentioned, we are rapidly approaching 2 important potential catalysts for sotagliflozin, both of which are anticipated around midyear. First, for HCM, we expect enrollment of our global Phase III SONATA trial of sotagliflozin in HCM to be completed by mid-2026. This pivotal study is evaluating approximately 500 patients with HCM, randomized across 130 enrolling sites in 20 countries and includes patients with obstructive and non-obstructive phenotype. Based on current enrollment trends, we continue to anticipate top line data from this study in the first quarter of 2027. In type 1 diabetes, we remain on track for an NDA submission of Zynquista for glycemic control in adults with type 1 diabetes based on clinical data from the STENO1 investigator-initiated trial. Based on the data from the study thus far and FDA discussions, we believe there is potential for Zynquista to be approved in 2026. On the base of our activities with SONATA-HCM trial and with the STENO study group, we believe that sotagliflozin has the potential to meaningfully advance the treatment landscape for people with HCM and for those with T1D. With this in mind, let me tell you a bit more about what gives us confidence in sotagliflozin in these 2 indications. As a reminder, SONATA-HCM is a large global registration trial with a primary endpoint of placebo-adjusted improvement in the KCCQ CSS score and is designed to support a regulatory filing and broad label in HCM. The study randomized adults with symptomatic HCM, which includes both obstructive and nonobstructive phenotypes. With its unique dual mechanism of action, we believe sotagliflozin should provide clinically meaningful improvements in both symptoms and function in both the obstructive and nonobstructive disease. Sotagliflozin is acting through a dual mechanism or a distinct mechanism from CMIs. Patients on a stable dose of CMI who continue to have heart failure symptoms are also enrolling in the study. What makes sotagliflozin different is that it's acting both as a hemodynamic agent and as a metabolic agent to treat HCM. To explain further, through SGLT1 inhibition, sotagliflozin acts as a metabolic agent directly on the heart to improve the heart -- the functioning of the heart muscle. Additionally, sotagliflozin is acting as a hemodynamic agent by acting on the cardiorenal axis to improve the body's fluid balance and improve outcomes. In total, if you consider its once-daily dosing regimen, established safety profile in clinical studies and post-marketing use and proven CV outcomes in patients with heart failure, we believe that sotagliflozin has the potential to be broadly adopted in the management of HCM with a strong benefit risk profile. In recent months, we've continued to present additional evidence supporting sotagliflozin's unique potential. In addition to recent data presented on T1D, I'd like to focus on the SOTA-P-CARDIA study of sotagliflozin at the American College of Cardiology Annual Meeting. These analyses provided further evidence of benefit across patient subgroups potentially related to its mechanism of action. As previously reported, results from SOTA-P-CARDIA demonstrated a placebo-adjusted 19-point improvement in the KCCQ score. These new analyses showed meaningful effects of SOTA on changes in patient functioning as measured by the 6-minute walk test. Additionally, there was an impact on a number of metabolic parameters, including a reduction of epicardial fat in patients treated with sotagliflozin. While not shown in this slide, there was also a reduction in the left atrial volume in those patients treated with sotagliflozin. Collectively, the data from this study demonstrate meaningful benefits on symptoms, function and physiology, which may validate the effectiveness of SOTA in HCM for clinicians. Turning now to Zynquista in type 1 diabetes. As we have previously discussed, the FDA has confirmed that data from STENO1, third-party funded investigator-initiated study being conducted by the STENO Diabetes Center in Denmark is adequate to support a resubmission for our NDA provided patient exposure and safety data requirements are achieved. Based on the data that we have seen to date, we are optimistic that we are on track for NDA resubmission midyear with potential approval in 2026. There are 3 key points supporting our time lines and potential for Zynquista. First, enrollment is going as expected in the trial. Second, we remain comfortable with the data and safety profile STENO1 has generated to date. And third, we are continuing to work on an ongoing basis with the FDA on the final parameters surrounding the exact formatting and submission dates for the data. In short, there are a number of items that need to be completed in order to file midyear, but we remain on track. If approved, Zynquista will be the first and only oral adjuvant to insulin therapy ever approved for glycemic control in type 1 diabetes. Our final cardiometabolic program is LX9851, our first-in-class non-incretin oral small molecule inhibitor of ACSL5 in development for obesity and associated metabolic disorders. Global development by our licensee, Novo Nordisk continues to advance and LX9851 is now in the clinic following Novo's initiation of a Phase I study in March. We are pleased by Novo's continued enthusiasm for this candidate and its novel mechanism and how swiftly Novo has advanced this program into clinical development. Now turning to our chronic pain program. Like sotagliflozin, pilavapadin has a broad pipeline and a pill potential. Pila is a novel investigative therapy targeting AAK1. Beyond DPNP, we believe that there are a number of potential applications for pilavapadin. The AAK1 pathway is central to a number of cellular processes such as synaptic signaling between neurons involved in pain signaling and also spasticity. With this in mind, we are conducting IND-enabling work in multiple additional neuroscience indications. Last month, we presented 2 additional data sets at the AAN Annual Meeting that further validate the development of pilavapadin in DPNP as well as other neuroscience indications. First, we shared additional efficacy data from the PROGRESS-3 Phase IIb study supporting the selection of pilavapadin 10 milligrams for Phase III development in DPNP. Following the top line results from the PROGRESS Phase II study last year, we knew we needed to deepen our understanding of these results through additional analyses. The data presented at AAN provided additional validation needed to advance pilavapadin 10 milligrams as well as a deeper understanding of the profile of this novel mechanism. The data we have seen to date give us further confidence that pilavapadin is Phase III ready in DPNP. Second, we presented preclinical evidence supporting pilavapadin as a novel oral therapy for spasticity, including evaluation in preclinical models of multiple sclerosis and spinal cord injury. The data shared at AAN underscore the opportunity to expand the potential of pilavapadin beyond DPNP, consistent with the pipeline in a pill opportunity that we have discussed. I'll now turn it over to Scott to provide an update on the company's financials. Scott Coiante: Thank you, Craig. I'll begin with a summary of our results for the first quarter of 2026. Total revenues were $21.1 million for the quarter compared to $1.3 million for the corresponding period in 2025. Revenues for the first quarter of 2026 include 2 $10 million milestones recognized from the Novo Nordisk agreement and net sales of INPEFA of $1.1 million. Research and development expenses for the first quarter of 2026 were $12.8 million compared to $15.3 million in the corresponding period of 2025, reflecting lower external research expense in 2026 due to the completion of our PROGRESS Phase IIb clinical trial and the licensing of LX9851 to Novo Nordisk. Selling, general and administrative expenses for the first quarter of 2026 were $9.2 million compared to $11.6 million in the corresponding period of 2025. The decrease in 2026 reflects reduced marketing efforts and lower personnel costs. Net loss for the first quarter of 2026 was $1.0 million or less than $0.01 per share compared to a net loss of $25.3 million or $0.07 per share in the corresponding period of 2025. Net loss for the first quarter of 2026 included noncash stock-based compensation expense of $3.1 million. As of March 31, 2026, Lexicon had $199.7 million in cash, cash equivalents, short-term investments and restricted cash as compared to $125.2 million as of December 31, 2025. Total debt as of March 31, 2026, was $49.7 million as compared to $54 million as of December 31, 2025. I'd like to now highlight a few items from the first quarter. As I mentioned, revenue for the first quarter included 2 $10 million milestones recognized under our Novo Nordisk licensing agreement. Quarter-over-quarter, our operating expenses decreased by $4.8 million, reflecting our continued operational discipline and the strategic repositioning we began implementing in late 2024. We are also reaffirming our full year 2026 outlook for operating expenses. Earlier this week, we took steps to improve our balance sheet and enhance our financial flexibility. We announced a $100 million debt facility with Hercules Capital. Under the terms of this agreement, an initial tranche of $55 million was funded at closing and was utilized to repay our existing loan facility with Oxford Finance. A second $20 million tranche is available for draw at Lexicon's option, subject to the achievement of certain clinical, regulatory and financial milestones and specified time requirements. A third $25 million tranche is available for draw at Lexicon's option, subject to Hercules consent and specified timing requirements. The loan facility provides for an initial interest-only period of 18 months with the potential for 2 6-month extensions. We are incredibly pleased with our financial accomplishments thus far in 2026, including the completion of our capital raise in February and our new loan facility with Hercules. We have strengthened our balance sheet and improved our financial flexibility while remaining prudent with our expenses ahead of our important milestones in the back half of this year. I will now turn it back to Mike for closing remarks. Michael Exton: Yes. Thanks, Scott. Now before we turn to Q&A, I just want to reiterate how -- just how pivotal year 2026 is for Lexicon. To ensure success for the year and to get us to this point where in H2, we will have a number of important things happen for the company, we've done 2 things. We've taken steps, firstly, to strengthen our financial foundation over the last few months. And second, we've executed incredibly well. And as a result, we have many significant milestones just weeks away. I'm excited for how the opportunities are really shaping up for us, both with our own actions, but also importantly, within the external environment, which is favoring our approach across the board for all of our programs. For HCM, as the field evolves and awareness of both obstructive and now importantly, nonobstructive disease really advance. We are well positioned with a therapy that has the potential for a strong benefit risk profile and ease of use at a time where market awareness will be high and the need will clearly remain significant. In T1D, we haven't given up. Indeed, our result is strengthened by the ongoing constructive dialogue with the FDA. Indeed, we're close to being able to submit new clinical data that we believe demonstrates a strong benefit risk for Zynquista with people with T1D, supported by high unmet need and strong patient support for approval. With pilavapadin, we're pursuing the right strategic partner to allow for the greatest potential for this novel asset at a time when the pain therapeutic space and legislative and regulatory environment are increasingly in our favor of new novel non-opioid approaches. And finally, with LX9851, our licensee, Novo Nordisk continues to prioritize the clinical development of the asset. And indeed, just yesterday, highlighted 9851 in their earnings call. So by next quarter, even in just the next few weeks, we believe we'll be able to share a number of positive developments, and we thank you for your continued attention and support. And with that, I'll turn it back to you, operator, to guide us through the Q&A. Operator: [Operator Instructions] And your first question comes from the line of Andrew Tsai with Jefferies. Brian Balchin: It's Brian here on for Andrew. Just given the ACACIA data in nonobstructive that just hit with aficamten, how does that make you feel about your own SONATA Phase III? And if you can just talk about potential differentiation there as well, please? Michael Exton: Yes. No, thanks, Brian. I appreciate the question. So look, I think first and foremost, it's really an exciting time to be in the field of HCM. I think there's a lot of enthusiasm and a lot of patient need. And what we saw yesterday from the ACACIA study really gives us a lot of confidence that we have an asset where we believe we will have an incredibly strong benefit risk profile. We know the safety of sotagliflozin through many years of study and many thousands of patient exposure. And if SONATA is positive, we believe that represents a strong benefit risk profile. And really, the opportunity, particularly in nonobstructive is incredibly large. And so we're really buoyed by that, and it gives us confidence in our step moving forward, particularly because with a strong benefit risk profile, together with that simple once-a-day oral dosing, we really see ourselves positioned particularly in nonobstructive as a first-line therapy. It makes a ton of sense where you don't have a REMS, you're a simple, well-known, safe product that provides significant symptom relief that first-line asset can work very well for us. And importantly, really, these are 2 very different mechanisms. And like many types of cardiometabolic disease, using multiple mechanisms for shots on goal to relieve symptoms and improve outcomes is typically done. So we're incredibly pleased that we have a strong opportunity in non-obstructive and obstructive disease. Craig Granowitz: Yes. I'll just add, Brian, a couple of other points. Thank you, Mike, for your comments. As Mike mentioned, the mechanisms of action here are not in conflict. In fact, they're probably complementary I think the general feeling in the field is that CMIs are acting primarily as hemodynamic agents. And as I tried to mention in my prepared remarks, SOTA is acting as a hemodynamic agent in a different manner, really acting on the cardiorenal axis and also improving a number of other parameters, some weight loss, increase in hemoglobin, decrease in blood pressure, all of which are beneficial for the heart in any heart failure state. And in addition, we believe that the SGLT1 effects with SGLT1 receptors upregulated, particularly in the myocardium that acting directly on the heart muscle tissue in a way that is novel and distinct from a CMI is important. As we've mentioned in prior calls, we have not excluded patients on CMIs in this trial. And I can tell you that we are enrolling symptomatic patients on CMIs. Obviously, they're all mavacamten because that was the only product that's been commercially available heretofore. I also think that the results from ACACIA had, I would say, at least on a median basis, a relatively modest effect on KCCQ score. And if the patients had baseline KCCQ scores similar to what was seen in ODYSSEY, my guess is a number of those patients will still remain symptomatic and will require additional therapy, which is consistent with what we're seeing in our trial enrollment that all the patients that are on CMIs remain symptomatic. So I think in that regard, as Mike said, the biggest issue in nonobstructive is going to be patient identification because people have not been looking for nonobstructive disease and I think historically have just sort of lumped them into a slightly different variant of HFpEF. And I think that differentiation of a much thicker left ventricular wall has probably not been appreciated to date and having another company out there really talking about the importance of nonobstructive HCM as a separate disease state from HFpEF, I think will be extraordinarily important for the field and for Lexicon. Operator: Your next question comes from the line of Yigal Nochomovitz with Citigroup. Unknown Analyst: This is Caroline on for Yigal. We're wondering if you can tell us what percent of enrollment in the Phase III SONATA-HCM study has been completed? And how is the split in enrollment trending between obstructive and nonobstructive patients? Is there a risk of too many nonobstructive patients relative to obstructive patients given some obstructive patients are currently being treated with CMI, which you've mentioned before? And what if the enrollment is weighted more towards one group or the other? Craig Granowitz: Yes. Great questions. I'll answer them in the order that you asked them. We haven't given exact numbers of enrollment, but I can say confidently that we reaffirm the time lines that we have with enrollment middle of this year in terms of last patient first visit of 500 target patients. We've seen, as expected as all the sites come online, the expected and dramatic uptick in enrollment as the sites open and become familiar with the study and its availability. The distribution of patients, again, I don't want to comment too early before we finalize enrollment. I think as we've said, the need is larger in the nonobstructive group since there is an obstructive therapy available with CAMZYOS during the duration of the trial, but we are enrolling significant numbers of both obstructive and nonobstructive patients in the trial. Operator: [Operator Instructions] And your next question comes from the line of Yasmeen Rahimi with Piper Sandler. Dominic Lorenzi: This is Dominic on for Yas. Congrats on the great quarter. We just had a few questions and then kind of going along with some of the conversation about enrollment. At the time of enrollment completion in mid-2026 for SONATA, would you potentially unveil baseline demographics? And then kind of in line with that, do you have any thoughts on how similar SONATA's patient population will look to ACACIA for the recent readout? And we have one more question just on what would be a clinically meaningful difference in KCCQ? And what did you power SONATA for on this endpoint? Michael Exton: Yes. Thanks, Dominic. Let me start up and then Craig can take some of the detailed SONATA questions as well. So we haven't finalized exactly the information that we will release at the time of enrollment, but we're certainly committed and understand that there's interest across a number of parameters. Of course, this split as given by the questions that are coming, the split of obstructive, nonobstructive is of interest and to really get the final baseline dems to compare that to SONATA. So we will -- we're very cognizant of that, and we will determine over the coming weeks exactly what we will release when. So we haven't sort of finalized, but we will be providing updates because we are cognizant that, that's important for folks to understand. As it comes to the sort of the SONATA specific questions, I might let you take those, Craig. Craig Granowitz: Yes. Thanks, Mike. I hope I have your questions correct. I'll answer the one on demographics first. Again, we're still enrolling the trial and ACACIA has not really, to my knowledge, given details on the demographics similar to what was done with ODYSSEY since ODYSSEY is now already published. But I think we're seeing a patient population similar to what has been reported for ODYSSEY. You're really looking at a population in their mid-50s to 60, pretty symptomatic disease, a good distribution by gender, equal distribution of gender. So we have a population, I think, was very consistent with what we expected, particularly the demographic and the geography that we're enrolling in this trial, which is U.S. and across Europe. So I think in that regard, we've not seen anything unexpected. We haven't looked at detail yet at the KCCQ scores or anything else. But certainly, we know that patients are symptomatic that are coming into the disease. Michael Exton: And broadly similar entry criteria, right? Craig Granowitz: Yes. Exactly, Mike. Yes. Thank you. Very similar entry criteria to the other trials. Clinically meaningful KCCQ score, I think the field is generally focused on 5, 4 to 5 as a number. I think there may be a rethinking of that in light of some of the more recent study results that have come out. But certainly, historically, that has been seen as an important threshold for clinical meaningfulness. And that's how we powered our trial is based on that range. Again, we haven't given the exact statistical plan that we're using, but we can certainly detect in that range comfortably with a high degree of probability of success. And I do think that is going to be a real point of discussion in the field of risk benefit with modest improvements in KCCQ, but with potential for safety concerns and monitoring, I think those are going to be important discussions that the field will be having as the field of nonobstructive HCM is further discussed at upcoming medical meetings and probably also with payers and regulatory authorities. Operator: And there are no further questions at this time. I will now turn the call back over to Mike Exton for closing remarks. Michael Exton: Thanks so much, everyone. Thanks for tuning in and listening to our update. As I mentioned, the team has really worked incredibly hard to put us in a strong financial and strategic position and to execute across all of our programs. And we're really looking forward to H2 here in 2026. I think as you see from our remarks, we've got many things that we've been working on diligently over the last week while are going to come to fruition. And so I really look forward to updating you with a lot more information in the not-too near future. So have a great day and look forward to speaking with you all again soon. Thank you very much. Operator: Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect. 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Interested in Lexicon Pharmaceuticals, Inc.? Here are five stocks we like better. SONATA: The Phase 3 trial of sotagliflozin in HCM is on track to complete enrollment by mid-2026 with top-line data expected in Q1 2027, and management highlights SGLT1-related cardiac effects and potential as a once-daily oral therapy—notably for non-obstructive HCM. ZYNQUISTA: Lexicon plans to resubmit the NDA for ZYNQUISTA for type 1 diabetes by mid-year using STENO1 data, and says the FDA has indicated those data could support approval in 2026 if exposure and safety requirements are met. Financials and financing: Q1 revenue rose to $21.1 million (including two $10M Novo Nordisk milestones), net loss narrowed to $1.0M, cash totaled ~$199.7M, and the company secured a new $100 million debt facility with Hercules (an initial $55M tranche funded). Lexicon Pharmaceuticals (NASDAQ:LXRX) executives highlighted progress across late-stage regulatory programs and efforts to bolster the company’s financial position during the company’s first-quarter 2026 earnings call on May 7. Chief Executive Officer Mike Exton said the company entered 2026 with objectives focused on advancing “late-stage regulatory programs,” expanding internationally through collaborations, and maintaining “operationally disciplined” execution. Exton said Lexicon has executed on those priorities, pointing to expense reductions, a capital raise earlier in the year, and a new debt facility announced during the quarter. → Insider Sales: Top AST SpaceMobile Insider Cuts Postion Over 30% Lexicon’s most advanced programs center on sotagliflozin, its dual SGLT1 and SGLT2 inhibitor. Chief Medical Officer Craig Granowitz emphasized the “importance of the SGLT1 effect,” noting SGLT1 expression in tissues including the gastrointestinal tract and the heart, and stating that SGLT1 expression is “upregulated” in ischemic heart conditions and hypertrophic cardiomyopathy (HCM). For HCM, management said it remains on track to complete enrollment in the global Phase 3 SONATA trial by mid-2026. Granowitz said SONATA is evaluating approximately 500 patients across 130 sites in 20 countries, including both obstructive and non-obstructive HCM phenotypes. Based on current enrollment trends, he said the company continues to anticipate top-line data in the first quarter of 2027. → Light Speed Returns: Corning Cashes In on NVIDIA Growth Granowitz said SONATA’s primary endpoint is a placebo-adjusted improvement in the Kansas City Cardiomyopathy Questionnaire clinical summary score (KCCQ-CSS) and is designed to support a regulatory filing and “broad label” in HCM. He added that patients on stable doses of cardiac myosin inhibitors (CMIs) who remain symptomatic are enrolling in the study. In the Q&A, Exton addressed a question about recent non-obstructive HCM data from aficamten’s ACACIA trial, calling it “an exciting time to be in the field of HCM.” He said the readout increased Lexicon’s confidence in sotagliflozin’s potential benefit-risk profile, citing “simple once-a-day oral dosing” and the drug’s safety history. Exton added that if SONATA is positive, Lexicon sees an opportunity “particularly in non-obstructive as a first-line therapy.” → Years in the Making, AMD’s Upside Movement Has Just Begun Granowitz also commented on mechanism differences versus CMIs, saying CMIs are viewed as acting “primarily as hemodynamic agents,” while sotagliflozin has hemodynamic effects via the cardiorenal axis and additional effects such as “some weight loss, increase in hemoglobin, [and] decrease in blood pressure.” He also pointed to what he described as novel direct cardiac effects tied to SGLT1 inhibition. When asked about SONATA enrollment progress and the split between obstructive and non-obstructive patients, management did not disclose exact enrollment percentages. Granowitz said the company reaffirmed its mid-year timeline for last patient first visit and noted a “dramatic uptick in enrollment” as sites came online. He said Lexicon is enrolling “significant numbers of both obstructive and non-obstructive patients,” while acknowledging that need is larger in non-obstructive disease given available obstructive therapy during the trial. Regarding what constitutes a meaningful improvement on KCCQ, Granowitz said the field has “generally focused on” a four-to-five point change as clinically meaningful, and said SONATA was powered based on that range, without providing the detailed statistical plan. Granowitz referenced analyses from the Phase 2 SOTA-P-CARDIA study presented at the American College of Cardiology Annual Meeting. He said previously reported results demonstrated a placebo-adjusted 19-point improvement in KCCQ and that newer analyses showed effects on six-minute walk test measures as well as changes in metabolic parameters, including a reduction of epicardial fat. He also said there was a reduction in left atrial volume in patients treated with sotagliflozin. In type 1 diabetes, management reiterated plans to resubmit the NDA for ZYNQUISTA for glycemic control in adults with type 1 diabetes by mid-year, leveraging data from the investigator-initiated STENO1 trial. Granowitz said the FDA has confirmed that STENO1 data are adequate to support resubmission “provided patient exposure and safety data requirements are achieved.” Based on the data seen so far and ongoing FDA discussions, he said Lexicon believes there is potential for approval in 2026, adding that the company remains comfortable with the study’s data and safety profile to date and continues to work with the FDA on submission parameters. Granowitz said that if approved, ZYNQUISTA would be “the first and only oral adjuvant to insulin therapy ever approved for glycemic control in type 1 diabetes.” Lexicon also provided updates on two other programs. For LX9851, a first-in-class oral ACSL5 inhibitor for obesity, Exton and Granowitz said licensee Novo Nordisk initiated a Phase 1 study in March, triggering a $10 million milestone payment. Exton added that Novo Nordisk highlighted LX9851 on its own earnings call. For pilavapadin, Lexicon’s chronic pain candidate targeting AAK1, Exton said the company has met regulatory objectives and remains in discussions with third parties about next steps. He said Lexicon’s initial partnering goal was to secure non-dilutive capital to support cardiometabolic opportunities in HCM and type 1 diabetes and stated that Lexicon currently has “no plans to fund the phase III development” of pilavapadin. Granowitz said Lexicon presented additional data at the American Academy of Neurology Annual Meeting, including analyses supporting selection of pilavapadin 10 mg for Phase 3 development in diabetic peripheral neuropathic pain (DPNP). He also cited preclinical evidence supporting pilavapadin as a potential oral therapy for spasticity, including models of multiple sclerosis and spinal cord injury. Chief Financial Officer Scott Coiante reported total revenue of $21.1 million for the first quarter of 2026, compared with $1.3 million in the year-ago quarter. Coiante said first-quarter revenue included two $10 million milestones recognized from the Novo Nordisk agreement and net sales of INPEFA of $1.1 million. R&D expenses: $12.8 million vs. $15.3 million in Q1 2025, reflecting lower external research expense due to completion of the PROGRESS Phase 2B trial and the LX9851 licensing deal. SG&A expenses: $9.2 million vs. $11.6 million in Q1 2025, attributed to reduced marketing efforts and lower personnel costs. Net loss: $1.0 million, or less than $0.01 per share, compared with a net loss of $25.3 million, or $0.07 per share, in Q1 2025. Coiante said the Q1 2026 net loss included $3.1 million of non-cash stock-based compensation. As of March 31, 2026, Lexicon had $199.7 million in cash, cash equivalents, short-term investments, and restricted cash, compared with $125.2 million at Dec. 31, 2025. Total debt was $49.7 million at quarter end, compared with $54.0 million at the end of 2025. Coiante also discussed a new $100 million debt facility with Hercules Capital. He said an initial $55 million tranche funded at closing was used to repay an existing loan facility with Oxford Finance. He added that a second $20 million tranche and a third $25 million tranche may be available subject to milestones, timing requirements, and, for the third tranche, Hercules’ consent. The facility includes an 18-month interest-only period with potential extensions. Exton, in closing remarks, called 2026 a “pivotal” year and said the company expects multiple milestones in the second half of the year, including mid-year catalysts tied to the SONATA enrollment completion and the planned ZYNQUISTA resubmission. Lexicon Pharmaceuticals, Inc is a biopharmaceutical company focused on the discovery and development of novel medicines through its proprietary genome biology platform. By leveraging large-scale gene knockout libraries, the company identifies potential therapeutic targets and advances them through preclinical and clinical development. Lexicon's approach emphasizes the translation of genetic insights into targeted therapies for a range of human diseases. The company's most advanced product is telotristat ethyl (sold under the brand name XERMELO), an oral treatment approved for the management of carcinoid syndrome diarrhea in patients inadequately controlled by somatostatin analog therapy. The article "Lexicon Pharmaceuticals Q1 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for May 2026.

SONATA-HCM anticipated to be fully enrolled mid-2026 Resubmission of NDA for ZYNQUISTA® in type 1 diabetes anticipated mid-2026 with potential for approval this year Clinical development of LX9851 initiated by Novo Nordisk Capital raise, development milestone payments, and recent $100 million loan facility reinforce strong financial position Conference call and webcast at 8:30 am ET THE WOODLANDS, Texas, May 07, 2026 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today reported financial results for the three months ended March 31, 2026, and provided an update on key corporate milestones and accomplishments. “We have been intently focused on progressing our late and early-stage development pipeline in cardiometabolism and we are now well positioned to achieve several pivotal milestones as a result of those efforts,” said Mike Exton, Ph.D., Lexicon’s chief executive officer and director. “Over the next 12 months, those events potentially include the announcement of topline data from our ongoing registrational trial of sotagliflozin in hypertrophic cardiomyopathy, U.S. regulatory approval of ZYNQUISTA as the first adjunct to insulin for glycemic management in people with type 1 diabetes and the completion of initial Phase 1 development of LX9851 by our licensee, Novo Nordisk. Taken together, we believe these events have the potential to be transformative for Lexicon’s future.” “Following our capital raise, receipt of two development milestones from Novo Nordisk earlier this year and our recently announced loan facility, our operations are now underpinned by a strengthened balance sheet,” said Scott Coiante, Lexicon’s chief financial officer, “We remain focused on disciplined capital allocation as we continue to advance our clinical programs and seek to maximize long-term shareholder value.” First Quarter 2026 Business and Pipeline Highlights Cardiometabolic Sotagliflozin Sotagliflozin is an oral inhibitor of sodium-glucose cotransporter types 1 and 2 (SGLT1 and SGLT2) and has been studied in approximately 20,000 patients across multiple cardiometabolic indications. Sotagliflozin is commercially available in the U.S. for heart failure as INPEFA®. Hypertrophic Cardiomyopathy (HCM) Enrollment continues in SONATA-HCM, a pivotal Phase 3 placebo-controlled study with a targeted enrollment of 500 patients with obstructive or nonobstructive HCM. Lexicon continues to expect enrollment completion in mid-2026, with topline results in the first quarter of 2027. Type 1 Diabetes (T1D) (ZYNQUISTA®) Lexicon remains focused on bringing ZYNQUISTA to market for glycemic control in adults with T1D, a patient population which has not benefitted from a new treatment mechanism since the discovery of insulin. Lexicon remains on track for potential New Drug Application (NDA) resubmission and regulatory approval in 2026 if the patient exposure and safety data requirements identified by the U.S. Food and Drug Administration are achieved by STENO1, a third-party funded, investigator-initiated study of sotagliflozin being conducted by the STENO Diabetes Center (Denmark). Viatris License for All Indications Ex-U.S. and Ex-Europe Lexicon continues to support licensee Viatris in its regulatory filing and commercial strategy for sotagliflozin outside of the U.S. and Europe. Viatris has obtained regulatory approval in the United Arab Emirates, has submitted applications for regulatory approval in several other markets, including Canada, Australia and New Zealand, and is preparing for regulatory submissions in additional ex-U.S. and ex-European markets throughout 2026. LX9851 for Obesity and Associated Cardiometabolic Disorders LX9851 is a first-in-class, non-incretin, oral, small molecule inhibitor of acyl-CoA synthetase 5 (ACSL5) in development by Novo Nordisk for obesity and associated metabolic disorders. In March 2026, Novo Nordisk initiated a Phase 1 study investigating single and multiple ascending doses of LX9851 compared to placebo in overweight or obese people. The Phase 1 program is expected to be completed in the first quarter of 2027. Lexicon earned a second $10 million milestone payment in 2026 from Novo Nordisk in connection with initiation of the Phase 1 study and is eligible for a third $10 million milestone payment that may be achieved later this year. Under the terms of Lexicon’s exclusive license agreement with Novo Nordisk, Lexicon received an upfront payment of $45 million in April 2025 and is eligible to receive up to an aggregate of $1 billion in upfront and development, regulatory and sales milestone payments. Lexicon is also eligible for tiered royalties on net sales of LX9851. Pain Pilavapadin (LX9211) for Diabetic Peripheral Neuropathic Pain (DPNP) Pilavapadin is an orally delivered, small molecule drug candidate for the treatment of DPNP, among other potential indications. Pilavapadin has the potential to be the first oral, non-opioid drug therapy approved in neuropathic pain in more than 20 years. The FDA has raised no objections to the advancement of pilavapadin into Phase 3 development, which would include two placebo-controlled, 12-week, two arm registrational studies comparing the 10 mg daily dose to placebo. The primary endpoint of the Phase 3 studies would be the change in average daily pain score (ADPS) from baseline to Week 12. Lexicon continues to explore strategic opportunities to maximize the global potential of this investigative therapy. Recent Data Presentations Sotagliflozin In March 2026, Lexicon presented results of a post hoc analysis of clinical data evaluating the impact of kidney function on the long-term efficacy and safety of sotagliflozin in people with T1D at the International Conference on Advanced Technologies & Treatments for Diabetes (ATTD). The analysis concluded that sotagliflozin improved glycemic control after one year in patients with normal and mildly reduced kidney function. In March 2026, Lexicon presented three analyses from the SCORED and SOTA-P-CARDIA studies of sotagliflozin at the American College of Cardiology (ACC) Annual Meeting. The data provided further evidence of benefits of sotagliflozin across patient subgroups potentially related to its mechanism of action. Pilavapadin In April 2026, Lexicon presented additional pilavapadin clinical data at the American Academy of Neurology (AAN) Annual Meeting, including additional data from the PROGRESS Phase 2b study supporting the selection of pilavapadin 10 mg as the optimal dose for Phase 3 development in DPNP, as well as an evaluation of pilavapadin as a potential novel, oral therapy for spasticity based on spasticity-related endpoints in preclinical models of multiple sclerosis and spinal cord injury. First Quarter 2026 Financial Highlights Revenues: Total revenues were $21.1 million for the first quarter of 2026, consisting of $20.0 million of development milestone revenue from our license agreement with Novo Nordisk and net sales of INPEFA of $1.1 million. Total revenues for the first quarter of 2025 were $1.3 million representing net sales of INPEFA. Research and Development (R&D) Expenses: Research and development expenses for the first quarter of 2026 decreased to $12.8 million from $15.3 million for the corresponding period in 2025, reflecting lower external research expense in 2026 due to completion of our PROGRESS Phase 2b clinical trial and the licensing of LX9851 to Novo Nordisk. Selling, General and Administrative (SG&A) Expenses: Selling, general and administrative expenses for the first quarter of 2026 decreased to $9.2 million from $11.6 million for the corresponding period in 2025. The decrease in 2026 reflects reduced marketing efforts in 2025 for INPEFA and lower personnel costs. Net Loss: Net loss for the first quarter of 2026 was $1.0 million, or less than $0.01 per share, as compared to a net loss of $25.3 million, or $0.07 per share, in the corresponding period in 2025. For the first quarters of 2026 and 2025, net loss included non-cash, stock-based compensation expense of $3.1 million and $3.0 million, respectively. Cash, Investments, and Restricted Cash: As of March 31, 2026, Lexicon had $199.7 million in cash, investments and restricted cash, as compared to $125.2 million as of December 31, 2025. The increase in cash and investments reflects net proceeds of $96.5 million from the sale of common and preferred stock in February 2026. Hercules Capital Loan Facility In May 2026, Lexicon announced a $100 million loan facility with Hercules Capital. An initial $55 million tranche was funded at closing and used to repay Lexicon’s previous loan facility with Oxford Finance. The second $20 million tranche is available for draw at Lexicon’s option subject to the achievement of certain clinical, regulatory and financial milestones and specified timing requirements. The third $25 million tranche is available for draw at Lexicon’s option subject to Hercules’ consent and specified timing requirements. The loan facility carries a floating interest rate equal to the prime rate plus 3.1%, with a floor not less than 9.85%, and provides for an initial interest-only period of 18 months, with the potential for two six-month extensions. The outstanding principal amount and all accrued but unpaid interest shall be repaid on or before May 4, 2030. Lexicon’s obligations under the loan facility are subject to a minimum cash covenant beginning on June 1, 2027, subject to extension upon the achievement of certain clinical, regulatory and financial milestones and waiver upon the achievement of certain financial conditions. Conference Call and Webcast Information Lexicon management will hold a live conference call and webcast today at 8:30 am ET / 7:30 am CT to review its financial and operating results and to provide a general business update. A live audio webcast of the call can be accessed by visiting the Events page of the Company’s investor relations website at https://investors.lexpharma.com/. Participants who wish to ask a question may join by phone at 800-715-9871 and use passcode 9826247. An archived version of the webcast will be available on the website for 30 days. About Lexicon Pharmaceuticals Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Lexicon has a pipeline of drug candidates in discovery, preclinical, and clinical development in neuropathic pain, hypertrophic cardiomyopathy (HCM), obesity and metabolic disorders, and other cardiometabolic indications. For additional information, please visit www.lexpharma.com. Safe Harbor Statement This press release contains “forward-looking statements,” including statements relating to Lexicon’s financial position and long-term outlook on its business, including the commercialization of its approved products and the clinical development of regulatory filings for, and potential therapeutic and commercial potential of its other drug candidates. In addition, this press release also contains forward looking statements relating to Lexicon’s growth and future operating results, discovery, development and commercialization of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicon’s ability to meet its capital requirements, successfully commercialize its approved products, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of its other drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its approved products and other drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2025, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise. For Media Inquiries: Dave Belian Lexicon Pharmaceuticals, Inc. [email protected] For Investor Inquiries: Lisa DeFrancesco Lexicon Pharmaceuticals, Inc. [email protected]