Lexicon Pharmaceuticals Q2 2026 Earnings Report

Lexicon Pharmaceuticals EPS Results

• Actual EPS: -$0.06
• Consensus EPS: -$0.05
• Beat/Miss: Missed by -$0.01
• One Year Ago EPS: N/A

Lexicon Pharmaceuticals Revenue Results

• Actual Revenue: $0.69 million
• Expected Revenue: $3.99 million
• Beat/Miss: Missed by -$3.30 million
• YoY Revenue Growth: N/A

Lexicon Pharmaceuticals Announcement Details

• Quarter: Q2 2026
• Date: 8/6/2026
• Time: Before Market Opens
• Conference Call Date: Thursday, August 6, 2026
• Conference Call Time: 8:30AM ET

Lexicon Pharmaceuticals (NASDAQ:LXRX) 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. In addition to this marketed asset, Lexicon maintains a diversified pipeline with programs spanning metabolic diseases, neuropathic pain, and rare genetic disorders. Key development candidates include small-molecule inhibitors modulating glucose transport and neuroreceptor activity, each designed to address unmet medical needs through precise mechanism-based intervention.

Founded in 1995 and headquartered in The Woodlands, Texas, Lexicon Pharmaceuticals has been publicly traded on the NASDAQ exchange since 2000. The company collaborates with academic institutions, strategic partners and patient advocacy groups to advance its research and expand clinical development globally. With a core scientific team experienced in genomics, medicinal chemistry and clinical development, Lexicon continues to pursue innovative solutions aimed at improving patient outcomes across a variety of therapeutic areas.

Lexicon Pharmaceuticals Q2 2026 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: SONATA-HCM enrollment was completed significantly ahead of plan, with the Phase 3 trial including both obstructive and non-obstructive HCM patients. Lexicon expects top-line results in the first quarter of 2027.
• Positive Sentiment: Lexicon expects to satisfy the FDA’s requirements for a ZYNQUISTA (sotagliflozin) resubmission after Steno-1 reaches the required exposure level by the end of August; the company currently anticipates filing the NDA in the fourth quarter of 2026. DKA rates in Steno-1 remain similar to standard of care and below prior inTandem-trial levels.
• Negative Sentiment: Second-quarter revenue fell to $0.7 million from $28.9 million a year earlier, largely because the prior-year period included $27.5 million in Novo Nordisk licensing revenue. Lexicon reported a $31.8 million net loss, versus net income of $3.3 million in the prior-year quarter, while R&D spending increased due to SONATA.
• Positive Sentiment: Lexicon strengthened its liquidity, ending June with $190.6 million in cash and short-term investments and replacing its prior debt with a Hercules Capital facility that provided $55 million at closing, with up to $45 million more potentially available subject to conditions.
• Positive Sentiment: Novo Nordisk continues to advance LX9851, Lexicon’s first-in-class oral ACSL5 inhibitor for obesity, in Phase 1 development. Lexicon could receive another $10 million milestone payment later this year.

Presentation

[Operator]

Welcome to the Lexicon Pharmaceuticals Second Quarter 2026 Financial Results Conference Call. At this time, all participants are in listen-only mode. Following management's prepared remarks, we will hold a brief question and answer session. As a reminder, this call is being recorded today, August 6th, 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, SVP of Investor Relations and Corporate Communications at Lexicon]

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.

[Lisa DeFrancesco, SVP of Investor Relations and Corporate Communications at Lexicon]

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 a 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.

[Lisa DeFrancesco, SVP of Investor Relations and Corporate Communications at Lexicon]

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.

[Lisa DeFrancesco, SVP of Investor Relations and Corporate Communications at Lexicon]

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.

[Lisa DeFrancesco, SVP of Investor Relations and Corporate Communications at Lexicon]

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?

[Mike Exton, CEO and Director at Lexicon]

Yeah. Thank you, Lisa. 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.

[Mike Exton, CEO and Director at Lexicon]

This study is the largest phase III study to date in both obstructive and non-obstructive HCM. This marks an important milestone for patients living with the symptoms of HCM, as sotagliflozin would be a completely novel and complementary treatment for their disease, as compared to all approved treatments currently available and other agents in development.

[Mike Exton, CEO and Director at Lexicon]

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. We eagerly await the top-line data, which we expect to announce in Q1 of next year.

[Mike Exton, CEO and Director at Lexicon]

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're at an important and exciting moment for the program. If you recall, the FDA asked for three 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, SVP and Chief Medical Officer at Lexicon]

The FDA has previously confirmed that STENO-1, an open-label, investigator-initiated study of sotagliflozin being conducted by the Steno Diabetes Center in Denmark, may serve as that prospective study. STENO-1 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.

[Craig Granowitz, SVP and Chief Medical Officer at Lexicon]

As a result, we believe that each of the FDA's criteria for resubmission of the NDA will soon be satisfied. We expect that STENO-1 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.

[Craig Granowitz, SVP and Chief Medical Officer at Lexicon]

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 timeline, we could not 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.

[Craig Granowitz, SVP and Chief Medical Officer at Lexicon]

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.

[Craig Granowitz, SVP and Chief Medical Officer at Lexicon]

Viatris anticipates regulatory decisions in Australia and Canada and additional regulatory submissions in other markets this year. Turning to LX9851, 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 two $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.

[Craig Granowitz, SVP and Chief Medical Officer at Lexicon]

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.

[Mike Exton, CEO and Director at Lexicon]

Sorry about that, everyone. Thanks, Craig, for taking that on. 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. With that, I'll ask Craig to continue and give you the pipeline update.

[Craig Granowitz, SVP and Chief Medical Officer at Lexicon]

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 a tremendous unmet need in this space.

[Craig Granowitz, SVP and Chief Medical Officer at Lexicon]

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.

[Craig Granowitz, SVP and Chief Medical Officer at Lexicon]

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.

[Craig Granowitz, SVP and Chief Medical Officer at Lexicon]

Both types of HCM are characterized by a thickened 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.

[Craig Granowitz, SVP and Chief Medical Officer at Lexicon]

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. As a reminder, SGLT2 is not routinely expressed in the myocardium.

[Craig Granowitz, SVP and Chief Medical Officer at Lexicon]

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.

[Craig Granowitz, SVP and Chief Medical Officer at Lexicon]

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 over-enrolled and as such, should positively impact the overall study powering.

[Craig Granowitz, SVP and Chief Medical Officer at Lexicon]

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.

[Craig Granowitz, SVP and Chief Medical Officer at Lexicon]

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.

[Craig Granowitz, SVP and Chief Medical Officer at Lexicon]

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.

[Craig Granowitz, SVP and Chief Medical Officer at Lexicon]

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.

[Craig Granowitz, SVP and Chief Medical Officer at Lexicon]

We have been providing these data, along with additional information from the study, to the FDA on an ongoing basis, as 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.

[Craig Granowitz, SVP and Chief Medical Officer at Lexicon]

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, SVP and CFO at Lexicon]

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 30th, 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.

[Scott Coiante, SVP and CFO at Lexicon]

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.

[Scott Coiante, SVP and CFO at Lexicon]

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 non-cash stock-based compensation expense of $3.3 million and $3.2 million respectively.

[Scott Coiante, SVP and CFO at Lexicon]

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.

[Scott Coiante, SVP and CFO at Lexicon]

As of June 30th, 2026, Lexicon had $190.6 million in cash equivalents, and short-term investments, as compared to $125.2 million of cash equivalents, short-term investments, and restricted cash as of December 31st, 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.

[Scott Coiante, SVP and CFO at Lexicon]

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 at 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.

[Scott Coiante, SVP and CFO at Lexicon]

The loan facility provides for an initial interest-only period of 18 months, with the potential for two six-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 pre-commercial activities focused primarily on medical education and marketing preparation.

[Scott Coiante, SVP and CFO at Lexicon]

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.

[Scott Coiante, SVP and CFO at Lexicon]

I will now turn it back to Mike for closing remarks.

[Mike Exton, CEO and Director at Lexicon]

Yeah. Thanks, Scott. Look, this quarter, we're really starting to see the output of the Lead to Succeed strategy, which we put in place a year and a half 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.

[Mike Exton, CEO and Director at Lexicon]

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.

[Mike Exton, CEO and Director at Lexicon]

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.

[Mike Exton, CEO and Director at Lexicon]

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 a submission of our NDA.

[Mike Exton, CEO and Director at Lexicon]

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]

Thank you. At this time, we will conduct the question-and-answer session. Our first question today is from Yigal with Citigroup. Your line is open.

[Yigal Nochomovitz, Analyst at Citigroup]

Hi, this is Yigal Nochomovitz on from Yigal. Thanks for taking our question. 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 this study if the overall population is positive? Is directionality across both phenotypes more important, in your view, than the exact magnitude in each group? Thanks.

[Craig Granowitz, SVP and Chief Medical Officer at Lexicon]

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.

[Craig Granowitz, SVP and Chief Medical Officer at Lexicon]

That really is a large number of non-obstructive 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 at past calls, and I hope I was able to communicate, the trial is powered on the overall population. That was what we had discussed with the FDA. That includes both obstructive and non-obstructive.

[Craig Granowitz, SVP and Chief Medical Officer at Lexicon]

Particularly with the significant over-enrollment, this gives us even more confidence in the primary endpoint that we selected and our power to observe that primary endpoint. Also to reinforce, while there are more non-obstructive patients in the trial, we believe that there's a significant enough number of the obstructive patients that gives us great confidence that we'll be able to observe and find meaningful the results in both the obstructive and non-obstructive groups.

[Mike Exton, CEO and Director at Lexicon]

From a commercial perspective, we see that there's opportunity across the spectrum of disease, both in obstructive and non-obstructive. Obstructive, clearly where there are already approved agents, but still a significant number of patients remain symptomatic. Non-obstructive, where there are currently no approved agents.

[Mike Exton, CEO and Director at Lexicon]

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.

[Yigal Nochomovitz, Analyst at Citigroup]

Got it. 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 phase I. What would constitute a supportive data package for Novo to move the program forward?

[Mike Exton, CEO and Director at Lexicon]

Yeah. 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 phase I trial is progressing extremely well.

[Mike Exton, CEO and Director at Lexicon]

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. Clearly, Novo being the leader of oral weight loss medicines, is taking that approach with LX9851 as well. We're really excited to see the continued development and progress that Novo's making.

[Yigal Nochomovitz, Analyst at Citigroup]

Great. Congrats on the progress. Thanks so much.

[Operator]

Thank you.

[Mike Exton, CEO and Director at Lexicon]

Thank you.

[Operator]

Our next question is from Andrew Tsai with Jefferies. Your line is open.

[Brian Balchin, Analyst at Jefferies]

Hello, 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 2026 before. Is it fair to assume approval could be closer to mid 2027, assuming a Class 2 resubmission? Could you just talk a little bit about why that's taking longer to accrue data? Thank you.

[Craig Granowitz, SVP and Chief Medical Officer at Lexicon]

Yeah, it's a great question. We've been working very hard with both the FDA and STENO. I hope I've been effective at communicating over time that STENO is an investigator-initiated trial that was never designed for regulatory purpose. We've been continuously at work with STENO to pull all of the data together. We had a certain regulatory path that we were considering, 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.

[Craig Granowitz, SVP and Chief Medical Officer at Lexicon]

As both Mike and I reinforced, the most important aspect 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 are seeing.

[Craig Granowitz, SVP and Chief Medical Officer at Lexicon]

As a reminder, it is an open- label trial, we are 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 is certainly well below that which was observed in the inTandem trial.

[Craig Granowitz, SVP and Chief Medical Officer at Lexicon]

To me, it is 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.

[Mike Exton, CEO and Director at Lexicon]

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 six-month review would put us nicely in Q2, but not at the end of Q2.

[Mike Exton, CEO and Director at Lexicon]

Having said that, this is an unusual review because clearly the FDA has seen a lot of the information that they will see in this submission. The actual data that they will be reviewing from STENO is not as comprehensive as a normal review. 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 timeline.

[Brian Balchin, Analyst at Jefferies]

Thank you very much.

[Operator]

Thank you. Our next question is from Roanna Ruiz with Leerink Partners. Your line is open.

[Roanna Ruiz, Analyst at Leerink Partners]

Hey, morning, everyone? 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 both the overall results and informing future prescribing, because I noticed that you were talking about majority of patients are NHCM. What does that mean for the OHCM proportion of patients in the trial?

[Craig Granowitz, SVP and Chief Medical Officer at Lexicon]

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. I can say that there are a fair number of patients on a CMI, as you would expect, the availability of CMIs in the trial was rather limited.

[Craig Granowitz, SVP and Chief Medical Officer at Lexicon]

We included 20 countries in the study, and while the U.S. was the single largest enrolling country, it was certainly not a majority of the patients. I think sort of taking that into account and the protocol required patients to be on a stable dose of any of their underlying HCM medications for at least six months. I can say that we do have patients in the trial that are on a CMI, and both patients that at the baseline were considered obstructive by the criteria and non-obstructive by the criteria.

[Craig Granowitz, SVP and Chief Medical Officer at Lexicon]

What I would infer from that is that all of the patients are put on a CMI because they were obstructive at some point. 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. We have, in a sense, all different options.

[Craig Granowitz, SVP and Chief Medical Officer at Lexicon]

We have patients who are obstructive and non-obstructive 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 non-obstructive. The single unifying characteristic of the trial is they all have a baseline KCCQ score of less than 85. I think that really is the gold standard today is managing symptomatic relief of these patients.

[Roanna Ruiz, Analyst at Leerink Partners]

Yep, super helpful. 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 into the market. How do you see prescribers making decisions between these different programs?

[Mike Exton, CEO and Director at Lexicon]

I think, overall, the important thing is that this is a complementary mechanism to the currently approved agents and potentially newer agents as well. 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 standalone or combination therapy with other agents.

[Mike Exton, CEO and Director at Lexicon]

There are a few unique attributes to Sota in this market that really all go 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. That really has the propensity to be prescribed very easily, with broad access for patients.

[Mike Exton, CEO and Director at Lexicon]

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 CMI if they are still symptomatic.

[Roanna Ruiz, Analyst at Leerink Partners]

Got it. Thanks.

[Operator]

Thank you. Our next question is from Yasmeen Rahimi from Piper Sandler. Your line is open.

[Yasmeen Rahimi, Analyst at Piper Sandler]

Good morning, team. Thank you so much for all the great updates. Again, congrats on SONATA. Excited to look forward to the data. Craig, question for you is, obviously the population contains both obstructive and non-obstructive, and the study's powered for a KCCQ in both populations.

[Yasmeen Rahimi, Analyst at Piper Sandler]

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? How much flexibility do you have until you lock the database and provide that update? If you could talk about sort of the statistical protocol, how you're thinking, whether you want to change it or not.

[Yasmeen Rahimi, Analyst at Piper Sandler]

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 ensure a filing to be near complete and the timing around that. I'll jump back in the queue.

[Craig Granowitz, SVP and Chief Medical Officer at Lexicon]

Thanks, Yas. Great questions. Yeah, it's a really good question about the statistical analysis plan. Good clinical practice, normally, you want to finalize your SAP before you close your database. We have a number of months, theoretically, that we can do that. In light of as we're completing enrollment, we are certainly taking another good hard look at the SAP.

[Craig Granowitz, SVP and Chief Medical Officer at Lexicon]

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. As I said previously, and Mike has said, that includes both the obstructive and non-obstructive.

[Mike Exton, CEO and Director at Lexicon]

I think depending upon how the market unfolds and as other pieces 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 and the statistical plan. Right now, the key secondary is New York Heart.

[Craig Granowitz, SVP and Chief Medical Officer at Lexicon]

I think there are potential things that we could think about in the hierarchy of the statistical plan. But I think right now, we are 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 hope that answers the first. I will move to the second question on STENO.

[Craig Granowitz, SVP and Chief Medical Officer at Lexicon]

The amount of interaction we have 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 case of DKA. We have the detailed narratives of every single patient that has developed DKA. They have been translated. We have been in continuous dialogue with the PIs of that group. We have looked at their database.

[Craig Granowitz, SVP and Chief Medical Officer at Lexicon]

We have looked at their electronic medical records. We have 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 have looked at the programming of SAS. We have really extensively looked at this from both a data quantity and quality standpoint. We have agreed on the key variables that FDA wants to see as baseline characteristics, the exposure of DKA.

[Craig Granowitz, SVP and Chief Medical Officer at Lexicon]

As I said, we have the detailed narratives of the DKA cases, so we feel comfortable that we understand each individual patient that has developed a DKA event, whether or not they were on Sota or not. So I feel that we have really detailed gone through this in a really extensive fashion.

[Mike Exton, CEO and Director at Lexicon]

Let me just pile on there quickly, 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. This is a significant amount of data, a significant amount of exposure.

[Mike Exton, CEO and Director at Lexicon]

As we mentioned in the prepared remarks, what we are seeing in the DKA rates between Sota and the standard of care is similar. Exactly, no more than standard of care. This is really compelling data that we have engaged with FDA over a number of months now, and we are at the precipice of being able to really have all that together and submit the NDA, and really, it is a pretty significant moment for this program, which has a history both with Lexicon and the FDA, as you know, so I am really, really delighted that we have reached this milestone.

[Yasmeen Rahimi, Analyst at Piper Sandler]

Thank you so much.

[Operator]

Thank you. I'm showing no other questions at this time, I would now like to turn it back to Mike Exton, Chief Executive Officer of Lexicon.

[Mike Exton, CEO and Director at Lexicon]

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.

[Mike Exton, CEO and Director at Lexicon]

I really want to thank the Lexicon team for all the effort that they put in particularly progressing these two 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.

Participants

Analysts

• Lisa DeFrancesco, SVP of Investor Relations and Corporate Communications at Lexicon
• Mike Exton, CEO and Director at Lexicon
• Craig Granowitz, SVP and Chief Medical Officer at Lexicon
• Scott Coiante, SVP and CFO at Lexicon
• Yigal Nochomovitz, Analyst at Citigroup
• Brian Balchin, Analyst at Jefferies
• Roanna Ruiz, Analyst at Leerink Partners
• Yasmeen Rahimi, Analyst at Piper Sandler