Group 1 - Lexicon Pharmaceuticals will participate in a fireside chat at the Leerink Partners Global Healthcare Conference 2025 on March 12 at 10:00 a.m. ET [1] - The event will be accessible live and as a replay on the company's website [1] Group 2 - Lexicon Pharmaceuticals is a biopharmaceutical company focused on pioneering medicines that transform patients' lives [2] - The company utilizes the Genome5000™ program to study nearly 5,000 genes, identifying over 100 protein targets with significant therapeutic potential [2] - Lexicon has advanced multiple medicines to market and has a pipeline of drug candidates in various stages of development for conditions such as heart failure, neuropathic pain, obesity, cardiology, and diabetes [2]

Financial Data and Key Metrics Changes - Lexicon Pharmaceuticals ended 2024 with $238 million in cash, cash equivalents, and short-term investments, compared to $170 million as of December 31, 2023 [28] - The company reported $26.6 million in revenue for Q4 2024 and $31.1 million for the full year 2024, including a $25 million upfront payment from the Beatrice licensing agreement [28] - Research and development expenses for Q4 2024 increased to $26.7 million from $14.8 million in Q4 2023, while full-year R&D expenses decreased to $84.5 million from $106 million in 2023 [29] - Net loss for Q4 2024 was $33.8 million, or $0.09 per share, compared to a net loss of $49.8 million, or $0.20 per share, in Q4 2023 [31] Business Line Data and Key Metrics Changes - The PROGRESS Phase 2b study of pilabapatin showed a clear separation in Average Daily Pain Score (ADPS) from baseline, with the 10-milligram dose demonstrating meaningful improvement compared to placebo [11][14] - The Sonata Phase 3 study of sotagliflozin in hypertrophic cardiomyopathy (HCM) is ongoing, with patient enrollment proceeding as planned [10] Market Data and Key Metrics Changes - Diabetic peripheral neuropathic pain (DPNP) affects approximately nine million people in the US, indicating a significant market opportunity for new treatment options [17] - Current treatments for DPNP are inadequate, with about 60% of patients having tried multiple therapies and only a third being somewhat satisfied with their treatment [19] Company Strategy and Development Direction - Lexicon Pharmaceuticals has strategically repositioned to focus on clinical development programs, including advancing IND enabling studies for LX9851, an oral ACSL5 inhibitor for obesity [10][21] - The company aims to enhance its clinical and commercial capabilities through partnership discussions, particularly for its novel therapies [36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of pilabapatin to be the first novel oral, non-opioid DPN medication in over two decades, with plans to advance the 10-milligram dose into pivotal trials [14][16] - The company anticipates total operating expenses for 2025 to be in the range of $135 million to $145 million, with R&D expenses projected between $100 million to $105 million [33] Other Important Information - Lexicon Pharmaceuticals has ceased all promotion of Impepper in the U.S. heart failure market due to a challenging market access environment [24] - The company is actively working with Beatrice on registration and regional development efforts for sotagliflozin outside the U.S. and Europe [25] Q&A Session Summary Question: What is the clinical development plan for LX9851? - Management sees LX9851 being developed as both monotherapy and combination therapy, with a standard Phase 1 program focusing on weight loss, tolerability, and mechanistic differentiation from GLP-1 [42][44][48] Question: How is enrollment progressing in the HCM study? - Enrollment is on track with approximately 500 patients targeted, and final study results are expected towards the end of 2026, with an FDA filing anticipated in Q1 2027 [54][56] Question: Will the Phase 2b data support pivotal trial status? - The current assumption is that the Phase 2b trial will not be considered pivotal, with plans for two pivotal trials in the Phase 3 program [76] Question: What are the commercialization plans for sotagliflozin? - The company plans to commercialize sotagliflozin in the U.S. while seeking a partner for Europe, focusing on centers of excellence for HCM patients [84][86]

Lexicon Pharmaceuticals (LXRX) came out with a quarterly loss of $0.09 per share versus the Zacks Consensus Estimate of a loss of $0.11. This compares to loss of $0.20 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 18.18%. A quarter ago, it was expected that this drugmaker would post a loss of $0.17 per share when it actually produced a loss of $0.18, delivering a surprise of -5.88%.Over the last four quarters, the company ha ...

[Overview and Business Update](index=1&type=section&id=Overview%20and%20Business%20Update) The company repositioned to prioritize its R&D pipeline, highlighting progress in key programs and positive clinical data [Strategic Repositioning and CEO Remarks](index=1&type=section&id=Strategic%20Repositioning%20and%20CEO%20Remarks) Lexicon Pharmaceuticals prioritized its R&D pipeline in 2024, highlighting progress in its key clinical programs - The company has completed a repositioning to focus on advancing its **R&D pipeline** as its core priority[3](index=3&type=chunk) - The CEO highlighted three key pipeline opportunities: **pilavapadin for DPNP, LX9851 for obesity, and sotagliflozin for HCM**[3](index=3&type=chunk) [Pipeline Highlights](index=1&type=section&id=Pipeline%20Highlights) The company provided updates on key clinical programs including pilavapadin, LX9851, and sotagliflozin [Pilavapadin (LX9211) for DPNP](index=1&type=section&id=Pilavapadin%20(LX9211)%20for%20DPNP) The Phase 2b study identified a 10 mg dose for Phase 3 trials despite not meeting the primary endpoint - The **10 mg dose** of pilavapadin achieved meaningful pain reduction versus placebo and was well-tolerated, supporting its advancement into a Phase 3 program in 2025[3](index=3&type=chunk)[4](index=4&type=chunk) - The overall study **did not meet its primary endpoint** for statistical significance because the 20 mg dose arm did not show separation from placebo[4](index=4&type=chunk) [LX9851 for Obesity](index=2&type=section&id=LX9851%20for%20Obesity) The novel, non-incretin oral candidate LX9851 is on track for a 2025 IND submission for obesity - LX9851 is a **novel, non-incretin oral development candidate** for obesity and weight management[5](index=5&type=chunk) - The company is on track to submit an **IND application for LX9851 in 2025**[5](index=5&type=chunk) [Sotagliflozin (INPEFA and Zynquista)](index=2&type=section&id=Sotagliflozin%20(INPEFA%20and%20Zynquista)) Enrollment is underway for the Phase 3 HCM study while promotion of INPEFA has ceased - Enrollment is underway in the **SONATA HCM Phase 3 study**, with global site initiation expected to be complete by Q3[12](index=12&type=chunk) - The company has reprioritized SG&A investment by **ceasing active promotion of INPEFA**[6](index=6&type=chunk) - Preparations for a potential Zynquista launch in type 1 diabetes were **discontinued** after receiving a complete response letter from the FDA[7](index=7&type=chunk) [Data and Publications](index=2&type=section&id=Data%20and%20Publications) A recent publication highlighted sotagliflozin's unique ischemic benefits in reducing major adverse cardiovascular events - A prespecified analysis of the SCORED trial, published in The Lancet, concluded that sotagliflozin **reduced major adverse cardiovascular events**, including heart attack (MI) and stroke[13](index=13&type=chunk) - This ischemic benefit on both MI and stroke reduction **has not been observed with other SGLT inhibitors**, providing a key point of differentiation for sotagliflozin[13](index=13&type=chunk) [Financial Performance](index=2&type=section&id=Financial%20Performance) The company reported a significant revenue increase driven by a licensing agreement, alongside a wider net loss due to higher R&D expenses [Q4 and Full Year 2024 Financial Results](index=2&type=section&id=Q4%20and%20Full%20Year%202024%20Financial%20Results) Revenues surged in Q4 and FY2024 due to a licensing payment, while the net loss widened on increased R&D spending Financial Results Summary | Metric | Q4 2024 | Q4 2023 | Full Year 2024 | Full Year 2023 | | :--- | :--- | :--- | :--- | :--- | | **Total Revenues** | $26.6M | $0.7M | $31.1M | $1.2M | | **R&D Expenses** | $26.7M | $14.8M | $84.5M | $58.9M | | **SG&A Expenses** | $32.3M | $32.6M | $143.1M | $114.0M | | **Net Loss** | $(33.8)M | $(49.8)M | $(200.4)M | $(177.1)M | | **Net Loss Per Share** | $(0.09) | $(0.20) | $(0.63) | $(0.80) | - The significant increase in 2024 revenues was driven by increased sales of INPEFA and a **$25.0 million upfront payment** from the Viatris INPEFA licensing agreement in October 2024[9](index=9&type=chunk) - The rise in full-year R&D expenses was primarily due to investments in the **SONATA Phase 3 study** (sotagliflozin) and the **PROGRESS Phase 2b study** (pilavapadin)[10](index=10&type=chunk) [Financial Position](index=3&type=section&id=Financial%20Position) The company ended 2024 with a significantly strengthened cash position and increased stockholders' equity Balance Sheet Highlights | Balance Sheet Item (in thousands) | Dec 31, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | **Cash and investments** | $237,957 | $170,026 | | **Total assets** | $298,420 | $229,429 | | **Long-term debt, net** | $100,298 | $99,508 | | **Total stockholders' equity** | $145,950 | $93,110 | [Corporate Information](index=3&type=section&id=Corporate%20Information) Covers investor communications, corporate background, and forward-looking statement disclosures [Conference Call and Webcast](index=3&type=section&id=Conference%20Call%20and%20Webcast) Management held a conference call and webcast to review financial results and provide a business update - A conference call and webcast was held at 5:00 pm ET to discuss financial results and provide a business update[16](index=16&type=chunk) [About Lexicon Pharmaceuticals](index=3&type=section&id=About%20Lexicon%20Pharmaceuticals) Lexicon is a biopharmaceutical company using its proprietary genomics platform to discover and develop new medicines - Lexicon uses its proprietary **Genome5000™ genomics platform** to identify novel protein targets for drug discovery and development[17](index=17&type=chunk) [Safe Harbor Statement](index=3&type=section&id=Safe%20Harbor%20Statement) The press release includes forward-looking statements subject to significant risks and uncertainties - The press release contains **forward-looking statements** based on management's current assumptions, which involve risks and uncertainties[18](index=18&type=chunk) - Key risks include the ability to meet capital requirements, successfully commercialize products, conduct clinical development, and obtain regulatory approvals[18](index=18&type=chunk) [Product Information: INPEFA (sotagliflozin)](index=6&type=section&id=Product%20Information%3A%20INPEFA%20(sotagliflozin)) Details the indication, dosing, and important safety information for the company's product INPEFA [Indication and Dosing](index=6&type=section&id=Indication%20and%20Dosing) INPEFA is an oral SGLT1/SGLT2 inhibitor indicated to reduce cardiovascular risks in adults with heart failure - INPEFA is an oral inhibitor of both **SGLT2 (kidney) and SGLT1 (gastrointestinal tract)**[22](index=22&type=chunk) - The drug is indicated to **reduce the risk of cardiovascular death and heart failure events** in adults with heart failure or with T2DM, CKD, and other CV risk factors[23](index=23&type=chunk)[30](index=30&type=chunk) [Important Safety Information](index=6&type=section&id=Important%20Safety%20Information) Key safety warnings for INPEFA include risks of ketoacidosis, volume depletion, and serious urinary tract infections - INPEFA **increases the risk of ketoacidosis**, and is not indicated for glycemic control[25](index=25&type=chunk) - The drug can cause **intravascular volume depletion**, with increased risk for elderly patients, those with impaired renal function, or patients on loop diuretics[27](index=27&type=chunk) - **Serious urinary tract infections**, including urosepsis and pyelonephritis, have been reported with SGLT2 inhibitors[28](index=28&type=chunk) - The most commonly reported adverse reactions (≥ 5% incidence) were **urinary tract infection, volume depletion, diarrhea, and hypoglycemia**[32](index=32&type=chunk)

Topline Results for Phase 2b PROGRESS Study of Pilavapadin (LX9211) in Diabetic Peripheral Neuropathic Pain (DPNP); 10 mg dose to Advance into Phase 3 Development Leaner organization focused on Advancing Strong Pipeline Conference Call and Webcast at 5:00 pm ET THE WOODLANDS, Texas, March 06, 2025 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today reported financial results for the three months and year ended December 31, 2024, and provided an update on key corporate milestones and acc ...

THE WOODLANDS, Texas, March 04, 2025 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced the Company will release its fourth quarter and full year 2024 financial results on Thursday, March 6, 2025 after the markets close. Management will conduct a conference call and live webcast at 5:00 p.m. ET (4:00 p.m. CT) that day to discuss the financial results and to provide a business update. Participants can access the conference call live via webcast on the Events page of the Company’ ...

Pilavapadin achieved meaningful pain reduction versus placebo and was well-tolerated in the 10 mg dose, meeting the Company’s objectives for the study Advancement of 10 mg dose into Phase 3 development in DPNP supported by both PROGRESS and RELIEF DPN-1 studies, which collectively enrolled approximately 600 pilavapadin-treated patients Conference call and webcast at 8:00 a.m. ET THE WOODLANDS, Texas, March 03, 2025 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced topline resu ...

Core Insights - Lexicon Pharmaceuticals announced a conference call and webcast to share topline results from the Phase 2b PROGRESS study evaluating pilavapadin (LX9211) for diabetic peripheral neuropathic pain (DPNP) [1][2] Group 1: PROGRESS Study Details - The PROGRESS study began in December 2023, enrolling 496 adult patients with diabetes and moderate to severe DPNP [3] - The study was placebo-controlled, with the primary endpoint being the change from baseline to Week 8 in the Average Daily Pain Score (ADPS) compared to placebo [3] - Three treatment groups received once-daily doses of pilavapadin: 10 mg, 20 mg, or 20 mg for seven days followed by 10 mg thereafter [3] - Secondary endpoints included changes in burning pain and pain interference on sleep from baseline to Week 8 [3] - Patients were allowed to remain on stable-dose DPNP therapies, aligning with practical usage of new DPNP drugs [3] Group 2: Diabetic Peripheral Neuropathic Pain (DPNP) - DPNP is a chronic complication of diabetes characterized by burning pain, numbness, and other symptoms in extremities [4] - Approximately 9 million patients in the U.S. suffer from DPNP [4] Group 3: Pilavapadin Overview - Pilavapadin (LX9211) is an investigational AAK1 inhibitor, designed to be a potent, once-daily, orally delivered small molecule [5] - It targets neuropathic pain by inhibiting neurotransmitter reuptake and recycling without affecting opiate pathways [5] - Preclinical studies indicated that pilavapadin penetrates the central nervous system and reduces pain behavior in neuropathic pain models [5] Group 4: Company Background - Lexicon Pharmaceuticals is focused on pioneering medicines that transform patients' lives through its Genome5000™ program [6] - The company has identified over 100 protein targets with therapeutic potential across various diseases [6] - Lexicon has advanced multiple medicines to market and has a pipeline of drug candidates in various stages of development, including heart failure, neuropathic pain, obesity, and diabetes [6]

Core Insights - The article highlights the unique clinical advantages of sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, in reducing life-threatening cardiovascular outcomes compared to empagliflozin [2][3] - A published study in The Lancet Diabetes & Endocrinology confirms the ischemic benefits of sotagliflozin, showing significant reductions in major adverse cardiovascular events (MACE), myocardial infarction (MI), and stroke among patients with type 2 diabetes (T2D), chronic kidney disease (CKD), and high cardiovascular risk [3][5] Study Findings - The study titled "Reduction in Major Adverse Cardiovascular Events with Sotagliflozin" is a secondary analysis of the SCORED trial, which was a double-blind, placebo-controlled, randomized clinical trial [4] - Sotagliflozin demonstrated a lower rate of MACE outcomes at 4.8 events per 100 person-years compared to 6.3 events per 100 person-years in the placebo group, with a hazard ratio of 0.77 [5] - The reduction in MI was significant, with 1.8 events per 100 person-years in the sotagliflozin group versus 2.7 events per 100 person-years in the placebo group, yielding a hazard ratio of 0.68 [5] - Stroke rates were also lower in the sotagliflozin group at 1.2 events per 100 person-years compared to 1.8 events per 100 person-years in the placebo group, with a hazard ratio of 0.66 [5] Expert Commentary - Dr. Deepak L. Bhatt emphasized that sotagliflozin is the only SGLT inhibitor to show significant reductions in both heart attack and stroke [6] - Craig Granowitz, M.D., noted that the comprehensive findings illustrate how sotagliflozin stands apart from other SGLT inhibitors [7] Company Overview - Lexicon Pharmaceuticals is focused on pioneering medicines that transform patients' lives, utilizing its Genome5000™ program to discover therapeutic targets [9] - The company has a pipeline of drug candidates in various stages of development, addressing conditions such as neuropathic pain, hypertrophic cardiomyopathy, and obesity [9]

Core Insights - The study published in The Lancet Diabetes & Endocrinology highlights the clinical advantages of sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, in reducing life-threatening cardiovascular outcomes compared to empagliflozin [2][3] - Sotagliflozin demonstrated a significant reduction in major adverse cardiovascular events (MACE), myocardial infarction (MI), and stroke among patients with type 2 diabetes (T2D), chronic kidney disease (CKD), and high cardiovascular risk [3][5] Study Findings - The secondary analysis of the SCORED trial revealed that patients receiving sotagliflozin had a lower rate of MACE outcomes at 4.8 events per 100 person-years compared to 6.3 events per 100 person-years in the placebo group, with a hazard ratio of 0.77 [4][5] - The study also found that sotagliflozin reduced the rate of MI to 1.8 events per 100 person-years versus 2.7 events per 100 person-years in the placebo group, with a hazard ratio of 0.68 [5] - Additionally, the rate of stroke was reduced to 1.2 events per 100 person-years in the sotagliflozin group compared to 1.8 events per 100 person-years in the placebo group, with a hazard ratio of 0.66 [5] Company Overview - Lexicon Pharmaceuticals is focused on pioneering medicines that transform patients' lives, utilizing its Genome5000™ program to discover therapeutic targets [9] - The company has a pipeline of drug candidates in various stages of development, addressing conditions such as neuropathic pain, hypertrophic cardiomyopathy, and obesity [9]