Core Insights - Lexicon Pharmaceuticals announced the publication of a research paper on its Phase 2 RELIEF-DPN-1 clinical trial for LX9211, aimed at treating diabetic peripheral neuropathic pain (DPNP) [1][3] Summary by Sections Clinical Trial Results - The RELIEF-DPN-1 study demonstrated that LX9211 provides clinically significant benefits for patients with DPNP, with a focus on pain relief over an 11-week evaluation period [7] - The primary efficacy endpoint was the change in average daily pain score (ADPS) from baseline to week 6, which was achieved in the low-dose LX9211 group [7] - Patient-reported outcomes improved significantly in those treated with LX9211, which was generally well tolerated [7] Current Treatment Landscape - Existing therapies for DPNP offer only modest pain relief, with less than 50% of patients achieving a 50% reduction in pain severity [2] - Many patients continue to use opioids as first-line therapy despite the associated high risks and complications, including mortality [2] Future Developments - The positive outcomes from the RELIEF-DPN-1 study support the initiation of Lexicon's larger Phase 2b PROGRESS trial, which is currently enrolling patients across the United States [3][15] - LX9211 has received Fast Track designation from the U.S. FDA for its development in DPNP, indicating its potential significance in addressing this medical need [11] Company Overview - Lexicon Pharmaceuticals is focused on pioneering innovative medicines, having launched INPEFA® (sotagliflozin) and developing a pipeline of drug candidates targeting neuropathic pain, diabetes, and metabolism [10] - The company utilizes its Genome5000™ program to identify therapeutic targets, having discovered over 100 protein targets with significant potential [10]

Investigators conclude that clinical outcomes of RELIEF-DPN 1 support commencement of Lexicon's dose-ranging Phase 2b PROGRESS trial, currently enrolling patients In the proof-of-concept RELIEF-DPN-1 study, the effects of LX9211 were assessed over an 11-week evaluation period, which included a six-week double-blind treatment period and a 5-week single-blind safety follow-up period. The primary efficacy endpoint under evaluation was the change from baseline to week 6 in average daily pain score (ADPS), which ...

Company Overview - Lexicon Pharmaceuticals is a biopharmaceutical company focused on pioneering medicines that transform patients' lives through innovative drug discovery and development [4][12]. - The company has launched INPEFA® (sotagliflozin) in the United States and is developing a pipeline of other drug candidates targeting various diseases, including neuropathic pain and diabetes [4][12]. Product Information - INPEFA® (sotagliflozin) is an oral inhibitor of SGLT2 and SGLT1, which are proteins involved in glucose regulation [5]. - Sotagliflozin has been studied in clinical trials involving approximately 20,000 patients across multiple populations, including those with heart failure and diabetes [5]. Research Findings - A recent study published in the Journal of Comparative Effectiveness Research concluded that INPEFA is cost-effective for patients with diabetes and recent worsening heart failure, demonstrating a net gain in quality-adjusted life years (QALYs) of 0.425 compared to standard care [2][12]. - The analysis indicated that lifetime QALYs were 4.43 for the INPEFA group versus 4.04 for the placebo group, reinforcing the financial value of INPEFA for the U.S. healthcare system [13][14]. Clinical Implications - The findings suggest that INPEFA not only provides clinical benefits to heart failure patients but also offers significant economic value for payors [14]. - The research supports the use of INPEFA as a cost-effective addition to standard care for patients hospitalized with heart failure and comorbid diabetes [2][12].

Company Overview - Lexicon Pharmaceuticals, Inc. is a biopharmaceutical company focused on pioneering medicines that transform patients' lives, with a unique genomics target discovery platform called Genome5000™ [4][5] - The company has commercially launched one medicine, INPEFA® (sotagliflozin), in the United States and has a pipeline of promising drug candidates in various stages of development for neuropathic pain, diabetes, metabolism, and other indications [5][6] Research Presentations - Lexicon will present three poster presentations at the 84th Scientific Sessions of the American Diabetes Association from June 21 - 24, 2024, in Orlando, Florida [4] - The presentations include topics such as the burden of diabetic peripheral neuropathic pain and the impact of sotagliflozin as an add-on treatment for inadequately controlled type 2 diabetes [5] Drug Development - LX9211 is an investigational small molecule inhibitor of adaptor-associated kinase 1 (AAK1), identified as a promising treatment for neuropathic pain, with preclinical studies showing effectiveness without affecting opiate pathways [6] - Sotagliflozin is an oral inhibitor of SGLT2 and SGLT1 proteins, studied in clinical trials involving approximately 20,000 patients across various conditions including heart failure and chronic kidney disease [7]

THE WOODLANDS, Texas, June 14, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that three poster presentations will be delivered during the 84th Scientific Sessions of the American Diabetes Association being held June 21 - 24, 2024 at the Orange County Convention Center in Orlando, Florida. All three poster presentations will occur on Sunday, June 23, 12:30 - 1:30 p.m. ET, in the Poster Hall (West A4-B2). Details are as follows: "Patient-Reported Burden of Disease in Di ...

THE WOODLANDS, Texas, May 14, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) today announced a new post-hoc analysis of clinical data showing that INPEFA® (sotagliflozin), a dual oral inhibitor of SGLT2 and SGLT1, reduced the risk of heart failure-related events across a diverse population of patients, including patients with preserved ejection fraction (HFpEF). Researchers noted that INPEFA appeared to be particularly effective in reducing the risk of heart failure events in patients ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended March 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period from _____________ to _____________ Commission File Number: 000-30111 Lexicon Pharmaceuticals, Inc. (Exact Name of Registrant as Specified in its Charter) | Title ...

[Corporate Highlights and Outlook](index=1&type=section&id=Corporate%20Highlights%20and%20Outlook) Lexicon Pharmaceuticals reported Q1 2024 progress with INPEFA's launch, pipeline advancements, and strong capitalization - The commercial launch of INPEFA for heart failure is progressing, with an expected inflection in the second half of 2024 driven by expanded market access[1](index=1&type=chunk)[3](index=3&type=chunk) - Planning to resubmit the New Drug Application (NDA) for ZYNQUISTA™ for type 1 diabetes with chronic kidney disease (CKD) around mid-year 2024[1](index=1&type=chunk)[3](index=3&type=chunk) - A Phase 3 study of sotagliflozin in hypertrophic cardiomyopathy (HCM) is starting, with enrollment expected to begin mid-year 2024[1](index=1&type=chunk)[3](index=3&type=chunk) - Enrollment is on track for the Phase 2b PROGRESS study of LX9211 for diabetic peripheral neuropathic pain, with topline data expected in Q2 2025[1](index=1&type=chunk)[3](index=3&type=chunk) - Selected LX9851 as a new development candidate for obesity and weight management, now entering IND-enabling studies[3](index=3&type=chunk) - The company is well-capitalized following a recent successful financing, enabling targeted investments for growth[3](index=3&type=chunk) [Pipeline Highlights](index=1&type=section&id=Pipeline%20Highlights) Lexicon's pipeline demonstrated strong Q1 2024 momentum with significant progress across its key drug candidates [INPEFA (sotagliflozin) for Heart Failure](index=1&type=section&id=INPEFA%20%28sotagliflozin%29%20for%20Heart%20Failure) INPEFA's commercial launch progressed in Q1 2024, showing significant sales growth and anticipated market access expansion | Metric | Value | | :--- | :--- | | Q1 2024 Net Sales | $1.1 million | | QoQ Growth | 63% | | Current Market Access | ~40% | [ZYNQUISTA (sotagliflozin) for Type 1 Diabetes](index=1&type=section&id=ZYNQUISTA%20%28sotagliflozin%29%20for%20Type%201%20Diabetes) Lexicon plans mid-2024 NDA resubmission for ZYNQUISTA as adjunctive therapy for type 1 diabetes with CKD - NDA resubmission for ZYNQUISTA is planned for mid-year 2024 as an adjunct to insulin for people with type 1 diabetes and CKD[5](index=5&type=chunk) - Chronic kidney disease (CKD) is estimated to impact **20% to 25%** of people with type 1 diabetes[6](index=6&type=chunk) [Sotagliflozin for HCM](index=2&type=section&id=Sotagliflozin%20for%20HCM) Lexicon is initiating a Phase 3 study of sotagliflozin for hypertrophic cardiomyopathy (HCM), expected mid-year 2024 - A Phase 3 study of sotagliflozin in HCM is being initiated, with study start expected mid-year 2024[7](index=7&type=chunk) [LX9211 for DPNP](index=2&type=section&id=LX9211%20for%20DPNP) Enrollment for LX9211's Phase 2b DPNP study is on track, with topline data anticipated in Q2 2025 - The PROGRESS Phase 2b study of LX9211 is on track, with topline data anticipated in Q2 2025[8](index=8&type=chunk) [LX9851 for Obesity and Weight Management](index=2&type=section&id=LX9851%20for%20Obesity%20and%20Weight%20Management) Lexicon selected LX9851, an oral ACSL5-inhibitor, as a development candidate for obesity, now entering IND-enabling studies - LX9851, an oral ACSL5-inhibitor, has been selected as a development candidate for obesity and is now commencing IND-enabling studies[9](index=9&type=chunk) [First Quarter 2024 Financial Highlights](index=2&type=section&id=First%20Quarter%202024%20Financial%20Highlights) Lexicon's Q1 2024 financials show **$1.1 million** revenue, a **$48.4 million** net loss, and a **$355.6 million** cash position | Financial Metric | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Total Revenues | $1.1 million | $0.02 million | | R&D Expenses | $14.4 million | $12.0 million | | SG&A Expenses | $32.1 million | $19.1 million | | Net Loss | $(48.4) million | $(31.9) million | | Net Loss per Share | $(0.20) | $(0.17) | | Cash and Investments (End of Period) | $355.6 million | N/A | [Selected Financial Data](index=6&type=section&id=Selected%20Financial%20Data) This section provides Lexicon's unaudited consolidated statements of operations and balance sheet data for Q1 2024 Consolidated Statements of Operations Data (Unaudited, In thousands, except per share data) | | Three Months Ended March 31, | | :--- | :---: | :---: | | | **2024** | **2023** | | **Total revenues** | **$1,130** | **$24** | | Cost of sales | $31 | $— | | Research and development | $14,372 | $12,026 | | Selling, general and administrative | $32,060 | $19,140 | | **Total operating expenses** | **$46,463** | **$31,166** | | Loss from operations | $(45,333) | $(31,142) | | **Net loss** | **$(48,397)** | **$(31,934)** | | Net loss per common share | $(0.20) | $(0.17) | Consolidated Balance Sheet Data (Unaudited, In thousands) | | As of March 31, 2024 | As of December 31, 2023 | | :--- | :---: | :---: | | **Cash and investments** | **$355,598** | **$170,026** | | Total assets | $417,219 | $229,429 | | Long-term debt, net | $99,874 | $99,508 | | **Total stockholders' equity** | **$288,867** | **$93,110** | [About INPEFA (sotagliflozin)](index=3&type=section&id=About%20INPEFA%20%28sotagliflozin%29) INPEFA (sotagliflozin) is an oral SGLT1/SGLT2 inhibitor indicated for cardiovascular risk reduction in heart failure and type 2 diabetes, with safety warnings - INPEFA is an oral inhibitor of both SGLT1 (gastrointestinal tract) and SGLT2 (kidney), which regulate glucose and sodium[17](index=17&type=chunk) - Indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure or type 2 diabetes with CKD and other CV risk factors[18](index=18&type=chunk)[21](index=21&type=chunk) - Key safety risks include ketoacidosis, volume depletion (especially in patients with impaired renal function or on loop diuretics), urosepsis, hypoglycemia (when used with insulin), necrotizing fasciitis of the perineum, and genital mycotic infections[20](index=20&type=chunk)[22](index=22&type=chunk)[23](index=23&type=chunk) - Common adverse reactions (≥5% incidence) include urinary tract infection, volume depletion, diarrhea, and hypoglycemia[26](index=26&type=chunk) [About Lexicon Pharmaceuticals and Safe Harbor](index=5&type=section&id=About%20Lexicon%20Pharmaceuticals%20and%20Safe%20Harbor) Lexicon Pharmaceuticals is a biopharmaceutical company leveraging its Genome5000™ platform, with a Safe Harbor statement on forward-looking statements - Lexicon's mission is to pioneer medicines using its unique Genome5000™ genomics target discovery platform[29](index=29&type=chunk) - The press release contains forward-looking statements based on current expectations, which are subject to risks and uncertainties that could cause actual results to differ materially[30](index=30&type=chunk)

THE WOODLANDS, Texas, April 29, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) will release its first quarter 2024 financial results on Thursday, May 2, 2024 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. Dial-in InformationU.S. Dial-in Number: (888) 317-6003International Dial-in Number: (412) 317-6061Conference ID: 5993982 Replay InformationU. ...

THE WOODLANDS, Texas, April 18, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) today announced that senior company executives will be joined by leading physicians at the Lexicon 2024 Investor Day on April 22, 2024. The event will be held in New York City from 9:00 a.m. to 12:00 p.m. ET. Business and scientific updates will be presented by Lonnel Coats, Lexicon's chief executive officer; Jeff Wade, Lexicon's president and chief financial officer; Alan Main, Ph.D., Lexicon's executive vi ...