Core Insights - Lexicon Pharmaceuticals is hosting a virtual webcast titled "LX9211 - Changing the Paradigm for Treatment of Neuropathic Pain" on January 28, 2025, from 9:00 a.m. to 11:00 a.m. ET [1] - The event will provide an in-depth overview of LX9211, a novel non-opioid treatment for diabetic peripheral neuropathic pain (DPNP), ahead of the anticipated topline data from the Phase 2b PROGRESS trial [2] - The webcast will feature presentations from Lexicon leadership and an expert panel, along with a Q&A session focused on DPNP [2] Company Overview - Lexicon Pharmaceuticals is a biopharmaceutical company dedicated to pioneering medicines that transform patients' lives, utilizing its Genome5000™ program to study nearly 5,000 genes and identify over 100 protein targets with therapeutic potential [3] - The company has a pipeline of promising drug candidates in various stages of discovery and development, targeting indications such as cardiology, neuropathic pain, and metabolism [3]

Core Insights - Lexicon Pharmaceuticals received a complete response letter (CRL) from the FDA regarding the New Drug Application (NDA) for Zynquista™ (sotagliflozin) as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease (CKD) [4] - The company has decided to discontinue launch preparations for Zynquista and will focus on its clinical development pipeline [2] - Lexicon is committed to advancing its clinical pipeline, particularly LX9211 for diabetic neuropathic pain (DPNP), with top line data from the PROGRESS Phase 2b study expected in Q1 2025 [6] Company Overview - Lexicon Pharmaceuticals is a biopharmaceutical company focused on pioneering medicines that transform patients' lives, utilizing its Genome5000™ program to study nearly 5,000 genes and identify over 100 protein targets with therapeutic potential [5] - The company has a pipeline of promising drug candidates in various stages of development, targeting conditions such as neuropathic pain, hypertrophic cardiomyopathy (HCM), obesity, and metabolism [5]

Core Insights - Lexicon Pharmaceuticals has successfully completed patient enrollment in the PROGRESS study, exceeding the target by 20% with a total of 494 patients enrolled, and finishing eight weeks ahead of schedule [2][3][4] - Top-line data from the PROGRESS study is expected to be announced in Q1 2025, which will provide critical insights for the Phase 3 design of LX9211 [3][4] Study Details - The PROGRESS study is a Phase 2b trial evaluating LX9211 for diabetic peripheral neuropathic pain (DPNP), a condition with significant unmet treatment needs [2][5] - The primary endpoint of the study is the reduction of Average Daily Pain Score (ADPS) at 8 weeks, with secondary endpoints including changes in burning pain and pain interference with sleep [5] - The study design allows patients to maintain one stable-dose DPNP therapy, aligning with real-world treatment practices [5] Background on DPNP - Diabetic peripheral neuropathic pain (DPNP) affects approximately 5 million patients in the U.S., resulting from nerve damage due to chronically high blood sugar levels [6] - DPNP can lead to debilitating symptoms such as pain and numbness in extremities, highlighting the urgent need for new non-opioid treatment options [6][4] About LX9211 - LX9211 is a novel, orally delivered, selective small molecule inhibitor of adaptor-associated kinase 1 (AAK1), identified through Lexicon's gene science approach [7] - Preclinical studies have shown that LX9211 can penetrate the central nervous system and reduce pain behavior without affecting opiate pathways [7] - The drug has received Fast Track designation from the U.S. FDA for development in DPNP [7] Company Overview - Lexicon Pharmaceuticals is focused on pioneering medicines that transform patients' lives, utilizing its Genome5000™ program to identify therapeutic targets [8] - The company has a pipeline of drug candidates in various stages of development for conditions including neuropathic pain, hypertrophic cardiomyopathy, and obesity [8]

Group 1 - Lexicon Pharmaceuticals will present at two investor conferences in December 2024, including the Piper Sandler 36th Annual Healthcare Conference on December 3 and the 7th Annual Evercore HealthCONx Conference on December 5 [1] - The presentations will be available via simultaneous webcasts on Lexicon's website, with recordings accessible for two weeks post-event [1] Group 2 - Lexicon Pharmaceuticals is a biopharmaceutical company focused on pioneering medicines that transform patients' lives [2] - The company utilizes its Genome5000™ program to study nearly 5,000 genes, identifying over 100 protein targets with significant therapeutic potential across various diseases [2] - Lexicon has a pipeline of drug candidates in discovery and clinical development targeting neuropathic pain, hypertrophic cardiomyopathy, obesity, metabolism, and other indications [2]

Core Viewpoint - Lexicon Pharmaceuticals has decided to eliminate its commercial operations and rationalize resources to focus on advancing its clinical development pipeline, aiming to reduce operating costs by $100 million in 2025 [1][4]. Group 1: Strategic Restructuring - The company will completely eliminate its commercial field team and reduce the size of other functions, including all promotional efforts for INPEFA® and planned commercial activities for ZYNQUISTA [4]. - Approximately 60% of employees will be affected by this restructuring, with most reductions effective by December 31, 2024 [4]. - The expected reduction in operating costs for the full year 2025 is $100 million, in addition to $40 million in cost savings previously announced [4]. Group 2: Focus on R&D Pipeline - Lexicon will concentrate on its R&D pipeline, including the Phase 2b PROGRESS study for LX9211 in diabetic peripheral neuropathic pain (DPNP), with topline data expected in Q1 2025 [5]. - The pivotal Phase 3 SONATA HCM study for sotagliflozin in hypertrophic cardiomyopathy (HCM) is currently enrolling participants [5]. - The company is also advancing IND-enabling studies for LX9851, a novel oral candidate for obesity and associated cardiometabolic disorders, and exploring strategic partnerships to enhance its pipeline [5]. Group 3: Regulatory Challenges - The decision to restructure follows a "deficiencies preclude discussion" letter from the FDA regarding the New Drug Application for Zynquista™ for type 1 diabetes and chronic kidney disease, indicating issues that prevent further discussion on labeling and post-marketing requirements [2][3].

Core Insights - Lexicon Pharmaceuticals has elected Ivan H. Cheung to its Board of Directors, marking a significant moment in the company's history [1][4] - Mr. Cheung brings over 25 years of experience in the healthcare industry and has a strong track record in shareholder value creation [2][3] - The appointment coincides with the retirement of Robert J. Lefkowitz, who served on the board for 23 years [4][5] Company Overview - Lexicon Pharmaceuticals is focused on pioneering medicines that transform patients' lives, utilizing its Genome5000™ program to study nearly 5,000 genes and identify over 100 protein targets with therapeutic potential [5] - The company has commercially launched INPEFA® (sotagliflozin) in the United States and has a pipeline of drug candidates in various stages of development for conditions such as neuropathic pain, diabetes, and metabolism [5]

Financial Performance - Revenues for the three months ended September 30, 2024, were approximately $1.8 million, a significant increase from $0.2 million in the same period in 2023, and for the nine months ended September 30, 2024, revenues were $4.5 million compared to $0.5 million in 2023, primarily driven by sales of INPEFA[67] - The net loss for the three months ended September 30, 2024, was $64.8 million, or $0.18 per share, compared to a net loss of $50.5 million, or $0.21 per share, in the same period in 2023[81] - The company reported a net loss of $166.6 million for the nine months ended September 30, 2024, which included non-cash charges of $6.9 million related to stock-based compensation[89] Expenses - Research and development expenses for the three months ended September 30, 2024, increased by 47% to $25.8 million from $17.6 million in 2023, and for the nine months, they rose by 31% to $57.8 million from $44.1 million[69] - Selling, general and administrative expenses for the three months ended September 30, 2024, increased by 23% to $39.6 million from $32.2 million in 2023, and for the nine months, they rose by 36% to $110.8 million from $81.4 million[74] - Interest and other expenses increased to $4.6 million for the three months ended September 30, 2024, from $3.9 million in 2023, reflecting additional borrowing under the Oxford Term Loans[79] Cash and Funding - As of September 30, 2024, the company had $258.4 million in cash, cash equivalents, and short-term investments, compared to $170.0 million as of December 31, 2023[89] - The company entered into a loan and security agreement with Oxford providing up to $150 million in borrowing capacity, with $100 million funded under the first three tranches as of September 30, 2024[84] - The company is required to maintain a minimum unrestricted cash and investments balance of $10 million until specified net sales are achieved, increasing to $25 million upon funding of the fourth tranche[85] Future Outlook - The company expects to continue incurring significant research and development costs and selling, general and administrative expenses, necessitating higher revenues to achieve profitability[65] - The company expects to continue substantial capital resources for the commercialization of INPEFA and the launch of ZYNQUISTA, with current cash and investment balances projected to fund operations for at least the next 12 months[93] - Future capital requirements will depend on the success of commercialization efforts and ongoing research and development, with potential needs for additional liquidity through collaborations or equity sales[92] Product Development - The company is commercializing INPEFA (sotagliflozin) in the U.S. to reduce cardiovascular risks in adults with heart failure or type 2 diabetes[55] - The company is pursuing regulatory approval for ZYNQUISTA™ (sotagliflozin) for type 1 diabetes, with a New Drug Application currently under review by the FDA, expected to be completed by December 20, 2024[56] - Research and development efforts include ongoing Phase 3 trials for sotagliflozin in hypertrophic cardiomyopathy and Phase 2b trials for LX9211 in diabetic peripheral neuropathic pain[57][58] - An exclusive license agreement with Viatris was signed for the development of sotagliflozin, resulting in an upfront payment of $25 million[88] - Upon regulatory approval of sotagliflozin, the company will make royalty payments totaling $4.5 million in three annual installments[90] Market and Currency Exposure - The company has operated primarily in the U.S., with all sales made in U.S. dollars, resulting in no material exposure to foreign currency fluctuations[97] Accumulated Deficit - The company has an accumulated deficit of $1.9 billion as of September 30, 2024, primarily due to research and development costs and selling, general and administrative expenses[65]

Lexicon Pharmaceuticals (LXRX) came out with a quarterly loss of $0.18 per share versus the Zacks Consensus Estimate of a loss of $0.17. This compares to loss of $0.21 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -5.88%. A quarter ago, it was expected that this drugmaker would post a loss of $0.18 per share when it actually produced a loss of $0.17, delivering a surprise of 5.56%.Over the last four quarters, the company has ...

Financial Performance - Lexicon Pharmaceuticals reported Q3 2024 revenues of $1.8 million, a significant increase from $0.2 million in Q3 2023, primarily driven by product sales of INPEFA[10] - The company achieved net sales of $1.7 million for INPEFA in Q3 2024, with an 18% increase in active prescribers[6] - Lexicon reported a net loss of $64.8 million, or $0.18 per share, in Q3 2024, compared to a net loss of $50.5 million, or $0.21 per share, in Q3 2023[13] - Selling, general and administrative expenses increased to $39.6 million in Q3 2024, compared to $32.2 million in Q3 2023, reflecting higher marketing costs and severance expenses[12] - Research and development expenses rose to $25.8 million in Q3 2024, up from $17.6 million in Q3 2023, due to investments in clinical trials[11] - The company has $258.4 million in cash and investments as of September 30, 2024, up from $170.0 million at the end of 2023[14] Product Development and Regulatory Updates - An exclusive licensing agreement with Viatris for sotagliflozin was announced, including a $25 million upfront payment and potential additional milestones of $197 million[3] - Topline data from the Phase 2b PROGRESS study of LX9211 is expected in Q1 2025[8] - The PDUFA target action date for ZYNQUISTA is set for December 20, 2024, following a recent FDA Advisory Committee meeting[4] - The company is conducting a pivotal Phase 3 study (SONATA) for sotagliflozin in hypertrophic cardiomyopathy (HCM) with a target enrollment of 500 patients[7] Safety and Efficacy Concerns - INPEFA may increase the risk of hypoglycemia when combined with insulin or insulin secretagogues, necessitating a lower dose of these medications[26] - Reports of Fournier's Gangrene have been identified in patients with diabetes receiving SGLT2 inhibitors, requiring immediate treatment and monitoring[27] - INPEFA increases the risk of genital mycotic infections, which should be monitored and treated appropriately[28] - Co-administration of INPEFA 400 mg with digoxin increases digoxin exposure, requiring appropriate patient monitoring[29] - INPEFA is not recommended during the second and third trimesters of pregnancy or while breastfeeding[30] - Elderly patients may be at increased risk for volume depletion adverse reactions, including hypotension[30] - INPEFA was evaluated in patients with chronic kidney disease (eGFR 25 to 60 mL/min/1.73 m²) and showed a consistent safety profile across eGFR subgroups[30] - There was an increase in volume-related adverse events in patients with eGFR < 30 mL/min/1.73 m² compared to the overall safety population[30] - INPEFA is not recommended in patients with moderate or severe hepatic impairment[30] - Urinary glucose tests are not reliable for patients taking SGLT2 inhibitors; alternative testing methods should be used[28]

Announced Exclusive Licensing Agreement with Viatris for Sotagliflozin in all Markets Outside of the U.S. and Europe Completed ZYNQUISTA™ FDA Advisory Committee Meeting; PDUFA Goal Date December 20, 2024 Concluded Enrollment Screening For Phase 2b PROGRESS Study of LX9211 in Diabetic Peripheral Neuropathic Pain (DPNP); Topline Data Expected in Q1 2025 Executed Repositioning of INPEFA® (sotagliflozin); Net Sales of $1.7 Million in Q3 2024 Conference Call and Webcast at 5:00pm ET THE WOODLANDS, Texas, Nov. 12 ...