Lexicon Seeks Approval for Sotagliflozin as an Adjunct to Insulin Therapy for Glycemic Control in People with Type 1 Diabetes and Chronic Kidney Disease Company Anticipates Six Month Review and Potential Launch in Early 2025 THE WOODLANDS, Texas, June 21, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced that, following multiple interactions with and recent feedback from the U.S. Food and Drug Administration (FDA), it has resubmitted its New Drug Application (NDA) for so ...

Clinical trial of LX9211, an investigational non-opioid investigational therapy, demonstrated clinically significant benefits for people with diabetic peripheral neuropathic pain (DPNP) Investigators conclude that clinical outcomes of RELIEF-DPN 1 support commencement of Lexicon's dose-ranging Phase 2b PROGRESS trial, currently enrolling patients THE WOODLANDS, Texas, June 19, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) today announced that Diabetes Care, the peer-reviewed journal o ...

Clinical trial of LX9211, an investigational non-opioid investigational therapy, demonstrated clinically significant benefits for people with diabetic peripheral neuropathic pain (DPNP) Investigators conclude that clinical outcomes of RELIEF-DPN 1 support commencement of Lexicon’s dose-ranging Phase 2b PROGRESS trial, currently enrolling patients THE WOODLANDS, Texas, June 19, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that Diabetes Care, the peer-reviewed journal ...

New analysis of the pivotal Phase 3 SOLOIST-WHF trial demonstrates INPEFA cost-effectiveness Findings consistent with another study recently published in the Journal of Comparative Effectiveness Research THE WOODLANDS, Texas, June 18, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) today announced that the peer-reviewed Journal of the American College of Cardiology: Heart Failure has published a research paper concluding that INPEFA® (sotagliflozin) is cost-effective for people with dia ...

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 A-4-B2). Details are as follows: "Patient-Reported Burden of Disease in Di ...

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 A-4-B2). Details are as follows: "Patient-Reported Burden of Disease in D ...

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 ...

财务数据和关键指标变化 - 公司在2024年第一季度实现收入1.1百万美元,几乎全部来自INPEFA的净销售额,而2023年同期收入很少 [65] - 研发费用从2023年同期的1200万美元增加到2024年第一季度的1440万美元,主要由于外部研发费用的增加 [65] - 销售、一般及管理费用从2023年同期的1910万美元增加到2024年第一季度的3210万美元,反映了公司在INPEFA商业化发展方面的投入,包括销售团队人员成本增加以及差旅和营销成本的增加 [65] - 2024年第一季度净亏损为4840万美元或每股0.20美元,而2023年同期净亏损为3190万美元或每股0.17美元 [67] 各条业务线数据和关键指标变化 - 公司正在推进INPEFA在心力衰竭治疗领域的商业化,取得了积极进展,包括提高医生对INPEFA的认知度和意愿,以及与主要支付方就获得更广泛的患者覆盖进行谈判 [23][24][27][28][30][31] - 公司正准备在2024年中期重新提交Zynquista用于1型糖尿病合并慢性肾脏病适应症的新药申请,希望获批后能满足这一人群的重大未满足需求 [14][36][37][38][39][40][41] - 公司正在启动一项关于sotagliflozin用于治疗肥厚型心肌病的III期临床试验,希望能证明其在这一领域的潜力 [47][48][49] - 公司的LX9211正在进行II期临床试验,用于治疗糖尿病周围神经病性疼痛,预计2025年第二季度能够获得关键性试验数据 [52][53] - 公司最近公布了一种新的口服药物候选化合物LX9851,针对ACSL5靶点,有望在慢性体重管理领域发挥作用 [54][55][56][57][58][59][60] 各个市场数据和关键指标变化 - 心力衰竭患者群体在未来几年将持续增长,预计到2030年将达850万人,同时相关医疗费用也将从2020年的440亿美元增加到700亿美元 [22] - 1型糖尿病患者中,20%-25%合并有慢性肾脏病,这一人群存在严重的血糖控制和并发症管理需求,目前尚无特效治疗方案 [37][38][39][40][41] - 肥厚型心肌病是一个巨大的未满足医疗需求领域,现有治疗手段主要针对症状改善,而公司希望sotagliflozin能够带来预后改善 [47][48][49][51] - 糖尿病周围神经病性疼痛是一个数十亿美元的市场,LX9211有望成为首个上市的非阿片类新药 [52][53] - 肥胖和代谢综合征是一个巨大的市场机会,LX9851有望在体重管理和改善代谢指标方面发挥作用 [54][55][56][57][58][59][60] 公司战略和发展方向及行业竞争 - 公司正在积极推进INPEFA在心力衰竭治疗领域的商业化,并计划在2024年下半年实现销售的大幅增长 [13][23][24][33] - 公司正在为Zynquista在1型糖尿病合并慢性肾脏病适应症的重新申报做准备,希望能在2024年中期提交新药申请 [14][36][41][44] - 公司正在启动一项关于sotagliflozin用于治疗肥厚型心肌病的III期临床试验,以拓展该药物的适应症 [47][48][49][51] - 公司正在推进LX9211用于糖尿病周围神经病性疼痛的II期临床试验,并有望在2025年获得关键性试验数据 [52][53] - 公司最近公布了一种新的口服药物候选化合物LX9851,针对ACSL5靶点,有望在慢性体重管理领域发挥作用 [54][55][56][57][58][59][60] - 公司正在积极探索各项目的商业化和合作机会,以最大化资产价值 [64] 管理层对经营环境和未来前景的评论 - 公司CEO Lonnel Coats即将于7月7日退休,但他表示公司正处于最强劲的状态,有一支出色的管理团队和充足的资金支持未来发展 [9][10][11][12] - 公司管理层对INPEFA在心力衰竭治疗领域的商业化前景持乐观态度,预计在2024年下半年将实现销售的大幅增长 [13][23][24][33] - 公司管理层对Zynquista在1型糖尿病合并慢性肾脏病适应症获批的前景表示乐观,认为能满足这一人群的重大未满足需求 [14][36][41][44] - 公司管理层对sotagliflozin在肥厚型心肌病领域的潜力表示信心,认为其独特的作用机制可能带来优势 [47][48][49][51] - 公司管理层对LX9211在糖尿病周围神经病性疼痛领域的前景表示乐观,认为其有望成为一种创新的非阿片类治疗方案 [52][53] - 公司管理层对LX9851在慢性体重管理领域的前景表示乐观,认为其能在GLP-1受体激动剂基础上提供进一步改善 [54][55][56][57][58][59][60] 问答环节重要的提问和回答 问题1 **Amin 提问** 对于INPEFA的销售,公司预计在下半年会出现哪些主要因素推动销售的大幅增长?[73][74] **Lonnel Coats和Tom Garner回答** - 公司正在积极与支付方进行谈判,预计将在今年中期获得更广泛的患者覆盖,这将是推动销售增长的关键因素之一 [75][77] - 与此同时,公司正在持续提高医生对INPEFA的认知度和使用意愿,这也将是销售增长的重

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) Delaware ...

Exhibit 99.1 LEXICON PHARMACEUTICALS REPORTS FIRST QUARTER 2024 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE Commercial launch of INPEFA® (sotagliflozin) for Heart Failure continues to progress Resubmission of NDA for ZYNQUISTA™ (sotagliflozin) in Type 1 Diabetes expected mid-year 2024 Start-up ongoing for Phase 3 study of sotagliflozin in Hypertrophic Cardiomyopathy, with enrollment expected to begin mid-year 2024 Enrollment in Phase 2b PROGRESS study of LX9211 in Diabetic Peripheral Neuropathic Pain on ...