Lexicon Pharmaceuticals (LXRX) investor relations material

Strategic focus and pipeline development

• Focused on cardiometabolic diseases and pain, with oral, once-daily medicines targeting broad indications.

• INPEFA (sotagliflozin) commercialized for heart failure in the U.S., in phase III for HCM, and planned NDA resubmission for type 1 diabetes in 2026 based on new data.

• Pilavapadin, a first-in-class AAK1 inhibitor, showed efficacy and safety in phase II for DPNP; phase III trials and partnership discussions are ongoing.

• LX9851, a non-incretin oral obesity candidate, licensed globally to Novo Nordisk, with IND-enabling studies completed and milestone payments supporting operations.

• Over 80 clinical trials conducted, with multiple medicines approved and brought to market.

Clinical progress and regulatory milestones

• SONATA phase III trial for HCM is enrolling well, with top-line data expected in early 2025.

• Steno-1 trial data supports Zynquista’s resubmission, addressing FDA’s DKA risk assessment requirement.

• INPEFA received first ex-U.S. approval via Viatris in UAE, with ongoing submissions in multiple countries.

• FDA alignment achieved on key parameters for Zynquista’s approval pathway in type 1 diabetes.

• Pilavapadin’s phase II results support advancement to phase III for DPNP.

Market opportunity and differentiation

• Sotagliflozin is the only HCM agent with dual SGLT1/SGLT2 inhibition, targeting both obstructive and non-obstructive HCM.

• High unmet need in T1D and DPNP, with no approved oral therapies for T1D and limited effective non-opioid options for DPNP.

• DPNP affects 9 million U.S. patients, with significant dissatisfaction with current treatments.

• LX9851 offers a novel, oral, non-incretin approach for obesity, aiming for better tolerability and long-term adherence.

• Legislative and payer support for non-opioid pain therapies expected to facilitate market access.