Lexicon Pharmaceuticals (LXRX) investor relations material

Strategic transformation and pipeline progress

• Focus has shifted to cardiometabolic diseases, with late-stage programs for sotagliflozin in type 1 diabetes and hypertrophic cardiomyopathy (HCM) as key priorities.

• Enrollment in the SONATA-HCM phase III trial exceeded targets, with over 500 patients, and top-line data expected in Q1 2027.

• The STENO1 study in type 1 diabetes completed recruitment, supporting a planned FDA resubmission in Q4 2026.

• Partnerships with Viatris and Novo Nordisk are advancing, with milestone payments and international approvals for heart failure indications.

• Pre-launch and commercialization activities are underway, including key leadership hires and expanded medical affairs teams.

Clinical and scientific insights

• Sotagliflozin targets both SGLT1 and SGLT2, offering potential benefits in HCM by improving cardiac energetics and addressing diastolic dysfunction.

• SONATA-HCM is the largest trial to date for both obstructive and non-obstructive HCM, with broad inclusion criteria and pragmatic design.

• The drug's safety profile in heart failure and oral, once-daily dosing position it as a potential first-line option for HCM.

• Market research indicates significant unmet need and physician interest in non-obstructive HCM, where no approved therapies exist.

• The trial design allows for inclusion of patients with lower ejection fractions, broadening potential applicability.

Forward-looking statements and milestones

• Top-line SONATA-HCM data is expected in Q1 2027, with potential for first-in-class approval in both obstructive and non-obstructive HCM.

• FDA resubmission for type 1 diabetes is planned for Q4 2026, with a potential decision in 2027.

• Phase III for pilavapadin in diabetic peripheral neuropathic pain is set to begin, with additional indications under evaluation.

• Novo Nordisk may initiate phase II for LX9851 in obesity, triggering further milestone payments.

• The next six months are expected to bring significant clinical, regulatory, and commercial developments.