Lexicon Pharmaceuticals (LXRX) H.C. Wainwright 4th Annual BioConnect Investor Conference summary

Company overview and pipeline highlights

• Focuses on cardiometabolic diseases with both late- and early-stage programs, including sotagliflozin (dual SGLT1/2 inhibitor) marketed as INPEFA for heart failure and in late-stage trials for Type 1 Diabetes and hypertrophic cardiomyopathy (HCM).

• Sotagliflozin is being resubmitted for Type 1 Diabetes by mid-year, targeting approval in 2026; phase III SONATA trial in HCM to complete enrollment soon, with data expected Q1 2027.

• LX9851, a novel oral obesity drug targeting ACSL5, is partnered with Novo Nordisk, now in phase I, with milestone payments received and further payments expected as development progresses.

• Pilavapadin (AAK1 inhibitor) for diabetic peripheral neuropathy completed phase II, cleared by FDA for phase III, and shows potential in additional indications like spasticity.

• Multiple near-term milestones are anticipated through Q1 2027, including regulatory submissions, trial readouts, and commercial launches.

Clinical data and regulatory strategy

• SOTA-P-CARDIA study in non-diabetic HFpEF showed significant improvements in cardiac function and endpoints, supporting potential efficacy in HCM.

• Sotagliflozin’s safety profile may avoid REMS requirements, unlike cardiac myosin inhibitors, due to its established safety and lack of heart failure risk.

• For Type 1 Diabetes, FDA requires prospective data on diabetic ketoacidosis (DKA) from the Steno-2 study, not additional efficacy trials; international DKA management guidelines ensure data relevance across regions.

• Key inflection points include potential Type 1 Diabetes approval and SONATA HCM trial readout in Q1 2027.

Financial position and partnerships

• Raised capital in early 2024, holding ~$197 million in cash, sufficient to fund operations through HCM data readout and into 2027.

• Refinanced $45 million debt facility and secured access to up to $100 million in non-dilutive capital.

• Novo Nordisk collaboration on LX9851 provides milestone payments and positions the asset for further development, with phase II trials anticipated in 2027.

• Pilavapadin partnership strategy remains flexible, with options for co-development or external funding to maximize value.