Lexicon Pharmaceuticals (LXRX) Evercore ISI 8th Annual HealthCONx Conference summary

Strategic focus and recent milestones

• Five key areas of focus include regulatory progress, clinical trials, partnerships, and data readouts.

• Zynquista's resubmission path for type 1 diabetes is being shaped by new safety data from an ongoing trial and FDA dialogue.

• SONATA phase III trial in HCM is enrolling, with data expected by late next year or Q1 2027.

• LX9851, a preclinical obesity asset, was licensed to Novo Nordisk for over $1 billion in upfront and milestone payments.

• INPEFA heart failure drug partnered with Viatris has seen regulatory filings and approval progress in multiple territories.

Zynquista regulatory and clinical update

• FDA accepted efficacy for glycemic control in type 1 diabetes but requested new DKA rate data from an external Danish study.

• The Danish Steno study provides exposure data on sotagliflozin, addressing FDA's DKA concerns without a new trial.

• Agreement reached with FDA on exposure and DKA event rate requirements for resubmission.

• Approval could mark the first non-insulin agent for glycemic control in type 1 diabetes, addressing a significant unmet need.

• Target population includes older patients with CKD or cardiovascular history, not newly diagnosed individuals.

SONATA HCM program and broader implications

• SONATA is the pivotal registration trial for HCM, powered for a clinically meaningful KCCQ benefit.

• Complementary studies may inform combination therapy approaches, especially for non-obstructive HCM.

• Sota's unique dual SGLT1/2 mechanism may address diastolic dysfunction and reduce MACE events, differentiating it from SGLT2 inhibitors.

• KOLs express interest in Sota for both obstructive and non-obstructive HCM, especially for patients with persistent symptoms.