LB Pharmaceuticals (LBRX) Stifel 2025 Healthcare Conference summary

Company overview and vision

• Aims to be a fully integrated CNS company focused on improving patient lives.

• Founded in 2015 to develop a derivative of amisulpride with better blood-brain barrier penetration and potency.

• LB-102, the lead asset, showed statistically significant efficacy and a strong safety profile in phase II trials.

• Engaged with FDA, allowing pursuit of schizophrenia approval with one successful phase III trial.

• Holds composition of matter IP through 2041, including patent term extension.

Clinical development and trial design

• Phase II schizophrenia trial enrolled 359 patients, showing robust efficacy and low EPS rates.

• Phase III trial will enroll 460 patients at 25 sites, increasing statistical power to 85%.

• Measures to manage placebo rate include third-party patient vetting, central raters, and streamlined scales.

• Phase III will last six weeks with three arms, compared to four weeks and four arms in phase II.

• Open-label safety trial will include subset analyses for cognition and negative symptoms.

Differentiation and safety profile

• LB-102 demonstrated very low EPS rates: 0.9% at 50 mg and 5.6% at 100 mg, lower than competitors.

• Amisulpride, the reference molecule, is widely used in Europe with over 2 million prescriptions in 2024.

• Amisulpride has the lowest all-cause discontinuation rate among antipsychotics.

• LB-102 shares CNS receptor binding with amisulpride, avoiding receptors linked to adverse events.