LB Pharmaceuticals (LBRX) Corporate presentation summary

Strategic positioning

• Lead candidate LB-102 is being developed across schizophrenia, bipolar depression and adjunctive major depressive disorder, with potential expansion into other psychosis and mood indications.

• The presentation cites a ~$12B U.S. branded antipsychotic market and a potential ~10x addressable-market expansion from developing beyond schizophrenia.

• Issued composition-of-matter IP is estimated to extend through ~2041 including potential patent term extension; the underlying IP expires in 2037.

LB-102 profile

• LB-102 is a methylated structural modification of amisulpride, designed for improved blood-brain barrier penetration, greater potency and once-daily dosing; 50 mg LB-102 is stated as equivalent to 400 mg amisulpride.

• Its D2, D3 and 5HT7 receptor profile is presented as supporting potential effects on psychosis, mood, cognition, anhedonia and negative symptoms, with few off-target effects.

• Amisulpride has more than 2 million monthly prescriptions in Europe; the presentation cites its use in schizophrenia, dysthymia and mood disorders.

Schizophrenia clinical evidence

• In the 4-week NOVA-1 trial (N=359), PANSS change from baseline at Day 28 was -14.3 at 50 mg, -14.0 at 75 mg and -16.1 at 100 mg, versus -9.3 for placebo; all doses were statistically superior to placebo.

• Effect sizes were 0.50 for 50 mg and 0.64 for exploratory 100 mg by MMRM analysis; the presentation says results are near the top of effect sizes reported for approved first-line antipsychotics.

• Exploratory cognition results showed dose-dependent effect sizes versus placebo of 0.26 at 50 mg, 0.41 at 75 mg and 0.66 at 100 mg; the analysis was post hoc and excluded certain outliers.

• EPS rates were 1.0% at 50 mg, 5.6% at 75 mg, 5.6% at 100 mg and 3.7% with placebo; most adverse events were mild or moderate and similar to placebo.

• Phase 3 NOVA-2 is underway with 50 mg, 100 mg and placebo arms over six weeks; topline data are expected in 1H 2027, followed by a pre-NDA meeting expected in 2H 2027.