LB Pharmaceuticals (LBRX) investor relations material

Pipeline and funding

• LB-102 readouts planned: Phase III schizophrenia in H1 2027, bipolar depression in 2028, and adjunctive MDD in 2029; cash extends beyond Q2 2029. All trials and schizophrenia NDA-enabling work are funded.

• Additional data expected beyond these readouts in negative symptoms or Alzheimer’s disease, agitation, or psychosis.

Schizophrenia Phase III design

• NOVA-2 targets 460 patients at 25 U.S. sites; six-week inpatient study tests 50 mg and 100 mg, versus three dose arms and four weeks in NOVA-1.

• Risk controls include real-time site and data monitoring, professional-patient screening, fewer assessment scales, and measures to limit rater and patient fatigue and placebo response.

• NOVA-1 was designed as registrational; FDA said it had many characteristics of an adequate and well-controlled trial. A similarly robust NOVA-2 could support an NDA filing.

Schizophrenia profile and commercial positioning

• A successful profile would combine competitive efficacy for positive symptoms with tolerability that supports persistence; low EPS, early effect, once-daily dosing, no titration, and no food effect are key aims.

• NOVA-1 showed low EPS despite D2 antagonism and 70% dopamine receptor occupancy; preclinical findings suggest less activity in the motor striatum may explain the profile.

• Prolactin increases are expected; NOVA-1 showed a very low rate of related adverse events, with none leading to discontinuation.

• Commercial adoption may benefit from physician familiarity with D2 antagonists; education on switching or adding LB-102 to current regimens will be important.

• COBENFY’s GI effects and difficulty reaching studied top doses were cited as potential launch challenges; starting LB-102 at a therapeutic dose without titration may support prescriber confidence.