Company: LBRX
Filing Date: 2025-08-22
Form Type: S-1
Source: 0001193125-25-186467
Chunk: 185

Company: LB PHARMACEUTICALS INC
Filing Date: 2025-08-22
Form: S-1
Chunk 185
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 increase (2%); sedation (2%) |     | 4 mg               |     | Once-daily                                                 |
| Vraylar |     | Dopamine Receptor Partial Agonist |     | 97.1 – 96.7 (Trial 1) 96.1 –  
 95.7 (Trial 2) 96.3 (Trial 3) |     | 19.4 – 22.3 (Trial 1) 20.2 –         
 23.0 (Trial 2) 22.8 – 25.9 (Trial 3) |     | 7.6 – 10.4 (Trial 1) 6.0            
 – 8.8 (Trial 2) 6.8 – 9.9 (Trial 3) |     | EPS (15-19%)*, akathisia (9-13%)                                                                                                              |     | 1.5 - 6 mg         |     | Once-daily                                                 |

Note: Characteristics of antipsychotic drugs approved for the treatment of schizophrenia. PANSS is a measure of symptoms in schizophrenia patients including positive and negative symptoms, and general psychopathology, and reduction in PANSS v. baseline is a measure of efficacy of antipsychotic drugs. The change in PANSS score has been used as the primary endpoint in many registrational trials of antipsychotic drugs, as it provides a comparative measure against baseline; a higher change from baseline can suggest greater improvement in patient symptoms. As this assessment requires patients or raters to undertake a questionnaire regarding symptoms at protocol specified timepoints in the trial, it is, however, inherently subjective, which can increase the variability of clinical results across clinical trials and creates a significant degree of uncertainty in 122

determining overall clinical benefit. Caplyta efficacy data is based on four-week data from one Phase 2 trial and one Phase 3 trial (n=335; n=450). Cobenfy data is based on five-week data from two Phase 3 trials (n=236; n=234). Rexulti data is based on six-weekdata from two Phase 3 trials (n=674 total). Vraylar data is based on six-weekdata from three Phase 3 trials (n=1,655 total). Akathisia is a form of EPS but is reported separately in a number of product labels.

Because of the
fragility of the patient population and high