Company: LBRX
Filing Date: 2025-09-08
Form Type: S-1/A
Source: 0001193125-25-197877
Chunk: 210

Company: LB PHARMACEUTICALS INC
Filing Date: 2025-09-08
Form: S-1/A
Chunk 210
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100 mg 
 (N=36) |     | Placebo 
 (N=108) |
| Baseline                     |     |   393.4 |     |   394.7 |     |    390 |     |   393.4 |
| Day 28                       |     |     4.9 |     |     4.3 |     |    5.4 |     |     1.7 |

Stopping criteria not met at any dose

Exploratory Endpoints We also included a measure of cognition as an exploratory endpoint in our Phase 2 trial. This analysis utilized the CogState Computerized Schizophrenia Battery of Tests, a well validated measure of cognitive ability in subjects with schizophrenia. Patients had one practice session during the screening visit and completed the actual test on the first day of treatment (Day 1), the baseline assessment, and again on the last day of treatment (Day 28), the final assessment. The CogState battery utilized in our Phase 2 trial consisted of five tests designed to evaluate psychomotor function, memory, attention, working memory, and executive function. Test completion rate, one measure of quality control, was greater than or equal to 99% for each test across baseline and Day 28 visits. The test performance pass rate, another metric of quality control where data for a complete test is compared to expected rates of performance, was generally high for each test, with rates ranging from 93.6% to 99.4%. As part of our analysis of this data and consistent with other published literature utilizing the same CogState battery of tests, we conducted a post-hoc analysis in which we computed a global composite effect size, or overall improvement in cognition, versus placebo after excluding certain outliers that did not meet the test performance pass quality control metric. After excluding these outliers, the analysis was completed in all patients and did not enrich for patients with higher levels of cognitive impairment at baseline. After 4 weeks of treatment with LB-102,a robust, dose-dependent, and significant treatment effect size was identified in the completer population for all doses of LB-102compared with placebo. Results of this analysis are highlighted in the table below. 147

| Dose   |     | Effect Size versus Placebo |     | p-value |     |  n |
| 50 mg  |     |                       0.26 |     |  0.0476 |     | 84 |
| 75 mg