Novan, Inc. announced the comprehensive safety data readout as part of the Company’s B-SIMPLE4 pivotal Phase 3 study of SB206 for the treatment of molluscum contagiosum (“molluscum”). B-SIMPLE4 was a multi-center, double-blind, randomized, vehicle-controlled study that exceeded its enrollment target by randomizing 891 patients (1:1 randomization) in the study, across 55 clinical sites. Patients were treated for up to 12 weeks with a follow-up visit at Week 24. The primary endpoint for the study is the proportion of patients with complete clearance of all treatable molluscum lesions at Week 12. In June 2021, Novan reported statistically significant positive topline results for the primary endpoint (p-value <0.0001) of complete clearance of all treatable lesions at Week 12 in its B-SIMPLE4 pivotal Phase 3 clinical study of SB206. Consistent with results from the Company’s prior Phase 2 and Phase 3 studies, SB206 was also found to be safe and well tolerated in the B-SIMPLE4 study at Week-12. In July 2021, the Company announced that the last patient had completed their planned Week-24 follow-up visit in the B-SIMPLE4 study. The treatment emergent adverse events (“TEAEs”) profile of SB206 through the Week-24 visit was found to be favorable and consistent with the previous Phase 3 studies, B-SIMPLE1 and B-SIMPLE2. The TEAEs reported in greater than 5% of subjects in the SB206 treated groups were all at the application site (pain, erythema, pruritis, exfoliation, and dermatitis) with the high majority of these TEAEs being mild or moderate by severity. Molluscum, caused by the molluscipoxvirus, is known to occasionally heal with some scarring, or small pitting at the lesion site. Scar formation was assessed by the investigator, regardless of the size of the scar, throughout the study for TEAEs, as well as occurrence. The TEAEs for scarring throughout the study were slightly higher in the vehicle group (6.3%) vs. SB206 (4.7%). Subjects treated with SB206 showed a lower occurrence of scarring at the Week-24 visit when compared to vehicle (4.0% in vehicle vs. 2.7% in SB206). These findings were generally consistent with observations from B-SIMPLE1 and B-SIMPLE2.