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Novan Completes Enrollment in B-SIMPLE4 Pivotal Phase 3 Study of SB206 for Treatment of Molluscum

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– Topline data on track for targeted readout before the end of Q2 2021 –
– SB206, if approved, has the potential to meet an important need for the treatment of molluscum, an area with no current FDA-approved treatment –MORRISVILLE, N.C., Feb. 01, 2021 (GLOBE NEWSWIRE) — Novan, Inc. (“the Company” or “Novan”) (Nasdaq: NOVN), today announced it has completed patient enrollment in the B-SIMPLE4 pivotal Phase 3 clinical study of SB206, a topical antiviral gel, for the treatment of molluscum contagiosum (“molluscum”).B-SIMPLE4 is a multi-center, double-blind, randomized, vehicle-controlled study. The Company exceeded its enrollment target of 850 patients (1:1 randomization) in the study, across 55 clinical sites, due to the number of patients in screening at the time of achieving the trial’s stated goal. Patients will be treated for 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 (Intent-to-Treat or “ITT” population, where the analysis assumes that patients with missing data at Week 12 are assessed as treatment failures).“We are excited about the response from patients for this study and to have completed enrollment, amidst a challenging time with the current coronavirus pandemic. I believe SB206 has the potential to be an important choice in the treatment landscape of molluscum, which affects millions of people each year, and importantly, can provide a much-needed treatment benefit to patients. We look forward to seeing the clinical efficacy results from the B-SIMPLE4 study and SB206’s ability to address the unmet need in this indication,” stated John Browning, M.D., F.A.A.D, F.A.A.P., MBA, Adjunct Associate Professor of Pediatrics and Dermatology at UT Health San Antonio and the Chief of Staff of Pediatric Dermatology at Texas Dermatology and Laser Specialists, and a Principal Investigator in the B-SIMPLE4 study.Topline efficacy results from the B-SIMPLE4 study are anticipated before the end of the second quarter of 2021, subject to the targeted timing and trial execution plan which have been and may be further impacted by the COVID-19 pandemic.“This is a significant milestone for the Company and our molluscum program. We are very pleased with the enthusiasm we have seen across the molluscum patient population and the over-enrollment that our team was able to accomplish in such a short period of time. Our team is now keenly focused on bringing the study to completion and working to minimize the potential risk for missing data. We aim to report the topline efficacy data before the end of the second quarter and look forward to ultimately advancing this important product candidate toward potential approval,” commented Elizabeth Messersmith, Ph.D, Chief Development Officer of Novan.There are currently no FDA-approved therapies for the treatment of molluscum. The Company believes that SB206 as a topical, at-home, caregiver-applied therapy with a rapid treatment benefit, if approved, would satisfy an important patient-care need for the treatment of molluscum.For more information about the B-SIMPLE4 study, please visit clinicaltrials.gov and reference identifier: NCT04535531.About MolluscumAbout NovanForward-Looking StatementsINVESTOR AND MEDIA CONTACT:

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