Novan (NOVN) Anticipates Current Cash Position Provides Sufficient Capital to Conduct Additional SB206 Phase 3 Pivotal Trial
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Novan, Inc. ("the Company" or "Novan") (Nasdaq: NOVN) today announced that the Company anticipates that its current cash position will be sufficient to fund costs associated with conducting an additional Phase 3 pivotal trial for SB206 as a treatment for molluscum, or B-SIMPLE4 (Berdazimer Sodium In Molluscum Patients with Lesions). Since June 1, 2020, the Company has secured approximately $16.9 million in capital from the use of common stock purchase agreements with Aspire Capital Fund, LLC and the exercise of common stock warrants sold in its March 2020 public offering.
The Company is targeting enrolling the first patient for B-SIMPLE4 in September 2020 and, if the trial is initiated on this timetable and not further impacted by the COVID-19 pandemic, top-line efficacy results would be targeted for late in the second quarter of 2021.
“We are delighted to be in a position to proceed with the B-SIMPLE4 study,” commented Paula Brown Stafford, Novan’s President and Chief Executive Officer. “An unmet need remains for molluscum patients and their caregivers, and we look forward to advancing the SB206 program.”
Currently there are no U.S. Food and Drug Administration-approved therapies for the treatment of molluscum. Treatment choices for patients, the majority of whom are below the age of 10, include in-office and often painful, physician-administered scraping, freezing, burning and blistering treatments. The only other choices appear to be off-label prescriptions and over-the-counter products with no clinical data that support a molluscum indication and therefore have no proven clinical efficacy and an unknown safety profile. 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.
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