Shares of Novan (NOVN) surged a whopping 5% on news two days ago that the company has reported earnings for the quarter.
Recent Highlights
- Announced the final patient completed their last Week-12 visit in the B-SIMPLE4 pivotal Phase 3 trial for SB206 as a treatment for molluscum contagiosum;
- Appointed Steven D. Skolsky to Board of Directors, a recognized healthcare and life science industry leader with over 35 years of international product development, strategy and commercialization experience; and
- Secured new location to serve as corporate headquarters and to support various cGMP activities, including research and development and small-scale manufacturing capabilities for drug substance and drug product.
Pipeline Update
The Company announced on May 3, 2023 that the final patient had completed their last Week-12 visit in the B-SIMPLE4 trial. B-SIMPLE4 is a multi-center, double-blind, randomized, vehicle-controlled study. The Company exceeded its enrollment target by randomizing 891 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 planned enrollment goal. Patients have been 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 (Intent-to-Treat or “ITT” population, where the analysis assumes that patients with missing data at Week 12 are considered treatment failures).
Upcoming catalysts
- Topline efficacy and safety results from the B-SIMPLE4 study continue to be targeted for reporting before the end of the second quarter of 2023.
- Potential filing of new drug application (“NDA”) targeted no later than Q3 2023.
There are currently no U.S. Food and Drug Administration (“FDA”) approved therapies for the treatment of molluscum. The Company believes that SB206 as a topical, at-home, self or caregiver-applied therapy with a rapid treatment benefit, if approved, would satisfy an important patient-care need for the treatment of molluscum.
- Ongoing preclinical program with results targeted in the second quarter of 2023.
- Pending results of preclinical studies, the Company anticipates exploring possible strategic partners and filing a potential investigational new drug (“IND”) application with the FDA in 2023.
- Targeting initiating human clinical trials in the second half of 2023, subject to regulatory guidance and obtaining additional financing or strategic partnering.
- Proof-of-concept results from exploratory in vivo and in vitro assessments targeted for the second quarter of 2023.
- Pending results of the exploratory assessment, the Company anticipates engaging with a potential collaborator or strategic partner to advance development in this area.
NOVN targets $23 per share
According to a previous corporate filing, the executives updated their performance plan to target NOVN share prices between $11 and $24. The executives set a bonus incentive to reach these price per share targets by expiration date of March 1, 2023. If the share price does not reach $11 or $25 and the performance plan expires then executives get no bonus.
