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Novan Announces Receipt of Written Minutes from Type C Meeting with FDA Regarding Development of SB206

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  • Enrollment of first patient targeted for September 2020
  • Top line results expected late in the second quarter of 2021 based on anticipated timeline

MORRISVILLE, N.C., April 30, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN) today announced that the Company has received meeting minutes from the April 1, 2020 Type C meeting with the U.S. Food and Drug Administration ("FDA") regarding SB206 for the treatment of molluscum contagiosum ("molluscum"). Based on guidance the Company received during the meeting and subsequently contained within the meeting minutes, Novan is preparing to conduct one additional pivotal trial ("B-SIMPLE4"), which, if successful, could be supported by the previously completed B-SIMPLE2 trial in a future New Drug Application ("NDA"). In addition, the FDA provided guidance with regard to the study design for B-SIMPLE4 and expectations for a future NDA submission, which has been incorporated in the B-SIMPLE4 preliminary trial design characteristics:

  • Number of patients: approximately 750 (1:1 randomization)
  • Stratification: investigator type, subjects per household and inflammation of molluscum lesions as measured by BOTE1 (beginning of the end)
  • Primary endpoint: 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)
  • Visits: Screening/Baseline, Week 2, Week 4, Week 8, Week 12 and safety follow-up at Week 24
  • Implementation of additional patient and caregiver training and retention efforts
  • Use of decentralized visit capabilities for conduct during COVID-19 pandemic

Novan plans to send the proposed protocol to the FDA in the near term. The Company has begun the planning and start-up phase for B-SIMPLE4. Novan is targeting enrolling the first patient for B-SIMPLE4 in September 2020, and if the trial is initiated on this timetable, the Company would expect top-line efficacy results late in the second quarter of 2021. The initiation and execution of B-SIMPLE4, beyond the start-up phase, is subject to additional funding or strategic partnering and may be further impacted by the COVID-19 pandemic.

"We believe the totality of the clinical data for SB206 is positive and the B-SIMPLE4 protocol incorporates both the input from the FDA and our learnings from B-SIMPLE1 and B-SIMPLE2," commented Paula Brown Stafford, Novan's President and Chief Executive Officer. Ms. Stafford further commented, "We also believe that the time between now and first-patient-in, which we anticipate in September, provides a window of opportunity to explore and evaluate potential value-creating strategic and other relationships in order to advance this important program."

As announced on April 20, 2020, the Company has engaged H.C. Wainwright & Co., LLC to assist the Company in exploring and evaluating a range of strategic and financial alternatives. This evaluation is on-going. The Company has not stated a definitive timeline for completion of the evaluation process and there can be no assurance that the evaluation process will result in the Company pursuing any strategic or financial alternatives, or that a strategic or financial alternative, if any, would be completed successfully or at all.

1. Butala, N., et al. "Molluscum BOTE Sign: A Predictor of Imminent Resolution." Pediatrics, vol. 131, no. 5, 2013, doi:10.1542/peds.2012-2933.

About Novan

Novan, Inc. is a clinical development-stage biotechnology company focused on leveraging nitric oxide's naturally occurring anti-microbial and immunomodulatory mechanisms of action to treat a range of diseases with significant unmet needs. We believe that our ability to deploy nitric oxide in a solid form, on demand and in localized formulations allows us the potential to improve patient outcomes in a variety of dermatology, women's health and gastrointestinal diseases.

Forward-Looking Statements

This press release contains forward-looking statements including, but not limited to, statements related to potential strategic or financial transactions involving the Company, pharmaceutical development of nitric oxide-releasing product candidates and our intention to advance development of certain product candidates, including the timing for the B-SIMPLE4 Phase 3 trial and anticipated top-line results, the timing of potential regulatory submissions, and our needs for funding. Forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from our expectations, including, but not limited to, the risk that we may not be able to begin enrollment as planned or that enrollment in or the conduct of the B-SIMPLE4 Phase 3 trial may be delayed or otherwise impacted as a result of the COVID-19 pandemic or other factors, the risk that results from the B-SIMPLE4 Phase 3 trial will not be received timely or will not achieve significance sufficient to support an NDA; our ability to complete any strategic alternatives and/or obtain additional funding necessary to continue our business and the further development of our product candidates, including to enable or complete the B-SIMPLE4 trial, on a timely basis, or at all; risks and uncertainties as to the terms, timing, structure, value, benefits and costs of any strategic or financial transaction, and our ability to complete one at all; our ability to reduce cash expenditures; risks and uncertainties in the clinical development process, including, among others, length, expense, ability to enroll patients, reliance on third parties, potential for delays and that results of earlier research and preclinical or clinical trials may not be predictive of results, conclusions or interpretations of later research activities or additional trials; risks related to the regulatory approval process, which is lengthy, time-consuming and inherently unpredictable, including the risk that our product candidates may not be approved or that additional studies may be required for approval or other delays may occur and that we may not obtain funding sufficient to complete the regulatory or development process; the risk that disruptions at the FDA and other agencies could cause such agencies to cancel or postpone meetings or otherwise impact the ability of such agencies to provide regulatory guidance or feedback or timely review and process our regulatory submissions, all of which could have a material adverse effect on our business; risks related to the manufacture of clinical trial materials; any operational or other disruptions as a result of the COVID-19 pandemic, including any delays or disruptions to our evaluation of strategic alternatives or the conduct of the B-SIMPLE4 trial; and other risks and uncertainties described in our annual report filed with the SEC on Form 10-K for the twelve months ended December 31, 2019, and in our subsequent filings with the SEC. These forward-looking statements speak only as of the date of this press release, and Novan disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements, except as may be required by law.

CONTACT:

(Investors & Media)
Cole Ikkala
Director, Investor Relations, Communications & Business Development
cikkala@novan.com

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