NOVN Novan Inc.

0.5
+0.01  (+3%)
Previous Close 0.49
Open 0.49
52 Week Low 0.215
52 Week High 3.72
Market Cap $69,421,533
Shares 137,468,382
Float 136,348,606
Enterprise Value $39,917,532
Volume 2,440,065
Av. Daily Volume 25,101,300
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Upcoming Catalysts

Drug Stage Catalyst Date
SB206 - B-SIMPLE4
Molluscum
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
SB414
Atopic Dermatitis
Phase 1b
Phase 1b
Phase 2 trial to be initiated 4Q 2019.
SB206
Human papillomavirus (HPV)
Phase 2
Phase 2
Phase 2 data released November 29, 2016. Primary endpoint met.
SB204
Acne vulgaris
Phase 3
Phase 3
Phase 3 top-line data released January 27, 2017. Met one of three co-primary endpoints in NI-AC301 trial. Met all endpoints in NI-AC302 trial. Additional Phase 3 trial required.
SB208
Fungal infections
Phase 2
Phase 2
Phase 2 data released April 12, 2017. Primary endpoint met.

Latest News

  1. - John M. Gay, Vice President, Finance and Corporate Controller with over 20 years of financial and accounting experience appointed as Chief Financial Officer

    - James L. Bierman, seasoned industry executive with extensive strategic financial expertise and business acumen and former CEO, COO and CFO of Owens & Minor, Inc. appointed to Board of Directors

    MORRISVILLE, N.C., Sept. 24, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced the appointment of John M. Gay to serve as the Company's Chief Financial Officer and the appointment of James L. Bierman to its Board of Directors.

    Mr. Gay is an accomplished finance and accounting executive with 20 years of professional experience and a demonstrated…

    - John M. Gay, Vice President, Finance and Corporate Controller with over 20 years of financial and accounting experience appointed as Chief Financial Officer

    - James L. Bierman, seasoned industry executive with extensive strategic financial expertise and business acumen and former CEO, COO and CFO of Owens & Minor, Inc. appointed to Board of Directors

    MORRISVILLE, N.C., Sept. 24, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced the appointment of John M. Gay to serve as the Company's Chief Financial Officer and the appointment of James L. Bierman to its Board of Directors.

    Mr. Gay is an accomplished finance and accounting executive with 20 years of professional experience and a demonstrated track record of strategic financial planning and analysis, accessing capital markets and public company technical and regulatory reporting over the course of his career. Mr. Gay joined Novan in May 2018 and has most recently served as Vice President, Finance and Corporate Controller, in addition to Principal Financial Officer and Corporate Secretary for the Company.

    "John has established himself as a key member of the team since joining Novan and is now perfectly suited to take on the role of Chief Financial Officer. He has proven himself to be a financial leader and is responsible for executing the Company's financial strategy, which has provided us with sufficient capital to advance SB206 through the B-SIMPLE4 pivotal Phase 3 study in molluscum, a potentially transformational catalyst for the Company, through to data targeted for Q2 2021," commented Paula Brown Stafford, Chairman and Chief Executive Officer of Novan.

    Mr. Bierman is a seasoned executive and brings extensive strategic financial expertise, including financial and operational strategies, mergers and acquisitions, strategic alliances, enterprise risk management and investor relations to Novan's Board of Directors.

    "We are thrilled to welcome Mr. Bierman to our Board of Directors. He is a proven industry leader with key executive experience amassed over the course of his career including having served as the CEO, COO and CFO of Owens & Minor, Inc., a FORTUNE 500 company. His strategic expertise will be an integral asset and bring a new perspective to our Board. With these two key appointments, I believe our financial leadership has never been stronger and believe we continue to make tremendous progress towards Novan's next phase of growth," continued Ms. Stafford.

    Mr. Bierman is an experienced independent director who has mentored and assisted in the professional development of both financial executives and senior members of management over the course of his career. In addition to his executive leadership experience, including serving as President and Chief Executive Officer of Owens & Minor, Inc. (NYSE:OMI), as well as Executive Vice President and Chief Financial Officer of Quintiles Transnational Corporation (NASDAQ:QTRN), he has also served on multiple public company boards, including currently serving as a member of the Board of Directors of Tenet Healthcare Corporation (NYSE:THC), a FORTUNE 500 company, and MiMedx Group, Inc. (OTC:MDXG).

    About Novan

    Novan, Inc. is a clinical development-stage biotechnology company focused on leveraging its proprietary nitric oxide (NO) based technology platform, NITRICIL™ to generate macromolecular New Chemical Entities (NCEs) to treat multiple indications in dermatology, men's and women's health, infectious diseases and gastroenterology conditions with significant unmet needs. The Company's lead product candidate, SB206, a topical antiviral gel, for the treatment of molluscum contagiosum, is currently being evaluated in the B-SIMPLE4 pivotal Phase 3 clinical study. The Company believes that SB206 as a topical, at-home, caregiver-applied therapy with a rapid treatment benefit, if approved, would address an important patient-care need for the treatment of molluscum.

    Forward-Looking Statements

    This press release contains forward-looking statements including, but not limited to, statements related to pharmaceutical development of nitric oxide-releasing product candidates and our intention to advance development of certain product candidates and the timing of reporting findings or results from our programs currently in process. 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, risks and uncertainties in the clinical development process, including, among others, length, expense, ability to enroll patients, reliance on third parties, potential for delays or other impacts, whether as a result of the COVID-19 pandemic or other factors, 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; our ability to retain key personnel; our ability to obtain additional funding or enter into strategic or other business relationships necessary or useful for the further development of our product candidates; any operational or other disruptions as a result of the COVID-19 pandemic, including any delays or disruptions to the enrollment in and conduct of the B-SIMPLE4 Phase 3 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, as amended, 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.

    INVESTOR AND MEDIA CONTACT:

    Jenene Thomas

    JTC Team, LLC

    833-475-8247

    Primary Logo

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  2. - Lead product candidate, SB206 currently being evaluated in B-SIMPLE4 pivotal Phase 3 study in molluscum contagiosum with topline data targeted for Q2 2021 -

    - In vitro assessments of ability of NITRICIL™ to inhibit the replication mechanisms of SARS-COV-2 (COVID-19) underway with key findings targeted before year end -

    - Exploratory work to evaluate NITRICIL™ for antimicrobial indications in companion animal health initiated -

    - Ongoing review of existing programs and opportunities to expand priority development pipeline -

    MORRISVILLE, N.C., Sept. 14, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today provided a priority pipeline update. In addition to focusing its primary efforts toward SB206, its lead…

    - Lead product candidate, SB206 currently being evaluated in B-SIMPLE4 pivotal Phase 3 study in molluscum contagiosum with topline data targeted for Q2 2021 -

    - In vitro assessments of ability of NITRICIL™ to inhibit the replication mechanisms of SARS-COV-2 (COVID-19) underway with key findings targeted before year end -

    - Exploratory work to evaluate NITRICIL™ for antimicrobial indications in companion animal health initiated -

    - Ongoing review of existing programs and opportunities to expand priority development pipeline -

    MORRISVILLE, N.C., Sept. 14, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today provided a priority pipeline update. In addition to focusing its primary efforts toward SB206, its lead product candidate for molluscum, the Company is also directing pre-IND development activities toward the ongoing in vitro work related to coronaviridae, as well as exploring the potential of its NITRICIL™ platform technology for use in an antimicrobial indication for companion animal health.

    "Over the course of the past few months, we have dedicated time and efforts evaluating our internal pipeline of late-stage assets, our broader dermatology platform and underlying NITRICIL™ technology. These components represent what we believe to be a solid foundation to build momentum and support Novan's next phase of growth," commented Paula Brown Stafford, Chairman, President and Chief Executive Officer of Novan. "We are focused on successfully executing our pivotal Phase 3 study of SB206 for the treatment of molluscum, which is now underway and dosing patients, and are pleased with the progress our team has continued to make in this important program."

    Ms. Stafford continued, "Additionally, we have continued to make progress with our in vitro work to evaluate the ability of NITRICIL™ to target the replication mechanisms of SARS-COV-2 (COVID-19) and target reporting of key findings from these assessments before year end. I am also pleased to announce that we have launched exploratory efforts to evaluate the use of NITRICIL™ for antimicrobial indications in companion animal health, an area we believe diversifies our pipeline and provides opportunities in an adjacent, yet important market."

    SB206: Topical antiviral gel for the treatment of viral skin infections, with a current focus on the treatment of molluscum contagiosum, a contagious skin infection caused by the molluscipoxvirus, a double-stranded DNA virus.

        Program Highlights:

    • B-SIMPLE4 pivotal Phase 3 study for treatment of molluscum underway
    • Target completion of enrollment in Q1 2021
    • Topline results targeted for Q2 2021, subject to the timing and trial execution plan which have been and may be further impacted by the COVID-19 pandemic

    For more information about the B-SIMPLE4 trial, please visit clinicaltrials.gov and reference identifier: NCT04535531.

    Coronaviridae (COVID-19): Currently conducting in vitro assessments to evaluate the ability of NITRICIL™ to inhibit the replication mechanisms of SARS-COV-2 (COVID-19).

        Program Highlights:

    • Nitric oxide may inhibit viral replication by cytotoxic reactions through intermediates such as peroxynitrite
    • In vitro assessments targeting the reduction of viral shedding and transmission
    • Targeting year end to report findings from in vitro assessments

    Companion Animal Program: Initiated exploratory work to evaluate NITRICIL™ as a potential product candidate for antimicrobial indications in companion animal health

        Program Highlights:

    • Contracted drug delivery technology specialist to undertake initial formulation development to assess viability
    • Engaged animal health experts to assess technical feasibility and market potential
    • Target seeking a potential strategic partner or collaborator following initial proof-of-concept work

    "In addition to advancing our priority development programs, we also have a rich pipeline of potential expansion opportunities in dermatology, men's and women's health, and gastroenterology conditions with significant unmet needs. We are continuing our review of existing programs and opportunities that could expand our priority development efforts," concluded Ms. Stafford.



    About Novan

    Novan, Inc. is a clinical development-stage biotechnology company focused on leveraging its proprietary nitric oxide (NO) based technology platform, NITRICIL™ to generate macromolecular New Chemical Entities (NCE's) to treat multiple indications in dermatology, men's and women's health, infectious diseases and gastroenterology conditions with significant unmet needs. The Company's lead product candidate, SB206, a topical antiviral gel, for the treatment of molluscum contagiosum, is currently being evaluated in the B-SIMPLE4 pivotal Phase 3 clinical study. The Company believes that SB206 as a topical, at-home, caregiver-applied therapy with a rapid treatment benefit, if approved, would address an important patient-care need for the treatment of molluscum.

    Forward-Looking Statements

    This press release contains forward-looking statements including, but not limited to, statements related to pharmaceutical development of nitric oxide-releasing product candidates and our intention to advance development of certain product candidates and the timing of reporting findings or results from our programs currently in process. 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, risks and uncertainties in our ongoing or future product development activities and preclinical studies, which may not prove successful in demonstrating proof-of concept, or may show adverse toxicological findings, and even if successful may not necessarily predict that subsequent clinical trials will show the requisite safety and efficacy of our product candidates; risks and uncertainties in the clinical development process, including, among others, length, expense, ability to enroll patients, reliance on third parties, potential for delays or other impacts, whether as a result of the COVID-19 pandemic or other factors, 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; our ability to obtain additional funding or enter into strategic or other business relationships necessary or useful for the further development of our product candidates; the risk that disruptions at the FDA or 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 the enrollment in and conduct of the B-SIMPLE4 Phase 3 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, as amended, 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.

    INVESTOR AND MEDIA CONTACT:

    Jenene Thomas

    JTC Team, LLC

    833-475-8247

      

     

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  3. - Live video webcast with President and CEO, Paula Brown Stafford, on Monday, September 14th at 4:00 PM EDT -

    MORRISVILLE, N.C., Sept. 09, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced that Paula Brown Stafford, Chairman, President and Chief Executive Officer of Novan will present at the H.C. Wainwright 22nd Annual Global Investment Conference on Monday, September 14, 2020 at 4:00 PM EDT.

    In addition to the presentation, management will also be available to participate in virtual one-on-one meetings with qualified members of the investor community who are registered to attend the conference. For more information, please visit the conference website here.

    A live video webcast of the presentation…

    - Live video webcast with President and CEO, Paula Brown Stafford, on Monday, September 14th at 4:00 PM EDT -



    MORRISVILLE, N.C., Sept. 09, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced that Paula Brown Stafford, Chairman, President and Chief Executive Officer of Novan will present at the H.C. Wainwright 22nd Annual Global Investment Conference on Monday, September 14, 2020 at 4:00 PM EDT.

    In addition to the presentation, management will also be available to participate in virtual one-on-one meetings with qualified members of the investor community who are registered to attend the conference. For more information, please visit the conference website here.

    A live video webcast of the presentation will be available on the Events page of the Investors section of the Company's website (novan.com). The video webcast replay will be made available two hours following the event and will be archived for 90 days.



    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.



    INVESTOR AND MEDIA CONTACT:



    Jenene Thomas

    JTC Team, LLC

    833-475-8247

    Primary Logo

    View Full Article Hide Full Article
  4. - Topline results targeted for Q2 2021, less than a year away -

    - 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., Sept. 03, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced the first patient has been enrolled and dosed in its B-SIMPLE4 pivotal Phase 3 clinical study of SB206, a topical antiviral gel, for the treatment of molluscum contagiosum ("molluscum").

    Molluscum contagiosum is a common, contagious skin infection caused by the molluscipoxvirus, affecting approximately six million people in the U.S. annually, with the greatest incidence in children aged one to 14 years.

    "I…

    - Topline results targeted for Q2 2021, less than a year away -

    - 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., Sept. 03, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced the first patient has been enrolled and dosed in its B-SIMPLE4 pivotal Phase 3 clinical study of SB206, a topical antiviral gel, for the treatment of molluscum contagiosum ("molluscum").

    Molluscum contagiosum is a common, contagious skin infection caused by the molluscipoxvirus, affecting approximately six million people in the U.S. annually, with the greatest incidence in children aged one to 14 years.

    "I believe that the design of the B-SIMPLE4 study positions us well to fully evaluate SB206 for the treatment of molluscum," commented Elizabeth Messersmith, Ph.D, Senior Vice President and Chief Development Officer of Novan. "We are encouraged by the trends in efficacy as well as the safety profile SB206 has demonstrated to-date and look forward to continuing to advance development of this important program where there remains no FDA approved treatment."

    Completion of patient enrollment is targeted for the first quarter of 2021. Topline results from the B-SIMPLE4 trial are anticipated in 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.

    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 trial, please visit clinicaltrials.gov and reference identifier: NCT04535531.

    About Molluscum

    Molluscum contagiosum is a common, contagious skin infection caused by the molluscipoxvirus, affecting approximately six million people in the U.S. annually, with the greatest incidence in children aged one to 14 years. Infected children typically present with 10 to 30 painless, yet unsightly lesions, and, in severe cases, they can have around 100 lesions. Due to the largely pediatric nature of the disease, parents are the caregivers for these children, in most cases, and tend to seek treatment. There are no FDA-approved therapies for molluscum, and, upon seeking treatment, caregivers are faced with potentially painful in-office, dermatologist-administered physical procedures or cantharidin, or recommended off-label prescriptions and over-the-counter products. More than half of the patients diagnosed with molluscum are untreated and over 30% of those treated receive an off-label prescription with no molluscum indication or proven clinical efficacy. The average time to resolution is 13 months, however, some children experience lesions that may not resolve in 24 months. Further dissemination of this highly-contagious disease is common, and transmission to other children living in the household is reported to be 41%. There is a significant unmet need in the molluscum treatment landscape.

    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 pharmaceutical development of nitric oxide-releasing product candidates and our intention to advance development of certain product candidates, including the timing, enrollment demand and progress of our Phase 3 program to evaluate SB206 for the treatment of molluscum and the timing of anticipated top-line results. 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, risks and uncertainties in the clinical development process, including, among others, length, expense, ability to enroll patients, reliance on third parties, potential for delays or other impacts, whether as a result of the COVID-19 pandemic or other factors, 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; our ability to obtain additional funding or enter into strategic or other business relationships necessary or useful for the further development of our product candidates; the risk that disruptions at the FDA or 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 the enrollment in and conduct of the B-SIMPLE4 Phase 3 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, as amended, 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.

    INVESTOR AND MEDIA CONTACT:

    Jenene Thomas

    JTC Team, LLC

    833-475-8247

    Primary Logo

    View Full Article Hide Full Article
  5. - Clinical sites actively enrolling patients -

     - 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. , Aug. 31, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced the initiation of the B-SIMPLE4 pivotal Phase 3 clinical study of SB206, a topical antiviral gel, for the treatment of molluscum contagiosum ("molluscum"). Clinical sites are now open for patient enrollment.

    Molluscum contagiosum is a common, contagious skin infection caused by the molluscipoxvirus, affecting approximately six million people in the U.S. annually, with the greatest incidence in children aged one to 14 years…

    - Clinical sites actively enrolling patients -

     - 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. , Aug. 31, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced the initiation of the B-SIMPLE4 pivotal Phase 3 clinical study of SB206, a topical antiviral gel, for the treatment of molluscum contagiosum ("molluscum"). Clinical sites are now open for patient enrollment.

    Molluscum contagiosum is a common, contagious skin infection caused by the molluscipoxvirus, affecting approximately six million people in the U.S. annually, with the greatest incidence in children aged one to 14 years.

    "Molluscum affects millions of people each year, a large percentage of those patients being children under the age of ten. SB206 represents, what I believe to be, an incredible opportunity to provide patients and caregivers an alternative treatment to the options currently available, including off-label prescriptions, procedures, and over-the-counter treatments with no clinical data that would support a molluscum indication and therefore have no proven clinical efficacy and an unknown safety profile. I believe SB206 has potential in addressing a significant unmet need in the treatment landscape of molluscum and if approved, would provide patients with a treatment benefit," stated John Browning, M.D., F.A.A.D, F.A.A.P., MBA, Assistant Professor of Pediatrics and Dermatology and the Chief of Staff of Pediatric Dermatology at Texas Dermatology and Laser Specialists, and a Principal Investigator in the B-SIMPLE 4 clinical study.

    B-SIMPLE4 is a multi-center, double-blind, randomized, vehicle-controlled study expected to enroll approximately 750 patients (1:1 randomization), across 45 clinical sites, who will be treated for 12 weeks with a follow-up visit at Week 24. The primary endpoint for the study is 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).

    Paula Brown Stafford, Chairman, President and Chief Executive Officer of Novan commented, "We are pleased to initiate this study and are grateful for the dedication of our team who continue to navigate the commencement of a clinical trial in these unprecedented times with the COVID-19 pandemic. We worked diligently to partner with clinical sites that are actively seeing patients and are optimistic that we will reach our target to complete enrollment in the first quarter of 2021."

    Topline results from the B-SIMPLE4 trial are anticipated late in the second quarter of 2021, subject to the targeted timing for completing enrollment and trial execution plan which have been and may be further impacted by the COVID-19 pandemic.

    Based on guidance the Company received during its Type C meeting with the U.S. Food and Drug Administration ("FDA") and subsequently contained within the meeting minutes, Novan is conducting B-SIMPLE4 a pivotal Phase 3 trial, which if successful, could be supported by the previously completed B-SIMPLE2 trial in a future New Drug Application ("NDA"). There are currently no FDA-approved therapies for the treatment of molluscum. Treatment choices for patients include in-office and often painful, physician-administered scraping, freezing, burning and blistering treatments. The only other choices, which lack proven clinical efficacy and unknown safety profiles, are off-label prescriptions and over-the-counter treatments. 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.

    About Molluscum

    Molluscum contagiosum is a common, contagious skin infection caused by the molluscipoxvirus, affecting approximately six million people in the U.S. annually, with the greatest incidence in children aged one to 14 years. Infected children typically present with 10 to 30 painless, yet unsightly lesions, and, in severe cases, they can have around 100 lesions. Due to the largely pediatric nature of the disease, parents are the caregivers for these children, in most cases, and tend to seek treatment. There are no FDA approved therapies for molluscum, and, upon seeking treatment, caregivers are faced with potentially painful in-office, dermatologist-administered physical procedures or cantharidin, or recommended off-label prescriptions and over-the-counter products. More than half of the patients diagnosed with molluscum are untreated and over 30% of those treated receive an off-label prescription with no molluscum indication or proven clinical efficacy. The average time to resolution is 13 months, however, some children experience lesions that may not resolve in 24 months. Further dissemination of this highly-contagious disease is common, and transmission to other children living in the household is reported to be 41%. There is a significant unmet need in the molluscum treatment landscape.

    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 pharmaceutical development of nitric oxide-releasing product candidates and our intention to advance development of certain product candidates, including the timing, enrollment demand and progress of our Phase 3 program to evaluate SB206 for the treatment of molluscum and the timing of anticipated top-line results. 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, risks and uncertainties in the clinical development process, including, among others, length, expense, ability to enroll patients, reliance on third parties, potential for delays or other impacts, whether as a result of the COVID-19 pandemic or other factors, 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; our ability to obtain additional funding or enter into strategic or other business relationships necessary or useful for the further development of our product candidates; the risk that disruptions at the FDA or 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 the enrollment in and conduct of the B-SIMPLE4 Phase 3 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, as amended, 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.

    INVESTOR AND MEDIA CONTACT:

    Jenene Thomas

    JTC Team, LLC

    833-475-8247

    Primary Logo

    View Full Article Hide Full Article
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