NOVN Novan Inc.

1.36
+0.05  (+4%)
Previous Close 1.31
Open 1.28
52 Week Low 0.215
52 Week High 1.57
Market Cap $192,458,756
Shares 141,513,791
Float 140,394,015
Enterprise Value $143,267,066
Volume 27,002,559
Av. Daily Volume 19,655,637
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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
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. – B-SIMPLE4 pivotal Phase 3 study in molluscum contagiosum reaches 90% enrollment with topline data targeted for Q2 2021 –

    – Company secures new location to serve as corporate headquarters and to support various cGMP activities, including research and development and small-scale manufacturing capabilities –   

    MORRISVILLE, N.C., Jan. 19, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today provided an update that enrollment for its B-SIMPLE4 pivotal Phase 3 study evaluating SB206, a topical antiviral gel for the treatment of molluscum contagiosum ("molluscum"), has reached 90% of the approximately 850 subjects targeted for enrollment in the study.

    In addition, the Company has entered into a lease agreement…

    – B-SIMPLE4 pivotal Phase 3 study in molluscum contagiosum reaches 90% enrollment with topline data targeted for Q2 2021 –

    – Company secures new location to serve as corporate headquarters and to support various cGMP activities, including research and development and small-scale manufacturing capabilities –   

    MORRISVILLE, N.C., Jan. 19, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today provided an update that enrollment for its B-SIMPLE4 pivotal Phase 3 study evaluating SB206, a topical antiviral gel for the treatment of molluscum contagiosum ("molluscum"), has reached 90% of the approximately 850 subjects targeted for enrollment in the study.

    In addition, the Company has entered into a lease agreement for approximately 15,000 square feet at a new location in Durham, North Carolina, to serve as the Company's corporate headquarters, and the Company expects to move into the new facility during the second quarter of 2021. The Company is building out the newly leased location to support various cGMP activities, including research and development and small-scale manufacturing capabilities.

    "This is an exciting time for the Company. With enrollment into our B-SIMPLE4 pivotal Phase 3 study, initiated in September of last year, we are encouraged by the progress that has been made in such a short period of time. We are grateful to all the investigators and staff who are driving enrollment for this important program forward, as well as the molluscum patients for their ongoing support. If approved, we believe that SB206 would help meet the need for patient care with an at-home treatment," commented Paula Brown Stafford, President and Chief Executive Officer of Novan. "As we look forward to the readout of B-SIMPLE4, in addition to advancing our priority pipeline and NITRICIL platform technology, equipping the Company with a new location to support potential future activities was a key decision for us. We believe these steps position us to build momentum and enter the next phase of growth for the Company."

    Patient enrollment in the B-SIMPLE4 pivotal Phase 3 study commenced in September 2020 and is expected to enroll approximately 850 patients (1:1 randomization), across 55 clinical sites, who will be treated for 12 weeks with a follow-up visit at Week 24. To-date the study has enrolled approximately 90% of patients for the study.

    Completion of patient enrollment is targeted for the first quarter of 2021. Topline efficacy results from the B-SIMPLE4 trial are targeted for 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. For more information about the B-SIMPLE4 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 U.S. Food and Drug Administration ("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 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



    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe," "expect," "target," "anticipate," "may," "plan," "potential," "will," and similar expressions, and are based on the Company's current beliefs and expectations. These forward-looking statements include, but are not limited to, statements related to the potential therapeutic value of the Company's NITRICIL™ platform technology, the Company's pharmaceutical development of nitric oxide-releasing product candidates, the Company's 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 topline results and the Company's plans regarding its new facility. Forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from the Company's expectations, including, but not limited to, the Company's reliance on arrangements with third parties to support its operations, including the lease agreement described herein, and development efforts and the risk that such parties will not successfully carry out their contractual duties or meet expected deadlines; risks and uncertainties in the clinical development process, including, among others, length, expense, ability to enroll patients, 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 the Company's product candidates may not be approved or that additional studies may be required for approval or other delays may occur and that the Company may not obtain funding sufficient to complete the regulatory or development process; the Company's ability to obtain additional funding or enter into strategic or other business relationships necessary or useful for the further development of the Company's 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 the Company's regulatory submissions, all of which could have a material adverse effect on the Company's business; risks related to the manufacture of raw materials, including the Company's active pharmaceutical ingredient, and drug product components utilized in clinical trial materials, including failure to transfer technology and processes to third parties effectively or failure of those third parties to obtain approval of and maintain compliance with the FDA or comparable regulatory authorities; 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 pivotal Phase 3 study; and other risks and uncertainties described in the Company's annual report filed with the SEC on Form 10-K for the twelve months ended December 31, 2019, as amended, and in the Company's subsequent filings with the SEC, including the Company's quarterly report on Form 10-Q for the three months ended September 30, 2020. Such 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. MORRISVILLE, N.C., Jan. 08, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced that Paula Brown Stafford, President and Chief Executive Officer of Novan, will participate in a fireside chat during the January 11th-14th H.C. Wainwright BioConnect 2021 Virtual Conference.

    A video webcast of the fireside chat will be available for viewing on-demand beginning Monday, January 11, 2021, at 6:00 AM ET for those registered for the event and accessible on the Events page of the Investors section of the Company's website (novan.com) for 90 days.

    For more information about the conference, please visit the event website: hcwevents.com/bioconnect/.

    About Novan

    Novan, Inc. is a clinical development-stage biotechnology…

    MORRISVILLE, N.C., Jan. 08, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced that Paula Brown Stafford, President and Chief Executive Officer of Novan, will participate in a fireside chat during the January 11th-14th H.C. Wainwright BioConnect 2021 Virtual Conference.

    A video webcast of the fireside chat will be available for viewing on-demand beginning Monday, January 11, 2021, at 6:00 AM ET for those registered for the event and accessible on the Events page of the Investors section of the Company's website (novan.com) for 90 days.

    For more information about the conference, please visit the event website: hcwevents.com/bioconnect/.

    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



    Any statements contained in this press release or in the announced presentation that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe," "expect," "may," "plan," "potential," "will," and similar expressions, and are based on the Company's current beliefs and expectations. These forward-looking statements include, but are not limited to, statements related to the potential therapeutic value of the Company's NITRICIL™ platform technology, the Company's pharmaceutical development of nitric oxide-releasing product candidates, the Company's intention to advance development of certain product candidates and the Company's expected cash runway. Forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from the Company's expectations, including, but not limited to, risks and uncertainties in the Company's 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 the Company's product candidates; the Company's reliance on arrangements with third parties to support its development efforts and the risk that such parties will not successfully carry out their contractual duties or meet expected deadlines; risks and uncertainties in the clinical development process, including, among others, length, expense, ability to enroll patients, 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 the Company's product candidates may not be approved or that additional studies may be required for approval or other delays may occur and that the Company may not obtain funding sufficient to complete the regulatory or development process; the Company's ability to obtain additional funding or enter into strategic or other business relationships necessary or useful for the further development of the Company's 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 the Company's regulatory submissions, all of which could have a material adverse effect on the Company's business; risks related to the manufacture of raw materials, including the Company's active pharmaceutical ingredient, and drug product components utilized in clinical trial materials, including failure to transfer technology and processes to third parties effectively or failure of those third parties to obtain approval of and maintain compliance with the FDA or comparable regulatory authorities; 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 the Company's annual report filed with the SEC on Form 10-K for the twelve months ended December 31, 2019, as amended, and in the Company's subsequent filings with the SEC, including the Company's quarterly report on Form 10-Q for the three months ended September 30, 2020. Such forward-looking statements speak only as of the date of this press release or the announced presentation, as applicable, 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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  3. – Catalent has a proven track record of accelerating molecules from early development through commercial manufacturing –

    – Company targets initiating preclinical Investigational New Drug (IND) enabling studies in Q1 2021 –

    MORRISVILLE, N.C., Dec. 21, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced it has entered into a Master Services Agreement (MSA) with Catalent, which will include support of chemistry, manufacturing and control (CMC) activities and development of an intranasal formulation of berdazimer sodium for use in the Company's coronavirus (COVID-19) program.

    Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs…

    – Catalent has a proven track record of accelerating molecules from early development through commercial manufacturing –

    – Company targets initiating preclinical Investigational New Drug (IND) enabling studies in Q1 2021 –

    MORRISVILLE, N.C., Dec. 21, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced it has entered into a Master Services Agreement (MSA) with Catalent, which will include support of chemistry, manufacturing and control (CMC) activities and development of an intranasal formulation of berdazimer sodium for use in the Company's coronavirus (COVID-19) program.



    Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. Catalent's advanced formulation development and manufacturing spans a range of technologies, along with integrated downstream clinical development and commercial supply solutions.



    "We are pleased to be working with Catalent, and to benefit from its expertise in drug development and manufacturing, which is of particular interest to us in our COVID-19 program. We look forward to advancing into preclinical IND-enabling studies and taking another step towards unlocking the potential of our proprietary nitric oxide-based medicines," commented Paula Brown Stafford, President and Chief Executive Officer of Novan.



    "This is a tremendous opportunity for Catalent and Novan," added Jonathan Arnold, President of Oral & Specialty Delivery, Catalent. "We are proud to leverage Catalent's broad knowledge and expertise in formulation and inhalation technologies to help address the pressing needs associated with the COVID-19 pandemic."



    Novan initiated in vitro assessments of its NITRICIL™ platform against the novel SARS-CoV-2 coronavirus, targeting the reduction of viral burden in differentiated normal human bronchial epithelial cells. The studies were conducted at the Institute for Antiviral Research at Utah State University, and these results demonstrated the first instance of an antiviral effect from a nitric oxide-based medicine in a 3-D tissue model that has similar structure to the human airway epithelium. The results from the in vitro assessment of concentrations as low as 0.75 mg/mL demonstrated that berdazimer sodium reduced 90% of virus after repeat dosing, once daily.



    Based on the scientific literature and data available to-date with berdazimer sodium and Novan's product candidate SB206, Novan believes that nitric oxide may inhibit viral replication by disrupting protein function critical for viral replication and infection through generation of reactive intermediates.



    "Following the initial positive in vitro results that we announced earlier, we believe berdazimer sodium has the potential to offer benefit in inhibiting the replication of SARS-CoV-2, the virus that causes COVID-19, and we look forward to further exploring its potential. The knowledge and experience in formulation that Catalent has to offer provides a key component as we execute on our development path forward for this important program," commented Dr. Carri Geer, Chief Technology Officer of Novan.



    Following the completion of preclinical studies, Novan is targeting filing a potential IND application with the U.S. Food and Drug Administration and, subject to obtaining additional funding, targets initiating human clinical trials in the second half of 2021.



    About Catalent



    Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs approximately 14,000 people including around 2,400 scientists and technicians, at more than 45 facilities, and in fiscal year 2020 generated over $3 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com.

    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



    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe," "expect," "may," "plan," "potential," "will," and similar expressions, and are based on the Company's current beliefs and expectations. These forward-looking statements include, but are not limited to, statements related to the potential therapeutic value of the Company's NITRICIL™ platform technology, the Company's pharmaceutical development of nitric oxide-releasing product candidates and the Company's intention to advance development of certain product candidates. Forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from the Company's expectations, including, but not limited to, risks and uncertainties in the Company's 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 the Company's product candidates; the Company's reliance on arrangements with third parties to support its development efforts and the risk that such parties will not successfully carry out their contractual duties or meet expected deadlines; risks and uncertainties in the clinical development process, including, among others, length, expense, ability to enroll patients, 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 the Company's product candidates may not be approved or that additional studies may be required for approval or other delays may occur and that the Company may not obtain funding sufficient to complete the regulatory or development process; the Company's ability to obtain additional funding or enter into strategic or other business relationships necessary or useful for the further development of the Company's 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 the Company's regulatory submissions, all of which could have a material adverse effect on the Company's business; risks related to the manufacture of raw materials, including the Company's active pharmaceutical ingredient, and drug product components utilized in clinical trial materials, including failure to transfer technology and processes to third parties effectively or failure of those third parties to obtain approval of and maintain compliance with the FDA or comparable regulatory authorities; 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 the Company's annual report filed with the SEC on Form 10-K for the twelve months ended December 31, 2019, as amended, and in the Company's subsequent filings with the SEC, including the Company's quarterly report on Form 10-Q for the three months ended September 30, 2020. 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
  4. – Completion of patient enrollment targeted for Q1 2021 with readout of topline results targeted for 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., Dec. 15, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced it has enrolled 525 patients of the approximately 850 patients expected to enroll in the 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…

    – Completion of patient enrollment targeted for Q1 2021 with readout of topline results targeted for 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., Dec. 15, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced it has enrolled 525 patients of the approximately 850 patients expected to enroll in the 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.

    B-SIMPLE4 is a multi-center, double-blind, randomized, vehicle-controlled study expected to enroll approximately 850 patients (1:1 randomization), across approximately 50 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).

    "Achieving 60% enrollment amidst the COVID-19 pandemic is a noteworthy accomplishment for our B-SIMPLE4 pivotal program and highlights the unmet need that exists for patients. We believe that SB206 has the potential to offer a solution to molluscum patients and we are encouraged by the overall enthusiasm we have seen for this study. I would like to take this opportunity to sincerely thank all the investigators and their staff, as well as the molluscum patients for their ongoing support and participation in the study," commented Paula Brown Stafford, President and Chief Executive Officer of Novan.

    Completion of patient enrollment is targeted for the first quarter of 2021. Topline efficacy 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 B-SIMPLE4 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 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



    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe," "expect," "may," "plan," "potential," "will," and similar expressions, and are based on the Company's current beliefs and expectations. These forward-looking statements include, but are not limited to, statements related to potential therapeutic value of the Company's NITRICIL™ platform technology, 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 topline 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, including the Company's active pharmaceutical ingredient, and drug product components utilized in clinical trial materials, including failure to transfer technology and processes to third parties effectively or failure of those third parties to obtain approval of and maintain compliance with the FDA or comparable regulatory authorities; 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. Trading on Nasdaq Capital Market is expected to begin on November 5, 2020 –

    Company receives additional 180-day grace period, until May 3, 2021, to satisfy the $1.00 bid price requirement to maintain Nasdaq listing

    MORRISVILLE, N.C., Nov. 04, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced that on November 3, 2020, the Listing Qualifications department of The Nasdaq Stock Market LLC ("Nasdaq") approved the Company's request to transfer its listing to The Nasdaq Capital Market from The Nasdaq Global Market. The transfer is expected to take effect on the start of trading on Thursday, November 5, 2020.

    The approval was, in part, based upon the Company meeting the applicable market…

    Trading on Nasdaq Capital Market is expected to begin on November 5, 2020 –

    Company receives additional 180-day grace period, until May 3, 2021, to satisfy the $1.00 bid price requirement to maintain Nasdaq listing

    MORRISVILLE, N.C., Nov. 04, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced that on November 3, 2020, the Listing Qualifications department of The Nasdaq Stock Market LLC ("Nasdaq") approved the Company's request to transfer its listing to The Nasdaq Capital Market from The Nasdaq Global Market. The transfer is expected to take effect on the start of trading on Thursday, November 5, 2020.

    The approval was, in part, based upon the Company meeting the applicable market value of publicly held shares requirement for continued listing and all other applicable requirements for initial listing on the Nasdaq Capital Market (except for the minimum bid price requirement), the Company's written notice of its intention to cure the minimum bid price deficiency by effecting a reverse stock split, if necessary, its agreement to the conditions outlined in the Nasdaq Listing Agreement, and additional supporting information provided in the Company's application.

    The transfer of the Company's listing to The Nasdaq Capital Market is not expected to have any impact on trading in the Company's shares. The Company's shares will continue to trade uninterrupted under the symbol "NOVN." The Nasdaq Capital Market is a continuous trading market that operates in substantially the same manner as The Nasdaq Global Market, and listed companies must meet certain financial and corporate governance requirements to qualify for continued listing.

    On transfer to The Nasdaq Capital Market, Nasdaq granted the Company its second grace period of 180 calendar days, or until May 3, 2021, to regain compliance with the minimum bid price requirement for continued listing. To regain compliance, the closing bid price of the Company's common stock must meet or exceed $1.00 per share for a minimum of 10 consecutive business days prior to May 3, 2021.

    The Company intends to continue to actively monitor the minimum bid price requirement and, as appropriate, will consider available options to resolve any deficiencies and regain compliance.

    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

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe," "expect," "may," "plan," "potential," "will," and similar expressions, and are based on the Company's current beliefs and expectations. These forward-looking statements include, but are not limited to, statements related to the potential therapeutic value of the Company's NITRICIL™ platform technology and the Company's plans to regain compliance with the Nasdaq listing standards. Forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from the Company's expectations, including, but not limited to, risks and uncertainties in the Company's 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 the Company's product candidates; the Company's ability to enter arrangements with third parties to support its development efforts on terms that are acceptable to the Company or at all; 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 the Company's product candidates may not be approved or that additional studies may be required for approval or other delays may occur; the Company's ability to obtain additional funding or enter into strategic or other business relationships necessary or useful for the further development of the Company's product candidates; risks related to the manufacture of raw materials, including the Company's active pharmaceutical ingredient, and drug product components utilized in clinical trial materials, including failure to transfer technology and processes to third parties effectively or failure of those third parties to obtain approval of and maintain compliance with the FDA or comparable regulatory authorities; 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 the Company's annual report filed with the SEC on Form 10-K for the twelve months ended December 31, 2019, as amended, and in the Company's 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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