1. DURHAM, N.C., Sept. 20, 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 hosted by Jennifer Kim, Vice President, Equity Research, at the Cantor Fitzgerald Virtual Global Healthcare Conference on Tuesday, September 28, 2021 at 8:00 AM ET.

    In addition to the fireside chat, management will be available to participate in virtual one-on-one meetings with qualified members of the investor community who are registered to attend the conference.

    A webcast of the live fireside chat will be accessible on the Events page in the Investors section of the Company's website (novan.com) and available…

    DURHAM, N.C., Sept. 20, 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 hosted by Jennifer Kim, Vice President, Equity Research, at the Cantor Fitzgerald Virtual Global Healthcare Conference on Tuesday, September 28, 2021 at 8:00 AM ET.

    In addition to the fireside chat, management will be available to participate in virtual one-on-one meetings with qualified members of the investor community who are registered to attend the conference.

    A webcast of the live fireside chat will be accessible on the Events page in the Investors section of the Company's website (novan.com) and available for 90 days following the event.

    About Novan



    Novan, Inc. is a pre-commercial nitric oxide-based pharmaceutical company focused on dermatology and anti-infective therapies. We leverage our core synergies of science, capital, resources and patient needs to create value by bringing new nitric oxide-based medicines to market. Our goal is to create the world's leader in nitric oxide-based science, technology, and clinical translation in support of delivering safe and efficacious therapies using our proprietary nitric oxide-based technology platform, NITRICIL™ to generate macromolecular New Chemical Entities (NCEs) to treat multiple indications.

    INVESTOR AND MEDIA CONTACT:

    Jenene Thomas

    JTC Team, LLC

    833-475-8247

    NOVN@jtcir.com



    Primary Logo

    View Full Article Hide Full Article
  2. Company planning for three potential New Drug Application (NDA) filings in three years with the first submission expected in Q3 2022 for lead program SB206 in molluscum contagiosum

    Late-stage product candidate, SB204 for the treatment of acne vulgaris, selected to advance as second lead program toward pivotal Phase 3 study

    SB019 SARS-CoV-2 development program advancing toward Phase 1 study in healthy volunteers, targeted for 1H 2022

    Company to host conference call and webcast today at 8:30 AM ET

    DURHAM, N.C., Sept. 09, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. (the "Company" or "Novan") (NASDAQ:NOVN), today announced its key strategic priorities including its decision to advance late-stage asset, SB204, for the treatment of…

    Company planning for three potential New Drug Application (NDA) filings in three years with the first submission expected in Q3 2022 for lead program SB206 in molluscum contagiosum

    Late-stage product candidate, SB204 for the treatment of acne vulgaris, selected to advance as second lead program toward pivotal Phase 3 study

    SB019 SARS-CoV-2 development program advancing toward Phase 1 study in healthy volunteers, targeted for 1H 2022

    Company to host conference call and webcast today at 8:30 AM ET

    DURHAM, N.C., Sept. 09, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. (the "Company" or "Novan") (NASDAQ:NOVN), today announced its key strategic priorities including its decision to advance late-stage asset, SB204, for the treatment of acne vulgaris as its second lead program. The Company provided a general update and outlined key milestones for its priority pipeline programs in development for the treatment of dermatology and infectious diseases. Novan management will host a conference call and webcast to discuss the updates today, September 9, 2021, at 8:30 a.m. ET (details below).

    "This year has been transformational for Novan. Our proprietary and innovative platform, NITRICIL™, has continued to demonstrate robust clinical data and support our confidence in our ability to deliver therapeutic amounts of topical nitric oxide with an attractive safety profile across a number of dermatology and infectious disease indications, in addition to potential applications in animal health. Our recently completed B-SIMPLE4 study of SB206 for the treatment of molluscum has provided validation of our platform technology, demonstrated our ability to execute our clinical development programs effectively and has helped to guide prioritization of our pipeline programs," stated Paula Brown Stafford, President and Chief Executive Officer.

    "We are confident and excited to be advancing SB204 for the treatment of acne vulgaris. As our second lead program, we believe that SB204 has the potential to address an unmet medical need and address a significant market opportunity. We believe Novan is well-positioned to be the world leader in nitric oxide-based science, technology, and clinical development in support of delivering safe and efficacious therapies to patients. We remain committed to leveraging our core synergies of science, human and capital resources and medical need to create value by bringing new nitric oxide-based medicines to market. We believe that our strategic priorities are aligned to help us realize the full potential of Novan," added Ms. Brown Stafford.

    SB206 – A Topical Antiviral Treatment for Molluscum Contagiosum

    In June 2021, Novan reported statistically significant positive topline results for the primary endpoint (p-value <0.0001) of complete clearance of all treatable lesions in its B-SIMPLE4 pivotal Phase 3 clinical study of SB206 for the treatment of molluscum. Additionally, and consistent with results from the Company's prior Phase 2 and Phase 3 studies, SB206 was found to be safe and well tolerated in the B-SIMPLE4 study. No treatment-related serious adverse events were reported. In July 2021, the Company announced that the last patient had completed their planned Week-24 follow-up visit in the B-SIMPLE4 study. This follow-up visit at Week-24 is intended to further evaluate the safety of SB206, 12-weeks following completion of treatment.



    The Company recently announced it has engaged Syneos Health (NASDAQ:SYNH), a fully integrated biopharmaceutical solutions organization, as its commercial solutions provider for SB206 prelaunch strategy and commercial preparation, in addition to sales and marketing support of SB206, if approved by the U.S. Food and Drug Administration (FDA).

    Upcoming Targeted Milestones:

    • Full data readout from the B-SIMPLE4 study, including Week-24 safety, within the next several weeks.
    • Pre-NDA meeting with the FDA, as well as conduct of stability testing, targeted for 1H 2022.
    • Potential submission of an NDA targeted for Q3 2022.

    The Company believes that SB206 as a topical, at-home administered therapy, with a rapid treatment benefit would address an important patient-care need for the treatment of molluscum.

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

    SB204 – A Novel Multi-factorial Mechanism of Action for the Treatment of Acne Vulgaris

    Novan is developing SB204 as a topical monotherapy for the treatment of acne vulgaris. This form of acne represents a multi-factorial disease with varying disease pathology (inflammatory and bacterial). SB204 utilizes the same active pharmaceutical ingredient used in the Company's lead product candidate, SB206, and it is formulated specifically to address acne via an anti-inflammatory and anti-bacterial mechanism.

    In two previous Phase 3 studies, AC301 and AC302, SB204 demonstrated consistent and promising results across two of three co-primary endpoints. In addition, AC302 was a successful pivotal trial with respect to all three co-primary endpoints, including non-inflammatory lesions, inflammatory lesions, and Investigator's Global Assessment (IGA). Based on the recent positive pivotal Phase 3 results in the SB206 molluscum development program, the Company believes it can optimize the trial design of a pivotal Phase 3 study for SB204 that has the potential to serve as a second pivotal trial to support an NDA submission.

    Novan believes that acne has continued to be characterized as an unmet medical need due to the difficulty of balancing efficacy, systemic safety and cutaneous tolerability, as well as growing concerns with anti-bacterial resistance with existing therapies.

    Upcoming Targeted Milestones:

    • Prepare for pivotal Phase 3 study during 2022.
    • Conduct planned pivotal Phase 3 trial targeted for 2023, subject to obtaining additional financing or strategic partnering.
    • Potential submission of an NDA targeted for 2024.

    SB019 – An Intranasal Formulation for the Treatment of Infectious Disease, COVID-19

    In June 2021, Novan announced positive preclinical results demonstrating the anti-viral effect of the Company's NITRICIL™ platform technology, berdazimer sodium, against SARS-CoV-2, the virus that causes COVID-19. To evaluate SB019 as a potential intranasal treatment option for COVID-19, the Company completed preclinical in vivo studies evaluating the effect of berdazimer sodium to reduce viral load in infected animals and to deter viral transmission to uninfected animals. Results from two separate studies independently demonstrated the ability of berdazimer sodium to prevent progression of infection into the lungs following transmission, significantly limiting severity of disease, with statistically significant reduction (p<0.0001) in the amount of virus in the lungs of animals treated with berdazimer sodium at concentrations as low as 2 mg/mL, as compared to placebo-treated control animals. This intranasal treatment was well-tolerated during the preclinical in vivo studies, and no treatment-related adverse events were observed. Additional studies assessing the preclinical toxicology of SB019 in another species have been conducted at a third-party research organization and support the overall safety profile and favorable tolerability of intranasally administered SB019.



    Based on the strong preclinical and clinical data demonstrating anti-viral effect of berdazimer sodium against multiple viruses, as well as increasing public health need to reduce breakthrough infections and transmission, the Company plans to advance its SB019 product candidate.

    Upcoming Targeted Milestones:

    • Initiation of Phase 1 study in healthy volunteers targeted for 2022.
    • Phase 2/3 study(s) targeted for 2023, subject to obtaining additional financing or strategic partnering.
    • Potential submission of an NDA targeted for 2024.

    Conference Call and Webcast Details

    As previously announced, Novan will host a corporate update conference call and webcast today, Thursday, September 9th at 8:30 a.m. ET. The call will be led by Paula Brown Stafford, President and Chief Executive Officer of Novan, who will be joined by additional members of the Novan management team. Interested participants and investors may access the conference call by dialing (844) 707-0661 (domestic) or (703) 318-2240 (international) and referencing conference ID: 6243828. The live webcast will be accessible on the Events page of the Investors section of the Novan website, novan.com, and will be archived for 90 days.

    About Novan



    Novan, Inc. is a pre-commercial nitric oxide-based pharmaceutical company focused on dermatology and anti-infective therapies. We leverage our core synergies of science, capital, resources and patient needs to create value by bringing new nitric oxide-based medicines to market. Our goal is to create the world's leader in nitric oxide-based science, technology, and clinical translation in support of delivering safe and efficacious therapies using our proprietary nitric oxide-based technology platform, NITRICIL™ to generate macromolecular New Chemical Entities (NCEs) to treat multiple indications.

    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, including SB206, SB204 and SB019, the potential timing of clinical trials and FDA submission(s), the potential market opportunity for the Company's product candidates, plans for launch and commercialization of SB206, if approved, and the Company's intention to partner with third parties. 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 related to the regulatory approval process, which is lengthy, time-consuming and inherently unpredictable, including the risk that the FDA will not agree with the Company's approach to a potential NDA submission, that the Company's product candidates may not be approved or that additional studies may be required for approval or other delays may occur, that the Company may not have sufficient quantities of drug substance and/or drug product to support regulatory submissions and that the Company may not obtain funding sufficient to complete the regulatory or development process; the Company's limited experience as a company in obtaining regulatory approvals and commercializing pharmaceutical products; changes in the size and nature of the market for our product candidates, including potential competition; 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; any operational or other disruptions as a result of the COVID-19 pandemic; the Company's ability to obtain additional funding or enter into strategic or other business relationships necessary or useful for the further development or commercialization 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 supply chain disruptions or delays, failure to transfer technology and processes to third parties effectively or failure of those third parties (or the Company in connection with the upfit of the Company's new facility) to obtain approval of and maintain compliance with the FDA or comparable regulatory authorities; the Company's reliance on arrangements with third parties to support its operations and development efforts and the risk that such parties will not successfully carry out their contractual duties or meet expected deadlines; and other risks and uncertainties described in the Company's annual report filed with the Securities and Exchange Commission on Form 10-K for the twelve months ended December 31, 2020, and in the Company's subsequent filings with the Securities and Exchange Commission. 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

    NOVN@jtcir.com



    Primary Logo

    View Full Article Hide Full Article
  3. – Company targeting New Drug Application (NDA) for SB206 in Q3 2022, following recent clinically and statistically significant topline efficacy results from a pivotal Phase 3 B-SIMPLE4 trial in patients with molluscum contagiosum –

    – Syneos Health provides immediate access to commercial infrastructure with deep dermatology expertise and a track record of success –

    DURHAM, N.C., Sept. 08, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced its selection of Syneos Health (NASDAQ:SYNH), a fully integrated biopharmaceutical solutions organization, as its commercial solutions provider for SB206 for the treatment of molluscum. The strategic relationship with Syneos Health will focus on implementing…

    – Company targeting New Drug Application (NDA) for SB206 in Q3 2022, following recent clinically and statistically significant topline efficacy results from a pivotal Phase 3 B-SIMPLE4 trial in patients with molluscum contagiosum –

    – Syneos Health provides immediate access to commercial infrastructure with deep dermatology expertise and a track record of success –

    DURHAM, N.C., Sept. 08, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced its selection of Syneos Health (NASDAQ:SYNH), a fully integrated biopharmaceutical solutions organization, as its commercial solutions provider for SB206 for the treatment of molluscum. The strategic relationship with Syneos Health will focus on implementing the SB206 prelaunch strategy and commercial preparation, followed by sales of SB206, if approved by the U.S. Food and Drug Administration. SB206, Novan's lead product candidate, utilizes its innovative and proprietary NITRICILTM technology platform.

    Syneos Health is an industry leader for helping biopharma companies commercialize products and is the longest-tenured U.S. provider of outsourced field teams. Novan and Syneos Health began working together in 2019 to assess molluscum market data. The companies have since expanded their relationship to assemble a leadership team and incorporate full-service commercialization solutions to support Novan's SB206 program.

    "This strategic relationship brings together our robust clinical and scientific data from SB206 for the treatment of molluscum and Syneos Health's deep dermatology expertise, experience, and network," commented Paula Brown Stafford, Novan's President and Chief Executive Officer. "As we prepare for commercialization of SB206, subject to FDA approval, Syneos Health's proven track record will be invaluable to Novan as we plan to maximize the market opportunity of SB206, which has the potential to be the first in class in-home topical treatment for molluscum."

    Michelle Keefe, President, Commercial Solutions at Syneos Health, added, "We are proud to expand our relationship with Novan, and be part of filling a high unmet medical need in the dermatology and pediatric spaces with SB206. We believe our comprehensive, best-in-class capabilities will provide the strategic insights needed to execute a successful launch of Novan's first potential commercial product."

    In June 2021, the Company reported positive topline results from its pivotal Phase 3 B-SIMPLE4 clinical study for the primary endpoint (p-value ≤ 0.0001), with complete clearance of all treatable lesions in more than 32% of patients at week 12. The Company targets submitting a new drug application for SB206 for the treatment of molluscum with the FDA during the third quarter of 2022.

    About Syneos Health

    Syneos Health® (NASDAQ:SYNH) is the only fully integrated biopharmaceutical solutions organization. The Company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to accelerate customer performance to address modern market realities. Syneos Health brings together approximately 27,000 clinical and commercial minds with the ability to support customers in more than 110 countries. Together Syneos Health shares insights, uses the latest technologies and applies advanced business practices to speed Syneos Health's customers' delivery of important therapies to patients. To learn more about how Syneos Health is Shortening the distance from lab to life®, visit syneoshealth.com or subscribe to its podcast.

    About Novan

    Novan, Inc. is a late clinical-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 various other medical conditions with significant unmet needs. The Company's lead product candidate is SB206, a topical gel with antiviral properties, 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 address an important unmet medical 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, including SB206, the potential timing of an NDA submission for SB206, the potential market opportunity and plans for launch and commercialization of SB206, if approved, and the Company's intention to partner with third parties. 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 related to the regulatory approval process, which is lengthy, time-consuming and inherently unpredictable, including the risk that the FDA will not agree with the Company's approach to a potential NDA submission, that the Company's product candidates may not be approved or that additional studies may be required for approval or other delays may occur, that the Company may not have sufficient quantities of drug substance and/or drug product to support regulatory submissions and that the Company may not obtain funding sufficient to complete the regulatory or development process; the Company's limited experience as a company in obtaining regulatory approvals and commercializing pharmaceutical products; changes in the size and nature of the market for our product candidates, including potential competition; any operational or other disruptions as a result of the COVID-19 pandemic; the Company's ability to obtain additional funding or enter into strategic or other business relationships necessary or useful for the further development or commercialization 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 supply chain disruptions or delays, failure to transfer technology and processes to third parties effectively or failure of those third parties (or the Company in connection with the upfit of the Company's new facility) to obtain approval of and maintain compliance with the FDA or comparable regulatory authorities; the Company's reliance on arrangements with third parties to support its operations and development efforts and the risk that such parties will not successfully carry out their contractual duties or meet expected deadlines; and other risks and uncertainties described in the Company's annual report filed with the Securities and Exchange Commission on Form 10-K for the twelve months ended December 31, 2020, and in the Company's subsequent filings with the Securities and Exchange Commission. 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

    NOVN@jtcir.com



    Primary Logo

    View Full Article Hide Full Article
  4. DURHAM, N.C., Sept. 07, 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 September 13th – 15th H.C. Wainwright 23rd Annual Global Investment Conference.

    In addition to the fireside chat, management will be available to participate in virtual one-on-one meetings with qualified members of the investor community who are registered to attend the conference.

    A video webcast of the fireside chat will be available for viewing on-demand beginning Monday, September 13, 2021 at 7:00 AM ET for those registered for the event and accessible on the Events page in the Investors section of…

    DURHAM, N.C., Sept. 07, 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 September 13th – 15th H.C. Wainwright 23rd Annual Global Investment Conference.

    In addition to the fireside chat, management will be available to participate in virtual one-on-one meetings with qualified members of the investor community who are registered to attend the conference.

    A video webcast of the fireside chat will be available for viewing on-demand beginning Monday, September 13, 2021 at 7:00 AM ET for those registered for the event and accessible on the Events page in the Investors section of the Company's website (novan.com) for 90 days.

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

    About Novan



    Novan, Inc. is a late clinical-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 various other medical conditions with significant unmet needs. The Company's lead product candidate is SB206, a topical gel with antiviral properties, 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 address an important unmet medical need for the treatment of molluscum.

    INVESTOR AND MEDIA CONTACT:

    Jenene Thomas

    JTC Team, LLC

    833-475-8247

    NOVN@jtcir.com



    Primary Logo

    View Full Article Hide Full Article
  5. – Conference call with live audio webcast to be held on Thursday, September 9th at 8:30 a.m. ET –

    DURHAM, N.C., Sept. 02, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced that Novan management will host a corporate update conference call with live audio webcast on Thursday, September 9, 2021 at 8:30 a.m. ET.

    The call will be led by Paula Brown Stafford, President and Chief Executive Officer of Novan, who will be joined by additional members of the Novan management team. Interested participants and investors may access the conference call by dialing (844) 707-0661 (domestic) or (703) 318-2240 (international) and referencing conference ID: 6243828. The live webcast will be accessible on the Events…

    – Conference call with live audio webcast to be held on Thursday, September 9th at 8:30 a.m. ET –

    DURHAM, N.C., Sept. 02, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced that Novan management will host a corporate update conference call with live audio webcast on Thursday, September 9, 2021 at 8:30 a.m. ET.

    The call will be led by Paula Brown Stafford, President and Chief Executive Officer of Novan, who will be joined by additional members of the Novan management team. Interested participants and investors may access the conference call by dialing (844) 707-0661 (domestic) or (703) 318-2240 (international) and referencing conference ID: 6243828. The live webcast will be accessible on the Events page of the Investors section of the Novan website, novan.com, and will be archived for 90 days.

    About Novan

    Novan, Inc. is a late clinical-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 various other medical conditions with significant unmet needs. The Company's lead product candidate is SB206, a topical gel with antiviral properties, 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 address an important unmet medical need for the treatment of molluscum.

    INVESTOR AND MEDIA CONTACT:

    Jenene Thomas

    JTC Team, LLC

    833-475-8247

    NOVN@jtcir.com



    Primary Logo

    View Full Article Hide Full Article
  6. – Dr. Maeda-Chubachi, who served as Novan's Senior Vice President, Medical has played a key role in the design and execution of the Company's development programs –

    – Dr. Maeda-Chubachi was instrumental in the execution of B-SIMPLE4, the Company's pivotal Phase 3 trial of SB206 in molluscum contagiosum, which recently reported positive topline efficacy and safety results –

    – Additionally, the Company announces Dr. Maeda-Chubachi's publication in JID Innovations based on previously completed Phase 3 studies (B-SIMPLE1 and B-SIMPLE2) suggesting SB206 may trigger the beginning-of-the-end ("BOTE") inflammation and shorten the duration of molluscum infection –

    DURHAM, N.C., Aug. 24, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan…

    – Dr. Maeda-Chubachi, who served as Novan's Senior Vice President, Medical has played a key role in the design and execution of the Company's development programs –

    – Dr. Maeda-Chubachi was instrumental in the execution of B-SIMPLE4, the Company's pivotal Phase 3 trial of SB206 in molluscum contagiosum, which recently reported positive topline efficacy and safety results –

    – Additionally, the Company announces Dr. Maeda-Chubachi's publication in JID Innovations based on previously completed Phase 3 studies (B-SIMPLE1 and B-SIMPLE2) suggesting SB206 may trigger the beginning-of-the-end ("BOTE") inflammation and shorten the duration of molluscum infection –

    DURHAM, N.C., Aug. 24, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced the appointment of Tomoko Maeda-Chubachi, MD, PhD, MBA as Chief Medical Officer. Dr. Maeda-Chubachi has served as Novan's Senior Vice President, Medical since March of 2021 and Vice President, Medical Dermatology since joining the Company in September of 2017.

    "The leadership and expertise that Dr. Maeda-Chubachi has brought to the Company have been invaluable. She has played an instrumental role in the advancement of our development programs, and of particular note, SB206, which recently demonstrated positive topline data in our pivotal Phase 3 study," commented Paula Brown Stafford, President and Chief Executive Officer of Novan. "With the leadership of Dr. Maeda-Chubachi as our Chief Medical Officer, I believe we are well-positioned to continue advancing our current development programs, unlock additional pipeline opportunities and build value for all stakeholders."

    Prior to joining the Company, Dr. Maeda-Chubachi served as senior medical director at GlaxoSmithKline (GSK), leading clinical development projects for psoriasis, atopic dermatitis, pemphigus, and androgenic alopecia. Prior to GSK, she held clinical and medical affairs roles at Eli Lilly and Company and Pfizer, Inc. Dr. Maeda-Chubachi was an academic physician and dermatologist for ten years before entering the pharmaceutical industry. Dr. Maeda-Chubachi received her MD and PhD from Osaka University.

    "Over the course of my career, I have been involved with and led numerous development programs but none have I been as excited about as I am for SB206. The recently observed data from the positive B-SIMPLE4 trial gives me great confidence as we work towards a potential NDA filing and potential approval for the treatment of molluscum contagiosum," stated Dr. Maeda-Chubachi, Chief Medical Officer of Novan. "Additionally, we are working to build on this successful study as we work to continue to leverage our clinically proven NITRICIL™ technology platform to advance additional pipeline candidates."

    The Company also announced Dr. Maeda-Chubachi's manuscript entitled, SB206, a Nitric Oxide–releasing Topical Medication Induces the BOTE (Beginning-of-the-End) Sign and Molluscum Clearance1, was recently published in the JID Innovations journal. The recently published data was an integrated analysis from two of Novan's previously completed Phase 3 studies (B-SIMPLE1 and B-SIMPLE2).

    Dr. Maeda-Chubachi added, "The recently published integrated data from the previously completed B-SIMPLE1 and B-SIMPLE2 studies give us further confidence in the potential for SB206 as an important treatment for molluscum. With the average time to resolution of molluscum being 13 months, the analysis based on BOTE status of molluscum strongly suggests SB206 may shorten the duration of infection. The result not only suggests the mechanism of action of SB206, but also serves to elucidate the healing process of molluscum. We are committed to advancing the development of this important product candidate that we believe, if approved, has the potential to provide patients with a much-needed treatment benefit."

    The BOTE sign is indicative of inflammation that predicts imminent resolution of molluscum. The integrated analysis of the two prospective, 12-week, randomized, double-blind clinical trials of topical nitric oxide–releasing SB206 gel evaluated an association between BOTE sign and molluscum contagiosum lesion reduction. Of the 707 randomized patients, ~80% exhibited BOTE sign during the treatment period regardless of treatment assignment. At week 12, molluscum lesions decreased from baseline by 50.7% for baseline BOTE+ versus 29.1% for BOTE– (P = 0.0015) vehicle-treated patients compared with a 63.3% decrease for baseline BOTE+ versus 51.7% for BOTE– (P = 0.0194) SB206-treated patients. Among vehicle-treated patients, 48 (22.3%) who were never BOTE+ had an 18.5% reduction from baseline versus a 34.0% reduction in 165 patients (76.7%) who experienced BOTE at any time, suggesting that the projected duration of lesion clearance for patients with 18–20 molluscum lesions is 15 months for BOTE– versus 6 months for BOTE+ patients. Patients who were both BOTE+ and treated with SB206 had the greatest reduction in lesions. This result strongly suggests SB206 may trigger BOTE signs and shorten the duration of molluscum contagiosum infection.

    The article published in JID Innovations is now available online and can be accessed here: http://www.sciencedirect.com/journal/jid-innovations/vol/1/issue/3.

    About Novan

    Novan, Inc. is a late clinical-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 various other medical conditions with significant unmet needs. The Company's lead product candidate is SB206, a topical gel with antiviral properties, 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 address an important unmet medical 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, including SB206, and the potential for an NDA submission for SB206. 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 related to the regulatory approval process, which is lengthy, time-consuming and inherently unpredictable, including the risk that the FDA will not agree with the Company's approach to a potential NDA submission, that the Company's product candidates may not be approved or that additional studies may be required for approval or other delays may occur, that the Company may not have sufficient quantities of drug substance and/or drug product to support regulatory submissions and that the Company may not obtain funding sufficient to complete the regulatory or development process; the Company's limited experience as a company in obtaining regulatory approvals and commercializing pharmaceutical products; 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; any operational or other disruptions as a result of the COVID-19 pandemic; the Company's ability to obtain additional funding or enter into strategic or other business relationships necessary or useful for the further development or commercialization 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 supply chain disruptions or delays, failure to transfer technology and processes to third parties effectively or failure of those third parties (or the Company in connection with the upfit of the Company's new facility) to obtain approval of and maintain compliance with the FDA or comparable regulatory authorities; the Company's reliance on arrangements with third parties to support its operations and development efforts and the risk that such parties will not successfully carry out their contractual duties or meet expected deadlines; and other risks and uncertainties described in the Company's annual report filed with the Securities and Exchange Commission on Form 10-K for the twelve months ended December 31, 2020, and in the Company's subsequent filings with the Securities and Exchange Commission. 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

    NOVN@jtcir.com

    1 JID Innovations (2021);1:100019 doi:10.1016/j.xjidi.2021.100019



    Primary Logo

    View Full Article Hide Full Article
  7. – Positive data across all three of the Company's priority pipeline development programs, announced in Q2 2021, further validating the potential of its novel, proprietary NITRICIL™ technology –

    – Preparation underway for the Company's first New Drug Application filing for lead program, SB206, following the statistically significant topline efficacy results from pivotal Phase 3 trial in patients with molluscum contagiosum –

    – Ongoing exploration of opportunities for pipeline expansion and clinical development, leveraging internal expertise and strategic partnerships –

    – Company to host update conference call and webcast today at 8:30 a.m. ET –

    DURHAM, N.C., Aug. 12, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ…

    – Positive data across all three of the Company's priority pipeline development programs, announced in Q2 2021, further validating the potential of its novel, proprietary NITRICIL™ technology –

    – Preparation underway for the Company's first New Drug Application filing for lead program, SB206, following the statistically significant topline efficacy results from pivotal Phase 3 trial in patients with molluscum contagiosum –

    – Ongoing exploration of opportunities for pipeline expansion and clinical development, leveraging internal expertise and strategic partnerships –

    – Company to host update conference call and webcast today at 8:30 a.m. ET –

    DURHAM, N.C., Aug. 12, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced its financial and operating results for the quarter ended June 30, 2021 and provided a corporate update. The Company will host a conference call and webcast, today, August 12, 2021, at 8:30 a.m. ET (details below).

    "The second quarter of 2021 has been truly transformative, and nothing short of exciting for Novan. We have successfully demonstrated the potential of our NITRICIL™ platform technology with positive data readouts across all three of our priority development pipeline candidates. We have strengthened our cash position and ability to fund operations and provide optionality with our recently completed $40.0 million public offering. Importantly, we have well-positioned the Company to build value and potentially bring to market our first product, SB206, to provide patients with much-needed treatment benefit," commented Paula Brown Stafford, President and Chief Executive Officer of Novan.

    Recent Highlights

    • Ended the second quarter of 2021 with a total cash and cash equivalents balance of $65.8 million and positive working capital of $57.2 million;
    • Announced that the final patient completed their last planned Week-24 visit in the B-SIMPLE4 pivotal Phase 3 trial for SB206 as a treatment for molluscum contagiosum ("molluscum");
    • Completed a $40.0 million public offering of common stock;
    • Reported positive topline efficacy and favorable safety data at Week-12 with primary endpoint achieving statistically significant results from pivotal Phase 3 trial of SB206 in patients with molluscum;
    • Announced positive preclinical results evaluating berdazimer sodium in a SARS-CoV-2 transmission model in two independent trials of golden Syrian hamsters; and
    • Further demonstrated the antimicrobial effect of NITRICIL™ platform technology against a wide variety of bacteria with positive in vitro results for NVN4100 in Companion Animal Health.

    Development Pipeline Update

    SB206 – A Topical Antiviral Treatment for Viral Skin Infections (Molluscum Contagiosum)

    Novan is developing SB206 as a topical gel with anti-viral properties for the treatment of molluscum. SB206 has been most recently evaluated in a pivotal Phase 3 study, B-SIMPLE4. B-SIMPLE4 was a multi-center, double-blind, randomized, vehicle-controlled study that exceeded its enrollment target by randomizing 891 patients (1:1 randomization) in the study, across 55 clinical sites. Patients were treated for up to 12 weeks with a follow-up visit at Week 24. The primary endpoint for the study was the proportion of patients with complete clearance of all treatable molluscum lesions at Week 12 (Intent-to-Treat population, where the analysis assumes that patients with missing lesion counts at Week 12 are considered treatment failures).

    In June 2021, the Company reported positive topline results, including statistical significance for the primary endpoint with a p-value of less than 0.0001. Additionally, as was consistent with results from the Company's Phase 2 and earlier Phase 3 studies, SB206 was found to be safe and well tolerated in the B-SIMPLE4 study. No treatment-related serious adverse events were reported. In July 2021, the Company announced that the last patient had completed their planned Week-24 follow-up visit in the B-SIMPLE4 pivotal Phase 3 clinical study. The planned follow-up visit at Week-24 was intended to further evaluate safety of SB206, 12 weeks following patient completion of treatment.

    Upcoming Targeted Milestones:

    • Full data readout from the B-SIMPLE4 study, including Week-24 safety follow-up, targeted in Q3 2021.
    • Potential filing of a new drug application ("NDA") targeted no later than Q3 2022.

    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.

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

    SB019 – Infectious Disease, Coronaviridae (COVID-19)

    In June 2021, Novan announced positive preclinical results demonstrating efficacy of the Company's NITRICIL™ platform technology, berdazimer sodium (NVN1000), as an anti-viral therapy against SARS-CoV-2, the virus that causes COVID-19. To further evaluate the potential of its NITRICIL™ platform technology as an intranasal treatment option for COVID-19, the Company initiated preclinical in vivo studies evaluating the efficacy of berdazimer sodium to reduce viral burden in infected animals and to deter viral transmission to uninfected animals. The work was conducted at the Institute for Antiviral Research at Utah State University. Results from two separate studies independently demonstrated the ability of berdazimer sodium to prevent progression of infection into the lungs after transmission, significantly limiting severity of disease in this model. The intranasal treatment was well-tolerated during the preclinical in vivo studies, and no treatment-related adverse events were observed.

    The Company observed a dose-dependent, statistically significant reduction (P<0.0001) in the amount of virus in the lungs of animals treated with berdazimer sodium concentrations as low as 2 mg/mL compared to placebo-treated controls. The effect was observed after co-habitation with infected hamsters who were also treated with berdazimer sodium. The average amount of virus in the lungs was reduced by greater than 4 logs (>99.99%) with more than half of the animals having no detectable virus in lung tissue at all.

    Based on the scientific literature and the Company's previously reported in vitro and in vivo results, Novan believes that nitric oxide may inhibit viral replication by disrupting protein function that is critical for viral replication and infection through generation of reactive intermediates. The Company plans to submit a request to the FDA for guidance on an appropriate path for bringing a new potential treatment option to patients, as quickly as possible. The Company is evaluating its strategy to submit an Investigational New Drug application ("IND") for the purposes of advancing its SB019 product candidate, subject to regulatory guidance, successful completion of IND-enabling toxicology studies and obtaining additional financing or strategic partnering.

    NVN4100 – Companion Animal Health

    In June 2021, Novan announced positive proof-of-concept in vitro results and informative in vivo results with its new chemical entity, NVN4100, explored as a potential product candidate for topical antimicrobial indications in companion animal health.

    Results from the in vitro assay demonstrated that NVN4100 had both inhibitory and bactericidal effects for a variety of pathogens. The tested pathogens include both antimicrobial resistant and antimicrobial susceptible strains of the most prevalent species associated with skin and ear conditions in animal health, including Escherichia coli, Pseudomonas aeruginosa, Staphylococcus pseudintermedius, and Staphylococcus schleiferi.

    Additionally, in collaboration with an independent third-party animal health research organization, Novan established a model of canine pyoderma, one of the most common skin conditions of dogs that is often resistant to first-line antimicrobials, to evaluate topically applied NVN4100 in an in vivo setting. The in vivo results suggest that the canine pyoderma model may serve as an appropriate tool to facilitate further development of NVN4100 as an alternative therapy to systemic and topical antimicrobials for the treatment of canine superficial pyoderma or other dermatology indications.

    Based on the results to date and subject to the availability of funding, Novan intends to conduct additional studies and formulation work with NVN4100 to build a robust data set and engage with potential collaborators and strategic partners moving forward. The Company plans to disclose the full data set from the companion animal health exploratory studies at an upcoming scientific congress and/or in a peer-reviewed publication.

    Financial Update

    Summary of Financial Results for Second Quarter 2021

    • Novan reported a net loss of $6.0 million for the three months ended June 30, 2021, compared to an $8.1 million net loss for the same period in 2020.
    • As of June 30, 2021, Novan had a total cash and cash equivalents balance of $65.8 million and positive working capital of $57.2 million.
    • The Company believes that its existing cash and cash equivalents balance as of June 30, 2021, plus expected contractual payments to be received in connection with existing licensing agreements, will provide it with adequate liquidity to fund its operating needs into the first quarter of 2023, based on management's projections and planned operating and development activities described in the Company's quarterly report on Form 10-Q for the six month period ended June 30, 2021.

    Summary of Financial Results for Year-to-Date June 2021

    • Novan reported a net loss of $15.0 million for the six months ended June 30, 2021, compared to a $14.3 million net loss for the same period in 2020.
    • License and collaboration revenue was $1.5 million for the six months ended June 30, 2021, compared to $2.1 million for the same period in 2020. The decrease from the prior year related to the change in the Company's estimated performance period related to the non-refundable upfront and expected milestone payments under one of the Company's license agreements, which was extended during the fourth quarter of 2020.
    • Research and development expenses were $11.7 million for the six months ended June 30, 2021, compared to $8.7 million for the same period in 2020. The increase was primarily attributable to (i) net increased costs of $5.2 million related to Novan's ongoing conduct and treatment phase activities of the B-SIMPLE4 Phase 3 trial during the first six months of 2021, compared to the relatively lower cost of wind down activities for its B-SIMPLE1 and B-SIMPLE2 Phase 3 trials during the comparative period in 2020; partially offset by (ii) a decrease of $1.9 million in other research and development expenses; and (iii) a $0.2 million decrease in costs related to the SB414 program. The decrease in other research and development expenses was primarily related to a $1.4 million decrease in research and development personnel costs, driven by (i) a $0.4 million decrease in non-cash compensation expense related to the change in the fair value of the Company's Tangible Stockholder Return Plan; (ii) a $0.4 million decrease in non-cash compensation expense associated with stock option compensation; (iii) a $0.4 million decrease in discrete severance charges and retention incentive compensation associated with business realignment and personnel reduction actions taken during the first quarter of 2020; and (iv) a $0.2 million decrease in recurring salary and benefits costs due to a reduced number of research and development personnel between the two comparative periods.
    • General and administrative expenses were $5.1 million for the six months ended June 30, 2021, compared to $5.7 million for the same period in 2020. The decrease was primarily due to $0.8 million of non-cash expense recognized in the second quarter of 2020 related to the issuance of commitment shares in consideration for entering into the June 2020 Aspire Common Stock Purchase Agreement.
    • Other income (expense), net was $0.4 million income for the six months ended June 30, 2021, compared to $0.1 million income for the six months ended June 30, 2020. During the second quarter of 2021, the Company recognized a $1.0 million gain on debt extinguishment related to the forgiveness of its Paycheck Protection Program loan in June 2021. This gain was partially offset by $0.6 million of other expense related to the impact of foreign currency exchange rate fluctuations for certain time-based milestones related to one of the Company's license agreements.

    Conference Call and Webcast

    Novan management will host a conference call and webcast presentation for investors, analysts, and other interested parties today, Thursday, August 12, 2021, at 8:30 a.m. ET.

    Interested participants and investors may access the conference call by dialing (844) 707-0661 (domestic) or (703) 318-2240 (international) and referencing conference ID: 6686508. The live webcast will be accessible on the Events page of the Investors section of the Novan website, novan.com, and will be archived for 90 days.

    About Novan

    Novan, Inc. is a late clinical-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 various other medical conditions with significant unmet needs. The Company's lead product candidate is SB206, a topical gel with antiviral properties, 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 address an important unmet medical 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, including SB206, the timing of follow-up safety results from B-SIMPLE4, the potential timing of an NDA submission for SB206, the Company's expected cash runway, the timing of anticipated results of the Company's preclinical development programs, and the Company's intention to partner with third parties. 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 related to the regulatory approval process, which is lengthy, time-consuming and inherently unpredictable, including the risk that the FDA will not agree with the Company's approach to a potential NDA submission, that the Company's product candidates may not be approved or that additional studies may be required for approval or other delays may occur, that the Company may not have sufficient quantities of drug substance and/or drug product to support regulatory submissions and that the Company may not obtain funding sufficient to complete the regulatory or development process; the Company's limited experience as a company in obtaining regulatory approvals and commercializing pharmaceutical products; 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; any operational or other disruptions as a result of the COVID-19 pandemic; the Company's ability to obtain additional funding or enter into strategic or other business relationships necessary or useful for the further development or commercialization 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 supply chain disruptions or delays, failure to transfer technology and processes to third parties effectively or failure of those third parties (or the Company in connection with the upfit of the Company's new facility) to obtain approval of and maintain compliance with the FDA or comparable regulatory authorities; the Company's reliance on arrangements with third parties to support its operations and development efforts and the risk that such parties will not successfully carry out their contractual duties or meet expected deadlines; and other risks and uncertainties described in the Company's annual report filed with the Securities and Exchange Commission on Form 10-K for the twelve months ended December 31, 2020, and in the Company's subsequent filings with the Securities and Exchange Commission. 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.



    NOVAN, INC.

    Condensed Consolidated Statements of Operations and Comprehensive Loss

    (unaudited)

    (in thousands, except share and per share amounts)

      Three Months Ended June 30, Six Months Ended June 30,
      2021 2020 2021 2020
    License and collaboration revenue $747  $1,100  $1,494  $2,124 
    Government research contracts and grants revenue   221  72  410 
    Total revenue 747  1,321  1,566  2,534 
    Operating expenses:        
    Research and development 5,257  3,761  11,675  8,677 
    General and administrative 2,431  3,232  5,117  5,739 
    Impairment loss on long-lived assets 114  2,421  114  2,421 
    Total operating expenses 7,802  9,414  16,906  16,837 
    Operating loss (7,055) (8,093) (15,340) (14,303)
    Other income (expense), net:        
    Interest income 3  10  6  45 
    Gain on debt extinguishment 956    956   
    Other income (expense) 73  (3) (597) 5 
    Total other income (expense), net 1,032  7  365  50 
    Net loss and comprehensive loss $(6,023) $(8,086) $(14,975) $(14,253)
    Net loss per share, basic and diluted $(0.39) $(1.00) $(0.98) $(2.42)
    Weighted-average common shares outstanding, basic and diluted 15,570,290  8,060,317  15,288,156  5,882,352 



    NOVAN, INC.

    Selected Condensed Consolidated Balance Sheet Data

    (unaudited)

    (in thousands)

      June 30, 2021 December 31, 2020
    Cash and cash equivalents $65,802  $35,879 
    Total current assets 68,778  44,007 
    Total assets 79,716  46,829 
    Total current liabilities 11,605  8,700 
    Total liabilities 47,390  43,852 
    Total stockholders' equity 32,326  2,977 
    Total liabilities and stockholders' equity $79,716  $46,829 



    INVESTOR AND MEDIA CONTACT:

    Jenene Thomas

    JTC Team, LLC

    833-475-8247

    NOVN@jtcir.com



    Primary Logo

    View Full Article Hide Full Article
  8. DURHAM, N.C., Aug. 05, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced that it will report its second quarter 2021 financial results on Thursday, August 12th. Novan management will host a conference call and live audio webcast to discuss the operational and financial results at 8:30 a.m. ET that same day.

    The call will be led by Paula Brown Stafford, President and Chief Executive Officer of Novan, who will be joined by additional members of the Novan management team. Interested participants and investors may access the conference call by dialing (844) 707-0661 (domestic) or (703) 318-2240 (international) and referencing conference ID: 6686508. The live webcast will be accessible on the Events…

    DURHAM, N.C., Aug. 05, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced that it will report its second quarter 2021 financial results on Thursday, August 12th. Novan management will host a conference call and live audio webcast to discuss the operational and financial results at 8:30 a.m. ET that same day.

    The call will be led by Paula Brown Stafford, President and Chief Executive Officer of Novan, who will be joined by additional members of the Novan management team. Interested participants and investors may access the conference call by dialing (844) 707-0661 (domestic) or (703) 318-2240 (international) and referencing conference ID: 6686508. The live webcast will be accessible on the Events page of the Investors section of the Novan website, novan.com, and will be archived for 90 days.

    About Novan

    Novan, Inc. is a late clinical-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 various other medical conditions with significant unmet needs. The Company's lead product candidate is SB206, a topical gel with antiviral properties, 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 address an important unmet medical need for the treatment of molluscum.

    INVESTOR AND MEDIA CONTACT:

    Jenene Thomas

    JTC Team, LLC

    833-475-8247

    NOVN@jtcir.com

     



    Primary Logo

    View Full Article Hide Full Article
  9. – Company previously reported positive topline efficacy and favorable safety data at Week 12 from B-SIMPLE4 in June 2021, with primary endpoint achieving statistical significance with p-value less than 0.0001 and no serious adverse events related to treatment with SB206 –

    – Planned follow-up visit at week 24 is intended to further evaluate safety of SB206, 12 weeks following patient completion of treatment, with results expected in Q3 2021 –

    – Novan intends to submit New Drug Application ("NDA") no later than the third quarter of 2022 –

    – Currently no FDA-approved therapies for the treatment of molluscum –

    DURHAM, N.C., July 28, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced the last patient…

    – Company previously reported positive topline efficacy and favorable safety data at Week 12 from B-SIMPLE4 in June 2021, with primary endpoint achieving statistical significance with p-value less than 0.0001 and no serious adverse events related to treatment with SB206 –

    – Planned follow-up visit at week 24 is intended to further evaluate safety of SB206, 12 weeks following patient completion of treatment, with results expected in Q3 2021 –

    – Novan intends to submit New Drug Application ("NDA") no later than the third quarter of 2022 –

    – Currently no FDA-approved therapies for the treatment of molluscum –

    DURHAM, N.C., July 28, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced the last patient has completed their planned Week-24 follow-up visit in the B-SIMPLE4 pivotal Phase 3 clinical study of SB206, a topical gel with antiviral properties for the treatment of molluscum contagiosum ("molluscum").

    Tomoko Maeda-Chubachi, M.D., Ph.D., M.B.A., Senior Vice President, Medical at Novan commented, "The completion of all Week-24 patient visits is an exciting step forward towards bringing a promising treatment option to molluscum patients. We continue to be encouraged by the positive topline results from this study and the potential benefit SB206 has for this contagious disease, which currently has no FDA-approved therapies. We look forward to reporting the full data set and importantly, potentially shifting the treatment landscape of molluscum for millions of people, primarily children, affected every year."

    B-SIMPLE4 is a multi-center, double-blind, randomized, vehicle-controlled study that exceeded its enrollment target by randomizing 891 patients (1:1 randomization) in the study, across 55 clinical sites. Patients were 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 lesion counts at Week 12 are considered treatment failures).

    In June 2021, the Company reported positive topline results, including statistical significance for the primary endpoint with p-value less than 0.0001. Additionally, as was consistent with results from the Company's Phase 2 and earlier Phase 3 studies, SB206 was found to be safe and well tolerated in the B-SIMPLE4 study. No treatment-related serious adverse events were reported.

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

    About Molluscum Contagiosum

    Molluscum is a common, contagious skin infection caused by the molluscipoxvirus, affecting millions of people in the U.S. annually, with the greatest incidence in children. Approximately 70% of patients are below the age of 10. There are currently no U.S. Food and Drug Administration ("FDA") approved therapies for the treatment of molluscum. More than half of patients diagnosed with the infection are untreated.

    About Novan

    Novan, Inc. is a late clinical-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 various other medical conditions with significant unmet needs. The Company's lead product candidate is SB206, a topical gel with antiviral properties, 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 address an important unmet medical 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," "intends" 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, including SB206, the timing of follow-up safety results from B-SIMPLE4 and the potential timing of an NDA submission. 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, risks related to the regulatory approval process, which is lengthy, time-consuming and inherently unpredictable, including the risk that the FDA will not agree with the Company's approach to a potential NDA submission, that the Company's product candidates may not be approved or that additional studies may be required for approval or other delays may occur, that the Company may not have sufficient quantities of drug substance and/or drug product to support regulatory submissions and that the Company may not obtain funding sufficient to complete the regulatory or development process; the Company's limited experience as a company in obtaining regulatory approvals and commercializing pharmaceutical products; the Company's ability to obtain additional funding or enter into strategic or other business relationships necessary or useful for the further development or, following regulatory approval, commercialization of the Company's product candidates; the Company's reliance on arrangements with third parties to support its operations and development efforts and the risk that such parties will not successfully carry out their contractual duties or meet expected deadlines; any operational or other disruptions as a result of the COVID-19 pandemic; and other risks and uncertainties described in the Company's annual report filed with the Securities and Exchange Commission on Form 10-K for the twelve months ended December 31, 2020, and in the Company's subsequent filings with the Securities and Exchange Commission. 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

    NOVN@jtcir.com



    Primary Logo

    View Full Article Hide Full Article
  10. Pharmaceutical Services Leader Strengthens PPC's Capabilities and Enhances Strategic Initiative to Invest in Market-Leading Healthcare Companies

    Pritzker Private Capital ("PPC"), a leader in family direct investing, today announced the appointment of Paula Brown Stafford to the Pritzker Advisory Board. Ms. Stafford, currently Chairman and CEO of biotechnology company Novan, brings more than 30 years of healthcare industry experience to the Pritzker Advisory Board and PPC's family of companies. Her appointment will enhance PPC's initiatives to invest in and partner with market-leading healthcare companies, specifically in healthcare services, medical products, pharmaceutical services and the life sciences supply chain.

    Chaired by Tony Pritzker…

    Pharmaceutical Services Leader Strengthens PPC's Capabilities and Enhances Strategic Initiative to Invest in Market-Leading Healthcare Companies

    Pritzker Private Capital ("PPC"), a leader in family direct investing, today announced the appointment of Paula Brown Stafford to the Pritzker Advisory Board. Ms. Stafford, currently Chairman and CEO of biotechnology company Novan, brings more than 30 years of healthcare industry experience to the Pritzker Advisory Board and PPC's family of companies. Her appointment will enhance PPC's initiatives to invest in and partner with market-leading healthcare companies, specifically in healthcare services, medical products, pharmaceutical services and the life sciences supply chain.

    Chaired by Tony Pritzker, the Pritzker Advisory Board is a team of eight world-class strategic and operational executives, with diverse skill sets and proven experience leading global organizations. PAB members advise on PPC's investment strategy, strengthen partnerships with management teams and enhance the firm's operations capabilities.

    "We are pleased to welcome Paula to the Pritzker Advisory Board and the PPC family," said Michael Dal Bello, Investment Partner – Healthcare at PPC and co-leader of PPC's Healthcare team. "Paula is a globally recognized leader in the pharmaceutical industry with a proven track record of growth and success. Her deep expertise and strong relationships across the sector will help us continue to identify exciting new partnership opportunities and expand our family of healthcare companies."

    "Paula is a great addition to the Pritzker Advisory Board. Her unique experience, growth mindset and history of value creation will strengthen the operations capabilities PPC provides to its companies," said David King, Operating Partner – Healthcare at PPC and co-leader of PPC's Healthcare team. "At PPC, we believe in building businesses for the long term, and I look forward to working closely with Paula as we build value across our family of companies."

    "I am delighted to join the accomplished group of executives that make up the Pritzker Advisory Board," said Ms. Stafford. "I have long admired PPC's philosophy, culture and the remarkable Pritzker legacy. I am eager to contribute to the PPC team, identifying new companies that are a compelling fit with PPC's values and partnering with strong management teams to support their long-term growth."

    Ms. Stafford is currently Chairman and CEO of Novan (NASDAQ:NOVN), an innovative biotechnology company and a leader in developing nitric oxide-based therapies for dermatological, women's health and infectious diseases. She previously led the clinical development operations division of Quintiles (now IQVIA), one of the world's largest contract research organizations (CRO). At Quintiles, she oversaw a division that delivered approximately $3 billion of annual revenue, with 22,000 employees across 60 countries. Ms. Stafford serves on the Board of Health Decisions, Inc., and is an emeritus member of the Public Health Foundation Board of the University of North Carolina's Gillings School of Public Health. She holds a Bachelor of Science and a Master of Public Health, both from the University of North Carolina at Chapel Hill.

    In addition to Tony Pritzker as Chairman, members of the Pritzker Advisory Board include the following distinguished business leaders:

    Ruby Chandy, Pall Corp.

    Former President, Industrial Division

     

    Doug Ray Oberhelman, Caterpillar Inc.

    Former Chairman and Chief Executive Officer

    J.Phillip Holloman, Cintas Corp.

    Former President and Chief Operating Officer

     

    Paula Brown Stafford, Novan, Inc.

    Chairman and Chief Executive Officer

    Alan Muney, Cigna Corp.

    Former Chief Medical Officer

     

    David Steiner, Waste Management, Inc.

    Former President and Chief Executive Officer

    Stephen Newlin, Univar Solution & PolyOne Corp.

    Former Chairman and Chief Executive Officer

     

    About Pritzker Private Capital

    Pritzker Private Capital partners with middle-market companies based in North America with leading positions in the manufactured products, services and healthcare sectors. The firm's differentiated, long-duration capital base allows for efficient decision-making, broad flexibility with transaction structure and investment horizon, and alignment with all stakeholders. Pritzker Private Capital builds businesses for the long term and is an ideal partner for entrepreneur- and family-owned companies. Pritzker Private Capital is a signatory to the United Nations Principles for Responsible Investment (PRI). For more information, visit PPCPartners.com.

    View Full Article Hide Full Article
  11. DURHAM, N.C., June 24, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced that as part of the annual reconstitution of the Russell stock indexes, Novan has been selected to join the Russell Microcap® Index, effective after the U.S. market close on June 25, 2021, according to the list of additions published by FTSE Russell as of June 4, 2021.

    "This is truly an exciting time for Novan, on multiple fronts. On the heels of our recently announced positive data across all three of our priority pipeline development programs, importantly, the statistically significant results from our Phase 3 study of SB206 for the treatment of molluscum, we are confident in the potential of our NITRICIL™ technology to…

    DURHAM, N.C., June 24, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced that as part of the annual reconstitution of the Russell stock indexes, Novan has been selected to join the Russell Microcap® Index, effective after the U.S. market close on June 25, 2021, according to the list of additions published by FTSE Russell as of June 4, 2021.

    "This is truly an exciting time for Novan, on multiple fronts. On the heels of our recently announced positive data across all three of our priority pipeline development programs, importantly, the statistically significant results from our Phase 3 study of SB206 for the treatment of molluscum, we are confident in the potential of our NITRICIL™ technology to treat multiple indications. Our team's hard work and dedication have brought us to this point, and we remain dedicated to advancing these programs. We believe we are well-positioned to continue building momentum and drive value in the near- and long-term," commented Paula Brown Stafford, President and Chief Executive Officer of Novan.

    John M. Gay, Chief Financial Officer of Novan, added, "Our addition to the Russell Microcap® Index is another step demonstrating the evolution of Novan. For the first time in the Company's history, we are in a position to potentially submit an NDA with the FDA, targeted for no later than the third quarter of 2022, representing a watershed moment for our shareholders. The inclusion of Novan on this index should allow us greater access and visibility to institutional investors and investment managers as we continue to progress our pipeline portfolio."

    Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $10.6 trillion in assets are benchmarked against Russell's US indexes. Russell indexes are part of FTSE Russell, a leading global index provider.

    For more information on the Russell Microcap® Index and the Russell indexes reconstitution, go to the "Russell Reconstitution" section on the FTSE Russell website.

    About FTSE Russell

    FTSE Russell is a global index leader that provides innovative benchmarking, analytics and data solutions for investors worldwide. FTSE Russell calculates thousands of indexes that measure and benchmark markets and asset classes in more than 70 countries, covering 98% of the investable market globally.

    FTSE Russell index expertise and products are used extensively by institutional and retail investors globally. Approximately $17.9 trillion is currently benchmarked to FTSE Russell indexes. For over 30 years, leading asset owners, asset managers, ETF providers and investment banks have chosen FTSE Russell indexes to benchmark their investment performance and create ETFs, structured products and index-based derivatives.

    A core set of universal principles guides FTSE Russell index design and management: a transparent rules-based methodology is informed by independent committees of leading market participants. FTSE Russell is focused on applying the highest industry standards in index design and governance and embraces the IOSCO Principles. FTSE Russell is also focused on index innovation and customer partnerships as it seeks to enhance the breadth, depth and reach of its offering.

    FTSE Russell is wholly owned by London Stock Exchange Group.

    For more information, visit www.ftserussell.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 is SB206, a topical antiviral gel, for the treatment of molluscum contagiosum. 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 contagiosum.

    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," "intends" 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, including SB206, the potential timing of an NDA submission and the ability to have greater access and visibility to institutional investors and investment managers. 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 related to the regulatory approval process, which is lengthy, time-consuming and inherently unpredictable, including the risk that the FDA will not agree with the Company's approach to a potential NDA submission, that the Company's product candidates may not be approved or that additional studies may be required for approval or other delays may occur, that the Company may not have sufficient quantities of drug substance and/or drug product to support regulatory submissions and that the Company may not obtain funding sufficient to complete the regulatory or development process; the Company's limited experience as a company in obtaining regulatory approvals and commercializing pharmaceutical products; the Company's ability to obtain additional funding or enter into strategic or other business relationships necessary or useful for the further development or, following regulatory approval, commercialization of the Company's product candidates; the Company's reliance on arrangements with third parties to support its operations and development efforts and the risk that such parties will not successfully carry out their contractual duties or meet expected deadlines; any operational or other disruptions as a result of the COVID-19 pandemic; and other risks and uncertainties described in the Company's annual report filed with the Securities and Exchange Commission on Form 10-K for the twelve months ended December 31, 2020, and in the Company's subsequent filings with the Securities and Exchange Commission. 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

    NOVN@jtcir.com



    Primary Logo

    View Full Article Hide Full Article
  12. DURHAM, N.C., June 21, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. (the "Company" or "Novan") (NASDAQ:NOVN) today announced the closing of the Company's previously announced underwritten public offering (the "Offering") of 3,636,364 shares of common stock at a public offering price of $11.00 per share. All of the shares of common stock sold in the offering were offered by the Company. In addition, the Company granted the underwriter of the Offering a 30-day option to purchase up to an additional 545,454 shares of its common stock. The gross proceeds from the offering were approximately $40 million, before deducting underwriting discounts and commissions and other estimated offering expenses payable by the Company.

    Cantor Fitzgerald & Co. acted…

    DURHAM, N.C., June 21, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. (the "Company" or "Novan") (NASDAQ:NOVN) today announced the closing of the Company's previously announced underwritten public offering (the "Offering") of 3,636,364 shares of common stock at a public offering price of $11.00 per share. All of the shares of common stock sold in the offering were offered by the Company. In addition, the Company granted the underwriter of the Offering a 30-day option to purchase up to an additional 545,454 shares of its common stock. The gross proceeds from the offering were approximately $40 million, before deducting underwriting discounts and commissions and other estimated offering expenses payable by the Company.

    Cantor Fitzgerald & Co. acted as the sole book-running manager for the Offering. In addition, ROTH Capital Partners, LLC acted as financial advisor to the Company in connection with the Offering.

    Novan intends to use the net proceeds from the Offering, together with existing cash, to fund research and development program activities, including (i) preparing for and seeking regulatory approval of its product candidate SB206 as a treatment for molluscum contagiosum, (ii) planning for potential commercialization of SB206 and (iii) continuing research and development activities primarily related to its product candidate SB204 as a treatment for acne vulgaris, as well as for general corporate purposes.

    The Offering was made pursuant to a shelf registration statement on Form S-3 (Registration No. 333-236583) filed with the Securities and Exchange Commission (the "SEC") and declared effective on April 10, 2020. The final prospectus supplement and the accompanying prospectus relating to this Offering was filed with the SEC and is available on the SEC's website, http://www.sec.gov. Alternatively, copies of the final prospectus supplement and the accompanying base prospectus relating to the Offering can be obtained from Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Avenue, 4th Floor, New York, New York 10022 or by email at prospectus@cantor.com.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    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 is SB206, a topical antiviral gel, for the treatment of molluscum contagiosum. 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 contagiosum.

    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," "intends" 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 statements regarding the anticipated use of proceeds from the public offering. 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 associated with the clinical development and regulatory approval processes, as well as 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, 2020, and in the Company's subsequent filings with the SEC. Such forward-looking statements speak only as of the date of this press release or the announced presentation, as applicable, and the Company 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

    NOVN@jtcir.com



    Primary Logo

    View Full Article Hide Full Article
  13. DURHAM, N.C., June 17, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. (the "Company" or "Novan") (NASDAQ:NOVN) today announced the pricing of the Company's previously announced underwritten public offering (the "Offering") of 3,636,364 shares of common stock at a public offering price of $11.00 per share for gross proceeds of approximately $40 million, before deducting underwriting discounts and commissions and other estimated offering expenses payable by Novan. All of the shares of common stock to be sold in the offering are being offered by Novan. The Offering is expected to close on or about June 21, 2021, subject to customary closing conditions. In addition, Novan has granted the underwriter of the Offering a 30-day option to purchase up to 545,454…

    DURHAM, N.C., June 17, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. (the "Company" or "Novan") (NASDAQ:NOVN) today announced the pricing of the Company's previously announced underwritten public offering (the "Offering") of 3,636,364 shares of common stock at a public offering price of $11.00 per share for gross proceeds of approximately $40 million, before deducting underwriting discounts and commissions and other estimated offering expenses payable by Novan. All of the shares of common stock to be sold in the offering are being offered by Novan. The Offering is expected to close on or about June 21, 2021, subject to customary closing conditions. In addition, Novan has granted the underwriter of the Offering a 30-day option to purchase up to 545,454 additional shares of its common stock.

    Cantor Fitzgerald & Co. is acting as the sole book-running manager for the Offering. In addition, ROTH Capital Partners, LLC acted as financial advisor to the Company in connection with the Offering.

    Novan intends to use the net proceeds from the Offering, together with existing cash, to fund research and development program activities, including (i) preparing for and seeking regulatory approval of its product candidate SB206 as a treatment for molluscum contagiosum, (ii) planning for potential commercialization of SB206 and (iii) continuing research and development activities primarily related to its product candidate SB204 as a treatment for acne vulgaris, as well as for general corporate purposes.

    The Offering is being made pursuant to a shelf registration statement on Form S-3 (Registration No. 333-236583) filed with the Securities and Exchange Commission (the "SEC") and declared effective on April 10, 2020. A preliminary prospectus supplement relating to the Offering has been filed with the SEC and a final prospectus supplement and the accompanying prospectus relating to this offering will be filed with the SEC. The securities may be offered only by means of a written prospectus, including a prospectus supplement, forming a part of the effective registration statement. When available, electronic copies of the final prospectus supplement and the accompanying base prospectus relating to the Offering may be obtained from the SEC at http://www.sec.gov. Alternatively, copies of the final prospectus and the accompanying base prospectus relating to the Offering can be obtained, when available, from Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Avenue, 4th Floor, New York, New York 10022 or by email at prospectus@cantor.com.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    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 is SB206, a topical antiviral gel, for the treatment of molluscum contagiosum. 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 contagiosum.

    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," "intends" 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, statements regarding the Company's expectations as to the completion of the public offering, and statements regarding the anticipated use of proceeds from the public offering. 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 associated with the clinical development and regulatory approval processes, market conditions and the satisfaction of customary closing conditions related to the proposed public offering, as well as 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, 2020, and in the Company's subsequent filings with the SEC. Such forward-looking statements speak only as of the date of this press release or the announced presentation, as applicable, and the Company 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

    NOVN@jtcir.com 



    Primary Logo

    View Full Article Hide Full Article
  14. DURHAM, N.C., June 16, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. (the "Company" or "Novan") (NASDAQ:NOVN) today announced a proposed underwritten public offering of its common stock (the "Offering"). All shares to be sold in the Offering will be sold by Novan. The Company also expects to grant to the underwriter for the Offering a 30-day option to purchase up to an additional 15 percent of the number of shares of common stock offered in the public offering. The Offering is subject to market conditions, and there can be no assurance as to whether or when the Offering may be completed, or as to the actual size or terms of the Offering.

    Cantor Fitzgerald & Co. is acting as the sole book-running manager for the Offering.

    Novan intends to use the…

    DURHAM, N.C., June 16, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. (the "Company" or "Novan") (NASDAQ:NOVN) today announced a proposed underwritten public offering of its common stock (the "Offering"). All shares to be sold in the Offering will be sold by Novan. The Company also expects to grant to the underwriter for the Offering a 30-day option to purchase up to an additional 15 percent of the number of shares of common stock offered in the public offering. The Offering is subject to market conditions, and there can be no assurance as to whether or when the Offering may be completed, or as to the actual size or terms of the Offering.

    Cantor Fitzgerald & Co. is acting as the sole book-running manager for the Offering.

    Novan intends to use the net proceeds from the Offering, together with existing cash, to fund research and development program activities, including (i) preparing for and seeking regulatory approval of its product candidate SB206 as a treatment for molluscum contagiosum, (ii) planning for potential commercialization of SB206 and (iii) continuing research and development activities primarily related to its product candidate SB204 as a treatment for acne vulgaris, as well as for general corporate purposes.

    The Offering is being made pursuant to a shelf registration statement on Form S-3 (Registration No. 333-236583) filed with the Securities and Exchange Commission (the "SEC") and declared effective by the SEC on April 10, 2020. A preliminary prospectus supplement relating to the Offering will be filed with the SEC. The securities may be offered only by means of a written prospectus, including a prospectus supplement, forming a part of the effective registration statement. When available, electronic copies of the preliminary prospectus supplement and the accompanying base prospectus relating to the Offering may be obtained from the SEC at http://www.sec.gov. Alternatively, copies of the preliminary prospectus and the accompanying base prospectus relating to the Offering can be obtained, when available, from Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Avenue, 4th Floor, New York, New York 10022 or by email at prospectus@cantor.com.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    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 is SB206, a topical antiviral gel, for the treatment of molluscum contagiosum. 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 contagiosum.

    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," "intends" 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 offer and sell securities in a public offering, statements regarding the Company's expectations as to the completion and timing of the proposed public offering, and statements regarding the anticipated use of proceeds from the proposed public offering. 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 associated with the clinical development and regulatory approval processes, market conditions and the satisfaction of customary closing conditions related to the proposed public offering, risks and uncertainties as to the final terms of the proposed public offering, as well as 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, 2020, and in the Company's subsequent filings with the SEC. Such forward-looking statements speak only as of the date of this press release or the announced presentation, as applicable, and the Company 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

    NOVN@jtcir.com



    Primary Logo

    View Full Article Hide Full Article
  15. – B-SIMPLE4 achieves statistical significance for the primary endpoint with p-value less than 0.0001 –

    – No serious adverse events related to treatment with SB206 –

    – Novan intends to submit New Drug Application ("NDA") no later than the third quarter of 2022 –

    – Management to host video webcast today at 8:00 a.m. ET –

    DURHAM, N.C., June 11, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced positive topline efficacy and safety results for the B-SIMPLE4 pivotal Phase 3 clinical study of SB206, a topical antiviral gel, for the treatment of molluscum contagiosum ("molluscum"). Molluscum is a common, contagious skin infection caused by the molluscipoxvirus, affecting approximately six million people…

    – B-SIMPLE4 achieves statistical significance for the primary endpoint with p-value less than 0.0001 –

    – No serious adverse events related to treatment with SB206 –

    – Novan intends to submit New Drug Application ("NDA") no later than the third quarter of 2022 –

    – Management to host video webcast today at 8:00 a.m. ET –

    DURHAM, N.C., June 11, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced positive topline efficacy and safety results for the B-SIMPLE4 pivotal Phase 3 clinical study of SB206, a topical antiviral gel, for the treatment of molluscum contagiosum ("molluscum"). Molluscum 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. The Company will host a video webcast, today, June 11, 2021, at 8:00 a.m. ET (details below) to discuss the results of the study.

    "The positive results from B-SIMPLE4 represent a transformational milestone for our employees, investors and most importantly, people living with molluscum. The strong safety and statistically significant efficacy results give us confidence as we move forward in preparing a New Drug Application to potentially bring SB206 to market and to patients in need of an effective therapy," commented Paula Brown Stafford, President and Chief Executive Officer of Novan. "We owe a great deal of gratitude to the collaborative efforts of our employees, partners, CROs, study investigators and participating patients who have contributed or participated in B-SIMPLE4."

    B-SIMPLE4 is a multi-center, double-blind, randomized, vehicle-controlled study that exceeded its enrollment target by randomizing 891 patients (1:1 randomization) in the study, across 55 clinical sites. Patients were 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).

    Summary of the primary and secondary endpoint results are as follows:

     B-SIMPLE4
    SB206

    (N=444)
     Vehicle

    (N=447)
     p-value
    Primary Endpoint: Complete Clearance of All Lesions at Week 12 32.4% 19.7% p<0.0001
     
    Secondary Endpoint: Proportion Achieving a Lesion Count of 0 or 1 at Week 12 43.5% 24.6% p<0.0001
     
    Secondary Endpoint: Proportion Achieving ≥90% Clearance of Lesions at Week 12 43.0% 23.9% p<0.0001
     
    Secondary Endpoint: Complete Clearance of All Lesions at Week 8 19.6% 11.6% p=0.0014
           

    Consistent with results from the Company's Phase 2 and earlier Phase 3 studies, SB206 was found to be safe and well tolerated. No treatment-related serious adverse events ("TEAE") were reported.

    Tomoko Maeda-Chubachi, M.D., Ph.D., M.B.A., Senior Vice President, Medical at Novan added, "This is an exciting day for both Novan, the treatment landscape of molluscum and the millions of people, primarily children, affected every year. These results are a testament to Novan's solid execution of the SB206 clinical program and strategy, and our belief in the potential of SB206 to provide patients with treatment benefit. With 32% of patients experiencing total clearance at Week 12 and 43% of patients with total clearance or one remaining lesion at Week 12, I am pleased to say the data demonstrate SB206 can be a powerful treatment option to shorten the duration of this contagious disease with visible skin lesions that worry parents and caregivers."

    "I am proud to have been an investigator in this pivotal study. The results are better than I could have imagined. I am excited to potentially have a topical treatment that is safe and effective in treating molluscum for my patients," stated John Browning, M.D., F.A.A.D, F.A.A.P., MBA, Adjunct Associate Professor of Pediatrics and Dermatology at UT Health San Antonio and Baylor College of Medicine, and a Principal Investigator in the B-SIMPLE4 study.

    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.

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

    Conference Call and Webcast Details

    The Novan management will host a video webcast presentation for investors, analysts, and other interested parties today, Friday, June 11, 2021, at 8:00 a.m. ET. The live webcast will be accessible on the Events page of the Investors section of the Novan website, novan.com, and will be archived for 90 days.

    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," "intends" 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, including SB206, and the potential timing of an NDA submission. 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 related to the regulatory approval process, which is lengthy, time-consuming and inherently unpredictable, including the risk that the FDA will not agree with the Company's approach to a potential NDA submission, that the Company's product candidates may not be approved or that additional studies may be required for approval or other delays may occur, that the Company may not have sufficient quantities of drug substance and/or drug product to support regulatory submissions and that the Company may not obtain funding sufficient to complete the regulatory or development process; the Company's limited experience as a company in obtaining regulatory approvals and commercializing pharmaceutical products; the Company's ability to obtain additional funding or enter into strategic or other business relationships necessary or useful for the further development or, following regulatory approval, commercialization of the Company's product candidates; the Company's reliance on arrangements with third parties to support its operations and development efforts and the risk that such parties will not successfully carry out their contractual duties or meet expected deadlines; any operational or other disruptions as a result of the COVID-19 pandemic; and other risks and uncertainties described in the Company's annual report filed with the Securities and Exchange Commission on Form 10-K for the twelve months ended December 31, 2020, and in the Company's subsequent filings with the Securities and Exchange Commission. 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

    NOVN@jtcir.com



    Primary Logo

    View Full Article Hide Full Article
  16. – Data indicate that berdazimer sodium prevents progression of SARS-CoV-2 infection in two independent in vivo transmission studies –

    – Statistically significant, dose-dependent reduction in the amount of virus in the lung with doses as low as 2 mg/mL –

    – Preliminary toxicology and pharmacology study results suggest intranasal administration is well-tolerated and safe –

    DURHAM, N.C., June 10, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced positive preclinical results with berdazimer sodium in a SARS-CoV-2 transmission model in golden Syrian hamsters. In light of these promising results, the Company is exploring opportunities to develop an anti-viral therapy against COVID-19, the disease caused…

    – Data indicate that berdazimer sodium prevents progression of SARS-CoV-2 infection in two independent in vivo transmission studies –

    – Statistically significant, dose-dependent reduction in the amount of virus in the lung with doses as low as 2 mg/mL –

    – Preliminary toxicology and pharmacology study results suggest intranasal administration is well-tolerated and safe –

    DURHAM, N.C., June 10, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced positive preclinical results with berdazimer sodium in a SARS-CoV-2 transmission model in golden Syrian hamsters. In light of these promising results, the Company is exploring opportunities to develop an anti-viral therapy against COVID-19, the disease caused by the SARS-CoV-2 virus, both internally and potentially through strategic partnerships for this program.

    To further evaluate the potential of its NITRICIL™ platform technology as an intranasal treatment option for COVID-19, the Company initiated preclinical in vivo studies evaluating the efficacy of berdazimer sodium to reduce viral burden in infected animals and to deter viral transmission to uninfected animals. The work was conducted at the Institute for Antiviral Research at Utah State University. Results from two separate studies independently demonstrated the ability of berdazimer sodium to prevent progression of infection into the lungs after transmission, significantly limiting severity of disease in this model. The intranasal treatment was well-tolerated during the preclinical in vivo studies, and no treatment-related adverse events were observed.

    "These preclinical data are encouraging and provide the basis that we were looking for to support continuing down the development path for SB019. We are exploring avenues to interact with the FDA to expedite or streamline a development program for a potential intranasal treatment option for COVID-19," commented Paula Brown Stafford, President and Chief Executive Officer.

    SARS-CoV-2 infected animals were co-housed with healthy animals to induce infection via animal-to-animal transmission. The effect of a repeat, once daily intranasal treatment regimen with berdazimer sodium at various doses was assessed versus placebo controls. The endpoints included nasal and lung tissue viral count, in addition to body weight changes, an indicator of disease severity.

    The Company observed a dose-dependent, statistically significant reduction (P<0.0001) in the amount of virus in the lungs of animals treated with berdazimer sodium concentrations as low as 2 mg/mL compared to placebo-treated controls. The effect was observed after co-habitation with infected hamsters who were also treated with berdazimer sodium. The average amount of virus in the lungs was reduced by greater than 4 logs (>99.99%) with more than half of the animals having no detectable virus in lung tissue at all.

    Catalent, a leading global provider of advanced delivery technologies, development and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, continues to support Novan's CMC efforts and development of an intranasal formulation, SB019, for use in the Company's COVID-19 program.

    Preclinical tolerability and toxicology studies were conducted at a third-party research organization to inform product development at Catalent. The initial studies support the established safety profile of berdazimer sodium and suggest favorable tolerability when administered intranasally after repeat dosing.

    Further, preclinical dose-range finding studies are being conducted to inform potential human clinical trial design and dosing regimen.

    Based on the scientific literature, the Company's previously reported in vitro results and the in vivo results announced today, Novan believes that nitric oxide may inhibit viral replication by disrupting protein function critical for viral replication and infection through generation of reactive intermediates. The Company plans to submit a request to the FDA to determine an appropriate path to bring a new potential treatment option to patients, as quickly as possible. The Company is evaluating its strategy to submit an IND for the purposes of advancing its SB019 product candidate, subject to regulatory guidance, successful completion of IND-enabling toxicology studies and obtaining additional financing or strategic partnering.

    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," "intends" 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 potential for SB019 as an anti-viral therapy against COVID-19,the potential safety and tolerability of the Company's product candidates, the Company's plan to pursue discussions with the FDA regarding a regulatory pathway for SB019 and submit an IND, and the Company's intention to partner with third parties. 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, including the timing and outcome of discussions with the FDA, as well as completion of the additional preclinical studies described above; the Company's ability to enter into 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, 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; 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 Company's reliance on arrangements with third parties to support its operations and development efforts and the risk that such parties will not successfully carry out their contractual duties or meet expected deadlines; any operational or other disruptions as a result of the COVID-19 pandemic; and other risks and uncertainties described in the Company's annual report filed with the Securities and Exchange Commission on Form 10-K for the twelve months ended December 31, 2020, and in the Company's subsequent filings with the Securities and Exchange Commission. 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

    NOVN@jtcir.com 



    Primary Logo

    View Full Article Hide Full Article
  17. – Positive in vitro results demonstrate antimicrobial effect of NVN4100 against a wide variety of bacteria and suggest a promising bactericidal mode of action –

    – Novel in vivo canine pyoderma model established which serves as a tool for continued assessment and optimization of next steps –

    – Additional formulation and preclinical evaluations are contemplated as the Company explores potential strategic partnership opportunities –

    DURHAM, N.C., June 07, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced positive proof-of-concept in vitro results and informative in vivo results with its new chemical entity (NCE), NVN4100, explored as a potential product candidate for topical antimicrobial indications…

    – Positive in vitro results demonstrate antimicrobial effect of NVN4100 against a wide variety of bacteria and suggest a promising bactericidal mode of action –

    – Novel in vivo canine pyoderma model established which serves as a tool for continued assessment and optimization of next steps –

    – Additional formulation and preclinical evaluations are contemplated as the Company explores potential strategic partnership opportunities –

    DURHAM, N.C., June 07, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced positive proof-of-concept in vitro results and informative in vivo results with its new chemical entity (NCE), NVN4100, explored as a potential product candidate for topical antimicrobial indications in companion animal health.

    Novan initiated exploratory work to evaluate NVN4100 and engaged with animal health experts at Scullion Strategy Group, LLC to oversee the Company's initial animal health studies and to assess technical feasibility and market potential. The in vivo and in vitro studies were conducted by independent third party animal health research organizations.

    "We are pleased with results that further validate the anti-bacterial capabilities of our NITRICIL™ platform technology, specifically with NVN4100, a new chemical entity. The results from these exploratory studies bolster our confidence in Novan's strategy to continue building a data package to support our strategic partnering efforts for an animal health program. These exploratory studies were an important step in confirming our initial premise that there is an opportunity for the NITRICIL™ platform technology in animal health and we believe further development and evaluations are necessary," commented Paula Brown Stafford, President and Chief Executive Officer of Novan.

    The exploratory studies were conducted to determine the minimum inhibitory concentration (MIC) and minimum bactericidal concentration (MBC) of NVN4100 using broth dilution antimicrobial susceptibility testing against a set of clinically relevant microorganisms. Results from the in vitro assay demonstrated that NVN4100 had both inhibitory and bactericidal effects for a variety of pathogens. The tested pathogens include both antimicrobial resistant and antimicrobial susceptible strains of the most prevalent species associated with skin and ear conditions in animal health, including Escherichia coli, Pseudomonas aeruginosa, Staphylococcus pseudintermedius, and Staphylococcus schleiferi.

    Additionally, in collaboration with an independent third party animal health research organization, Novan established a model of canine pyoderma, one of the most common skin conditions of dogs that is often resistant to first-line antimicrobials, to evaluate topically applied NVN4100 in an in vivo setting. The in vivo results suggest that the canine pyoderma model may serve as an appropriate tool to facilitate further development of NVN4100 as an alternative therapy to systemic and topical antimicrobials for treatment of canine superficial pyoderma or other dermatology indications.

    Dr. Carri Geer, Chief Technology Officer of Novan added, "Among the results from these studies, one of the most valuable and informative outcomes of the exploratory work to date is the establishment and optimization of a clinically relevant model for canine pyoderma. The antimicrobial activity witnessed in the in vitro studies provides us with confidence in the potential broad utility of NVN4100. Those findings coupled with the establishment of the in vivo model will enable Novan to more efficiently and rapidly screen product candidates and optimize animal health targeted formulations as the development program progresses."

    "The results from the in vitro studies showed valuable insight into the potential of Novan's innovative platform technology and the potential of NVN4100 to treat resistant strains and minimize risk of developing resistance to antibiotics in animals. Importantly, NVN4100 demonstrated that it was effective, in cultures, against a wide variety of clinically relevant bacteria including a number of Staphylococcus pseudintermedius strains, which is encouraging as the Company looks to advance its animal health program. We are encouraged by these preliminary results and look forward to further confirmation of efficacy in clinical studies, unlocking value of this program," stated Dr. Thierry Olivry, DrVet, PhD, DECVD, DACVD, scientific advisor for Novan, and a board-certified veterinary dermatologist on Faculty for more than 26 years at North Carolina State University College of Veterinary Medicine.

    Based on the results to date and the availability of funding, Novan intends to conduct additional studies and formulation work with NVN4100 to build a robust data set and engage with potential collaborators and strategic partners moving forward. The Company seeks to publish the full data set from the companion animal health exploratory studies at an upcoming scientific congress and/or in a peer-reviewed publication.

    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.

    About NITRICILTM

    Novan's innovative NITRICIL™ technology leverages nitric oxide's naturally occurring antimicrobial and immunomodulatory effects to develop new therapies for unmet medical needs across multiple therapeutic areas. NITRICIL™ stores the gaseous species on large polymers, which allow nitric oxide to be applied as timed-release chemical entities. This technology allows Novan to control the level of nitric oxide storage, the rate of release, and the molecule size for targeted delivery. The result is stabilized, druggable nitric oxide that is optimized for a specific indication.

    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," "intends" 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 potential for NVN4100 for antimicrobial indications in companion animal health, and the Company's intention to partner with third parties. 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; any operational or other disruptions as a result of the COVID-19 pandemic; the Company's ability to enter into 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, 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; 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 Company's reliance on arrangements with third parties to support its operations and development efforts and the risk that such parties will not successfully carry out their contractual duties or meet expected deadlines; and other risks and uncertainties described in the Company's annual report filed with the Securities and Exchange Commission on Form 10-K for the twelve months ended December 31, 2020, and in the Company's subsequent filings with the Securities and Exchange Commission. 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

    NOVN@jtcir.com



    Primary Logo

    View Full Article Hide Full Article
  18. DURHAM, N.C., May 25, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced that it has filed a Certificate of Amendment to the Restated Certificate of Incorporation of the Company to implement a one-for-ten reverse split of its issued and outstanding common stock (the "Reverse Stock Split"). The Reverse Stock Split will become effective as of 5:00 p.m. Eastern Time on May 25, 2021, and the Company's common stock is expected to begin trading on a split-adjusted basis when the market opens on May 26, 2021.

    At Novan's Annual Meeting of Stockholders held on July 28, 2020 (the "2020 Annual Meeting"), the Company's stockholders approved the amendment to the Restated Certificate of Incorporation of the Company…

    DURHAM, N.C., May 25, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced that it has filed a Certificate of Amendment to the Restated Certificate of Incorporation of the Company to implement a one-for-ten reverse split of its issued and outstanding common stock (the "Reverse Stock Split"). The Reverse Stock Split will become effective as of 5:00 p.m. Eastern Time on May 25, 2021, and the Company's common stock is expected to begin trading on a split-adjusted basis when the market opens on May 26, 2021.

    At Novan's Annual Meeting of Stockholders held on July 28, 2020 (the "2020 Annual Meeting"), the Company's stockholders approved the amendment to the Restated Certificate of Incorporation of the Company to effect a reverse stock split of the Company's common stock at a ratio of not less than one-for-two and not more than one-for-fifteen, with such ratio and the implementation and timing of such reverse stock split to be determined by the Company's Board of Directors in its sole discretion. The Board of Directors has now approved the implementation of a one-for-ten reverse split with the timing described above.

    "We believe that the Reverse Stock Split is an important step for the Company and its stockholders to optimize our position as we work to execute strategic initiatives across all fronts. Our management team and Board of Directors believe that it is in the best interest of our stockholders and the Company to implement the Reverse Stock Split in order to enable us to be prepared for success with our anticipated upcoming milestones," said Paula Brown Stafford, President and Chief Executive Officer of Novan. "Implementing the Reverse Stock Split will make available an increased number of authorized but unissued shares allowing us to pursue additional financing activities and/or other strategic transactions to support the development and potential commercialization of our product candidates, and we believe it will also help us maintain compliance with Nasdaq's $1.00 minimum bid price requirement and potentially make our stock more attractive to a broader range of institutional and other investors."

    When the Reverse Stock Split becomes effective, every ten shares of the Company's issued and outstanding common stock will automatically be converted into one share of common stock, without any change in the par value per share. In addition, proportionate adjustments will be made to (i) the per share exercise price and the number of shares issuable upon the exercise of all outstanding stock options, warrants to purchase shares of common stock and stock appreciation right, (ii) the share price targets of the Company's Tangible Stockholder Return Plan and (iii) the number of shares reserved for issuance pursuant to the Company's equity incentive compensation plans. Any fraction of a share of common stock that would be created as a result of the Reverse Stock Split will be cashed out at a price equal to the product of the closing price of the Company's common stock on May 25, 2021 and the amount of the fractional share.

    The Company's common stock will continue to trade on The Nasdaq Stock Market LLC ("Nasdaq") under the symbol "NOVN." The new CUSIP number for the common stock following the Reverse Stock Split will be 66988N205.

    American Stock Transfer & Trust Company, has been appointed by the Company to act as its exchange agent for the Reverse Stock Split. Stockholders owning pre-split shares via a bank, broker or other nominee will have their positions automatically adjusted to reflect the Reverse Stock Split and will not be required to take further action in connection with the Reverse Stock Split, subject to brokers' particular processes. Similarly, registered stockholders holding pre-split shares of the Company's common stock electronically in book-entry form are also not required to take further action in connection with the Reverse Stock Split. Holders of certificated shares will be contacted by the Company or its exchange agent with further details about how to surrender old certificates.

    As previously announced, the final patient has completed their last Week-12 visit in the B-SIMPLE4 pivotal Phase 3 clinical study of SB206, a topical antiviral gel, for the treatment of molluscum contagiosum. The Company is currently blinded to the results of the study, and topline efficacy and safety results from the B-SIMPLE4 study are targeted to be reported before the end of the second quarter of 2021.

    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 timing of anticipated topline results from the B-SIMPLE4 pivotal Phase 3 clinical study of SB206 and the timing and potential outcomes of the Reverse Stock Split, including the possible beneficial effects described in this press release. 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; any operational or other disruptions as a result of the COVID-19 pandemic, including any delays or disruptions to the conduct of the B-SIMPLE4 Phase 3 trial; the Company's ability to enter into 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, 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, that the Company may not have sufficient quantities of drug substance and/or drug product to support regulatory submissions 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; 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 supply chain disruptions or delays, failure to transfer technology and processes to third parties effectively or failure of those third parties (or the Company in connection with the upfit of the Company's new facility) to obtain approval of and maintain compliance with the FDA or comparable regulatory authorities; the Company's reliance on arrangements with third parties to support its operations and development efforts and the risk that such parties will not successfully carry out their contractual duties or meet expected deadlines; volatility in the price of the Company's common stock; and other risks and uncertainties described in the Company's annual report filed with the Securities and Exchange Commission on Form 10-K for the twelve months ended December 31, 2020, and in the Company's subsequent filings with the Securities and Exchange Commission. 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

    NOVN@jtcir.com



    Primary Logo

    View Full Article Hide Full Article
  19. – Topline efficacy results for ongoing Phase 3 study evaluating SB206 as a treatment for molluscum on track for targeted readout before the end of Q2 2021 –

    – Preclinical program underway evaluating SB019 with berdazimer sodium as a potential intranasal therapy for COVID-19, with results targeted for readout in Q2 2021 –

    – Proof-of-concept results from companion animal health program, NVN4100, targeted for Q2 2021 –

    – Company expects current cash balance, plus expected contractual payments, to provide adequate liquidity to fund its operations into the first quarter of 2022 –

    DURHAM, N.C., May 11, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced its financial and operating results for the quarter…

    – Topline efficacy results for ongoing Phase 3 study evaluating SB206 as a treatment for molluscum on track for targeted readout before the end of Q2 2021 –

    – Preclinical program underway evaluating SB019 with berdazimer sodium as a potential intranasal therapy for COVID-19, with results targeted for readout in Q2 2021 –

    – Proof-of-concept results from companion animal health program, NVN4100, targeted for Q2 2021 –

    – Company expects current cash balance, plus expected contractual payments, to provide adequate liquidity to fund its operations into the first quarter of 2022 –

    DURHAM, N.C., May 11, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced its financial and operating results for the quarter ended March 31, 2021 and provided a corporate update.

    "We continued to make progress across our priority pipeline development programs over the course of the first quarter. With the final Week-12 patient visit completed in our pivotal Phase 3 study for molluscum, B-SIMPLE4, we continue to work toward the targeted readout of our topline efficacy and safety data before the end of June. Additionally, we continue to advance our preclinical program for COVID-19 and our animal health program, both targeting data readouts in the second quarter," commented Paula Brown Stafford, President and Chief Executive Officer of Novan. "With a number of near- and long-term milestones ahead, we believe we are well positioned for an exciting year ahead."

    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.

    Priority Development Pipeline Update

    SB206 – A Topical Antiviral Treatment for Viral Skin Infections (Molluscum Contagiosum)

    The Company announced on May 3, 2021 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 Targeted Milestones:

    • Topline efficacy and safety results from the B-SIMPLE4 study continue to be targeted for reporting before the end of the second quarter of 2021.



    • Potential filing of new drug application ("NDA") targeted no later than Q3 2022.

    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.

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

    SB019 – Infectious Disease, Coronaviridae (COVID-19)

    In the fourth quarter of 2020, Novan announced positive in vitro results showing the potential efficacy of the Company's NITRICIL™ platform technology, berdazimer sodium (NVN1000), as an anti-viral against SARS-CoV-2, the virus that causes COVID-19. The Company initiated in vitro assessments 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 demonstrate the first instance of an anti-viral 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 related to 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.

    Upcoming Targeted Milestones:

    • Ongoing preclinical program with results targeted in the second quarter of 2021.



    • 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 2021.



    • Targeting initiating human clinical trials in the second half of 2021, subject to regulatory guidance and obtaining additional financing or strategic partnering.

    NVN4100 – Companion Animal Health

    Novan has initiated exploratory work to evaluate the Company's new chemical entity, NVN4100, as a potential product candidate for antimicrobial indications in companion animal health. The Company has progressed efforts for initial formulation development to assess viability and has engaged animal health experts to assess technical feasibility and market potential.

    Upcoming Targeted Milestones:

    • Proof-of-concept results from exploratory in vivo and in vitro assessments targeted for the second quarter of 2021.



    • Pending results of the exploratory assessment, the Company anticipates engaging with a potential collaborator or strategic partner to advance development in this area.

    Financial Update

    Summary of Financial Results for First Quarter 2021

    • As of March 31, 2021, Novan had a total cash and cash equivalents balance of $32.7 million and positive working capital of $32.6 million.



    • The Company believes that its existing cash and cash equivalents balance as of March 31, 2021, plus expected contractual payments to be received in connection with existing licensing agreements, will provide it with adequate liquidity to fund its operating needs into the first quarter of 2022, based on management's projections and planned priority development activities described in the Company's quarterly report on Form 10-Q for the three month period ended March 31, 2021.



    • Novan reported a net loss of $9.0 million for the three months ended March 31, 2021, compared to a $6.2 million net loss for the same period in 2020.



    • License and collaboration revenue was $0.7 million for the three months ended March 31, 2021, compared to $1.0 million for the same period in 2020. The decrease from the prior year related to the change in the Company's estimated performance period related to the non-refundable upfront and expected milestone payments under one of the Company's license agreements, which was extended during the fourth quarter of 2020.



    • Research and development expenses were $6.4 million for the three months ended March 31, 2021, compared to $4.9 million for the same period in 2020. The increase was primarily attributable to (i) net increased costs of $3.3 million related to Novan's ongoing conduct, active enrollment and treatment phase activities of the B-SIMPLE4 Phase 3 trial during the first quarter of 2021, compared to relatively lower cost of B-SIMPLE1 and B-SIMPLE2 Phase 3 trials wind down activities during the comparative period in 2020; and (ii) a decrease of $1.5 million in other research and development expenses, primarily related to (i) a $1.0 million decrease in research and development personnel costs, (ii) a $0.4 million decrease in rent and depreciation expense and (iii) a $0.1 million decrease in material costs associated with manufacturing.



    • General and administrative expenses were $2.7 million for the three months ended March 31, 2021, compared to $2.5 million for the same period in 2020. The increase was primarily due to (i) a $0.3 million increase in insurance premium expenses associated with the renewal of the Company's directors' and officers' liability policies in 2020 and (ii) a $0.2 million increase in other administrative expenses, including investor and public relations expense, partially offset by (i) a $0.1 million net decrease in general and administrative personnel and related costs and (ii) a $0.2 million decrease in rent and depreciation expense.

    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 and progress of the Company's Phase 3 program to evaluate SB206 for the treatment of molluscum, the timing of anticipated topline results, the Company's expected cash runway, the timing of anticipated results of the Company's preclinical development programs, and the Company's intention to partner with third parties. 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; any operational or other disruptions as a result of the COVID-19 pandemic, including any delays or disruptions to the conduct of the B-SIMPLE4 Phase 3 trial; the Company's ability to enter into 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, 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, that the Company may not have sufficient quantities of drug substance and/or drug product to support regulatory submissions 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; 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 supply chain disruptions or delays, failure to transfer technology and processes to third parties effectively or failure of those third parties (or the Company in connection with the upfit of the Company's new facility) to obtain approval of and maintain compliance with the FDA or comparable regulatory authorities; the Company's reliance on arrangements with third parties to support its operations and development efforts and the risk that such parties will not successfully carry out their contractual duties or meet expected deadlines; and other risks and uncertainties described in the Company's annual report filed with the Securities and Exchange Commission on Form 10-K for the twelve months ended December 31, 2020, and in the Company's subsequent filings with the Securities and Exchange Commission. 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.

    NOVAN, INC.

    Condensed Consolidated Statements of Operations and Comprehensive Loss

    (unaudited)

    (in thousands, except share and per share amounts)

     Three Months Ended March 31,
     2021 2020
    License and collaboration revenue$747   $1,024 
    Government research contracts and grants revenue72   189 
    Total revenue819   1,213 
    Operating expenses:   
    Research and development6,418   4,916 
    General and administrative2,686   2,507 
    Total operating expenses9,104   7,423 
    Operating loss(8,285)  (6,210)
    Other (expense) income, net:   
    Interest income3   35 
    Other (expense) income(670)  8 
    Total other (expense) income, net(667)  43 
    Net loss and comprehensive loss$(8,952)  $(6,167)
    Net loss per share, basic and diluted$(0.06)  $(0.17)
    Weighted-average common shares outstanding, basic and diluted150,028,864   37,043,876 

    NOVAN, INC.

    Selected Condensed Consolidated Balance Sheet Data

    (unaudited)

    (in thousands)

     March 31, 2021 December 31, 2020
    Cash and cash equivalents$32,661  $35,879 
    Total current assets41,178  44,007 
    Total assets46,983  46,829 
    Total current liabilities8,585  8,700 
    Total liabilities46,133  43,852 
    Total stockholders' equity850  2,977 
    Total liabilities and stockholders' equity$46,983  $46,829 



    INVESTOR AND MEDIA CONTACT:

    Jenene Thomas

    JTC Team, LLC

    833-475-8247

    NOVN@jtcir.com 



    Primary Logo

    View Full Article Hide Full Article
  20. – Topline data on track for readout before the end of Q2 2021 –

    – Currently no FDA-approved therapies for the treatment of molluscum –

    – Potential for NDA filing no later than Q3 2022 –

    DURHAM, N.C., May 03, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced the final patient has completed their last Week-12 visit in the B-SIMPLE4 pivotal Phase 3 clinical study of SB206, a topical antiviral gel, for the treatment of molluscum contagiosum ("molluscum"). Topline efficacy and safety results from the B-SIMPLE4 study are targeted to be reported before the end of the second quarter of 2021.

    "We are incredibly pleased with the progress we have continued to make as we advance our lead program. We remain…

    – Topline data on track for readout before the end of Q2 2021 –

    – Currently no FDA-approved therapies for the treatment of molluscum –

    – Potential for NDA filing no later than Q3 2022 –

    DURHAM, N.C., May 03, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced the final patient has completed their last Week-12 visit in the B-SIMPLE4 pivotal Phase 3 clinical study of SB206, a topical antiviral gel, for the treatment of molluscum contagiosum ("molluscum"). Topline efficacy and safety results from the B-SIMPLE4 study are targeted to be reported before the end of the second quarter of 2021.

    "We are incredibly pleased with the progress we have continued to make as we advance our lead program. We remain focused on executing our remaining steps according to plan and reporting topline efficacy and safety data in June. On behalf of Novan, I would like to extend our sincere gratitude to the patients, families and clinical staff that have participated in the study," commented Paula Brown Stafford, President and Chief Executive Officer of Novan. "Each patient will visit their physician one more time, at Week 24, and the study is expected to fully complete in the third quarter, although no additional efficacy data will be collected at that time."



    Molluscum contagiosum is a common, contagious skin infection caused by the molluscipoxvirus, affecting up to six million people in the U.S. annually, with the greatest incidence in children aged one to 14 years. Infected children typically present with 10-30 painless, yet unsightly lesions, and, in severe cases, patients present with around 100 lesions.

    "There remains an unmet need in the treatment landscape of molluscum, which affects millions of people each year and primarily children under the age of 10. Our product candidate, SB206, represents a promising opportunity to provide patients with treatment benefit and address the unmet needs in the treatment landscape for molluscum. Depending on the results of the B-SIMPLE4 Phase 3 trial, we are targeting a potential NDA filing no later than the third quarter of 2022," stated Tomoko Maeda-Chubachi, M.D., Ph. D., M.B.A., Senior Vice President, Medical at Novan.

    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).

    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.

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

    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 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; any operational or other disruptions as a result of the COVID-19 pandemic, including any delays or disruptions to the conduct of the B-SIMPLE4 study; 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 U.S. Food and Drug Administration 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 U.S. Food and Drug Administration or comparable regulatory authorities; the Company's reliance on arrangements with third parties to support its operations and development efforts and the risk that such parties will not successfully carry out their contractual duties or meet expected deadlines; 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, 2020, and in the Company's subsequent filings with the SEC. 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

    NOVN@jtcir.com



    Primary Logo

    View Full Article Hide Full Article
  21. MORRISVILLE, N.C., April 22, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced that data from the Company's previously completed Phase 3 trials of SB206 for molluscum contagiosum (B-SIMPLE1, B-SIMPLE2) will be presented at the Virtual Annual Meeting of the Society for Investigative Dermatology (SID), being held May 3-8, 2021.

    Integrated data from the B-SIMPLE1 and B-SIMPLE2 multicenter, randomized, double-blind, vehicle-controlled clinical trials evaluating the Company's topical nitric oxide–releasing SB206 gel will be presented in an ePoster presentation on May 5, 2021 from 2:30 – 4:00 PM ET.

    About the ePoster Presentation

    Title: BOTE (Beginning Of The End) inflammation can be enhanced

    MORRISVILLE, N.C., April 22, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced that data from the Company's previously completed Phase 3 trials of SB206 for molluscum contagiosum (B-SIMPLE1, B-SIMPLE2) will be presented at the Virtual Annual Meeting of the Society for Investigative Dermatology (SID), being held May 3-8, 2021.

    Integrated data from the B-SIMPLE1 and B-SIMPLE2 multicenter, randomized, double-blind, vehicle-controlled clinical trials evaluating the Company's topical nitric oxide–releasing SB206 gel will be presented in an ePoster presentation on May 5, 2021 from 2:30 – 4:00 PM ET.

    About the ePoster Presentation

    Title: BOTE (Beginning Of The End) inflammation can be enhanced with SB206, a nitric oxide‐releasing topical medication for molluscum contagiosum

    Abstract and Poster Number: 400

    Authors: Tomoko Maeda-Chubachi, MD, PhD, MBA, David Hebert, PhD, Elaine Siegfried, MD, Elizabeth Messersmith, PhD

    Interactive Poster/Exhibitor Session I: Patient Targeted Research

    Date and Time: May 5, 2021 from 2:30 – 4:00 PM ET

    ePoster Talks: Available on-demand from May 3-May 31, 2021

    For more information about the conference, please visit www.sidannualmeeting.org.

    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 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 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; any operational or other disruptions as a result of the COVID-19 pandemic, including any delays or disruptions to the conduct of the B-SIMPLE4 study; the Company's ability to enter into 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, 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 U.S. Food and Drug Administration 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 U.S. Food and Drug Administration or comparable regulatory authorities; the Company's reliance on arrangements with third parties to support its operations and development efforts and the risk that such parties will not successfully carry out their contractual duties or meet expected deadlines; 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, 2020, and in the Company's subsequent filings with the SEC. 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

    NOVN@jtcir.com



    Primary Logo

    View Full Article Hide Full Article
  22. MORRISVILLE, N.C., March 05, 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 present at the virtual H.C. Wainwright Global Life Sciences Conference taking place March 9-10, 2021.

    In addition to the presentation, management will 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 about the event, please visit the conference website: https://hcwevents.com/globalconference/.

    The video webcast presentation will be available for viewing on-demand beginning Tuesday, March 9, 2021, at 7:00 AM…

    MORRISVILLE, N.C., March 05, 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 present at the virtual H.C. Wainwright Global Life Sciences Conference taking place March 9-10, 2021.

    In addition to the presentation, management will 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 about the event, please visit the conference website: https://hcwevents.com/globalconference/.

    The video webcast presentation will be available for viewing on-demand beginning Tuesday, March 9, 2021, at 7:00 AM ET for those registered for the conference and accessible on the Events page of the Investors section of the Company's website (novan.com) for 90 days.

    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; any operational or other disruptions as a result of the COVID-19 pandemic, including any delays or disruptions to the conduct of the B-SIMPLE4 study; the Company's ability to enter into 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, 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 U.S. Food and Drug Administration 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 U.S. Food and Drug Administration or comparable regulatory authorities; the Company's reliance on arrangements with third parties to support its operations and development efforts and the risk that such parties will not successfully carry out their contractual duties or meet expected deadlines; 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, 2020, and in the Company's subsequent filings with the SEC. 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

    NOVN@jtcir.com



    Primary Logo

    View Full Article Hide Full Article
  23. MORRISVILLE, N.C., March 02, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced the election of Steven D. Skolsky to its Board of Directors.

    Mr. Skolsky is a well-established senior executive with over 35 years of experience in healthcare and the life sciences in both private and public sectors. Over the course of his career, he has amassed expertise spanning all facets of the biopharmaceutical and healthcare services industry from research and early-stage discovery to product development and commercialization.

    "Electing Steve to our board, a leader in the industry with a successful track record in commercialization, marketing strategy, and multiple successful product launches, is invaluable. As…

    MORRISVILLE, N.C., March 02, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced the election of Steven D. Skolsky to its Board of Directors.

    Mr. Skolsky is a well-established senior executive with over 35 years of experience in healthcare and the life sciences in both private and public sectors. Over the course of his career, he has amassed expertise spanning all facets of the biopharmaceutical and healthcare services industry from research and early-stage discovery to product development and commercialization.

    "Electing Steve to our board, a leader in the industry with a successful track record in commercialization, marketing strategy, and multiple successful product launches, is invaluable. As we quickly approach a targeted data readout in our pivotal Phase 3 B-SIMPLE4 study, it is important for us to start planning for success and the potential commercialization of SB206 for the treatment of molluscum. We look forward to leveraging Steve's insights as we continue to advance the Company and build near and long-term shareholder value," commented Paula Brown Stafford, President and Chief Executive Officer of Novan.

    Mr. Skolsky currently serves as the founding Principal of Expis Partners, a strategic consulting firm to the biotech, pharmaceutical, life science and clinical services community, with a focused expertise in commercialization, marketing strategy, drug development, operations, strategic planning and corporate and business development. From 2011-2016, Mr. Skolsky held senior executive roles at Quintiles Transnational Holdings, Inc. (now IQVIA), most recently as Senior Vice President & Managing Director and previously, Senior Vice President and Head of Global Clinical Operations. Prior to joining Quintiles, he served as the President and Chief Executive Officer of Sequoia Pharmaceuticals Inc. and previously, Chief Executive Officer of Trimeris Inc. While at Trimeris, Mr. Skolsky expanded use and adoption of a novel HIV fusion inhibitor (Fuzeon®) to deliver a 10-fold increase in world-wide sales of $266M and ultimately transforming the business from a perennially loss making enterprise to one of sustained profitability.

    Prior to that, Mr. Skolsky served for more than 20 years at GlaxoSmithKline plc ("GSK") where he held a number of positions including senior leadership roles as Managing Director of GSK's operations in Australia and New Zealand. As Senior Vice President, Global Product Strategy and Clinical Development at GSK, Mr. Skolsky was responsible for optimizing its clinical-commercial interface to deliver 59 product submissions and 42 regulatory approvals while developing launch platforms for 10 global product launches and increasing new product portfolio value by developing and implementing strategic clinical development plans, product line extension and life cycle management plans.

    "I am excited to be joining Novan at this pivotal time for the Company. I believe they have the potential to address a significant unmet need in the treatment of molluscum contagiosum and I look forward to working closely with the management team as the Company advances towards potentially becoming a commercial-stage company," added Mr. Skolsky.

    In addition to joining the Novan Board, Mr. Skolsky serves on the Boards of Directors of Basilea Pharmaceutica, a Swiss-based biotech company, Clinipace Clinical Research, Elligo Health Research, The Foundation Board of University of North Carolina at Chapel Hill's Kenan Flagler Business School, The Board of Visitors of UNC-Chapel Hill and The Lineberger Cancer Center. Mr. Skolsky holds a B.A. in Biology from UNC-Chapel Hill.

    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 and potential commercialization of certain product candidates, including the timing 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 the Company's expectations, including, but not limited to, any operational or other disruptions as a result of the COVID-19 pandemic, including any delays or disruptions to the conduct of the B-SIMPLE4 study; 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 and potential commercialization 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; the Company's reliance on arrangements with third parties to support its operations and development efforts and the risk that such parties will not successfully carry out their contractual duties or meet expected deadlines; the risk that the Company may not be successful in commercializing any product candidate that receives regulatory approval if the Company is unable to establish sales, marketing and distribution capabilities for that product candidate; 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, 2020, and in the Company's subsequent filings with the SEC. 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

    NOVN@jtcir.com



    Primary Logo

    View Full Article Hide Full Article
  24. – B-SIMPLE4 pivotal Phase 3 trial evaluating SB206 as a treatment for molluscum contagiosum progressing with top-line efficacy results targeted before the end of Q2 2021 –

    – Company targeting initiating preclinical studies for intranasal formulation of berdazimer sodium for COVID-19 program, SB019, in Q1 2021 –

    – Ongoing evaluations for strategic partnering opportunities to leverage broader pipeline to secure next phase of growth –

    MORRISVILLE, N.C., Feb. 25, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced its financial and operating results for the year ended December 31, 2020 and provided a corporate update.

    "With our accomplishments achieved over the course of 2020 and our near-term…

    – B-SIMPLE4 pivotal Phase 3 trial evaluating SB206 as a treatment for molluscum contagiosum progressing with top-line efficacy results targeted before the end of Q2 2021 –

    – Company targeting initiating preclinical studies for intranasal formulation of berdazimer sodium for COVID-19 program, SB019, in Q1 2021 –

    – Ongoing evaluations for strategic partnering opportunities to leverage broader pipeline to secure next phase of growth –

    MORRISVILLE, N.C., Feb. 25, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced its financial and operating results for the year ended December 31, 2020 and provided a corporate update.

    "With our accomplishments achieved over the course of 2020 and our near-term milestones ahead of us this year, we believe we are well-positioned for an exciting 2021. As enrollment has been completed in our pivotal Phase 3 study for molluscum, B-SIMPLE4, we are quickly approaching the expected readout of our top-line efficacy data, targeted before the end of the second quarter and are working to advance this important product candidate toward potential approval," commented Paula Brown Stafford, President and Chief Executive Officer of Novan. "As we continue to grow and build momentum advancing our priority development pipeline and the NITRICIL platform technology, we are focused on preparing for success and equipping the Company with the necessary resources and capital."

    Recent Highlights

    • Completed enrollment for B-SIMPLE4 pivotal Phase 3 trial for SB206 as a treatment for molluscum with top-line efficacy results targeted before the end of the second quarter of 2021;



    • 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; and



    • Announced Master Services Agreement with Catalent, Inc. to support chemistry, manufacturing and control activities and development of an intranasal formulation of berdazimer sodium for the Company's COVID-19 program, SB019.

    Priority Development Pipeline Update

    SB206 – A Topical Antiviral Treatment for Viral Skin Infections (Molluscum Contagiosum)

    The Company announced the completion of patient enrollment for B-SIMPLE4 on February 1, 2021. B-SIMPLE4 is a multi-center, double-blind, randomized, vehicle-controlled study to evaluate the efficacy and safety of SB206 12% once-daily in approximately 850 total patients (1:1 active:vehicle randomization), ages 6 months and above, with molluscum. The Company exceeded its enrollment target of 850 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 trial's stated goal. Patients will be treated for 12 weeks with a safety follow-up visit at Week 24. The primary endpoint for the study is the proportion of patients achieving 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).

    Upcoming Targeted Milestones:

    • Top-line efficacy results targeted before the end of the second quarter of 2021, if the trial is not further impacted by the COVID-19 pandemic.

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

    SB019 – Infectious Disease, Coronaviridae (COVID-19)

    In the fourth quarter of 2020, Novan announced positive in vitro results showing the potential efficacy of our NITRICIL™ platform technology, berdazimer sodium (NVN10000), as an anti-viral against SARS-CoV-2, the virus that causes COVID-19. The Company initiated in vitro assessments 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 demonstrate the first instance of an anti-viral 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 related to 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.

    Upcoming Targeted Milestones:

    • Advancing this program through preliminary preclinical studies, which Novan targets to have results in the second quarter of 2021;



    • Pending the results of the preclinical studies, anticipates filing a potential IND application with the U.S. Food and Drug Administration in 2021; and



    • Targeting initiating human clinical trials in the second half of 2021, subject to obtaining additional financing or strategic partnering.

    NVN4100 – Companion Animal Health

    Novan has initiated exploratory work to evaluate the Company's new chemical entity, NVN4100, as a potential product candidate for antimicrobial indications in companion animal health. The Company has progressed internal efforts for initial formulation development to assess viability and has engaged animal health experts to assess technical feasibility and market potential.

    Upcoming Targeted Milestones:

    • Engaging with a potential collaborator or strategic partner to advance development in this area upon positive proof-of-concept work.

    Financial Update

    Summary of Full Year 2020 Financial Results

    • As of December 31, 2020, Novan had a total cash and cash equivalents balance of $35.9 million and positive working capital of $35.3 million.
    • As of December 31, 2020, the Company had an accumulated deficit of $249.3 million and there is substantial doubt about its ability to continue as a going concern. The Company believes that its existing cash and cash equivalents balance, plus expected contractual payments to be received in connection with existing licensing agreements, will provide it with adequate liquidity to fund its planned operating needs into the first quarter of 2022, based on management's projections and planned development and operating activities described in the Company's Annual Report on Form 10-K for the year ended December 31, 2020.
    • Novan incurred net losses of $29.3 million and $30.4 million in the years ended December 31, 2020 and 2019, respectively.
    • License and collaboration revenue of $4.2 million and $4.5 million for the years ended December 31, 2020 and 2019, respectively, was associated with the Company's performance during the period and the related amortization of non-refundable upfront and expected milestone payments under one of the Company's license agreements.
    • Research and development expenses were $19.8 million for the year ended December 31, 2020, compared to $25.2 million for the year ended December 31, 2019. The net decrease of $5.4 million was primarily related to (i) a net $0.7 million increase in the SB206 program, (ii) a $4.3 million decrease in other research and development expenses, and (iii) a $1.6 million decrease in the SB414 program. The $4.3 million decrease in other research and development expenses was primarily driven by (i) a $1.3 million net decrease in research and development personnel costs, (ii) a $1.6 million decrease in costs associated with Novan's manufacturing technology transfer projects to third-party manufacturers, (iii) a $0.7 million decrease in depreciation expense and (iv) a $1.0 million decrease in manufacturing materials and support costs at the Company's previous primary facility, partially offset by $0.3 million of discrete costs incurred during the second and third quarters of 2020 related to decommissioning manufacturing capabilities at the Company's previous primary facility.
    • General and administrative expenses were $11.3 million for the year ended December 31, 2020, compared to $10.4 million during the year ended December 31, 2019. The increase was primarily due to $1.7 million of aggregate non-cash expense related to the issuance of commitment shares as consideration for entering into common stock purchase arrangements with Aspire Capital Fund, LLC, partially offset by a $0.5 million decrease in general and administrative personnel and related costs and a $0.3 million decrease in other general and administrative expenses.
    • For the year ended December 31, 2020, the Company recognized $2.3 million of non-cash impairment charges related to the July 2020 termination of its previous primary facility lease and a $1.8 million loss on the disposition of related assets, of which $0.8 million was a non-cash charge.

    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.

    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 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.

    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 and progress of our Phase 3 program to evaluate SB206 for the treatment of molluscum, the timing of anticipated topline results, the Company's expected cash runway and the Company's intention to partner with third parties. 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, any operational or other disruptions as a result of the COVID-19 pandemic, including any delays or disruptions to the conduct of the B-SIMPLE4 study; the Company's ability to enter into 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, 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 U.S. Food and Drug Administration 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 U.S. Food and Drug Administration or comparable regulatory authorities; the Company's reliance on arrangements with third parties to support its operations and development efforts and the risk that such parties will not successfully carry out their contractual duties or meet expected deadlines; and other risks and uncertainties described in the Company's annual report filed with the Securities and Exchange Commission on Form 10-K for the twelve months ended December 31, 2020, and in the Company's subsequent filings with the Securities and Exchange Commission. 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.

    NOVAN, INC.

    Condensed Consolidated Statements of Operations and Comprehensive Loss

    (unaudited)

    (in thousands, except share and per share amounts)

     Year Ended December 31,
     2020 2019
        
    License and collaboration revenue$4,208  $4,477 
    Government research contracts and grants revenue712  419 
    Total revenue4,920  4,896 
    Operating expenses:   
    Research and development19,814  25,172 
    General and administrative11,271  10,412 
    Impairment loss on long-lived assets2,277   
    Loss on facility asset group disposition1,772   
    Total operating expenses35,134  35,584 
    Operating loss(30,214) (30,688)
    Other (expense) income, net:   
    Interest income51  177 
    Interest expense  (2)
    Other income, net870  136 
    Total other income (expense), net921  311 
    Net loss and comprehensive loss$(29,293) $(30,377)
    Net loss per share, basic and diluted$(0.30) $(1.16)
    Weighted-average common shares outstanding, basic and diluted98,808,114  26,254,119 
          

    NOVAN, INC.

    Selected Condensed Consolidated Balance Sheet Data

    (unaudited)

    (in thousands)

     Year Ended December 31,
     2020 2019
    Cash and cash equivalents$35,879  $13,711 
    Total current assets44,007  15,724 
    Total assets46,829  29,097 
    Total current liabilities8,700  12,899 
    Total liabilities43,852  51,380 
    Total stockholders' equity (deficit)2,977  (22,283)
    Total liabilities and stockholders' equity (deficit)$46,829  $29,097 
            

    INVESTOR AND MEDIA CONTACT:

    Jenene Thomas

    JTC Team, LLC

    833-475-8247

    NOVN@jtcir.com



    Primary Logo

    View Full Article Hide Full Article
  25. – Topline data on track for targeted readout before the end of 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., Feb. 01, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced it has completed patient enrollment 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…

    – Topline data on track for targeted readout before the end of 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., Feb. 01, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced it has completed patient enrollment 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. The Company exceeded its enrollment target of 850 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 trial's stated goal. Patients will be treated for 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 assessed as treatment failures).

    "We are excited about the response from patients for this study and to have completed enrollment, amidst a challenging time with the current coronavirus pandemic. I believe SB206 has the potential to be an important choice in the treatment landscape of molluscum, which affects millions of people each year, and importantly, can provide a much-needed treatment benefit to patients. We look forward to seeing the clinical efficacy results from the B-SIMPLE4 study and SB206's ability to address the unmet need in this indication," stated John Browning, M.D., F.A.A.D, F.A.A.P., MBA, Adjunct Associate Professor of Pediatrics and Dermatology at UT Health San Antonio and the Chief of Staff of Pediatric Dermatology at Texas Dermatology and Laser Specialists, and a Principal Investigator in the B-SIMPLE4 study.

    Topline efficacy results from the B-SIMPLE4 study are anticipated before the end of 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.

    "This is a significant milestone for the Company and our molluscum program. We are very pleased with the enthusiasm we have seen across the molluscum patient population and the over-enrollment that our team was able to accomplish in such a short period of time. Our team is now keenly focused on bringing the study to completion and working to minimize the potential risk for missing data. We aim to report the topline efficacy data before the end of the second quarter and look forward to ultimately advancing this important product candidate toward potential approval," commented Elizabeth Messersmith, Ph.D, Chief Development Officer of Novan.

    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 study, 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 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 the Company's expectations, including, but not limited to, any operational or other disruptions as a result of the COVID-19 pandemic, including any delays or disruptions to the conduct of the B-SIMPLE4 study; 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; the Company's reliance on arrangements with third parties to support its operations and development efforts and the risk that such parties will not successfully carry out their contractual duties or meet expected deadlines; 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

    NOVN@jtcir.com



    Primary Logo

    View Full Article Hide Full Article
  26. MORRISVILLE, N.C., Jan. 29, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced that it has received written notice from The Nasdaq Stock Market LLC ("Nasdaq") that the Company has regained compliance with Nasdaq's minimum bid price requirement for continued listing on the Nasdaq Capital Market. The notice indicated that, as a result of the closing bid price of the Company's common stock having been at $1.00 per share or greater for at least ten consecutive business days, from January 14, 2021 through January 28, 2021, the Company has regained compliance with Nasdaq Listing Rule 5550(a)(2).

    About Novan

    Novan, Inc. is a clinical development-stage biotechnology company focused on leveraging its proprietary…

    MORRISVILLE, N.C., Jan. 29, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced that it has received written notice from The Nasdaq Stock Market LLC ("Nasdaq") that the Company has regained compliance with Nasdaq's minimum bid price requirement for continued listing on the Nasdaq Capital Market. The notice indicated that, as a result of the closing bid price of the Company's common stock having been at $1.00 per share or greater for at least ten consecutive business days, from January 14, 2021 through January 28, 2021, the Company has regained compliance with Nasdaq Listing Rule 5550(a)(2).

    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. 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, any operational or other disruptions as a result of the COVID-19 pandemic, including any delays or disruptions to the conduct of the B-SIMPLE4 study; 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; the Company's reliance on arrangements with third parties to support its operations and development efforts and the risk that such parties will not successfully carry out their contractual duties or meet expected deadlines; 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 Securities and Exchange Commission, 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

    NOVN@jtcir.com



    Primary Logo

    View Full Article Hide Full Article
  27. – 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

    NOVN@jtcir.com



    Primary Logo

    View Full Article Hide Full Article
  28. 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

    NOVN@jtcir.com





    Primary Logo

    View Full Article Hide Full Article
  29. – 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

    NOVN@jtcir.com 



    Primary Logo

    View Full Article Hide Full Article
  30. – 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

    NOVN@jtcir.com 



    Primary Logo

    View Full Article Hide Full Article
  31. 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

    NOVN@jtcir.com

    Primary Logo

    View Full Article Hide Full Article
  32. – Lead product candidate, SB206 currently being evaluated in B-SIMPLE4 pivotal Phase 3 study in molluscum contagiosum with topline data targeted for Q2 2021 –

    – First to demonstrate antiviral effect of nitric oxide-based medicine against SARS-CoV-2 in an in vitro model that mimics the human airway epithelium –

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

    – Company actively seeking opportunities to leverage broader pipeline to secure next phase of growth –

    MORRISVILLE, N.C., Oct. 30, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced its financial results for the quarter ended September 30, 2020 and provided a corporate update…

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

    – First to demonstrate antiviral effect of nitric oxide-based medicine against SARS-CoV-2 in an in vitro model that mimics the human airway epithelium –

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

    – Company actively seeking opportunities to leverage broader pipeline to secure next phase of growth –

    MORRISVILLE, N.C., Oct. 30, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced its financial results for the quarter ended September 30, 2020 and provided a corporate update.

    "The last few months have been marked by many significant achievements for the Company and the advancement of our priority development pipeline. We initiated our pivotal Phase 3 study, B-SIMPLE4, and even during the current global pandemic, I am pleased to report that enrollment has remained on track and is targeted to complete in the first quarter of 2021. We also recently reported positive in vitro results demonstrating antiviral effect of our NITRICIL platform against coronavirus (SARS-CoV-2) and the next step would be to advance this program into preclinical IND-enabling studies. Additionally, we have taken deliberate actions to strengthen our balance sheet and believe we have sufficient capital to fund operations through the fourth quarter of 2021," commented Paula Brown Stafford, President and Chief Executive Officer of Novan.

    Recent Highlights

    • Initiated enrollment and dosed first patients in B-SIMPLE4 pivotal Phase 3 study of SB206, a topical antiviral gel, for treatment of molluscum;
    • Demonstrated in vitro antiviral effect of proprietary NITRICIL™ technology against SARS-CoV-2 in human airway infection in a 3D-model;
    • Commenced exploratory work to evaluate NITRICIL™ for antimicrobial indications in companion animal health;
    • Continued ongoing review of existing programs and opportunities to expand priority development pipeline;
    • Announced the appointment of John M. Gay to serve as the Company's Chief Financial Officer and the appointment of James L. Bierman to the Company's Board of Directors;
    • Announced an expanded role of Paula Brown Stafford, President and Chief Executive Officer of Novan, to also include Chairman of Novan's Board of Directors; and
    • Since January 1, 2020, secured approximately $50 million in capital from multiple sources including the use of common stock purchase agreements with Aspire Capital Fund, LLC, a March 2020 public offering (and the exercise of related common stock warrants), and a March 2020 registered direct offering.

    "While over the past few months we have raised capital to progress our lead asset for molluscum and provide an expected cash runway past our targeted topline results for our B-SIMPLE4 trial, maintaining our listing on Nasdaq remains a critical priority for the Company. We continue to pursue a course of action intended to allow us to work toward regaining compliance in a manner that we believe is in the best interests of the Company and its stockholders," commented John M. Gay, Chief Financial Officer. "Recognizing the importance of this process to our stockholders, we expect to provide an update on this matter in the near-term."

    Priority Development Pipeline Update

    SB206 – a Topical Antiviral Treatment for Viral Skin Infections (Molluscum Contagiosum)

    The Company commenced patient enrollment and dosing for B-SIMPLE4 in September 2020. B-SIMPLE4 is a multi-center, double-blind, randomized, vehicle-controlled study expected to enroll approximately 850 patients (1:1 randomization), across 50 clinical sites, who will be treated for 12 weeks with a follow-up visit at Week 24. To-date, the Company has completed more than 30% of the total expected patient enrollment for the study.

    Upcoming Targeted Milestones:

    • Completion of enrollment targeted in Q1 2021; and
    • Topline efficacy results targeted in Q2 2021, if the trial is not further impacted by the COVID-19 pandemic.

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

    Infectious Disease, Coronaviridae (COVID-19)

    The Company initiated in vitro assessments 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 demonstrate 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.

    Upcoming Targeted Milestones:

    • Initiate Chemistry, Manufacturing, and Controls (CMC) work with a global leader in providing integrated services, superior delivery technologies and manufacturing solutions to develop an intranasal formulation of berdazimer sodium.

    Companion Animal Health

    Novan has initiated exploratory work to evaluate the Company's new chemical entity, NVN4100, as a potential product candidate for antimicrobial indications in companion animal health. Additionally, the Company has engaged animal health experts to assess technical feasibility and market potential.

    Upcoming Targeted Milestones:

    • Currently intend to seek a potential strategic partner or collaborator following initial proof-of-concept work.

    Financial Update

    Summary of Financial Results for Third Quarter 2020

    • Novan reported a net loss of $8.4 million for the three months ended September 30, 2020, compared to a $9.5 million net loss for the same period in 2019.



    • As of September 30, 2020, Novan had a total cash and cash equivalents balance of $43.1 million and positive working capital of $36.7 million.



    • The Company believes that its existing cash and cash equivalents balance as of September 30, 2020, and expected contractual payments to be received in connection with existing licensing agreements, will provide it with adequate liquidity to fund its operating needs through the fourth quarter of 2021, based on management's projections and planned priority development activities described in the Company's quarterly report on Form 10-Q for the three month period ended September 30, 2020.

    Summary of Financial Results for Year-to-Date September 2020

    • Novan reported a net loss of $22.7 million for the nine months ended September 30, 2020, compared to a $24.4 million net loss for the same period in 2019.



    • License and collaboration revenue was $3.2 million for the nine months ended September 30, 2020, compared to $3.3 million for the same period in 2019, associated with the Company's performance during the period and the related amortization of the non-refundable upfront and expected milestone payments under one of the Company's license agreements.



    • Research and development expenses were $13.5 million for the nine months ended September 30, 2020, compared to $19.6 million for the same period in 2019. The decrease was primarily attributable to (i) net decreased costs of $1.7 million related to Novan's relative timing of the B-SIMPLE4 trial's enrollment initiation, which occurred in late third quarter of 2020, compared to enrollment initiations for the previous Phase 3 trials (B-SIMPLE1 and B-SIMPLE2), which occurred in late second quarter of 2019; and (ii) a decrease of $3.4 million in other research and development expenses, primarily related to a $2.1 million net decrease in research and development personnel costs, and a $0.9 million decrease in costs primarily associated with manufacturing technology transfer projects to third-party manufacturers.



    • General and administrative expenses were $8.8 million for the nine months ended September 30, 2020, compared to $8.6 million for the same period in 2019. The increase was primarily due to $1.7 million of non-cash expense related to the issuance of commitment shares as consideration for entering into common stock purchase arrangements with Aspire Capital, partially offset by a $1.4 million decrease in general and administrative personnel and related costs.



    • For the nine months ended September 30, 2020, the Company recognized $2.4 million of non-cash impairment charges related to the July 2020 termination of its previous primary facility lease and a $1.8 million loss on the disposition of related assets, of which $0.8 million was a non-cash charge.

    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, the Company's intention to advance development of certain product candidates, the Company's expected cash runway, the Company's plans to regain compliance with the Nasdaq listing standards and the Company's intention to partner with third parties. 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 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.

    NOVAN, INC.

    Condensed Consolidated Statements of Operations and Comprehensive Loss

    (unaudited)

    (in thousands, except share and per share amounts)

     Three Months Ended September 30, Nine Months Ended September 30,
     2020 2019 2020 2019
    License and collaboration revenue$1,100  $1,100  $3,224  $3,301 
    Government research contracts and grants revenue217  216  627  216 
    Total revenue1,317  1,316  3,851  3,517 
    Operating expenses:       
    Research and development4,836  8,598  13,513  19,614 
    General and administrative3,108  2,290  8,847  8,595 
    Impairment loss on long-lived assets    2,421   
    Loss on facility asset group disposition1,772    1,772   
    Total operating expenses9,716  10,888  26,553  28,209 
    Operating loss(8,399) (9,572) (22,702) (24,692)
    Other (expense) income, net:       
    Interest income2  53  47  149 
    Interest expense      (1)
    Other (expense) income(8) 23  (3) 115 
    Total other (expense) income, net(6) 76  44  263 
    Net loss and comprehensive loss$(8,405) $(9,496) $(22,658) $(24,429)
    Net loss per share, basic and diluted$(0.06) $(0.36) $(0.27) $(0.94)
    Weighted-average common shares outstanding, basic and diluted133,689,645  26,189,454  83,961,052  26,108,870 
                

    NOVAN, INC.

    Selected Condensed Consolidated Balance Sheet Data

    (unaudited)

    (in thousands)

     September 30, 2020 December 31, 2019
    Cash and cash equivalents$43,072  $13,711 
    Total current assets44,755  15,724 
    Total assets46,570  29,097 
    Total current liabilities8,049  12,899 
    Total liabilities39,117  51,380 
    Total stockholders' equity (deficit)7,453  (22,283)
    Total liabilities and stockholders' equity (deficit)$46,570  $29,097 
            

    INVESTOR AND MEDIA CONTACT:

    Jenene Thomas

    JTC Team, LLC

    833-475-8247

    NOVN@jtcir.com

    Primary Logo

    View Full Article Hide Full Article
  33. MORRISVILLE, N.C., Oct. 21, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced that members of management will participate in the Virtual Investor KOL Roundtable on Tuesday, October 27, 2020 at 12:00 PM ET.

    Participating in the KOL Roundtable discussion will be Paula Brown Stafford, Chairman and Chief Executive Officer of Novan and Carri Geer, SVP, Chief Technology Officer of Novan. Joining the Novan Management team for the roundtable will be John Browning, MD, FAAD, FAAP, MBA​, Clinical Assistant Professor of Pediatrics and Dermatology at Baylor College of Medicine and at the University of Texas Health Science Center at San Antonio, Chief of Dermatology at the Children's Hospital of San Antonio…

    MORRISVILLE, N.C., Oct. 21, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced that members of management will participate in the Virtual Investor KOL Roundtable on Tuesday, October 27, 2020 at 12:00 PM ET.

    Participating in the KOL Roundtable discussion will be Paula Brown Stafford, Chairman and Chief Executive Officer of Novan and Carri Geer, SVP, Chief Technology Officer of Novan. Joining the Novan Management team for the roundtable will be John Browning, MD, FAAD, FAAP, MBA​, Clinical Assistant Professor of Pediatrics and Dermatology at Baylor College of Medicine and at the University of Texas Health Science Center at San Antonio, Chief of Dermatology at the Children's Hospital of San Antonio.

    A live video webcast of the KOL roundtable discussion will be available on the Events page of the Investors section of the Company's website (novan.com). A webcast replay will be available two hours following the live presentation and will be accessible for one year.

    In addition to the KOL roundtable discussion, members of the management team will be available for one-on-one meetings with qualified members of the investment community. To schedule a one-on-one call with management, please submit a request through the conference website virtualinvestorco.com, or contact the conference at info@virtualinvestorco.com. For more information about the event, please visit virtualinvestorco.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.

    INVESTOR AND MEDIA CONTACT:

    Jenene Thomas

    JTC Team, LLC

    833-475-8247

    NOVN@jtcir.com

    Primary Logo

    View Full Article Hide Full Article
  34. - Access the event and schedule of presenting companies at virtualinvestorco.com -

    - Live video webcast roundtable discussions with members of Management and Key Opinion Leaders from each participating company -

    PITTSTOWN, NJ / ACCESSWIRE / October 20, 2020 / JTC Team ("JTC"), a fully integrated corporate communications firm, today announced they will host the Virtual Investor KOL Roundtable on October 27th, 28th, and 29th, 2020 with company presentations each day. The KOL Roundtable event will feature public companies across the life sciences industry. As part of the virtual video event, JTC will host a moderated, in-depth discussion with members of the Management team from each participating company along with Key Opinion Leaders over the three-day…

    - Access the event and schedule of presenting companies at virtualinvestorco.com -

    - Live video webcast roundtable discussions with members of Management and Key Opinion Leaders from each participating company -

    PITTSTOWN, NJ / ACCESSWIRE / October 20, 2020 / JTC Team ("JTC"), a fully integrated corporate communications firm, today announced they will host the Virtual Investor KOL Roundtable on October 27th, 28th, and 29th, 2020 with company presentations each day. The KOL Roundtable event will feature public companies across the life sciences industry. As part of the virtual video event, JTC will host a moderated, in-depth discussion with members of the Management team from each participating company along with Key Opinion Leaders over the three-day event.

    Investors and interested parties can access the event schedule and individual company webcast details at www.virtualinvestorco.com.

    In addition to the KOL roundtable discussions, each management team will be available for 1x1 virtual meetings from qualified members of the investment community which can be requested through the event website or by emailing a request to info@virtualinvestorco.com.

    The presenting company schedule for the KOL Roundtable series is:

    Tuesday, October 27, 2020

    Wednesday, October 28, 2020

    Thursday, October 29, 2020

    For more information about the event, please visit the conference website at virtualinvestorco.com or contact info@virtualinvestorco.com.

    About JTC Team

    JTC is a fully integrated corporate communications firm that is dedicated to helping you tell your story to the right audiences in order to build awareness and achieve your goals. JTC was founded over 8 years ago and has developed a reputation of excellence for executing on robust communication strategies that deliver results. The Company's client roster over the years has included both public and private companies across the Life Sciences and Technology industries to help them establish and execute their corporate communications, raise awareness and build shareholder value. For more information, please visit www.jtcir.com or connect with the company on Twitter and LinkedIn.

    Contact:

    Jenene Thomas
    JTC Team, LLC
    T: +1 (833) 475-8247
    jtc@jtcir.com

    SOURCE: JTC Team, LLC



    View source version on accesswire.com:
    https://www.accesswire.com/611314/JTC-Team-to-Host-Virtual-Investor-KOL-Roundtable-on-October-27th-28th-and-29th

    View Full Article Hide Full Article
  35. - First demonstration of antiviral effect of nitric oxide-based medicine against SARS-CoV-2 in an in vitro model that mimics the human airway epithelium

    - Company believes preclinical results demonstrate high potential for clinical translation

    - Company plans to initiate Chemistry, Manufacturing, and Controls (CMC) work to develop intranasal formulation of berdazimer sodium for use in coronavirus program


    MORRISVILLE, N.C., Oct. 14, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced positive in vitro results showing the potential efficacy of its NITRICIL™ platform technology as an antiviral against SARS-CoV-2, the virus that causes COVID-19. To evaluate the ability of its NITRICIL™ platform technology…

    - First demonstration of antiviral effect of nitric oxide-based medicine against SARS-CoV-2 in an in vitro model that mimics the human airway epithelium

    - Company believes preclinical results demonstrate high potential for clinical translation

    - Company plans to initiate Chemistry, Manufacturing, and Controls (CMC) work to develop intranasal formulation of berdazimer sodium for use in coronavirus program



    MORRISVILLE, N.C., Oct. 14, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced positive in vitro results showing the potential efficacy of its NITRICIL™ platform technology as an antiviral against SARS-CoV-2, the virus that causes COVID-19. To evaluate the ability of its NITRICIL™ platform technology as a potential nasal treatment option for COVID-19, the Company initiated in vitro assessments 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 demonstrate 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.

    "COVID-19 continues to have a major ongoing impact on global health and there remains a direct need for a safe and effective antiviral therapy. The naturally occurring antiviral effects of nitric oxide and the results we have generated from this assessment, provide us with confidence that our NITRICIL™ platform technology may be an effective treatment for COVID-19. We also believe the data from this sophisticated model of the human respiratory tract demonstrate a high potential for clinical translation," commented Paula Brown Stafford, Chairman and Chief Executive Officer of Novan.



    Novan plans to initiate Chemistry, Manufacturing, and Controls (CMC) work with a global leader in providing integrated services, superior delivery technologies and manufacturing solutions to develop an intranasal formulation of berdazimer sodium for use in the Company's COVID-19 program.

    Dr. Carri Geer, Senior Vice President and Chief Technology Officer added, "With these encouraging in vitro results in hand, the next step is to advance our program into preclinical IND-enabling studies to further confirm the safety of our NITRICIL™ technology when administered intranasally. We are in the process of finalizing arrangements with a global leader in drug development to assist in our development activities as we work toward a potential IND filing targeted in 2021."

    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.

    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 the potential therapeutic value of our NITRICIL™ platform technology, our pharmaceutical development of nitric oxide-releasing product candidates, our intention to advance development of certain product candidates, and our intention to partner with third parties. 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; our ability to enter arrangements with third parties to support our development efforts on terms that are acceptable to us 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 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

    NOVN@jtcir.com

    Primary Logo

    View Full Article Hide Full Article
  36. - 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

    NOVN@jtcir.com

    Primary Logo

    View Full Article Hide Full Article
  37. - 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

    NOVN@jtcir.com  

     

    Primary Logo

    View Full Article Hide Full Article
  38. - 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

    NOVN@jtcir.com

    Primary Logo

    View Full Article Hide Full Article
  39. - 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

    NOVN@jtcir.com

    Primary Logo

    View Full Article Hide Full Article
  40. - 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

    NOVN@jtcir.com

    Primary Logo

    View Full Article Hide Full Article
    • Expanded role of Ms. Stafford as Chairman reflects the Board's confidence in her leadership of the Company and strategic direction
    • Renowned pharmaceutical executive Robert Ingram retiring as Executive Chair and remaining a member of Board of Directors  

    MORRISVILLE, N.C., July 28, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced an expanded role of Paula Brown Stafford, President and Chief Executive Officer ("CEO") of Novan, to also include Chairman of Novan's Board of Directors ("Board"). Concurrently, Robert Ingram is retiring as Executive Chairman and will continue as a member of the Board. These changes to the Board are effective as of today, July 28, 2020.

    "Since Paula's appointment as President…

    • Expanded role of Ms. Stafford as Chairman reflects the Board's confidence in her leadership of the Company and strategic direction
    • Renowned pharmaceutical executive Robert Ingram retiring as Executive Chair and remaining a member of Board of Directors  

    MORRISVILLE, N.C., July 28, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced an expanded role of Paula Brown Stafford, President and Chief Executive Officer ("CEO") of Novan, to also include Chairman of Novan's Board of Directors ("Board"). Concurrently, Robert Ingram is retiring as Executive Chairman and will continue as a member of the Board. These changes to the Board are effective as of today, July 28, 2020.

    "Since Paula's appointment as President and CEO of Novan, she has done a tremendous job leading the Company on multiple fronts, including securing the necessary capital to advance the upcoming B-SIMPLE4 pivotal trial, a major inflection point for the Company. She has a clear strategic vision, has demonstrated solid execution, and I believe will propel the Company forward through the next stage of growth. Having been a member of the Novan Board for nearly a decade, I along with my fellow Board members, felt strongly it was appropriate for Paula to assume the role of Chairman as she continues to lead and build momentum. Moving forward, I am pleased to remain a member of the Board and participate in the great strides and many opportunities we expect for the future," commented Mr. Ingram.

    Ms. Stafford has been a member of the Board since August 2017 and has served as the Company's President and CEO since February 2020, after holding various executive roles including Chief Operating Officer and Chief Development Officer since joining Novan in March 2017.

    "On behalf of the Board of Directors, we would like to sincerely thank Bob for his above and beyond contributions and valuable insights while serving as our Executive Chairman since 2016," added Ms. Stafford. "His expertise in the industry, multitude of business relationships and wise judgment have been instrumental in guiding Novan through many business, developmental and financing milestones. I look forward to continuing to work closely with Bob as a member of our Board."

    About Robert A. Ingram

    Mr. Robert A. Ingram is a General Partner at Hatteras Venture Partners, a venture capital firm that invests in early stage life science companies. Prior to joining Hatteras, Mr. Ingram was Chief Executive Officer and Chairman of GlaxoWellcome. Upon reaching the mandatory retirement age of 60, Mr. Ingram served as the Vice Chairman, Pharmaceuticals at GSK before becoming Strategic Advisor to the CEO of GlaxoSmithKline Plc. Mr. Ingram is Chairman of the Board of BioCryst Pharmaceuticals and recently retired as the Chairman of the Board of Cree, Inc. In 2019, Mr. Ingram was appointed by President Donald J. Trump's administration to serve on the Presidential Cancer Panel.

    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 our next phase of business progress. 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 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 relationships or other business development necessary for the further development of our product candidates; 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

    833-475-8247

    NOVN@jtcir.com  

    JTC Team, LLC

    Primary Logo

    View Full Article Hide Full Article
  41. MORRISVILLE, N.C., July 23, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced that it will host a live audio webcast of the Company's 2020 Annual Meeting of Stockholders ("ASM") on Tuesday, July 28, 2020 at 9:30 a.m. Eastern Time.

    Considering the coronavirus (COVID-19) pandemic, for the safety and health of Novan's stockholders, employees and the broader community, the Company has determined that its 2020 Annual Meeting will be held solely via the Internet. To be admitted to the 2020 ASM webcast, stockholders need to visit www.virtualshareholdermeeting.com/NOVN2020 and enter the control number included on the proxy form or voting instruction form, as applicable. During the virtual annual meeting…

    MORRISVILLE, N.C., July 23, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN), today announced that it will host a live audio webcast of the Company's 2020 Annual Meeting of Stockholders ("ASM") on Tuesday, July 28, 2020 at 9:30 a.m. Eastern Time.

    Considering the coronavirus (COVID-19) pandemic, for the safety and health of Novan's stockholders, employees and the broader community, the Company has determined that its 2020 Annual Meeting will be held solely via the Internet. To be admitted to the 2020 ASM webcast, stockholders need to visit www.virtualshareholdermeeting.com/NOVN2020 and enter the control number included on the proxy form or voting instruction form, as applicable. During the virtual annual meeting, stockholders of record as of June 11, 2020 will be able to vote their shares electronically and will be able to ask questions via the web portal, as time permits.

    Guests may listen to the 2020 ASM by visiting www.virtualshareholdermeeting.com/NOVN2020 and completing the guest login section of the web portal. If you are not a stockholder of record, you may still access and listen to the meeting, however, guests will be unable to submit questions during the webcast.

    Online check-in will begin 15 minutes prior, at 9:15 a.m. ET. The ASM will begin promptly at 9:30 a.m. ET on July 28, 2020.

    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. 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 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; 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.

    INVESTOR AND MEDIA CONTACT:

    Jenene Thomas

    JTC Team, LLC

    833-475-8247

    NOVN@jtcir.com  

    Primary Logo

    View Full Article Hide Full Article
  42. MORRISVILLE, N.C., June 25, 2020 (GLOBE NEWSWIRE) -- 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…

    MORRISVILLE, N.C., June 25, 2020 (GLOBE NEWSWIRE) -- 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.

    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. 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 for the B-SIMPLE4 Phase 3 trial and anticipated top-line results, and the sufficiency of our cash position. 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 a new drug application; the risk that the cost of the B-SIMPLE4 Phase 3 trial or other operational costs will exceed our expectations; our ability to obtain any additional funding that may become necessary to continue our business and the further development of our product candidates, including SB206 for molluscum; 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 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 conduct of the B-SIMPLE4 Phase 3 trial; and other risks and uncertainties described in our annual report filed with the Securities and Exchange Commission on Form 10-K/A 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

    Primary Logo

    View Full Article Hide Full Article
  43. MORRISVILLE, N.C., June 24, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN) today announced that Paula Brown Stafford, the Company's President and Chief Executive Officer, will present a corporate overview at the Life Sciences Investor Forum on Thursday, June 25, 2020 at 2:00 p.m. Eastern.

    This will be a live, interactive online event where investors are invited to ask the company questions in real-time. The presentation and Q&A session will be webcast live and can be accessed through the Events page of the For Investors section of the Company's website at https://novan.gcs-web.com/events or at www.lifesciencesinvestorforum.com.

    If attendees are not able to join the event live on the day of the conference, an…

    MORRISVILLE, N.C., June 24, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN) today announced that Paula Brown Stafford, the Company's President and Chief Executive Officer, will present a corporate overview at the Life Sciences Investor Forum on Thursday, June 25, 2020 at 2:00 p.m. Eastern.

    This will be a live, interactive online event where investors are invited to ask the company questions in real-time. The presentation and Q&A session will be webcast live and can be accessed through the Events page of the For Investors section of the Company's website at https://novan.gcs-web.com/events or at www.lifesciencesinvestorforum.com.

    If attendees are not able to join the event live on the day of the conference, an archived webcast will also be made available after the event. It is recommended that investors pre-register and run the online system check to expedite participation and receive event updates.

    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.

    About Life Sciences Investor Forum

    Life Sciences Investor Forum is the leading proprietary investor conference series that provides an interactive forum for Life Sciences companies to meet with and present directly to investors. A real-time solution for investor engagement, Life Sciences Investor Forum is powered by Intrado Digital Media and specifically designed for more efficient investor access. Replicating the look and feel of on-site investor conferences, Life Sciences Investor Forum combines leading-edge conferencing and investor communications capabilities with a comprehensive global investor audience network.

    CONTACT:

    (Investors & Media)

    Cole Ikkala

    Director, Investor Relations, Communications & Business Development

    cikkala@novan.com

    Primary Logo

    View Full Article Hide Full Article
    • 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…

    • 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

    Primary Logo

    View Full Article Hide Full Article
    • Engages H.C. Wainwright & Co. as strategic and financial advisor
    • NITRICIL™ nitric oxide technology platform has enabled multiple early and late-stage pipeline opportunities in dermatology, women's health and GI disorders

    MORRISVILLE, N.C., April 20, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN) today announced that it has engaged H.C. Wainwright & Co., LLC ("H.C. Wainwright & Co.") to assist the Company in exploring and evaluating a range of strategic and financial alternatives, intended to maximize shareholder value.

    The Company has advanced several late stage development programs in the field of dermatology, including the Company's lead product candidate, SB206, that is in Phase 3 clinical trials for molluscum…

    • Engages H.C. Wainwright & Co. as strategic and financial advisor
    • NITRICIL™ nitric oxide technology platform has enabled multiple early and late-stage pipeline opportunities in dermatology, women's health and GI disorders

    MORRISVILLE, N.C., April 20, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN) today announced that it has engaged H.C. Wainwright & Co., LLC ("H.C. Wainwright & Co.") to assist the Company in exploring and evaluating a range of strategic and financial alternatives, intended to maximize shareholder value.

    The Company has advanced several late stage development programs in the field of dermatology, including the Company's lead product candidate, SB206, that is in Phase 3 clinical trials for molluscum contagiosum ("molluscum"), a primarily pediatric contagious skin infection. In addition, Novan has initiated several early stage programs in women's health and gastrointestinal ("GI") disorders. Novan's development programs were created from the Company's proprietary NITRICIL™ technology platform. This proprietary technology has been utilized in more than 3,400 subjects and patients, providing the Company with clinical efficacy and safety data, demonstrating anti-viral, bacterial, fungal and inflammatory properties.

    The Company believes that its clinical and preclinical data, technology platform and market potential, will provide for a range of opportunities in order to maximize shareholder value:

    • SB206 (molluscum): April 1, 2020 verbal guidance provided from the U.S. Food and Drug Administration ("FDA") indicating that the FDA will consider one additional pivotal trial ("B-SIMPLE4"), that, if successful, can be supported by the previously completed B-SIMPLE2 trial in a future New Drug Application ("NDA"). Management remains focused on SB206, Novan's lead product candidate for the treatment of molluscum, as a key value driver for the Company.
       
    • SB206 (external genital warts): positioned to initiate Phase 3 pivotal trials following positive Phase 2 results in the fourth quarter of 2016, and an end of Phase 2 meeting with the FDA in the second quarter of 2017.
       
    • SB204 (acne vulgaris): positioned to initiate one additional pivotal Phase 3 trial in moderate-to-severe acne patients. In the first quarter of 2017, announced statistically significant results compared to vehicle on all three co-primary endpoints in NI-AC302.
       
    • SB414 (atopic dermatitis): positioned to initiate a Phase 2 clinical program given the successful downregulation of key biomarkers, favorable tolerability and lack of systemic exposure in a Phase 1b study with SB414 2%, announced in the third quarter of 2018.
       
    • SB208 (tinea pedis and onychomycosis): positioned to initiate a Phase 2 trial in onychomycosis following positive results in a Phase 2 study of tinea pedis and a Phase 1 study in nail growth, announced in the second quarter of 2017 and the second quarter of 2018, respectively.
       
    • WH504 and WH602 (high-risk HPV, cervical intraepithelial neoplasia): since August 2019, awarded a total of $2.3 million in grants from the National Institutes of Health ("NIH") and U.S. Department of Defense's ("DoD") Congressionally Directed Medical Research Programs ("CDMRP") in order to advance formulation development of nitric oxide-containing intravaginal gel (WH602) and non-gel (WH504) product candidates.
       
    • GI disorders: berdazimer sodium demonstrated statistically significant improvements in disease activity (i.e., reduced disease activity index scores), as compared to vehicle in a dextran sulfate sodium (DSS)-induced acute colitis mouse model during the fourth quarter of 2019.
       
    • Coronaviridae family: initiated a work order in March 2020 to complete in vitro assessment of the Company's NITRICIL™ technology, berdazimer sodium, against species within the Coronaviridae family, including SARS-CoV-2, the virus that causes COVID-19.
       
    • New Chemical Entity ("NCE") development: the Company has the ability to rapidly generate NCEs and drug delivery capabilities, utilizing our NITRICIL™ nitric oxide technology platform, for discovery, research and development across segments such as animal health and ophthalmology, among additional therapeutic areas.

    Given the opportunities enabled by Novan's NITRCIL™ technology platform, the Company believes that in conjunction with H.C. Wainwright & Co. it is well-positioned to advance a strategic and financial review process intended to maximize shareholder value.

    "Despite the challenging business environment, our team has worked diligently, over the past sixty-days to gain FDA regulatory clarity regarding a path forward for SB206 in the molluscum indication and secure additional capital from the equity markets," commented Paula Brown Stafford, Novan's President and Chief Executive Officer. Ms. Stafford further commented, "With these milestones accomplished and the broader opportunities enabled by Novan's NITRCIL™ technology platform, the Board of Directors and senior management are now committed to working closely with H.C. Wainwright & Co. in order to explore Novan's strategic and financial alternatives, with the goal to advance our nitric-oxide based technology platform for the benefit of patients and maximize value for our shareholders and other stakeholders of our Company."

    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 Novan pursuing any strategic or financial alternatives, or that a strategic of financial alternative, if any, would be completed successfully or at all. Novan does not intend to discuss or disclose developments with respect to this process until the evaluation process has been completed, or the Novan Board of Directors has concluded that disclosure is appropriate or required.

    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 our nitric oxide-releasing product candidates and our intention to advance development of certain product candidates and the timing and contents of potential regulatory submissions. 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 related to 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; risks and uncertainties related to the impact of this announcement on the Company's securities, its employees and its third-party partners; 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 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; the risk that the B-SIMPLE4 Phase 3 trial will be delayed or postponed and that results will not be received timely or will not achieve significance sufficient to support an NDA; 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

    Primary Logo

    View Full Article Hide Full Article
    • Per verbal guidance, FDA to consider one additional pivotal trial
    • FDA-generated minutes expected on or before May 1, 2020
    • Sato Pharmaceutical to begin start-up of Phase 1 trial in Japan

    MORRISVILLE, N.C., April 03, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN) today announced that the Company has conducted its Type C meeting with the U.S. Food and Drug Administration ("FDA") regarding SB206 for the treatment of molluscum. The purpose of the meeting was to seek FDA feedback on the proposal to conduct one additional, well-controlled confirmatory study of SB206 to support a future New Drug Application ("NDA").

    Based on guidance received during the meeting, the Company understands the FDA will consider one additional…

    • Per verbal guidance, FDA to consider one additional pivotal trial
    • FDA-generated minutes expected on or before May 1, 2020
    • Sato Pharmaceutical to begin start-up of Phase 1 trial in Japan

    MORRISVILLE, N.C., April 03, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN) today announced that the Company has conducted its Type C meeting with the U.S. Food and Drug Administration ("FDA") regarding SB206 for the treatment of molluscum. The purpose of the meeting was to seek FDA feedback on the proposal to conduct one additional, well-controlled confirmatory study of SB206 to support a future New Drug Application ("NDA").

    Based on guidance received during the meeting, the Company understands the FDA will consider one additional pivotal trial ("B-SIMPLE4"), if successful, to be supported by the previously completed B-SIMPLE2 trial. In addition, the FDA provided guidance with regard to both the study design for B-SIMPLE4 and expectations for a future NDA submission. FDA-generated minutes, expected on or before May 1, 2020, will serve as the meeting's official record.

    "We are pleased with the promising dialogue that we had with the FDA and the clarity provided for a path forward for SB206," commented Paula Brown Stafford, Novan's President and Chief Executive Officer. Ms. Stafford further commented, "Our team is working diligently to incorporate the agency's suggestions and feedback into the B-SIMPLE4 study design as we seek to optimize execution success and minimize regulatory risk."

    Novan's Japanese development and commercialization partner, Sato Pharmaceutical Co., Ltd. ("Sato"), has also informed the Company of Sato's intention to progress the SB206 development program in Japan with a Phase 1 clinical trial given the observed treatment benefit and favorable safety profile in the B-SIMPLE program.

    "Upon review of the totality of the efficacy and safety data from the B-SIMPLE program, Novan and Sato share optimism for the continued progression of SB206 for molluscum in both the US and Japan," commented Ms. Stafford. "Sato is a tremendously valuable business and development partner and we look forward to continued collaboration to progress the program."

    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, pharmaceutical development of nitric oxide-releasing product candidates and our intention to advance development of certain product candidates, the expected timing and contents of meeting minutes from the FDA from our April 1, 2020 meeting regarding our B-SIMPLE program, the timing for the B-SIMPLE4 Phase 3 trial, Sato's progress of the clinical development program for SB206 in Japan and the timing of potential regulatory submissions. 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 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; the risk that the B-SIMPLE4 Phase 3 trial will be delayed or postponed and that results will not be received timely or will not achieve significance sufficient to support an NDA; risks and uncertainties related to our ability to obtain funding or enter into strategic relationships on a timely basis, or at all, to enable or complete the B-SIMPLE4 Phase 3 trial and to continue operations; our ability to reduce cash expenditures; 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 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

    Primary Logo

    View Full Article Hide Full Article
  44. MORRISVILLE, N.C., March 26, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN) today announced the closing of the Company's previously announced registered direct offering priced at-the-market under Nasdaq rules with several institutional and accredited investors of 18,604,652 shares of its common stock (or pre-funded warrants to purchase common stock in lieu thereof) at an effective purchase price of $0.43 per share (or pre-funded warrant).

    H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

    The gross proceeds to Novan from this offering are approximately $8.0 million, before deducting the placement agent's fees and other offering expenses payable by Novan. Novan intends to use the net…

    MORRISVILLE, N.C., March 26, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN) today announced the closing of the Company's previously announced registered direct offering priced at-the-market under Nasdaq rules with several institutional and accredited investors of 18,604,652 shares of its common stock (or pre-funded warrants to purchase common stock in lieu thereof) at an effective purchase price of $0.43 per share (or pre-funded warrant).

    H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

    The gross proceeds to Novan from this offering are approximately $8.0 million, before deducting the placement agent's fees and other offering expenses payable by Novan. Novan intends to use the net proceeds from the offering to fund its research and development programs and for general working capital purposes and other operating expenses.

    The offering was made by Novan pursuant to a shelf registration statement (Registration No. 333-220761) filed by Novan with the Securities and Exchange Commission ("SEC") that became effective on October 10, 2017. The offering was made only by means of a prospectus supplement and accompanying prospectus. A prospectus supplement and accompanying prospectus relating to the registered direct offering were filed with the SEC and may be obtained for free on the SEC's website located at http://www.sec.gov. Electronic copies of the prospectus supplement and accompanying prospectus relating to the offering may be obtained by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, or by telephone at (646) 975-6996, or by email to placements@hcwco.com.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    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 and statements regarding the anticipated use of proceeds from the offering. 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 associated with market conditions, as well as the 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

    Primary Logo

    View Full Article Hide Full Article
  45. MORRISVILLE, N.C., March 24, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN) today announced that it has entered into definitive agreements with several institutional and accredited investors for the issuance and sale of 18,604,652 shares of its common stock (or pre-funded warrants to purchase common stock in lieu thereof) at an effective purchase price of $0.43 per share (or pre-funded warrant) in a registered direct offering priced at-the-market under Nasdaq rules.

    H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

    The gross proceeds to Novan from this offering are expected to be approximately $8.0 million, before deducting the placement agent's fees and other offering expenses…

    MORRISVILLE, N.C., March 24, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN) today announced that it has entered into definitive agreements with several institutional and accredited investors for the issuance and sale of 18,604,652 shares of its common stock (or pre-funded warrants to purchase common stock in lieu thereof) at an effective purchase price of $0.43 per share (or pre-funded warrant) in a registered direct offering priced at-the-market under Nasdaq rules.

    H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

    The gross proceeds to Novan from this offering are expected to be approximately $8.0 million, before deducting the placement agent's fees and other offering expenses payable by Novan. Novan intends to use the net proceeds from the offering to fund its research and development programs and for general working capital purposes and other operating expenses. The offering is expected to close on or about March 26, 2020, subject to customary closing conditions.

    The securities described above are being offered by Novan pursuant to a shelf registration statement (Registration No. 333-220761) filed by Novan with the Securities and Exchange Commission ("SEC") that became effective on October 10, 2017. The offering is being made only by means of a prospectus supplement and accompanying prospectus. A prospectus supplement and accompanying prospectus relating to the registered direct offering will be filed with the SEC and, when available, may be obtained for free on the SEC's website located at http://www.sec.gov. When available, electronic copies of the final prospectus supplement and accompanying prospectus relating to the public offering may be obtained by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, or by telephone at (646) 975-6996, or by email to placements@hcwco.com.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    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; statements relating to the expected proceeds from the Company's offering; and statements regarding the anticipated use of proceeds from the offering. 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 associated with market conditions and the satisfaction of customary closing conditions related to the proposed public offering, as well as the 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

    Primary Logo

    View Full Article Hide Full Article
    • Favorable SB206 Week 24 safety and scarring profiles
    • Type C teleconference with FDA for SB206 remains scheduled on April 1, 2020
    • Novan intends to screen NVN1000 against a number of viruses, including SARS-CoV-2

    MORRISVILLE, N.C., March 23, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN) today announced data from the prospectively planned safety evaluation through Week 24 as part of the Company's Phase 3 B-SIMPLE program with SB206 for the treatment of molluscum contagiosum ("molluscum"). Top-line efficacy results from the B-SIMPLE program were announced in January 2020 with additional efficacy and safety analyses through Week 12 announced in February 2020.

    The B-SIMPLE program consisted of two multi-center, randomized…

    • Favorable SB206 Week 24 safety and scarring profiles
    • Type C teleconference with FDA for SB206 remains scheduled on April 1, 2020
    • Novan intends to screen NVN1000 against a number of viruses, including SARS-CoV-2

    MORRISVILLE, N.C., March 23, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN) today announced data from the prospectively planned safety evaluation through Week 24 as part of the Company's Phase 3 B-SIMPLE program with SB206 for the treatment of molluscum contagiosum ("molluscum"). Top-line efficacy results from the B-SIMPLE program were announced in January 2020 with additional efficacy and safety analyses through Week 12 announced in February 2020.

    The B-SIMPLE program consisted of two multi-center, randomized, double-blind, vehicle-controlled pivotal trials ("B-SIMPLE1" and "B-SIMPLE2") in 707 patients aged 6 months and older, with a 2:1 (active:vehicle) randomization. The primary efficacy endpoint of the trials is complete clearance of all treatable molluscum lesions at Week 12, and follow-up included a Week-24 safety assessment.

    The treatment emergent adverse events ("TEAEs") profile of SB206 through the Week-24 visit was found to be favorable and was very similar between the two studies. The TEAEs reported in greater than 5% of subjects in the SB206 treated groups were application site pain and application site erythema, with the majority of these TEAEs being mild or moderate by severity.

    Table 1: Overall Summary of TEAEs (Safety Population) at Week 24

      B-SIMPLE1 B-SIMPLE2
      SB206
    (n=235)
    Vehicle
    (n=116)
    SB206
    (n=237)
    Vehicle
    (n=117)
    Subjects with at least one…
    TEAE 115 (48.9%) 36 (31.0%) 120 (50.6%) 30 (25.6%)
    Serious TEAE 0 0 1 (0.4%) 1 (0.9%)
    Treatment-related TEAE 86 (36.6%) 19 (16.4%) 86 (36.3%) 8 (6.8%)
    TEAE leading to study drug discontinuation 7 (3.0%) 1 (0.9%) 17 (7.2%) 1 (0.9%)

    Study drug discontinuations in the SB206 treatment arm were all due to application site reactions and no treatment-related serious adverse events were reported across both studies.

    Molluscum, caused by a family of pox virus, is known to occasionally heal with small pitting. Scar formation was assessed by the investigator, regardless of the size of the scar, throughout the study for TEAEs, as well as occurrence. The TEAE for scarring was higher in vehicle group in both studies: B-SIMPLE1 (7.8% in vehicle vs. 2.6% in SB206) and B-SIMPLE2 (8.5% in vehicle vs. 4.2% in SB206). In addition, subjects treated with SB206 showed a lower occurrence of scarring consistently through the Week 24 visit when compared to vehicle.

    Table 2: Number of Subjects (%) with Scarring by Visit (ITT Population1)

      B-SIMPLE1 B-SIMPLE2
      SB206 (n=236) Vehicle (n=116) SB206 (n=237) Vehicle (n=118)
    Week 4 0 0 8 (3.4%) 6 (5.1%)
    Week 8 7 (3.0%) 7 (6.0%) 7 (3.0%) 9 (7.6%)
    Week 12 6 (2.5%) 4 (3.4%) 12 (5.1%) 12 (10.2%)
    Week 24 11 (4.7%) 11 (9.5%) 22 (9.3%) 14 (11.9%)

    These findings support that SB206 may provide an enduring cosmetic benefit to reduce scarring compared to the vehicle treatment independently within each study.

    "We believe the safety and scarring profiles of SB206 are attractive to the patients and caregivers that are currently faced with painful in-office, dermatologist-administered physical removal or blistering procedures," commented Elizabeth Messersmith, Ph.D, Senior Vice President and Chief Development Officer. Dr. Messersmith further commented, "We look forward to our meeting that is scheduled with the FDA and the presentation of the B-SIMPLE efficacy and safety data as we pursue a path forward for the SB206 molluscum program in the U.S."

    In light of the developing COVID-19 pandemic and as of March 23, 2020, Novan has not received notification from the U.S. Food and Drug Administration ("FDA") regarding a delay or cancellation of the Type C meeting scheduled on April 1, 2020. The meeting was originally scheduled and is set to be conducted as a teleconference. The purpose of the teleconference is to seek FDA feedback on the proposal to conduct one additional, well-controlled confirmatory study of SB206 to support a future New Drug Application ("NDA").

    As a further update, Novan intends to explore the use of its proprietary Nitricil technology to progress a potential topical oral or nasal treatment option for COVID-19, targeting the reduction of viral shedding and transmission. Nitric oxide (NO) has demonstrated the ability to inhibit viral replication of viruses within the Coronaviridae family2 and Novan has an extensive body of in vitro and in vivo anti-viral data demonstrating the efficacy of our proprietary technology. Novan has initiated a work order to complete in vitro assessment of our Nitricil technology, berdazimer sodium (NVN1000), against species within the Coronaviridae family, including SARS-CoV-2, the virus that causes COVID-19. The Company is also exploring the potential for federal grants to support these efforts.

    Novan's operations have continued amidst the COVID-19 pandemic, with the majority of employees working remotely, and the Company continues to monitor recommendations from the Centers for Disease Control and Prevention (CDC) and other federal, state and local public health and administration officials for further actions and adjustments.

    1. Intent-to-Treat Population ("ITT"): consists of all subjects who are randomized.
    2. Akerstrom S et. al., Nitric oxide inhibits the Replication Cycle of Severe Acute Respiratory Syndrome Coronavirus. J Virol 2005; 79(3):1966-9.

    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 testing of our Nitricil technology against species within the Coronaviridae family, pharmaceutical development of nitric oxide-releasing product candidates and our intention to advance development of certain product candidates, the schedule for and outcome of discussions with the FDA regarding our B-SIMPLE program, the timing for a third Phase 3 trial, the timing of potential regulatory submissions, our needs for funding and our intention to pursue funding alternatives. 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; 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; the risk that the FDA will not agree with our position that the B-SIMPLE2 results can be used to support an NDA alongside results of a third confirmatory trial; the risk that results from a third Phase 3 trial will not be received timely or will not achieve significance sufficient to support an NDA; our ability to obtain funding or enter into strategic relationships on a timely basis, or at all, to enable or complete a third Phase 3 trial and to continue operations; 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; risks related to the manufacture of clinical trial materials; our ability to obtain additional funding or complete other strategic alternatives necessary to continue our business and/or the further development of our product candidates; any operational or other disruptions as a result of the COVID-19 outbreak; 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

    Primary Logo

    View Full Article Hide Full Article
  46. MORRISVILLE, N.C., March 03, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN) today announced the closing of the Company's previously announced underwritten public offering of 18,333,334 shares of common stock (or pre-funded warrants to purchase common stock in lieu thereof) and warrants to purchase an aggregate of up to 18,333,334 shares of common stock, at a combined effective public offering price of $0.30 per share of common stock (or pre-funded warrant) and accompanying common warrant. The common warrants have an exercise price of $0.30 per share, are exercisable immediately and expire five years from the date of issuance. The Company also granted the underwriter a 30-day option to purchase up to an additional…

    MORRISVILLE, N.C., March 03, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN) today announced the closing of the Company's previously announced underwritten public offering of 18,333,334 shares of common stock (or pre-funded warrants to purchase common stock in lieu thereof) and warrants to purchase an aggregate of up to 18,333,334 shares of common stock, at a combined effective public offering price of $0.30 per share of common stock (or pre-funded warrant) and accompanying common warrant. The common warrants have an exercise price of $0.30 per share, are exercisable immediately and expire five years from the date of issuance. The Company also granted the underwriter a 30-day option to purchase up to an additional 2,750,000 shares of common stock and/or warrants to purchase 2,750,000 shares of common stock, which the underwriter partially exercised on March 2, 2020 to purchase 1,498,602 shares of common stock and common warrants to purchase up to 2,750,000 shares of common stock.

    H.C. Wainwright & Co. acted as the sole book-running manager for the offering.

    The gross proceeds from this offering to Novan are approximately $5.95 million, before deducting underwriting discounts and commissions and other estimated offering expenses payable by Novan. Novan intends to use the net proceeds from the offering to fund its research and development programs and for general working capital purposes and other operating expenses.

    The offering was made by Novan pursuant to a shelf registration statement (Registration No. 333-220761) filed by Novan with the Securities and Exchange Commission ("SEC") that became effective on October 10, 2017. The offering was made by means of a prospectus supplement and accompanying prospectus. A final prospectus supplement and accompanying prospectus were filed with the SEC and may be obtained for free on the SEC's website located at http://www.sec.gov. Electronic copies of the final prospectus supplement and accompanying prospectus relating to the public offering may be obtained by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, or by telephone at (646) 975-6996, or by email to placements@hcwco.com.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    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 and statements regarding the use of proceeds from the public offering. 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 associated with market conditions and the 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

    Primary Logo

    View Full Article Hide Full Article
  47. MORRISVILLE, N.C., Feb. 27, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN) today announced the pricing of the Company's previously announced underwritten public offering of 18,333,334 shares of common stock (or pre-funded warrants to purchase common stock in lieu thereof) and warrants to purchase an aggregate of 18,333,334 shares of common stock, at a combined effective public offering price of $0.30 per share of common stock (or pre-funded warrant) and accompanying common warrant. The common warrants have an exercise price of $0.30 per share, are exercisable immediately and expire five years from the date of issuance. 

    H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

    The Company…

    MORRISVILLE, N.C., Feb. 27, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN) today announced the pricing of the Company's previously announced underwritten public offering of 18,333,334 shares of common stock (or pre-funded warrants to purchase common stock in lieu thereof) and warrants to purchase an aggregate of 18,333,334 shares of common stock, at a combined effective public offering price of $0.30 per share of common stock (or pre-funded warrant) and accompanying common warrant. The common warrants have an exercise price of $0.30 per share, are exercisable immediately and expire five years from the date of issuance. 

    H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

    The Company has granted the underwriter a 30-day option to purchase up to an additional 2,750,000 shares of common stock and/or common warrants to purchase up to 2,750,000 shares of common stock at the public offering price, less underwriting discounts and commissions.

    The gross proceeds from this offering to Novan are expected to be approximately $5.5 million, before deducting underwriting discounts and commissions and other estimated offering expenses payable by Novan, and excluding the exercise of any warrants. Novan intends to use the net proceeds from the offering to fund its research and development programs and for general working capital purposes and other operating expenses. The offering is expected to close on or about March 3, 2020, subject to customary closing conditions.

    The securities described above are being offered by Novan pursuant to a shelf registration statement (Registration No. 333-220761) filed by Novan with the Securities and Exchange Commission ("SEC") that became effective on October 10, 2017. The offering is being made only by means of a prospectus supplement and accompanying prospectus. A final prospectus supplement and accompanying prospectus will be filed with the SEC and, when available, may be obtained for free on the SEC's website located at http://www.sec.gov. When available, electronic copies of the final prospectus supplement and accompanying prospectus relating to the public offering may be obtained by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, or by telephone at (646) 975-6996, or by email to placements@hcwco.com.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    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; statements regarding our expectations as to the completion of the public offering; and statements regarding the use of proceeds from the public offering. 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 associated with market conditions and the satisfaction of customary closing conditions related to the proposed public offering, as well as the 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 

    Primary Logo

    View Full Article Hide Full Article
  48. MORRISVILLE, N.C., Feb. 27, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN) today announced that it intends to offer and sell a combination of shares of its common stock (or pre-funded warrants to purchase common stock in lieu thereof) and warrants to purchase shares of its common stock in an underwritten public offering. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

    H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

    The Company expects to grant the underwriter a 30-day option to purchase up to an additional 15% of the number of shares of…

    MORRISVILLE, N.C., Feb. 27, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN) today announced that it intends to offer and sell a combination of shares of its common stock (or pre-funded warrants to purchase common stock in lieu thereof) and warrants to purchase shares of its common stock in an underwritten public offering. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

    H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

    The Company expects to grant the underwriter a 30-day option to purchase up to an additional 15% of the number of shares of common stock and/or warrants to purchase common stock to be sold in the offering at the public offering price, less underwriting discounts and commissions.

    Novan intends to use the net proceeds from the offering to fund its research and development programs and for general working capital purposes and other operating expenses.

    A shelf registration statement on Form S-3 (Registration No. 333-220761) relating to the public offering of the securities described above was filed with the Securities and Exchange Commission ("SEC") and was declared effective on October 10, 2017. A preliminary prospectus supplement describing the terms of the offering will be filed with the SEC and will form a part of the effective registration statement. Electronic copies of the preliminary prospectus supplement and the accompanying base prospectus relating to the offering may be obtained, when available, from H.C. Wainwright & Co., LLC, 430 Park Avenue 3rd Floor, New York, New York 10022, by calling (646) 975-6996 or by emailing placements@hcwco.com or at the SEC's website at http://www.sec.gov.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying base prospectus forming a part of the effective registration statement.

    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; statements regarding our intention to offer and sell securities in an underwritten public offering; statements regarding our intention to file the preliminary prospectus supplement with the SEC; statements regarding our expectations as to the completion, timing, and size of the proposed public offering; and statements regarding the anticipated use of proceeds from the proposed public offering. 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 associated with market conditions and the satisfaction of customary closing conditions related to the proposed public offering, risks and uncertainties as to the final terms of the proposed public offering, as well as the 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

    Primary Logo

    View Full Article Hide Full Article
    • Provides funds to evaluate the mechanistic antiviral activity of WH602
    • Novan to progress IND-enabling toxicology and pharmacology studies for WH602
    • Grant is additive to $223,000 Phase 1 NIH grant received in August 2019
    • Women's health initiative focused on potential HPV related onco-virus therapeutics

    MORRISVILLE, N.C., Feb. 20, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN) today announced that the Company has received approximately $1.0 million funding from the National Institutes of Health (NIH) to cover the first year of a two-year Phase 2 federal grant. Novan is eligible to receive approximately $500,000 of additional funding for the second year, subject to availability of NIH funds and satisfactory progress…

    • Provides funds to evaluate the mechanistic antiviral activity of WH602
    • Novan to progress IND-enabling toxicology and pharmacology studies for WH602
    • Grant is additive to $223,000 Phase 1 NIH grant received in August 2019
    • Women's health initiative focused on potential HPV related onco-virus therapeutics

    MORRISVILLE, N.C., Feb. 20, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN) today announced that the Company has received approximately $1.0 million funding from the National Institutes of Health (NIH) to cover the first year of a two-year Phase 2 federal grant. Novan is eligible to receive approximately $500,000 of additional funding for the second year, subject to availability of NIH funds and satisfactory progress of the project. This grant is additive to the approximately $223,000 Phase 1 NIH grant received in August 2019.

    The grant will provide reimbursement for certain project expenses related to the advancement of WH602, a central focus of Novan's women's health business unit. WH602 is a nitric oxide-containing intravaginal gel product candidate for the treatment of cervical intraepithelial neoplasia (CIN). There are an estimated 250,000 to 1 million women newly diagnosed with CIN annually in the U.S., creating a significant patient care need. 

    The Company expects to use the grant to support the following objectives:

    • Evaluate the intravaginal antiviral activity of WH602 in collaboration with Neil Christensen, Ph.D., Medical Director of the Jake Gittlen Laboratories for Cancer Research at Penn State College of Medicine. Dr. Christensen has developed a mouse model that enables evaluation of potential therapeutics in a preclinical setting that will inform clinical study design if the product candidate advances to human clinical trials. The specific focus of the work with Dr. Christensen is to ensure the nitric oxide delivery from the intravaginal gel replicates antiviral activity of nitric oxide previously demonstrated to be effective against papillomavirus in Novan's clinical and in vitro studies.

    • Deepen the mechanistic understanding of the antiviral activity of Novan's proprietary nitric oxide delivery platform against human papillomavirus in collaboration with a research team from the Department of Biochemistry and Molecular Genetics at the University of Alabama at Birmingham led by N. Sanjib Banerjee, Ph.D., Thomas R. Broker, Ph.D., Founding President of the International Papillomavirus Society, and Louise T. Chow, PhD, Member of the U.S. National Academy of Sciences and of Academia Sinica (Taiwan).

    • Complete or advance certain investigational new drug (IND)-enabling toxicology and pharmacology studies and other preclinical activities required by the Food and Drug Administration (FDA) to advance product candidates to human clinical trials in antiviral indications.

    The Company will continue to be supported through a collaboration with Health Decisions, Inc. ("Health Decisions"). Health Decisions is expected to provide consultation and insights for these initiatives and is expected to be involved in the first-in-human clinical studies, if the product candidates advance into the clinic.

    The research will be supported by the National Institute Of Allergy And Infectious Diseases of the National Institutes of Health under Award Number R44AI143022.

    About Cervical Intraepithelial Neoplasia (CIN)

    Cervical intraepithelial neoplasias (CIN), or precancerous lesions of the cervix caused by persistent high-risk human papillomavirus (HPV) infection, are categorized by HPV genotype and the depth of the infection within the epithelial tissue of the cervix. The CIN classifications include CIN 1 (low-grade neoplasia), CIN 2 (moderate) and CIN 3 (severe and carcinoma in situ). While there are an estimated 250,000 to 1 million women diagnosed with CIN annually in the U.S., there are no minimally invasive therapies with direct antiviral activity for the treatment of CIN and excisional procedures are often associated with pain, fertility issues and recurrence. Despite the availability of the prophylactic HPV vaccines, the incidence of HPV-induced cancer is steadily increasing, due to (a) the inability of the vaccine to cure preexisting infections; (b) a great majority of adolescent populations is not vaccinated; and (c) high rate of population growth. According to a survey on U.S. cervical cancer mortality rates, each year, nearly 12,000 women in the U.S. will be diagnosed with cervical cancer and more than 4,000 will die from the cancer.

    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, our intention to advance development of nitric oxide-releasing product candidates, the future prospects of additional grant funding and third-party cooperation and the future prospects of our business and our product candidates. 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; 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; our reliance on third parties; our ability to meet any of the requirements under the grants described above and the uncertainty involved with government grants, including the successful negotiation and availability of funding for the grants described above or any other grants to support funding for a women's health product candidate; our ability to obtain additional funding or enter into strategic relationships or other business development necessary for the further development of our product candidates; 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, 2018, 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

    Primary Logo

    View Full Article Hide Full Article
    • FDA grants Type C meeting for SB206 to be held on April 1, 2020
    • Last subject completes last visit, Week 24 safety evaluation
    • Additional 12-week efficacy and safety data provided

    MORRISVILLE, N.C., Feb. 06, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN) today provided an update on several aspects of its Phase 3 B-SIMPLE program (B-SIMPLE1 and B-SIMPLE2).  

    Novan has been granted a Type C meeting with the U.S. Food and Drug Administration ("FDA") on April 1, 2020. The Type C Meeting is to seek FDA feedback on the proposal to conduct one additional, well-controlled confirmatory study of SB206 to support a future New Drug Application ("NDA").

    In the Company's Phase 3 B-SIMPLE program with SB206 for the treatment…

    • FDA grants Type C meeting for SB206 to be held on April 1, 2020
    • Last subject completes last visit, Week 24 safety evaluation
    • Additional 12-week efficacy and safety data provided

    MORRISVILLE, N.C., Feb. 06, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN) today provided an update on several aspects of its Phase 3 B-SIMPLE program (B-SIMPLE1 and B-SIMPLE2).  

    Novan has been granted a Type C meeting with the U.S. Food and Drug Administration ("FDA") on April 1, 2020. The Type C Meeting is to seek FDA feedback on the proposal to conduct one additional, well-controlled confirmatory study of SB206 to support a future New Drug Application ("NDA").

    In the Company's Phase 3 B-SIMPLE program with SB206 for the treatment of molluscum contagiosum, the last subject completed their final visit as part of the ongoing safety evaluation through Week 24. Top-line efficacy results from this program were announced on January 2, 2020, and full efficacy and safety data, including data from the safety evaluation through Week 24, are targeted to be available in March 2020.

    The safety profile of SB206 through the Week 12 visit was found to be favorable. Adverse events experienced in the B-SIMPLE program were primarily mild to moderate and the only treatment emergent adverse events (TEAE) reported in greater than 5% of subjects in the SB206 treatment arm were application site pain and application site erythema. There were no treatment-related serious adverse events reported in B-SIMPLE1 or B-SIMPLE2.

      B-SIMPLE1 B-SIMPLE2
      SB206 (n=235) Vehicle (n=116) SB206 (n=237) Vehicle (n=117)
    Subjects with at least one…
    TEAE 115 (48.9%) 36 (31.0%) 120 (50.6%) 29 (24.8%)
    TEAE leading to study drug discontinuation 7 (3.0%) 1 (0.9%) 17 (7.2%) 1 (0.9%)
    Maximum severity of TEAE at any visit
    Mild 60 (25.5%) 25 (21.6%) 51 (21.5%) 18 (15.4%)
    Moderate 50 (21.3%) 10 (8.6%) 64 (27.0%) 10 (8.5%)
    Severe 5 (2.1%) 1 (0.9%) 5 (2.1%) 1 (0.9%)

    Subjects treated with SB206 (n=472, integrated safety population) experienced a lower occurrence of scarring (3.8%), as determined by the investigator, through the Week 12 visit when compared to vehicle (n=233, integrated safety population; 7.3%). Final safety profile and scarring assessments will be updated through Week 24 and are targeted to be released in March 2020.

    Additional post-hoc analyses of efficacy data were performed and identified discordant data in two-subject households (two subjects randomized to the same treatment arm within one household) in both studies. In two-subject households, a greater clearance response rate in vehicle was experienced when compared to SB206 in both B-SIMPLE1 and B-SIMPLE2. Both B-SIMPLE studies were stratified across treatment groups by household, two-subject or one-subject. The post-hoc analyses of the one-subject households are summarized below:

    Complete Clearance of all Molluscum Lesions at Week 12 (ITT, One-Subject Households Only)
    Pivotal Study SB206 Vehicle p-Value
    B-SIMPLE1 28.7%
    (n=181)
    19.1%
    (n=89)
    0.116
    B-SIMPLE2 29.0%
    (n=193)
    16.7%
    (n=96)
    0.025
     

    In the integrated primary analysis (combining data from B-SIMPLE1 and B-SIMPLE2), a treatment effect of 7.0% was observed, which includes subjects from one and two-subject households. When looking at one-subject households only (excluding the data from the discordant two-subject households), the treatment effect increases to 11.1%.

     
    Primary Endpoint: Complete Clearance of all Molluscum Lesions at Week 12 (ITT)
    Integrated Analysis SB206 Vehicle p-Value
    One and Two-Subject Households 27.9%
    (n=473)
    20.9%
    (n=234)
    0.049
    One-Subject Households Only 28.9%
    (n=374)
    17.8%
    (n=185)
    0.005

    Management, along with the Board of Directors, continues to explore both financial as well as strategic options in order to continue operations and to progress SB206 for the molluscum indication, subject to funding and FDA feedback. The Company intends to pursue financing, which may be dilutive, non-dilutive or both, in the near future and intends to engage one or more financial advisors to assist in this financial and strategic process.

    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 of full results of our Phase 3 program to evaluate SB206 for the treatment of molluscum, the outcome of discussions with the FDA regarding our B-SIMPLE program, the timing for a third Phase 3 trial, the timing of potential regulatory submissions, our needs for funding and our intention to pursue financing and strategic alternatives. 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 full results of the Phase 3 program will not be received timely or will not be consistent with our expectations; the risk that the FDA will not agree with our position that the B-SIMPLE2 results can be used to support an NDA alongside results of a third confirmatory trial; the risk that results from a third Phase 3 trial will not be received timely or will not achieve significance sufficient to support an NDA; our ability to obtain funding or enter into strategic relationships on a timely basis, or at all, to enable or complete a third Phase 3 trial and to continue operations; our ability to reduce cash expenditures; our ability to utilize the stock purchase agreement previously entered with Aspire Capital Fund, LLC; 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; risks related to the manufacture of clinical trial materials; our ability to obtain additional funding or complete other strategic alternatives necessary to continue our business and/or the further development of our product candidates; 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, 2018, 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

     

    Primary Logo

    View Full Article Hide Full Article
    • Company to hold conference call Friday, January 3, 2020 at 8:30 am Eastern Time
    • Focus of call: top-line efficacy data and sensitivity analyses

    MORRISVILLE, N.C., Jan. 02, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN) today announced top-line efficacy results from its Phase 3 B-SIMPLE program with SB206 for the treatment of molluscum contagiosum ("molluscum"). Statistical significance was not achieved for the primary endpoint in either B-SIMPLE1 or B-SIMPLE2, however multiple sensitivity analyses are supportive and consistent across both studies and support a potential path forward for the asset. The two trials are ongoing, awaiting 24-week safety data, thus the top-line results are for efficacy data only.

    Summary…

    • Company to hold conference call Friday, January 3, 2020 at 8:30 am Eastern Time
    • Focus of call: top-line efficacy data and sensitivity analyses

    MORRISVILLE, N.C., Jan. 02, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN) today announced top-line efficacy results from its Phase 3 B-SIMPLE program with SB206 for the treatment of molluscum contagiosum ("molluscum"). Statistical significance was not achieved for the primary endpoint in either B-SIMPLE1 or B-SIMPLE2, however multiple sensitivity analyses are supportive and consistent across both studies and support a potential path forward for the asset. The two trials are ongoing, awaiting 24-week safety data, thus the top-line results are for efficacy data only.

    Summary of Top-Line Efficacy Data and SB206 Program:

    • SB206 did not achieve statistically significant results for the primary endpoint.
    • B-SIMPLE2 was statistically significant for multiple pre-specified sensitivity analyses.
    • Similar analyses with B-SIMPLE1 demonstrated results are reasonably consistent and supportive of B-SIMPLE2.
    • Company intends to utilize B-SIMPLE2 as one of the confirmatory trials for New Drug Application ("NDA") submission, subject to discussions with the U.S. Food and Drug Administration ("FDA").
    • Company intends to support and confirm B-SIMPLE2 with an additional confirmatory Phase 3 trial targeted to commence in April 2020, subject to additional funding and FDA feedback.
    • Company's timeline for NDA submission remains consistent and targets potential NDA submission in the second quarter of 2021, depending on outcome of discussions with FDA and confirmatory results in the additional trial.
    • Full efficacy and safety data from both trials, including the prospectively planned safety evaluation ongoing through Week 24, targeted to be available by March 2020.

    The B-SIMPLE program consists of two multi-center, randomized, double-blind, vehicle-controlled pivotal trials of topical nitric oxide-releasing product candidate SB206 for the treatment of molluscum in 707 patients aged 6 months and older, with a 2:1 (active:vehicle) randomization.

    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 Week 12 missing data are computed as treatment failures):

    Pivotal Trial SB206 Vehicle p-Value
    B-SIMPLE1 25.8%
    (n=236)
    21.6%
    (n=116)
    0.375
    B-SIMPLE2 30.0%
    (n=237)
    20.3%
    (n=118)
    0.062

    SB206 was near statistically significant for the primary endpoint in B-SIMPLE2, and was statistically significant in the secondary endpoint and several pre-specified sensitivity analysis, which were included within the statistical analysis plan:

    Endpoint Population SB206 Vehicle p-Value
    Primary endpoint – complete
    Per-Protocol1 36.1%
    (n=194)
    23.3%
    (n=103)
    0.028
    clearance at Week 12 Intent-to-Treat2 with Last
    Observation Carried Forward3
    missing data method
    30.8%
    (n=237)
    20.3%
    (n=118)
    0.044
    Secondary endpoint – complete
    clearance at Week 8
    Intent-to-Treat2 13.9%
    (n=237)
    5.9%
    (n=118)
    0.028

    1. Per-protocol ("PP") population: all patients in the ITT population who completed the 12-week treatment period and had no significant protocol deviations that impacted the analyses of efficacy endpoints.
    2. Intent-to-Treat Population ("ITT"): consists of all subjects who are randomized.
    3. Last Observation Carried Forward ("LOCF") method for handling missing data: all patients randomized (ITT population) and where a patient missed their Week 12 visit but had reported complete clearance at their last collected lesion assessment, their last visit lesion count is included in the analysis as complete clearance at Week 12.

    Following an assessment of the primary analysis and pre-specified sensitivity analyses, Novan is able to demonstrate through multiple statistical tests and trends that B-SIMPLE1, while not statistically significant, is consistent with and supportive of the B-SIMPLE2 trial and results.

    Management, along with the Board of Directors, continues to explore both financial as well as strategic options in order to continue to progress SB206 for the molluscum indication. As disclosed in the latest 10-Q filing, as of September 30, 2019, the Company had $22.5 million in total cash, cash equivalents and restricted cash, which is targeted to fund operations into the first quarter of 2020, excluding the effect of any potential sales of stock under the Company's stock purchase agreement with Aspire Capital Fund, LLC ("Aspire"), if available. The Company is working to further address current operations with the aim of achieving a reduction in near term cash expenditures. Substantial additional funding will be required in order to continue to sustain business operations.

    The Company, along with the Board of Directors, will provide a further business update in a timely manner and when appropriate.

    Select members of the management team will attend the 7th Annual Dermatology Summit, taking place on January 12, 2020, as well as participate in additional meetings around the 38th Annual J.P. Morgan Healthcare Conference, taking place January 13-16, 2020, both in San Francisco, California.

    Conference Call & Webcast (with Slides)

    Novan will host a webcast tomorrow, Friday, January 3, 2020 at 8:30 am Eastern Time to present top-line efficacy data and sensitivity analyses. There will not be any Q&A and the Company intends to provide a more extensive business update in the near term, upon receipt of the totality of efficacy and safety data from the B-SIMPLE program.

    U.S. toll free: +1 (844) 707-0661
    International: +1 (703) 318-2240
    Conference ID: 8358294

    A live webcast will be accessible from the Events page of the Company's website at http://Events.Novan.com.

    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 of full results of our Phase 3 program to evaluate SB206 for the treatment of molluscum, the outcome of discussions with the FDA regarding our B-SIMPLE program, the timing for a third Phase 3 trial, 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 full results of the Phase 3 program will not be received timely or will not be consistent with our expectations; the risk that the FDA will not agree with our position that the B-SIMPLE2 results can be used to support an NDA alongside results of a third confirmatory trial; the risk that results from a third Phase 3 trial will not be received timely or will not achieve significance sufficient to support an NDA; our ability to obtain funding or enter into strategic relationships on a timely basis, or at all, to enable a third Phase 3 trial and to continue operations; our ability to reduce cash expenditures; our ability to utilize the stock purchase agreement with Aspire; 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; risks related to the manufacture of clinical trial materials; our ability to obtain additional funding or enter into strategic relationships or other business development necessary for the further development of our product candidates; 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, 2018, 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 

    Primary Logo

    View Full Article Hide Full Article
    • Paula Brown Stafford appointed as CEO effective February 2, 2020
    • G. Kelly Martin's term as CEO will end on February 1, 2020, per his employment contract
    • Mr. Martin will step down from the Novan Board of Directors effective February 3, 2020

    MORRISVILLE, N.C., Dec. 18, 2019 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN) today announced that Paula Brown Stafford, currently President and Chief Operating Officer ("COO") of Novan, will succeed G. Kelly Martin as its Chief Executive Officer ("CEO"), effective February 2, 2020, and she will remain a member of the Novan Board of Directors.

    Mr. Martin, as per previous agreement, has a fixed term employment contract that is due to expire on February 1, 2020 and Mr. Martin will…

    • Paula Brown Stafford appointed as CEO effective February 2, 2020
    • G. Kelly Martin's term as CEO will end on February 1, 2020, per his employment contract
    • Mr. Martin will step down from the Novan Board of Directors effective February 3, 2020

    MORRISVILLE, N.C., Dec. 18, 2019 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN) today announced that Paula Brown Stafford, currently President and Chief Operating Officer ("COO") of Novan, will succeed G. Kelly Martin as its Chief Executive Officer ("CEO"), effective February 2, 2020, and she will remain a member of the Novan Board of Directors.

    Mr. Martin, as per previous agreement, has a fixed term employment contract that is due to expire on February 1, 2020 and Mr. Martin will step down as Novan's CEO at that time. Concurrent with the end of his term as CEO, Mr. Martin will also step off the Board of Directors, effective February 3, 2020. Mr. Martin and Ms. Stafford will collaborate to execute a smooth transition of CEO responsibilities.

    Ms. Stafford joined Novan as the Chief Development Officer in March 2017 before being promoted to President and Chief Operating Officer in January 2019. Prior to Novan, Ms. Stafford was President of Clinical Development at Quintiles (now IQVIA). In this role, Ms. Stafford was responsible for global clinical development operations, overseeing approximately 20,000 professionals and reaching $3 billion in annual revenue. While at Quintiles, Ms. Stafford was a member of the Executive Committee, the Technology Investment Committee, and a Board Observer.

    "On behalf of the Board of Directors, we are extremely pleased to have Ms. Stafford assume the role of CEO and lead Novan into its next phase of business progress. Her extensive leadership and career experience are well suited for our CEO role," said Robert Ingram, Executive Chairman of Novan's Board of Directors.

    "I am honored and excited to lead Novan into our next chapter. We have the team in place to continue building on the great progress we've made to date," stated Ms. Stafford. "I look forward to continuing to collaborate with employees, investors, partners and patients as we take next steps together."

    For her outstanding contributions to healthcare and pharmaceutical development, Ms. Stafford was honored with a Distinguished Alumna Award from the University of North Carolina at Chapel Hill in 2016, was invited in July 2014 to provide expert testimony in the U.S. Congressional hearing on the topic of modernizing clinical trials: "21st Century Cures," was named one of the 10 top women in biotech by FierceBiotech in 2012, and in 2011 received the Triangle Business Journal's "Women in Business" award.

    In addition to her role at Novan, Ms. Stafford serves on the board of Health Decisions, Inc. and is an adjunct professor in Public Health Leadership at the Gillings School of Global Public Health at the University of North Carolina at Chapel Hill. Ms. Stafford holds a Bachelor of Science and a Master of Public Health, both from the University of North Carolina at Chapel Hill, with a specialization in Biostatistics.

    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 our next phase of business progress. 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 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 relationships or other business development necessary for the further development of our product candidates; 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, 2018, 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

    Primary Logo

    View Full Article Hide Full Article
  49. Former CEO of NPS Pharmaceuticals brings broad expertise to support Moderna's progress towards late-stage development and commercialization

    Moderna, Inc., (NASDAQ:MRNA) a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that François Nader, M.D., M.B.A. has joined its Board of Directors. Dr. Nader is an experienced biopharmaceutical executive and director with broad expertise across development, regulatory affairs and commercial at NPS Pharmaceuticals (acquired by Shire Plc, now part of Takeda (NYSE: TAK)), as well as Aventis-Pharma and the Pasteur Vaccines division of Rhone-Poulenc, now both part of Sanofi (NASDAQ…

    Former CEO of NPS Pharmaceuticals brings broad expertise to support Moderna's progress towards late-stage development and commercialization

    Moderna, Inc., (NASDAQ:MRNA) a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that François Nader, M.D., M.B.A. has joined its Board of Directors. Dr. Nader is an experienced biopharmaceutical executive and director with broad expertise across development, regulatory affairs and commercial at NPS Pharmaceuticals (acquired by Shire Plc, now part of Takeda (NYSE: TAK)), as well as Aventis-Pharma and the Pasteur Vaccines division of Rhone-Poulenc, now both part of Sanofi (NASDAQ:SNY).

    Concurrently with Dr. Nader's appointment, Peter Barton Hutt, LL.M. has elected to step down after seven years of service to Moderna. Mr. Hutt will remain as a consultant and advisor to the Company.

    "We are focused on continuing to add leaders to our board who understand the complexity of pioneering breakthrough innovations to support the next phase of Moderna's growth," said Noubar Afeyan, Ph.D., Co-Founder and Chairman of Moderna, and CEO of Flagship Pioneering. "François is a value builder with deep experience in vaccine and rare disease therapeutic development and expertise in leading companies from early to late-stage development. As we welcome François, I would like to thank Peter Hutt for the invaluable strategic and regulatory guidance he provided while serving on the board over the last seven years."

    "I am energized by Moderna's culture, science and the impact I believe mRNA medicines will make for patients across a range of therapeutic areas," said Dr. Nader. "I look forward to working with my fellow directors and applying learnings to support Moderna as the team continues generating new clinical data, prepares for pivotal trials and scales to ensure it is ready for commercialization."

    "As Moderna prepares for late-stage development and commercialization of our CMV vaccine, we sought a director with diverse experience across clinical development, regulatory affairs and commercial. François' success in leading late-stage companies as well as his deep experience in infectious and rare diseases make him an important addition to the board as we continue to advance our pipeline," said Stéphane Bancel, Chief Executive Officer of Moderna. "François has an impressive track record of leadership and value creation in the biopharmaceutical sector and I know we will benefit from his perspective. It has been a pleasure to work closely with Peter Hutt during his seven years on the board and I would like to thank him for his contributions to the Company's success."

    Dr. Nader served as President, Chief Executive Officer and Executive Director of NPS Pharmaceuticals from 2008 until 2015, when the company was acquired by Shire. During his tenure as CEO, Dr. Nader transformed NPS Pharma into a leading global biotechnology company focused on delivering innovative therapies to patients with rare diseases. Prior to NPS, Dr. Nader was a venture partner at Care Capital, a venture capital firm. He previously served on Aventis Pharma's North America Leadership Team, holding a number of executive positions in integrated healthcare markets and medical and regulatory affairs. Dr. Nader previously led global commercial operations at the Pasteur Vaccines division of Rhone-Poulenc.

    In addition to serving on the Moderna board of directors, Dr. Nader currently serves as Chairman of the board of directors of Acceleron Pharma (NASDAQ:XLRN), Prevail Therapeutics (NASDAQ:PRVL) and Talaris Therapeutics. He also serves on the Board of Directors of Alexion Pharmaceuticals (NASDAQ:ALXN) and advisor for SVB-Leerink. Dr. Nader is the past Chairman of BioNJ, New Jersey's biotechnology trade organization, and previously served on the board of the Biotechnology Industry Organization (BIO), NPS Pharma (NASDAQ:NPSP), Advanced Accelerator Applications (NASDAQ:AAAP), Baxalta (NYSE:BXLT), Clementia Pharmaceuticals (NASDAQ:CMTA), Trevena (NASDAQ:TRVN) and Noven (NASDAQ:NOVN). In 2013, he was recognized as the Ernst and Young National Life Science Entrepreneur of the Year.

    Dr. Nader earned his French doctorate in medicine from St. Joseph University in Lebanon and a physician executive MBA from the University of Tennessee.

    About Moderna

    Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body's cells to produce intracellular, membrane or secreted proteins that have a therapeutic or preventive benefit with the potential to address a broad spectrum of diseases. Moderna's platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases, independently and with strategic collaborators.

    Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca, Plc. (NASDAQ:AZN) and Merck, Inc. (NASDAQ:MRK), as well as the Defense Advanced Research Projects Agency (NASDAQ:DARPA), an agency of the U.S. Department of Defense and the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Moderna has been named a top biopharmaceutical employer by Science for the past five years. To learn more, visit www.modernatx.com.

    View Full Article Hide Full Article
  50. MORRISVILLE, N.C., Oct. 08, 2019 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN) today announced that the Company's Phase 2 molluscum study, designed to evaluate topical nitric oxide product candidate SB206 for the treatment of molluscum contagiosum, has been published in the Journal of the American Academy of Dermatology ("JAAD"). In this Phase 2 study, SB206 demonstrated clinical efficacy with a favorable safety profile.

    "The publication of this Phase 2 study through a prestigious platform such as JAAD underscores Novan's innovative nitric-oxide technology and provides exposure to the results that supported our decision to progress into a Phase 3 molluscum program. There remains an unmet medical need for an efficacious…

    MORRISVILLE, N.C., Oct. 08, 2019 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN) today announced that the Company's Phase 2 molluscum study, designed to evaluate topical nitric oxide product candidate SB206 for the treatment of molluscum contagiosum, has been published in the Journal of the American Academy of Dermatology ("JAAD"). In this Phase 2 study, SB206 demonstrated clinical efficacy with a favorable safety profile.

    "The publication of this Phase 2 study through a prestigious platform such as JAAD underscores Novan's innovative nitric-oxide technology and provides exposure to the results that supported our decision to progress into a Phase 3 molluscum program. There remains an unmet medical need for an efficacious and well-tolerated treatment that can be applied at home by patients or caregivers," commented Tomoko Maeda-Chubachi, M.D., Ph.D., Novan's Vice President of Medical Dermatology. Dr. Maeda-Chubachi further commented, "We look forward to reporting out the results from our Phase 3 B-SIMPLE pivotal program in the near future."

    Title: "Efficacy and Tolerability of an Investigational Nitric Oxide-releasing Topical Gel in Patients With Molluscum Contagiosum: A Randomized Clinical Trial"
    Authors: Adelaide A. Hebert, Elaine C. Siegfried, Todd Durham, Emily N. de León, Teresa Reams, Elizabeth Messersmith, Tomoko Maeda-Chubachi
    Publication: Journal of the American Academy of Dermatology (Available online 03 October 2019), doi: https://doi.org/10.1016/j.jaad.2019.09.064. [Epub ahead of print]

    Novan continues to target top line results from the ongoing Phase 3 "B-SIMPLE" (Berdazimer Sodium In Molluscum Patients with Lesions) pivotal trials with SB206 for the treatment of molluscum no later than early in the first quarter of 2020.

    About Molluscum Contagiosum

    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 and progress of our Phase 3 program to evaluate SB206 for the treatment of molluscum. 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 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 relationships or other business development necessary for the further development of our product candidates; 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, 2018, 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

    Primary Logo

    View Full Article Hide Full Article
    • Funds to progress women's health product candidate, WH504
    • Additive to recently announced NIH grant for WH602
    • Women's health initiative to focus on potential HPV related onco-virus therapeutics

    MORRISVILLE, N.C., Sept. 20, 2019 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN) today announced that the Company has received a grant from the U.S. Department of Defense's (DoD) Congressionally Directed Medical Research Programs (CDMRP) of approximately $1.1 million as part of its Peer Reviewed Cancer Research Program.

    The grant will support the development of a product candidate (WH504) for the treatment of cervical intraepithelial neoplasia (CIN), with well-characterized physical chemical properties suitable for intravaginal…

    • Funds to progress women's health product candidate, WH504
    • Additive to recently announced NIH grant for WH602
    • Women's health initiative to focus on potential HPV related onco-virus therapeutics

    MORRISVILLE, N.C., Sept. 20, 2019 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN) today announced that the Company has received a grant from the U.S. Department of Defense's (DoD) Congressionally Directed Medical Research Programs (CDMRP) of approximately $1.1 million as part of its Peer Reviewed Cancer Research Program.

    The grant will support the development of a product candidate (WH504) for the treatment of cervical intraepithelial neoplasia (CIN), with well-characterized physical chemical properties suitable for intravaginal administration. In addition, the grant will support the evaluation of the effect of varying concentrations and treatment durations of berdazimer sodium (NVN1000) against HPV-18 in human raft cell culture in vitro studies. There are, currently, no FDA-approved therapeutics indicated to treat CIN. The current standard of care is "watch and wait" or in-office procedures depending on severity. This targeted research aims to create a disease-altering treatment that could be used upon detection and the early signs of high-risk HPV infection to intervene before progression to cervical cancer.

    This grant is in addition to the previously announced National Institute of Health (NIH) Phase 1 grant of approximately $223,000 for the development of a separate product candidate (WH602). Both product candidates will represent core initiatives within the previously announced Novan women's health business unit.

    The views expressed in this press release are those of the Company and may not reflect the official policy or position of the Department of the Army, Department of Defense, or the U.S. Government.

    About Cervical Intraepithelial Neoplasia (CIN)

    Cervical intraepithelial neoplasias (CIN), or precancerous lesions of the cervix caused by persistent high risk-human papilloma virus (HPV) infection, are categorized by HPV genotype and the depth of the infection within the epithelial tissue of the cervix, with grades 1 and 2 considered precancerous and grade 3, carcinoma in situ. While there are an estimated 250,000 to 1 million women diagnosed with CIN annually in the U.S., there are no minimally invasive therapies with direct antiviral activity for the treatment of CIN and excisional procedures are often associated with pain, fertility issues and recurrence. Despite the availability of the prophylactic HPV vaccines, the incidence of HPV-induced cancer is steadily increasing, due to (a) the inability of the vaccine to cure preexisting infections; (b) a great majority of adolescent populations is not vaccinated; and (c) high rate of population growth. According to a survey on U.S. cervical cancer mortality rates, each year, nearly 12,000 women in the U.S. will be diagnosed with cervical cancer and more than 4,000 will die from the cancer.

    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, our intention to advance development of nitric oxide-releasing product candidates and the future prospects of our business and our product candidates. 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; the clinical development process, including, among others, length, expense, ability to enroll patients, reliance on third parties, potential for delays; 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 meet any of the requirements under the grants described above and the uncertainty involved with  government grants, including the successful negotiation and availability of funding for the grants described above or any other grants to support funding for a women's health product candidate; our ability to obtain additional funding or enter into strategic relationships or other business development necessary for the further development of our product candidates; 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, 2018, 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

    Primary Logo

    View Full Article Hide Full Article
  51. MORRISVILLE, N.C., Sept. 11, 2019 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN) today announced that the Compensation Committee of Novan's Board of Directors granted stock options to purchase an aggregate of 25,000 shares of its common stock to a newly-hired employee with a grant date of September 6, 2019. The stock options were granted as an inducement material to the new employee entering into employment with Novan in accordance with Nasdaq Listing Rule 5635(c)(4).

    The stock options have an exercise price of $2.62 per share, the closing price of Novan's common stock on September 6, 2019. Of these awards, 10,000 will vest on June 25, 2020, 7,500 will vest on June 25, 2021 and 7,500 will vest on June 25, 2022, subject…

    MORRISVILLE, N.C., Sept. 11, 2019 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN) today announced that the Compensation Committee of Novan's Board of Directors granted stock options to purchase an aggregate of 25,000 shares of its common stock to a newly-hired employee with a grant date of September 6, 2019. The stock options were granted as an inducement material to the new employee entering into employment with Novan in accordance with Nasdaq Listing Rule 5635(c)(4).

    The stock options have an exercise price of $2.62 per share, the closing price of Novan's common stock on September 6, 2019. Of these awards, 10,000 will vest on June 25, 2020, 7,500 will vest on June 25, 2021 and 7,500 will vest on June 25, 2022, subject to the employee's continued service as an employee or consultant to Novan through the applicable vesting dates. The stock option grants will be subject to terms and conditions generally consistent with the Company's 2016 Incentive Award Plan.

    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 dermatological, women's health and gastrointestinal diseases.

    CONTACT:

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

    Primary Logo

    View Full Article Hide Full Article
  52. MORRISVILLE, N.C., Sept. 05, 2019 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN) today announced that the Company has entered into a Common Stock Purchase Agreement (the "Agreement") of up to $25 million with Aspire Capital Fund, LLC ("Aspire Capital"), a Chicago-based institutional investor.

    Under the terms of the Agreement, Aspire Capital has committed to purchase up to $25 million of common stock of Novan. These purchases would occur at Novan's discretion from time to time during a 30-month period beginning on the effective date of a registration statement filed by Novan with the Securities and Exchange Commission ("SEC") related to the resale of shares to be issued to Aspire Capital. Individual transactions would…

    MORRISVILLE, N.C., Sept. 05, 2019 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN) today announced that the Company has entered into a Common Stock Purchase Agreement (the "Agreement") of up to $25 million with Aspire Capital Fund, LLC ("Aspire Capital"), a Chicago-based institutional investor.

    Under the terms of the Agreement, Aspire Capital has committed to purchase up to $25 million of common stock of Novan. These purchases would occur at Novan's discretion from time to time during a 30-month period beginning on the effective date of a registration statement filed by Novan with the Securities and Exchange Commission ("SEC") related to the resale of shares to be issued to Aspire Capital. Individual transactions would occur at prices based on public market trading of Novan common stock at the time of each sale. As part of the overall Agreement, Novan will retain full control as to the timing and amount of any sale of shares of common stock to Aspire Capital, subject to certain limitations specified in the Agreement.

    There are no warrants, options, financing swaps, derivatives or other securities associated with this Agreement. There are no limitations on the use of proceeds under the terms of the Agreement. Additionally, there are no financial covenants or restrictions on future financings and there are no rights of first refusal, participation rights, penalties or liquidated damages in the Agreement. Lastly, Novan maintains the right to terminate the Agreement at any time, at its discretion, without any additional cost or penalty.

    "This Agreement with Aspire Capital provides Novan with an additional financing tool in the toolbox to both complement non-dilutive capital and allow us to fund specific business platform initiatives," commented Kelly Martin, Chief Executive Officer of Novan. "The benefit of the Agreement is two-fold; it brings in a fundamentally-focused, long-term institutional investor, and as a micro-cap company, allows us to efficiently and opportunistically draw down capital over the next 30 months in a way that will help minimize our overall cost of capital and potential dilution." Martin added that, "the Novan team has earned the confidence of Aspire Capital and its high-quality leadership by making tangible and relevant business progress. We look forward to working with them as we continue to advance our platform."

    Steven Martin, Managing Member of Aspire Capital, commented that, "Novan has, first and foremost, the potential to build-out a unique nitric oxide technology platform that could have clinical applications in any number of therapeutic areas. With compelling clinical data from over 3,000 patients in-hand and several late stage assets, we have a high degree of enthusiasm in reaching this Agreement with the Company." Martin further added that, "the leadership team at Novan is highly unique with its combination of business vision, operating and execution skills, and financial acumen. The team's significant skill and experience was an important factor in our decision to move forward with this investment commitment." As a point of reference, Steven Martin from Aspire Capital and Kelly Martin from Novan are not related in any way.

    This is the latest in a series of important steps forward for the Company. The Agreement with Aspire is additive to the structural advancements made over the last ten months, which includes the expansion of our Japan dermatology partnership with Sato Pharmaceutical Co., Ltd., a royalty agreement for SB206 as a treatment for molluscum contagiosum with Ligand Pharmaceuticals Incorporated, and an asset finance transaction around SB206, SB204 and SB414 with Reedy Creek Investments LLC, both for the North America marketplace.

    As consideration for Aspire Capital's obligation under the Agreement, Novan issued 345,622 shares to Aspire Capital as a commitment fee, representing a dollar value equal to 3% of the aggregate amount authorized under the Agreement. The Company also entered into a Registration Rights Agreement (the "Registration Rights Agreement") with Aspire Capital that requires the Company to file a registration statement covering the resale of the shares that have been and may be issued to Aspire Capital under the Agreement. Additional detail regarding the Agreement and related Registration Rights Agreement is set forth in Novan's Current Report on Form 8-K, filed today with the SEC.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

    About Aspire Capital Fund, LLC

    Aspire Capital Fund, LLC is a Chicago-based, long-only investment fund focused on making open market and direct equity investments in publicly traded companies. Aspire Capital Fund, LLC is managed by Aspire Capital Partners, LLC. Aspire Capital invests in a broad range of industries with a strong emphasis in healthcare and technology.

    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. 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 expectations about our ability to satisfy the conditions under the Agreement and access the financing that may be available thereunder. 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 timing of when we can begin selling shares to Aspire Capital under the Agreement, 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; our ability to obtain additional funding or enter into strategic relationships or other business development necessary for the further advancement and development of our product candidates; changing market and economic conditions; the risk that we will not be able to utilize the full amount of the facility on favorable timing or price terms or otherwise, which may be due to market conditions or restrictions on the aggregate amount we can sell under the Agreement without stockholder approval; the risk that we may not be able to retain our current executive officers and to attract, retain and motivate qualified personnel; 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, 2018, 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

    Primary Logo

    View Full Article Hide Full Article
    • Underscores Company's preparation for potential NDA submission for SB206 in molluscum
    • Role to lead cross-functional coordination of key activities and timelines for the program
    • SB206 top line results are expected no later than early in the first quarter of 2020

    MORRISVILLE, N.C., Sept. 03, 2019 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN) today announced the appointment of Michelle Patterson as Vice President of Project Management.

    In this centrally positioned role, Ms. Patterson will manage the delivery of key product portfolio milestones by integrating work activity across Novan's business functions including regulatory, pre-clinical, clinical, manufacturing and CMC. Ms. Patterson will lead the cross-functional…

    • Underscores Company's preparation for potential NDA submission for SB206 in molluscum
    • Role to lead cross-functional coordination of key activities and timelines for the program
    • SB206 top line results are expected no later than early in the first quarter of 2020

    MORRISVILLE, N.C., Sept. 03, 2019 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN) today announced the appointment of Michelle Patterson as Vice President of Project Management.

    In this centrally positioned role, Ms. Patterson will manage the delivery of key product portfolio milestones by integrating work activity across Novan's business functions including regulatory, pre-clinical, clinical, manufacturing and CMC. Ms. Patterson will lead the cross-functional coordination and orchestration of integrated project plans for the SB206 New Drug Application ("NDA") submission, should the Phase 3 clinical program in molluscum contagiosum be positive. The role will report to Paula Brown Stafford in order to ensure alignment and coordination across functions.

    "Michelle is a highly-qualified and widely recognized industry leader who will have an immediate and positive impact on our Company," commented Paula Brown Stafford, President and Chief Operating Officer of Novan. Ms. Stafford further commented, "With Phase 3 molluscum pivotal trials well underway and results expected no later than early in the first quarter of 2020, Michelle will add tremendous value to our process, approach and project management mindset in order to be prepared for a potential NDA submission. We are lucky to bring her back to Novan and our team is thrilled to have her returning."

    Ms. Patterson brings nearly 20 years of industry project management experience to Novan. Most recently, she served as Senior Director of Program Management with Urovant Sciences. Prior to joining Urovant Sciences, Ms. Patterson served in senior project management roles at Roivant Sciences, Novan, GlaxoSmithKline, BioCryst Pharmaceuticals and Eli Lilly.

    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 dermatological, 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 the future prospects of our business and our product candidates. 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 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 relationships or other business development necessary for the further development or commercialization of our product candidates; 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, 2018, 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

    Primary Logo

    View Full Article Hide Full Article
  53. MORRISVILLE, N.C., Sept. 03, 2019 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN) today announced that it will participate in the H.C. Wainwright 21st Annual Global Investment Conference in New York on Monday, September 9, 2019. Participation will include a Company presentation as well as a Q&A session. The Company will also have a number of one-on-one meetings with investors during the conference.

    The Company presentation will occur on September 9, 2019 at 2:10 p.m. Eastern. The presentation will be webcast live and can be accessed through the Investors section of the Company's website at www.Novan.com. An archived version of the webcast will be available approximately two hours following the live presentation for…

    MORRISVILLE, N.C., Sept. 03, 2019 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN) today announced that it will participate in the H.C. Wainwright 21st Annual Global Investment Conference in New York on Monday, September 9, 2019. Participation will include a Company presentation as well as a Q&A session. The Company will also have a number of one-on-one meetings with investors during the conference.

    The Company presentation will occur on September 9, 2019 at 2:10 p.m. Eastern. The presentation will be webcast live and can be accessed through the Investors section of the Company's website at www.Novan.com. An archived version of the webcast will be available approximately two hours following the live presentation for 7 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 dermatological, women's health and gastrointestinal diseases.

    CONTACT:

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

    Primary Logo

    View Full Article Hide Full Article