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Novan, Inc. is a clinical-stage biotechnology company pioneering the use of nitric oxide’s natural antiviral and immunomodulatory properties to develop treatments for dermatological and oncovirus-mediated diseases. By harnessing the unique potential of nitric oxide in a solid form that can be conveniently deployed on demand in localized formulations, Novan aims to significantly enhance patient outcomes in various disease areas.
Novan's innovative approach allows it to address unmet medical needs by focusing on dermatological conditions and oncovirus-mediated diseases. The company's pipeline includes therapeutic candidates designed to treat conditions such as acne, psoriasis, and antiviral applications.
Recently, Novan announced the sale of substantially all its assets for $15 million in cash, subject to approval by the Bankruptcy Court. This transaction will include the repayment of the DIP credit facility, with the remaining cash paid at closing. The sale process is governed by the APA and includes procedures for higher or better offers, ensuring compliance with court-approved bidding procedures.
Novan's strategic partnerships and collaborations with leading pharmaceutical companies reflect its commitment to advancing its clinical programs and expanding its therapeutic portfolio. Despite financial challenges, Novan continues to pursue its mission of improving patient care through groundbreaking biotechnological innovations.
Novan, Inc. (NASDAQ: NOVN) announced data from its Phase 3 trials for SB206, a topical treatment for molluscum contagiosum, will be presented at the Society for Investigative Dermatology's virtual meeting from May 3-8, 2021. The integrated data from trials B-SIMPLE1 and B-SIMPLE2 will have an ePoster presentation on May 5, 2021. Molluscum contagiosum affects approximately six million people in the U.S. annually, primarily children, with no FDA-approved treatments available. This presentation aims to highlight the significant unmet needs in molluscum treatment.
Novan, a clinical development-stage biotechnology company, will have its President and CEO, Paula Brown Stafford, present at the virtual H.C. Wainwright Global Life Sciences Conference on March 9-10, 2021. Registered participants can engage in one-on-one meetings with management. A video webcast of the presentation will be available on-demand starting March 9 at 7:00 AM ET for 90 days on Novan's website. Novan is focused on its nitric oxide-based technology platform, NITRICIL™, with its lead product candidate, SB206, aimed at treating molluscum contagiosum.
Novan, Inc. (Nasdaq: NOVN) announced the election of Steven D. Skolsky to its Board of Directors, bringing over 35 years of experience in healthcare and life sciences. His expertise includes commercialization and product development, crucial as Novan approaches key data from its pivotal Phase 3 B-SIMPLE4 study for SB206, a treatment for molluscum contagiosum. Skolsky has a successful track record, including significant revenue growth at previous companies. His appointment is seen as vital for Novan's strategy and future commercialization efforts.
Novan, Inc. (Nasdaq: NOVN) reported its financial performance for 2020, highlighting a total cash balance of $35.9 million and a significant accumulated deficit of $249.3 million. The Company has completed patient enrollment in its pivotal Phase 3 trial, B-SIMPLE4, for SB206, with top-line efficacy data expected by Q2 2021. Despite net losses of $29.3 million in 2020, Novan is optimistic about upcoming milestones, including the initiation of preclinical studies on a COVID-19 treatment, SB019, and potential strategic partnerships to enhance growth.
Novan has completed patient enrollment in the pivotal Phase 3 clinical study B-SIMPLE4 for SB206, a topical gel aimed at treating molluscum contagiosum, a contagious skin infection affecting around six million people annually in the U.S. The study, which exceeded its target enrollment of 850 patients, will assess the treatment's efficacy over 12 weeks. Topline results are expected by the end of Q2 2021. Currently, there are no FDA-approved treatments for this condition, indicating a significant unmet need that SB206 aims to address.
Novan, Inc. (Nasdaq: NOVN) announced compliance with Nasdaq's minimum bid price requirement, with shares closing at $1.00 or greater for ten consecutive business days, from January 14 to January 28, 2021. This notification reflects the company's successful reinstatement on the Nasdaq Capital Market. Novan, focusing on nitric oxide-based therapies, is developing SB206, a topical antiviral gel for molluscum contagiosum, currently in the pivotal Phase 3 B-SIMPLE4 study, aimed at addressing significant patient-care needs.
Novan, Inc. (NASDAQ: NOVN) announced that enrollment for its pivotal Phase 3 study, B-SIMPLE4, evaluating SB206 for treating molluscum contagiosum, has reached 90% of the targeted 850 subjects. The enrollment began in September 2020, with topline data expected in Q2 2021. Additionally, Novan has signed a lease for a new corporate headquarters in Durham, North Carolina, to enhance its cGMP activities, including R&D and small-scale manufacturing. CEO Paula Brown Stafford highlighted the company's progress and commitment to addressing unmet needs in patient care.
Novan, Inc. (Nasdaq: NOVN) announced that Paula Brown Stafford, the President and CEO, will engage in a fireside chat at the H.C. Wainwright BioConnect 2021 Virtual Conference from January 11-14. The chat will be available on-demand starting January 11 at 6:00 AM ET for registered attendees, for a duration of 90 days on their website. Novan focuses on developing nitric oxide-based therapies for various medical conditions, with its lead candidate, SB206, currently in a pivotal Phase 3 study for molluscum contagiosum.
Novan, Inc. (NASDAQ: NOVN) has entered into a Master Services Agreement with Catalent to support the development of an intranasal formulation of berdazimer sodium for its COVID-19 program. The collaboration aims to initiate preclinical Investigational New Drug studies in Q1 2021. Early results from in vitro assessments suggest that berdazimer sodium reduced 90% of the SARS-CoV-2 virus in a 3-D tissue model. The company targets filing an IND application with the FDA and commencing human clinical trials in H2 2021, contingent on obtaining further funding.
Novan, Inc. (Nasdaq: NOVN) has announced the enrollment of 525 patients in its B-SIMPLE4 pivotal Phase 3 clinical study of SB206, a topical gel for treating molluscum contagiosum, with a target of 850 enrollees. The study aims to determine the gel's effectiveness, with topline results expected in Q2 2021. Molluscum contagiosum affects approximately six million people in the U.S. annually, primarily children. This trial is significant as there are currently no FDA-approved treatments available for molluscum, highlighting a critical unmet medical need.
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