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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. announced its transfer to the Nasdaq Capital Market, effective November 5, 2020, after receiving approval due to meeting market value requirements. The company has been granted an additional 180-day grace period, until May 3, 2021, to comply with the $1.00 minimum bid price requirement. Novan plans to monitor this requirement and will consider options like a reverse stock split if necessary. The company's significant product candidate, SB206, is currently in a pivotal Phase 3 study for treating molluscum contagiosum.
Novan, Inc. (NASDAQ: NOVN) reported its Q3 2020 financial results, highlighting a net loss of $8.4 million, an improvement from $9.5 million a year prior. The company is actively advancing its lead candidate, SB206, in the B-SIMPLE4 Phase 3 study for molluscum contagiosum, with completion targeted for Q1 2021 and topline results expected in Q2 2021. Additionally, Novan demonstrated in vitro antiviral effects of its NITRICIL platform against SARS-CoV-2 and initiated exploratory research for antimicrobial applications in companion animal health. The company reported cash reserves of $43.1 million, deemed sufficient to fund operations through Q4 2021.
Novan, Inc. (Nasdaq: NOVN) will host a live video webcast KOL Roundtable on October 27, 2020, at 12:00 PM ET, featuring management members and KOL John Browning, MD. The discussion will focus on Novan's proprietary nitric oxide-based technology platform, NITRICIL™, which aims to address unmet medical needs in dermatology and other fields. Participants include CEO Paula Brown Stafford and CTO Carri Geer. A replay will be available shortly after the event on the company’s website for up to a year. One-on-one meetings with management can also be scheduled.
Novan, Inc. (Nasdaq: NOVN) announced promising results from in vitro studies demonstrating that its NITRICIL™ technology can effectively reduce SARS-CoV-2 viral load in a model resembling human airway epithelium. The findings showed a 90% reduction in viral presence using berdazimer sodium at concentrations as low as 0.75 mg/mL. The company aims to initiate CMC work to develop an intranasal formulation for COVID-19 treatment, targeting a potential IND filing in 2021. These results suggest high potential for clinical application of nitric oxide as an antiviral therapeutic.
Novan, Inc. (Nasdaq: NOVN) has appointed John M. Gay as Chief Financial Officer, succeeding in his previous role as Vice President, Finance and Corporate Controller. Gay has over 20 years of experience in financial management and will lead the financial strategy that supports the advancement of SB206, a pivotal Phase 3 clinical study for molluscum contagiosum targeted for Q2 2021 data release. Additionally, James L. Bierman, former CEO and CFO of Owens & Minor, has joined the Board of Directors, bringing extensive strategic expertise.
Novan, Inc. (NASDAQ: NOVN) provided an update on its product pipeline, focusing on SB206, its lead candidate undergoing a pivotal Phase 3 study for molluscum contagiosum, with topline data expected in Q2 2021. Additionally, the company is assessing its NITRICIL™ platform for inhibiting SARS-COV-2 replication and exploring antimicrobial potentials in companion animal health. The Phase 3 study aims for enrollment completion by Q1 2021. Novan aims to expand its pipeline across dermatology and other health areas with unmet needs.
Novan, Inc. (Nasdaq: NOVN) announced a presentation by President and CEO Paula Brown Stafford at the H.C. Wainwright 22nd Annual Global Investment Conference on September 14, 2020, at 4:00 PM EDT. The conference will feature virtual one-on-one meetings for registered investors. A live video webcast of the presentation will be accessible on Novan's investor website, with a replay available two hours post-event and archived for 90 days. Novan focuses on developing nitric oxide-based treatments for various diseases, including dermatology and women’s health.
Novan announced the enrollment of the first patient in its pivotal Phase 3 clinical trial, B-SIMPLE4, for SB206, a topical gel targeting molluscum contagiosum. This common skin infection affects around six million Americans annually, primarily children. Currently, there are no FDA-approved treatments available. The trial aims to evaluate SB206's efficacy, with topline results expected by Q2 2021. The company emphasizes the unmet medical need for effective molluscum treatments. The trial's progress may be affected by COVID-19, with patient enrollment expected to conclude by Q1 2021.
Novan, Inc. initiated the B-SIMPLE4 pivotal Phase 3 trial for SB206, a topical gel for treating molluscum contagiosum, affecting 6 million people annually in the U.S., primarily children. The study aims to enroll 750 patients across 45 sites, assessing treatment efficacy at Week 12. If successful, SB206 could address a significant unmet need, as there are currently no FDA-approved treatments. Topline results are expected in late Q2 2021. The trial's progress may be influenced by the COVID-19 pandemic.
Novan, Inc. (NASDAQ: NOVN) announced on July 28, 2020, an expanded role for CEO Paula Brown Stafford as Chairman of the Board, highlighting the Board’s confidence in her leadership. Robert Ingram will retire as Executive Chairman but remain on the Board. Under Stafford's leadership since February 2020, Novan has focused on advancing its B-SIMPLE4 pivotal trial. Ingram acknowledged Stafford's strategic vision and successful execution as critical to the company’s growth. Novan specializes in developing nitric oxide-based treatments for unmet medical needs in dermatology and other areas.
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