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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 Acquires EPI Health for $27.5 Million
Novan, Inc. (NASDAQ: NOVN) has announced its acquisition of EPI Health, a specialty pharmaceutical company focused on dermatology, for a total upfront payment of $27.5 million. This includes $11 million in cash and $16.5 million in a seller's note. The deal aims to enhance Novan's commercial infrastructure to facilitate the launch of its lead candidate, SB206, for molluscum contagiosum, conditional on regulatory approval. EPI Health had 2021 revenues of $17.6 million and strengthens Novan's presence in the dermatological market.
Novan reported its financial results for the year ended December 31, 2021, showing a net loss of $29.7 million, slightly up from $29.3 million in 2020. The company aims to submit a New Drug Application (NDA) for its lead product, SB206 (berdazimer gel 10.3%), by Q4 2022. Significant milestones include advancements in its clinical pipeline for SB204 (acne) and SB019 (COVID-19), with pivotal studies planned. Despite a decrease in license revenue to $2.8 million, cash reserves stood at $47.1 million as of year-end. The company is expanding its team to bolster commercialization efforts.
Novan (Nasdaq: NOVN) will release its full year 2021 financial results on February 22, 2022. The management team, led by CEO Paula Brown Stafford, will hold a conference call at 8:30 a.m. ET to discuss both operational and financial outcomes. Investors can participate by calling (844) 707-0661 domestically or (703) 318-2240 internationally, using conference ID: 4368839. The live audio webcast will be available on the Novan website and archived for 90 days. Novan focuses on nitric oxide-based therapies in dermatology and anti-infectives.
Novan, Inc. (Nasdaq: NOVN) announced the presentation of data from its Phase 2 and Phase 3 studies on berdazimer 10.3% gel during the 2022 Winter Clinical Dermatology Conference in Hawaii. This gel is aimed at treating molluscum contagiosum, a viral skin condition impacting around 6 million Americans, primarily children. If approved, it would be the first FDA-sanctioned treatment for this condition. The data includes efficacy and safety results from the Phase 2 study and novel inflammation data from three Phase 3 studies, indicating potential advancements in treatment.
Novan, Inc. (Nasdaq: NOVN) will host a Virtual Investor Roundtable Event on November 17, 2021, at 1:00 PM ET, featuring CEO Paula Brown Stafford and a pediatric dermatology expert.
The event will include a presentation, a moderated discussion, and a live Q&A session, allowing investors to submit questions. The webcast will be accessible on the Company's website and will be available for replay for one year.
Novan focuses on developing nitric oxide-based therapies in dermatology and anti-infective treatments.
Novan (Nasdaq: NOVN) announced its Q3 2021 financial results and corporate updates, reporting a net loss of $6.5 million, a reduction from $8.4 million in Q3 2020. The company ended the quarter with $60 million in cash, sufficient to fund operations into Q4 2022. Key developments include plans for three New Drug Applications (NDAs) in three years, with SB206 targeting molluscum contagiosum and positive safety data for SB019 against COVID-19. Novan aims for a pivotal Phase 3 study of SB204 for acne in 2023 and expects NDA submissions for SB206 in Q3 2022 and SB204 in 2024.
Novan has announced positive preclinical results for its intranasal formulation SB019 containing berdazimer sodium, indicating it is well-tolerated in a 14-day GLP toxicity study. These findings support the advancement of SB019 toward human clinical trials, with an IND submission planned by Q2 2022. The study showcased significant efficacy in reducing SARS-CoV-2 transmission in preclinical models, suggesting potential for COVID-19 and other respiratory infections. The company is focused on obtaining financing and strategic partnerships to further develop this therapy.
Novan, Inc. (Nasdaq: NOVN) announced progress in its development pipeline during a fireside chat led by CEO Paula Brown Stafford. The company is preparing for a potential NDA submission for SB206, targeting a Q3 2022 filing for molluscum contagiosum treatment. Novan plans to submit three NDAs within three years, focusing on its proprietary nitric oxide-based NITRICIL™ platform to develop new therapies. The company emphasizes collaboration with Syneos Health for commercialization efforts.
Novan, Inc. (NASDAQ: NOVN) will report its Q3 2021 financial results on November 10, 2021, followed by a conference call at 8:30 a.m. ET. The call, led by President and CEO Paula Brown Stafford, will provide insights into the company’s operational and financial performance. Participants can join by dialing (844) 707-0661 (domestic) or (703) 318-2240 (international), referencing conference ID: 1142988. The live audio webcast will be available on the Novan website and archived for 90 days.
Novan, Inc. (Nasdaq: NOVN) has appointed Brian M. Johnson as Chief Commercial Officer, marking his return to the role he previously held from 2015 to 2018. Johnson brings over 30 years of experience in dermatology. The company also announced that the FDA has conditionally accepted KINSOLUS™ as the brand name for SB206, a topical antiviral gel aimed at treating molluscum contagiosum. The New Drug Application (NDA) for SB206 is on track for submission in Q3 2022, crucial for potentially addressing a significant unmet medical need.
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