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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.
On March 16, 2023, Novan (NASDAQ: NOVN) announced the closing of a registered direct offering, raising approximately $6 million. The offering involved 5,042,017 shares of common stock and warrants, priced at an effective combined purchase price of $1.19 per share. The warrants will be exercisable after six months at an exercise price of $1.20, lasting for five years. Novan intends to allocate the proceeds to fund its berdazimer gel (SB206) development, support sales and marketing, and cover general working capital. The offering was facilitated by H.C. Wainwright & Co. and follows the use of a shelf registration statement with the SEC.
Novan, Inc. (Nasdaq: NOVN) announced a presentation by CEO Paula Brown Stafford at the virtual Oppenheimer 33rd Annual Healthcare Conference on March 14, 2023, at 10:40 AM ET. The event aims to connect management with qualified investors through one-on-one meetings.
A live video webcast of the presentation will be available on Novan's website, along with a replay accessible for 90 days. The company focuses on innovative therapeutic products for skin diseases, notably pursuing FDA approval for berdazimer gel, 10.3% for treating molluscum contagiosum, while also utilizing its NITRICIL™ technology for future treatments.
Novan, Inc. (Nasdaq: NOVN) has announced a registered direct offering of 5,042,017 shares of common stock, along with warrants to purchase the same number of shares, at an effective price of $1.19 per share. The gross proceeds are estimated at $6 million. These funds will support the development of berdazimer gel, 10.3% (SB206), marketing efforts, and other operational expenses. The offering is set to close around March 16, 2023. Additionally, existing warrants will be amended to have a reduced exercise price of $1.20 per share. This offering is part of a shelf registration statement effective since February 2022.
Novan, Inc. (Nasdaq: NOVN) has announced that its commercial subsidiary, EPI Health, will rebrand as Novan, creating a unified corporate identity ahead of the potential commercial launch of berdazimer gel, 10.3% (SB206). This integration follows Novan's acquisition of EPI Health in early 2022, which provided necessary commercial infrastructure to promote its lead product effectively. The FDA has accepted Novan's New Drug Application for berdazimer gel targeting molluscum contagiosum. The company aims to address unmet medical needs in dermatology with its proprietary nitric oxide-based technology platform, NITRICIL.
Novan, Inc. announced that the FDA accepted its New Drug Application (NDA) for berdazimer gel, 10.3%, aimed at treating molluscum contagiosum. The FDA found no filing issues, allowing a substantive review to begin. With a PDUFA goal date set for January 5, 2024, Novan is poised to launch this product if approved. The company has assembled a robust commercial team and infrastructure to support the anticipated launch, highlighting the therapeutic potential of this New Chemical Entity (NCE). CEO Paula Brown Stafford emphasized the significance of this milestone for shareholders.
Novan, Inc. (Nasdaq: NOVN) announced that its CEO, Paula Brown Stafford, will present at the Virtual Investor 2023 Companies to Watch Event on January 19, 2023, at 12:00 PM ET. A live video webcast of this presentation will be available on Novan’s website, with a replay accessible for 90 days post-event. Novan is focused on innovative therapies for skin diseases, including berdazimer gel for viral skin infections, and has a robust commercial infrastructure following the acquisition of EPI Health. The company continues to leverage its proprietary nitric oxide-based technology platform, NITRICIL™, for developing new treatments.
Ligand Pharmaceuticals (NASDAQ: LGND) announced that its partner Novan, Inc. (NASDAQ: NOVN) has submitted a New Drug Application (NDA) for berdazimer gel, 10.3%, targeting molluscum contagiosum. The FDA approval is anticipated in Q1 2024, pending acceptance of the filing. This gel may become the first FDA-approved treatment for this viral skin infection affecting around 6 million people in the U.S., predominantly children. If approved, Ligand could receive up to
Novan, Inc. (Nasdaq: NOVN) announced the submission of a New Drug Application (NDA) to the FDA for berdazimer gel, 10.3% for the treatment of molluscum contagiosum, a contagious viral skin infection affecting around 6 million U.S. individuals, mainly children. If approved, this will be the first FDA-approved prescription product for molluscum. The Company anticipates potential approval in Q1 2024, based on positive Phase 3 study results demonstrating significant efficacy. There is currently no FDA-approved treatment available for this condition.
Novan, Inc. (NASDAQ: NOVN) announced a significant licensing agreement with Sato Pharmaceutical Co., Ltd. for the development and marketing of RHOFADE® (oxymetazoline hydrochloride 1% cream) for rosacea in Japan. EPI Health, a subsidiary of Novan, will receive $5 million upfront, $2.5 million upon regulatory approval, and royalties from net sales. The partnership aims to enhance Novan's revenue-generating products and addresses the Japanese market's dermatological needs. RHOFADE® is an FDA-approved topical treatment proven to reduce facial redness in rosacea patients.
Novan (Nasdaq: NOVN) announced a new $15 million accounts receivable-backed factoring agreement with Bay View Funding to enhance working capital for its subsidiary EPI Health. This non-dilutive funding will allow Novan to support ongoing operations and align with strategic goals. The agreement enables access to cash flow, utilizing up to 70% of EPI Health's gross eligible receivables. This funding follows a memorandum for potential out-licensing of the Rhofade product in Japan, aiding Novan's commercial growth initiatives.
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