NVN Liquidation Inc (fka NOVNQ)

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Novan Receives Phase 2 NIH Federal Grant of Approximately $1.0 Million

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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.