NASDAQ: NOVN | novan.com
Nitric Oxide-Based Medicine
Why Novan, Why Now
A world leader in nitric oxide-based science, technology, and clinical translation in support of delivering safe and efficacious therapies
Clinically proven NITRICIL™ technology platform allows stable, tunable, and targeted delivery of therapeutic quantities of nitric oxide (NO)
Robust body of data with nearly 4,000 treated subjects supporting anti-microbial and anti-bacterial properties
Potential to address multi-billion dollar U.S. market
THREE NDAs PLANNED OVER THREE YEARS | |||||||||
Product | Indication | Pre-IND Phase 1 Phase 2 Phase 3 Approval | NDA Submission | ||||||
Candidate | Targeted | ||||||||
DERMATOLOGY | |||||||||
SB206 | Molluscum | Q3 2022 | |||||||
SB204 | Acne Vulgaris | 2024¹ | |||||||
INFECTIOUS DISEASE
SB019 | SARS-CoV-2 | 2024¹ | |||||
1. Company has expected cash runway into Q4 2022.
INVESTOR RELATIONS | JTC Team // 833.475.8247 // novn@jtcir.com |
NASDAQ: NOVN | novan.com
Prevalence rate in | U.S. addressable market | ||||
children 0-16 years old is | |||||
of ~6 million² | |||||
5.1%-11.5%¹ in the U.S. | |||||
SB206 | PIVOTAL PHASE 3: PRIMARY EFFICACY ENDPOINT AT WEEK 12 | ||||
35.0% | Complete Clearance of Lesions | ||||
Molluscum | 32.4% | ||||
30.0% | |||||
Contagiosum | 25.0% | ||||
Positive topline results from pivotal Phase 3 with NDA submission targeted Q3 2022
20.0% | 19.6% | 19.7% | ||||||
Vehicle | ||||||||
15.0% | SB206 | |||||||
11.6% | ||||||||
10.0% | ||||||||
7.2% | ||||||||
5.0% | 3.6% | p-value <0.05 | ||||||
0.9% | 1.4% | p-value <0.01 | ||||||
p-value <0.001 | ||||||||
0.0% | p-value <0.0001 | |||||||
Week 2 | Week 4 | Week 8 | Week 12 | |||||
- Prevalence in the US of 5.1% to 11.5% in children aged 0-16 years. (Fam Pract. 2014 Apr;31(2):130-6).
- Molluscum Contagiosum - Epidemiology Forecast - 2028. Seven Major Markets (U.S., Germany, Spain, Italy, France, the United Kingdom, and Japan from 2017 - 2028).
Note: Two previously completed Phase 3 studies posted directionally similar results and one or both will be included in the NDA submission as confirmatory to the above, B-SIMPLE4 efficacy results.
SB204
Acne Vulgaris
Late-stage asset with two completed Phase 3 studies
~50 Million
people with acne in
the U.S.¹
Topical U.S. acne market (products and combos) is approximately
$2.9 Billion²
Same active pharmaceutical ingredient as used in SB206 for molluscum yet formulated specifically for acne
Potential advantages over other topical therapies for the most common form of acne
Excellent local tolerability and favorable safety profile
- Bickers DR, Lim HW, Margolis D, Weinstock MA, Goodman C, Faulkner E et al. The burden of skin diseases: 2004 a joint project of the American Academy of Dermatology Association and the Society for Investigative Dermatology. Journal of the American Academy of Dermatology 2006;55:490-500.
- IMS National Prescription Audit MAT Feb. 2016 - Acne Prescription Market TRx Dollars - MAT Feb 2016
SB019
COVID-19
Phase 1 in healthy volunteers in 1H 2022
Strong preclinical and clinical data demonstrate anti-viral effect of berdazimer sodium against multiple viruses
In vitro and in vivo studies have demonstrated anti-viral effect of berdazimer sodium against SARS-CoV-2
Public health need to reduce breakthrough infections and transmission
Intranasal administration of SB019 may reduce viral burden in the nasal epithelium and lead to reduced transmission, disrupted disease progression, and alleviated symptoms
INVESTOR RELATIONS | JTC Team // 833.475.8247 // novn@jtcir.com |
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Novan Inc. published this content on 22 October 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 22 October 2021 15:53:11 UTC.