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

  1. Prevalence in the US of 5.1% to 11.5% in children aged 0-16 years. (Fam Pract. 2014 Apr;31(2):130-6).
  2. 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

  1. 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.
  2. 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.