Nitric Oxide-Based Medicine

C O R P O R AT E P R E S E N TAT I O N / S E P T E M B E R 2 0 2 1

N A S D A Q : N O V N | n o v a n . c o m

FORWARD-LOOKING STATEMENTS

This presentation contains forward-looking statements including, but not limited to, statements related to the potential therapeutic value of the Company's NITRICIL™ platform technology, the Company's pharmaceutical development of nitric oxide-releasing product candidates, including SB206, the Company's strategic direction for development, the potential timing of FDA submission(s), the potential market opportunity for our product candidates, plans for launch and commercialization of SB206, if approved, the Company's expected cash runway and the Company's intention to partner with third parties. These forward-looking statements are included throughout this presentation, and the Company uses the words "believe," "expect," "target," "anticipate," "may," "plan," "potential," "will," and similar expressions to identify forward-looking statements in this presentation. Such statements are based on the Company's current beliefs and expectations. Forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from the Company's expectations, including, but not limited to, risks related to the regulatory approval process, which is lengthy, time-consuming and inherently unpredictable, including the risk that the FDA will not agree with the Company's approach to a potential NDA submission, that the Company's product candidates may not be approved or that additional studies may be required for approval or other delays may occur, that the Company may not have sufficient quantities of drug substance and/or drug product to support regulatory submissions and that the Company may not obtain funding sufficient to complete the regulatory or development process; the Company's limited experience as a company in obtaining regulatory approvals and commercializing pharmaceutical products; changes in the size and nature of the market for our product candidates, including potential competition; risks and uncertainties in the Company's ongoing or future product development activities and preclinical studies, which may not prove successful in demonstrating proof-of concept, or may show adverse toxicological findings, and even if successful may not necessarily predict that subsequent clinical trials will show the requisite safety and efficacy of the Company's product candidates; any operational or other disruptions as a result of the COVID-19 pandemic; the Company's ability to obtain additional funding or enter into strategic or other business relationships necessary or useful for the further development or commercialization of the Company's product candidates; risks related to the manufacture of raw materials, including the Company's active pharmaceutical ingredient and drug product components utilized in clinical trial materials, including supply chain disruptions or delays, failure to transfer technology and processes to third parties effectively or failure of those third parties (or the Company in connection with the upfit of the Company's new facility) to obtain approval of and maintain compliance with the FDA or comparable regulatory authorities; the Company's reliance on arrangements with third parties to support its operations and development efforts and the risk that such parties will not successfully carry out their contractual duties or meet expected deadlines; and other risks and uncertainties described in the Company's annual report filed with the Securities and Exchange Commission on Form 10-K for the twelve months ended December 31, 2020, and in the Company's subsequent filings with the Securities and Exchange Commission. Such forward-looking statements speak only as of the date of this presentation, and Novan disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements, except as may be required by law.

Certain information contained in this presentation relates to or is based on studies, publications, surveys and other data obtained from third-party sources and the Company's own estimates and research. While the Company believes these third-party sources to be reliable as of the date of this presentation, it has not independently verified, and makes no representation as to the adequacy, fairness, accuracy or completeness of or that any independent source has verified, any information obtained from third-party sources.

NOVAN.COM

2

A world leader in nitric oxide-based science, technology, and clinical translation in support of delivering safe and efficacious therapies

A COMPELLING INVESTMENT

OPPORTUNITY

Clinically proven platform technology, NITRICIL™

Robust body of data with nearly 4,000 treated subjects supporting anti-microbial and anti-inflammatory properties

Positive topline results from pivotal Phase 3 study of SB206 in patients with molluscum contagiosum

Previous results from pivotal Phase 3 study of SB204 in acne vulgaris give confidence to prioritize as second lead candidate

Positive preclinical data of SB019 in COVID-19

Management team with proven track record of execution

Potential to address multi-billion-dollar collective U.S. market

NOVAN.COM

4

THREE NDAs PLANNED OVER THREE YEARS

Product

Indication

Pre-IND

Phase 1

Phase 2

Phase 3 Approval

NDA Submission

Novan Revenue

Candidate

Targeted

Retention2

DERMATOLOGY

SB206

Molluscum

Q3 2022

~85% N. America3

>95% ROW (ex. Japan4)

SB204

Acne Vulgaris

20241

~95% N. America

>95% ROW (ex. Japan4)

INFECTIOUS DISEASE

SB019

SARS-CoV-2

20241

>95% Worldwide

1.

Company has expected cash runway into Q4 2022.

NOVAN.COM

2.

Net sales as defined by our existing license and research & development arrangements.

5

3.

Based on aggregate net sales royalty rates, excludes maximum potential milestone payments of ~$21m.

4.

Based on Sato Pharmaceutical Co., Ltd. amended license agreement for SB206 and SB204 in Japan.

This is an excerpt of the original content. To continue reading it, access the original document here.

Attachments

  • Original document
  • Permalink

Disclaimer

Novan Inc. published this content on 09 September 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 09 September 2021 14:41:01 UTC.