novn-20210909
false000146715400014671542021-09-092021-09-09

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
 
 
 CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of report (Date of earliest event reported): September 9, 2021
 _____________________
Novan, Inc.
(Exact name of registrant as specified in its charter) 
 _____________________
Delaware001-3788020-4427682
(State or other jurisdiction of
incorporation)
(Commission
File Number)
(IRS Employer
Identification No.)
4020 Stirrup Creek Drive, Suite 110, Durham, North Carolina 27703
(Address of principal executive offices) (Zip Code)
(919) 485-8080
(Registrant’s telephone number, including area code)
N/A
(Former name or former address, if changed since last report)
 _____________________
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
 
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act: 
Title of Each ClassTrading Symbol(s)
Name of Each Exchange on Which Registered 
Common Stock, $0.0001 par valueNOVNThe Nasdaq Stock Market LLC
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.



Item 8.01. Other Events.

On September 9, 2021, Novan, Inc. (the “Company”) issued a press release announcing its key strategic priorities and providing a general update on its priority pipeline programs. The full text of the Company’s press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Management of the Company will also host a conference call with live audio webcast to discuss the updates at 8:30 AM ET on September 9, 2021. A copy of the presentation that will accompany the call is filed as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.

(d)Exhibits
 
EXHIBIT INDEX
 
Exhibit No.Description
99.1
99.2
104Cover Page Interactive Data File (embedded within the Inline XBRL document)

The inclusion of any website address in this Form 8-K, and any exhibit thereto, is intended to be an inactive textual reference only and not an active hyperlink. The information contained in, or that can be accessed through, such website is not part of or incorporated into this Form 8-K.




SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
Novan, Inc.
Date: September 9, 2021
By:/s/ John M. Gay
John M. Gay
Chief Financial Officer
 


Document
Exhibit 99.1
https://cdn.kscope.io/0a5494a4ccb1d12a1309f12af9649886-novanlogoa06.jpg


Novan Announces Strategic Priorities and Outlines Key Milestones

Company planning for three potential New Drug Application (NDA) filings in three years with the first submission expected in Q3 2022 for lead program SB206 in molluscum contagiosum
Late-stage product candidate, SB204 for the treatment of acne vulgaris, selected to advance as second lead program toward pivotal Phase 3 study
SB019 SARS-CoV-2 development program advancing toward Phase 1 study in healthy volunteers, targeted for 1H 2022
Company to host conference call and webcast today at 8:30 AM ET

DURHAM, N.C. – September 9, 2021 – Novan, Inc. (the “Company” or “Novan”) (Nasdaq: NOVN), today announced its key strategic priorities including its decision to advance late-stage asset, SB204, for the treatment of acne vulgaris as its second lead program. The Company provided a general update and outlined key milestones for its priority pipeline programs in development for the treatment of dermatology and infectious diseases. Novan management will host a conference call and webcast to discuss the updates today, September 9, 2021, at 8:30 a.m. ET (details below).

“This year has been transformational for Novan. Our proprietary and innovative platform, NITRICIL™, has continued to demonstrate robust clinical data and support our confidence in our ability to deliver therapeutic amounts of topical nitric oxide with an attractive safety profile across a number of dermatology and infectious disease indications, in addition to potential applications in animal health. Our recently completed B-SIMPLE4 study of SB206 for the treatment of molluscum has provided validation of our platform technology, demonstrated our ability to execute our clinical development programs effectively and has helped to guide prioritization of our pipeline programs,” stated Paula Brown Stafford, President and Chief Executive Officer.

“We are confident and excited to be advancing SB204 for the treatment of acne vulgaris. As our second lead program, we believe that SB204 has the potential to address an unmet medical need and address a significant market opportunity. We believe Novan is well-positioned to be the world leader in nitric oxide-based science, technology, and clinical development in support of delivering safe and efficacious therapies to patients. We remain committed to leveraging our core synergies of science, human and capital resources and medical need to create value by bringing new nitric oxide-based medicines to market. We believe that our strategic priorities are aligned to help us realize the full potential of Novan,” added Ms. Brown Stafford.

SB206 – A Topical Antiviral Treatment for Molluscum Contagiosum

In June 2021, Novan reported statistically significant positive topline results for the primary endpoint (p-value <0.0001) of complete clearance of all treatable lesions in its B-SIMPLE4 pivotal Phase 3 clinical study of SB206 for the treatment of molluscum. Additionally, and consistent with results from the



Company’s prior Phase 2 and Phase 3 studies, SB206 was found to be safe and well tolerated in the B-SIMPLE4 study. No treatment-related serious adverse events were reported. In July 2021, the Company announced that the last patient had completed their planned Week-24 follow-up visit in the B-SIMPLE4 study. This follow-up visit at Week-24 is intended to further evaluate the safety of SB206, 12-weeks following completion of treatment.

The Company recently announced it has engaged Syneos Health (Nasdaq: SYNH), a fully integrated biopharmaceutical solutions organization, as its commercial solutions provider for SB206 prelaunch strategy and commercial preparation, in addition to sales and marketing support of SB206, if approved by the U.S. Food and Drug Administration (FDA).

Upcoming Targeted Milestones:

Full data readout from the B-SIMPLE4 study, including Week-24 safety, within the next several weeks.
Pre-NDA meeting with the FDA, as well as conduct of stability testing, targeted for 1H 2022.
Potential submission of an NDA targeted for Q3 2022.

The Company believes that SB206 as a topical, at-home administered therapy, with a rapid treatment benefit would address an important patient-care need for the treatment of molluscum.

For more information about the B-SIMPLE4 study, please visit clinicaltrials.gov and reference identifier: NCT04535531.

SB204 – A Novel Multi-factorial Mechanism of Action for the Treatment of Acne Vulgaris

Novan is developing SB204 as a topical monotherapy for the treatment of acne vulgaris. This form of acne represents a multi-factorial disease with varying disease pathology (inflammatory and bacterial). SB204 utilizes the same active pharmaceutical ingredient used in the Company’s lead product candidate, SB206, and it is formulated specifically to address acne via an anti-inflammatory and anti-bacterial mechanism.

In two previous Phase 3 studies, AC301 and AC302, SB204 demonstrated consistent and promising results across two of three co-primary endpoints. In addition, AC302 was a successful pivotal trial with respect to all three co-primary endpoints, including non-inflammatory lesions, inflammatory lesions, and Investigator’s Global Assessment (IGA). Based on the recent positive pivotal Phase 3 results in the SB206 molluscum development program, the Company believes it can optimize the trial design of a pivotal Phase 3 study for SB204 that has the potential to serve as a second pivotal trial to support an NDA submission.

Novan believes that acne has continued to be characterized as an unmet medical need due to the difficulty of balancing efficacy, systemic safety and cutaneous tolerability, as well as growing concerns with anti-bacterial resistance with existing therapies.

Upcoming Targeted Milestones:

Prepare for pivotal Phase 3 study during 2022.



Conduct planned pivotal Phase 3 trial targeted for 2023, subject to obtaining additional financing or strategic partnering.
Potential submission of an NDA targeted for 2024.

SB019 – An Intranasal Formulation for the Treatment of Infectious Disease, COVID-19

In June 2021, Novan announced positive preclinical results demonstrating the anti-viral effect of the Company's NITRICIL™ platform technology, berdazimer sodium, against SARS-CoV-2, the virus that causes COVID-19. To evaluate SB019 as a potential intranasal treatment option for COVID-19, the Company completed preclinical in vivo studies evaluating the effect of berdazimer sodium to reduce viral load in infected animals and to deter viral transmission to uninfected animals. Results from two separate studies independently demonstrated the ability of berdazimer sodium to prevent progression of infection into the lungs following transmission, significantly limiting severity of disease, with statistically significant reduction (p<0.0001) in the amount of virus in the lungs of animals treated with berdazimer sodium at concentrations as low as 2 mg/mL, as compared to placebo-treated control animals. This intranasal treatment was well-tolerated during the preclinical in vivo studies, and no treatment-related adverse events were observed. Additional studies assessing the preclinical toxicology of SB019 in another species have been conducted at a third-party research organization and support the overall safety profile and favorable tolerability of intranasally administered SB019.
Based on the strong preclinical and clinical data demonstrating anti-viral effect of berdazimer sodium against multiple viruses, as well as increasing public health need to reduce breakthrough infections and transmission, the Company plans to advance its SB019 product candidate.

Upcoming Targeted Milestones:

Initiation of Phase 1 study in healthy volunteers targeted for 2022.
Phase 2/3 study(s) targeted for 2023, subject to obtaining additional financing or strategic partnering.
Potential submission of an NDA targeted for 2024.

Conference Call and Webcast Details

As previously announced, Novan will host a corporate update conference call and webcast today, Thursday, September 9th at 8:30 a.m. ET. The call will be led by Paula Brown Stafford, President and Chief Executive Officer of Novan, who will be joined by additional members of the Novan management team. Interested participants and investors may access the conference call by dialing (844) 707-0661 (domestic) or (703) 318-2240 (international) and referencing conference ID: 6243828. The live webcast will be accessible on the Events page of the Investors section of the Novan website, novan.com, and will be archived for 90 days.

About Novan

Novan, Inc. is a pre-commercial nitric oxide-based pharmaceutical company focused on dermatology and anti-infective therapies. We leverage our core synergies of science, capital, resources and patient needs to create value by bringing new nitric oxide-based medicines to market. Our goal is to create the world’s leader in nitric oxide-based science, technology, and clinical translation in support of delivering



safe and efficacious therapies using our proprietary nitric oxide-based technology platform, NITRICIL™ to generate macromolecular New Chemical Entities (NCEs) to treat multiple indications.

Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe,” “expect,” “target,” “anticipate,” “may,” “plan,” “potential,” “will,” and similar expressions, and are based on the Company’s current beliefs and expectations. These forward-looking statements include, but are 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, SB204 and SB019, the potential timing of clinical trials and FDA submission(s), the potential market opportunity for the Company’s product candidates, plans for launch and commercialization of SB206, if approved, and the Company’s intention to partner with third parties. 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 press release, 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.    




INVESTOR AND MEDIA CONTACT:

Jenene Thomas
JTC Team, LLC
833-475-8247
NOVN@jtcir.com    
# # #

a09092021exhibit992
Nitric Oxide-Based Medicine N A S D A Q : N O V N | n o v a n . c o m C O R P O R AT E U P D AT E / S E P T E M B E R 9 , 2 0 2 1 Exhibit 99.2


 
NOVAN.COM 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. 2


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


 
NOVAN.COM AGENDA 4 A Compelling Investment Opportunity Our History of R&D and Innovation Our Near-Term Strategy Our Commercialization Plan Our Full Opportunity Why Novan – Why Now


 
NOVAN.COM 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 5


 
NOVAN.COM THREE NDAs PLANNED OVER THREE YEARS 6 Product Candidate Indication Pre-IND Phase 1 Phase 2 Phase 3 Approval NDA Submission Targeted Novan Revenue 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. 2. Net sales as defined by our existing license and research & development arrangements. 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.


 
NOVAN.COM Potential Value Creation 7 Product Candidate SB206 SB204 SB019 Type Topical Gel Topical Gel Nasal Suspension Indication Molluscum Acne COVID-19 Potential Global Addressable Market ~12 Million1 ~733 Million2 ~134 Million3 Current Treatment Options In-office procedures; off label scripts Antibiotics; tretinoins; combination products Vaccines or antibody cocktails Novan’s Pending Solution Once per day in-home up to 12 weeks Once per day up to 12 weeks with no antibiotic resistance Prophylactic or early treatment in mild to moderate cases 1. Molluscum Contagiosum - Epidemiology Forecast – 2028. Seven Major Markets (U.S., Germany, Spain, Italy, France, the United Kingdom, and Japan from 2017 – 2028). 2. Br J Dermatol. 2015 Jul;172 Suppl 1:3-12. doi: 10.1111/bjd.13462. "A global perspective on the epidemiology of acne" J K L Tan, K Bhate (Estimate of global population affected by acne - 9.4%) 3. Syneos Health Consulting - Preliminary Estimated Target Global Patient Population 2024 (Mild/Moderate) COVID cases per year.


 
NOVAN.COM NITRICIL™ 8 Clinically proven proprietary nitric oxide (NO)-based technology platform Macromolecular New Chemical Entities (NCEs) Storage: ability to store therapeutic quantities of NO Tunability: pH-controlled NO release profiles Targeted: delivery of NO to site of infection or inflammation Stability: druggable form of NO with shelf-life stability Indication specific formulations with differentiated NO release rates Dual phase: coadministration of the active gel with a pH-buffered hydrogel promotes NO release Delivers therapeutic amounts of NO to the site of infection or inflammation with what we believe is an attractive safety profile Berdazimer Sodium (NVN1000) Real-Time NO Release Burst Phase Sustained PhaseRe al -T im e N O Re le as e (n m ol ) Time (Hr) New Chemical Entity (NCE)


 
NOVAN.COM VALUE DRIVERS BEYOND 2024 9 Product Candidate Indication Preclinical Phase 1 Phase 2 Phase 3 DERMATOLOGY SB414 Atopic Dermatitis Psoriasis SB208 Tinea Pedis MEN’S AND WOMEN’S HEALTH SB207 Genital Warts WH504 High-Risk HPV WH602 High-Risk HPV COMPANION ANIMAL NVN4100 Various Ongoing Ongoing Supported by U.S. DoD CDMRP grant Supported by NIH grant Planned next phase of development subject to obtaining additional financing or strategic partnering All activities on hold Provides Opportunity for Global Pipeline Expansion, Business Development and Collaboration


 
STRATEGY TOWARDS DRIVING NEAR-TERM STAKEHOLDER VALUE Leverage core synergies of science, capital, resources and patient needs to create value by bringing new nitric oxide-based medicines to market


 
NOVAN.COM SB206 Molluscum Contagiosum 11 Positive topline results from pivotal Phase 3 with NDA submission targeted Q3 2022


 
NOVAN.COM MOLLUSCUM MARKET POTENTIAL FOR SB206 Contagious skin infection caused by the molluscipoxvirus, a double-stranded DNA virus 12 High unmet medical need for topical at-home solution Prevalence rate in children 0-16 years old is 5.1% - 11.5% in the U.S.1 U.S. addressable market of ~6 million2 The most used molluscum treatments (procedures) are reimbursed on the medical benefit side We believe reimbursement for SB206 (on formulary) is expected given lack of competitors and favorable efficacy, safety profile 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).


 
NOVAN.COM PIVOTAL PHASE 3: PRIMARY EFFICACY ENDPOINT 13 Complete Clearance of Lesions 0.9% 3.6% 11.6% 19.7% 1.4% 7.2% 19.6% 32.4% 0.0% 5.0% 10.0% 15.0% 20.0% 25.0% 30.0% 35.0% Week 2 Week 4 Week 8 Week 12 Vehicle SB206 p-value <0.05 p-value <0.01 p-value <0.001 p-value <0.0001 * ** *** **** **** ** * 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.


 
NOVAN.COM PIVOTAL PHASE 3: SECONDARY ENDPOINTS 14 90% Clearance and 0 or 1 Remaining Lesions at Week 12 0.00% 5.00% 10.00% 15.00% 20.00% 25.00% 30.00% 35.00% 40.00% 45.00% 50.00% 90% Clearance at Week 12 0 or 1 Lesions at Week 12 Vehicle SB206 ******** p-value <0.0001****


 
NOVAN.COM PIVOTAL PHASE 3: SECONDARY ENDPOINT - CHANGE AT WEEK 4 15 -60% -50% -40% -30% -20% -10% 0% BL Week 2 Week 4 Week 8 Week 12 Vehicle SB206 p-value <0.05 p-value <0.01 p-value <0.001 p-value <0.0001 * ** *** **** **** **** **** *** % Change From Baseline Lesion Count


 
NOVAN.COM PATH TOWARDS POTENTIAL APPROVAL 16 SB206 Targets to be the First FDA-Approved, In-Home Topical Treatment for Molluscum Finalize B-SIMPLE4 Week-24 Readout 3Q 2021 1H 2022 3Q 2022 Launch Pre-Commercial Activities NDA-Enabling Stability Testing Pre-NDA Meeting with FDA Submit New Drug Application


 
NOVAN.COMNOVAN.COM 17 SB206 COMMERCIALIZATION PLAN Commercialization of SB206 with Syneos Health’s Integrated Support Model, if Approved End-to-end commercial solution provider with proven track record of supporting successful commercial launches Provides immediate access to robust, existing commercial infrastructure with deep dermatology expertise Analytical approach to market research, patient journey and segmentation work to strategically position SB206 Novan will utilize a small group of internal experts to provide oversight and control of commercial execution


 
NOVAN.COM SB206 COMMERCIAL APPROACH 18 • Communication • Education • Evidence Base • Early Engagement • Economic Burden • Commercial Formulary • Digital Health • Build the brand • Establish Differentiation • Efficiently Target Stakeholders • Amplify Reach Generate data and build the holistic evidence story Engage stakeholders to build awareness, advocacy and access Execute in the marketplace to drive adoption


 
NOVAN.COM COMPETITIVE LANDSCAPE 191. Syneos Health Consulting Primary (n=40 Pediatricians, n=39 Dermatologists, n=4 Pediatric Dermatologists) and Secondary Research (2019) Today, approximately 1.3 million new U.S. cases diagnosed annually1 Potential Therapy Characteristics Topical – SB206 In-home treatment Safety profile Tolerability Primary care or pediatrician prescribed Therapy Characteristics Procedures – (cyro, curettage, cantharidin) Multiple in-office treatments Burning Pain / Scarring Primarily performed by dermatologist or pediatric dermatologist Tolerability of existing treatments remains a concern with Pediatricians and Dermatologists1


 
NOVAN.COM SB204 Acne Vulgaris Late-stage asset with two completed Phase 3 studies Priority Pipeline Expansion 20


 
NOVAN.COM SB204: ADVANCE DEVELOPMENT FOR ACNE VULGARIS Potential advantages over other topical therapies for the most common form of acne 21 Multi-factorial mechanism of action, including anti-bacterial and anti-inflammatory Convenience of once daily application Excellent local tolerability and favorable safety profile Non-bleaching, non-staining and non-irritating Elimination of patient, parental and societal concerns arising from antibiotic resistance Same active pharmaceutical ingredient as used in SB206 for molluscum yet formulated specifically for acne


 
NOVAN.COM DATA FROM POSITIVE PHASE 3 STUDY 22*Analysis includes all patients who were randomized. Absolute changes in lesion count reduction are shown as LSMean NI-AC302 ITT* (n = 1327) Non-Inflammatory Lesion Reduction SB204 -14.8 Vehicle -12.1 p-value p=0.001 Inflammatory Lesion Reduction SB204 -12.8 Vehicle -10.5 p-value p<0.001 Investigator Global Assessment Success SB204 18.9% Vehicle 14.3% p-value p=0.038


 
NOVAN.COM SB204 Acne Vulgaris: Why we are planning for success 23 FDA GUIDANCE: JUST ONE MORE PIVOTAL PHASE 3 TRIAL AC302 was a successful pivotal Phase 3 trial across all three co-primary endpoints Consistent results across AC301 and AC302 for two of three co-primary endpoints Positive B-SIMPLE4 results validated our technology and our effective study execution New study design and execution to be optimized through learnings across previous Phase 3 studies


 
NOVAN.COM REGULATORY PATH FOR SB204 IN ACNE 24 Targeted Timeline: Two Phase 3 studies completed in 2017 One pivotal Phase 3 study to be conducted Size of trial estimated to include >1,000 patients 3 co-primary endpoints (non-inflammatory lesions, inflammatory lesions, IGA success) Prepare for Pivotal Study Execute Pivotal Study Submit NDA 2022 2023 2024


 
NOVAN.COM ACNE VULGARIS MARKET POTENTIAL We believe among dermatology health-care providers there remains a significant unmet need for novel mechanisms of action with favorable tolerability profiles to improve patient outcomes in acne 25 ~50 million people with acne in the U.S.1 Topical U.S. acne market (products and combos) is approximately $2.9 Billion 2 Acne has significant physical and psychological morbidity, such as permanent scarring, poor self-image, depression and anxiety 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


 
NOVAN.COM SB019 COVID-19 26 Phase 1 in healthy volunteers in 1H 2022


 
NOVAN.COM SB019: Advance Development for COVID-19 Intranasal administration may reduce viral burden in the nasal epithelium and lead to reduced transmission, disrupted disease progression, and alleviated symptoms 27 Nitric oxide known to have potent anti-viral properties 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


 
NOVAN.COM REGULATORY PATH FOR SB019 IN COVID-19 28 Pre-clinical IND enabling studies completed1 Candidate formulation administered intranasally in animals Berdazimer sodium well-tolerated up to the maximum dose tested Drug-device combination in development for potential Phase 2/3 study(s) 1. Assumes pre-clinical studies completed to date are all that is required to initiate Phase 1 in human volunteers. Targeted Timeline: Execute Phase 1 Study in Healthy Volunteers 2022 2023 2024Execute Phase 2/3 Study(s) in Patients Submit New Drug Application


 
NOVAN.COM The Full Opportunity Building a fully integrated dermatology and anti-infectives company 29


 
NOVAN.COM ROBUST IP PROTECTION Over 35 issued US patents, over 125 issued non-US patents and over 85 pending applications throughout the world 30 NITRICIL™ Technology Patent Expiration1 Composition of Matter to 2026 Method of Manufacture to 2032 Formulation Science Formulation Composition and Manufacture to 2032 or 2033 Admixture Composition to 2034 Therapeutic Uses Methods of Reducing Sebum Production to 2031 Topical Antiviral Compositions and Methods of Using the Same to 2035 1. Expiry dates do not take into account any patent term extensions that may be available to Novan.


 
NOVAN.COM MILESTONES IN NEXT 12 MONTHS 31 2H 2021 1H 2022 Final Safety Results B-SIMPLE4 for SB206 Launch Pre-Commercial Activities for SB206 Submit SB019 Pre-IND Initiate Phase 1 with SB019 SB206 Pre-NDA Meeting with FDA Submit SB206 NDA


 
NOVAN.COM FULLY INTEGRATED TEAM SPECIFICALLY DESIGNED TO EXECUTE STRATEGY 32 Tomoko Maeda-Chubachi, MD, Ph.D., MBA Chief Medical Officer John M. Gay, CPA Chief Financial Officer Carri Geer, Ph.D. Chief Technology Officer Paula Brown Stafford, MPH Chairman and Chief Executive Officer Leveraging Extensive Network of Partners and Collaborators


 
NOVAN.COM NOVAN PRIDE UNDERPINS OUR EFFORTS 33


 
NOVAN.COM Why Novan, Why Now A world leader in nitric oxide-based science, technology, and clinical translation in support of delivering safe and efficacious therapies 34 NITRICIL™ technology platform allows stable, tunable, and targeted delivery of therapeutic quantities of NO Robust body of data with nearly 4,000 treated subjects supporting anti-microbial and anti-inflammatory properties Significant potential market opportunity with SB206 for the treatment of molluscum contagiosum Confidence to prioritize SB204 for the treatment of acne vulgaris as second lead candidate Near-term inflection point with SB019 pre-IND submission and Phase 1 initiation Significant upside potential with the full platform Three NDAs Planned Over Three Years


 
Nitric Oxide-Based Medicine N A S D A Q : N O V N | n o v a n . c o m INVESTOR RELATIONS JTC Team 833.475.8247 novn@jtcir.com Thank You!