Novan, Inc. (Form: 8-K, Received: 06/11/2021 06:42:12)

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of report (Date of earliest event reported): June 11, 2021

_____________________

(Exact name of registrant as specified in its charter)

_____________________

Delaware

001-37880

20-4427682

(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)

(Registrant’s telephone number, including area code)

(Former name or former address, if changed since last report)

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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)
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Securities registered pursuant to Section 12(b) of the Act:


Title of Each Class	Trading Symbol(s)	Name of Each Exchange on Which Registered
Common Stock, $0.0001 par value	NOVN	The 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 x

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. x

Item 7.01. Regulation FD Disclosure.

Novan, Inc.’s (the “Company”) management will host a video webcast at 8:00 AM ET on June 11, 2021 to discuss the top-line results from its pivotal Phase 3 clinical trial of SB206 for the treatment of molluscum contagiosum. A copy of the presentation that will accompany the webcast is being furnished as Exhibit 99.2, which is incorporated herein by reference.

The information set forth in Item 7.01 and Exhibit 99.2 is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

Item 8.01. Other Events.

On June 11, 2021, the Company issued a press release announcing top-line results from its pivotal Phase 3 clinical trial of SB206 for the treatment of molluscum contagiosum. 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.

Item 9.01. Financial Statements and Exhibits.



Exhibit No.						Description




99.1						Press Release dated June 1 1 , 2021.

99.2						Company Presentation.

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.

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: June 11, 2021

By:

/s/ John M. Gay

John M. Gay

Chief Financial Officer

Novan Reports Positive Topline Results from Pivotal Phase 3 Trial of SB206 in Patients with Molluscum Contagiosum

– B-SIMPLE4 achieves statistical significance for the primary endpoint with p-value less than 0.0001 –

– No serious adverse events related to treatment with SB206 –

– Novan intends to submit New Drug Application (“NDA”) no later than the third quarter of 2022 –

– Management to host video webcast today at 8:00 a.m. ET –

DURHAM, N.C. – June 11, 2021 – Novan, Inc. (“the Company” or “Novan”) (Nasdaq: NOVN), today announced positive topline efficacy and safety results for the B-SIMPLE4 pivotal Phase 3 clinical study of SB206, a topical antiviral gel, for the treatment of molluscum contagiosum (“molluscum”). Molluscum is a common, contagious skin infection caused by the molluscipoxvirus, affecting approximately six million people in the U.S. annually, with the greatest incidence in children aged one to 14 years. The Company will host a video webcast, today, June 11, 2021, at 8:00 a.m. ET (details below) to discuss the results of the study.

“The positive results from B-SIMPLE4 represent a transformational milestone for our employees, investors and most importantly, people living with molluscum. The strong safety and statistically significant efficacy results give us confidence as we move forward in preparing a New Drug Application to potentially bring SB206 to market and to patients in need of an effective therapy,” commented Paula Brown Stafford, President and Chief Executive Officer of Novan. “We owe a great deal of gratitude to the collaborative efforts of our employees, partners, CROs, study investigators and participating patients who have contributed or participated in B-SIMPLE4.”

B-SIMPLE4 is a multi-center, double-blind, randomized, vehicle-controlled study that exceeded its enrollment target by randomizing 891 patients (1:1 randomization) in the study, across 55 clinical sites. Patients were treated for up to 12 weeks with a follow-up visit at Week 24. The primary endpoint for the study is the proportion of patients with complete clearance of all treatable molluscum lesions at Week 12 (Intent-to-Treat or “ITT” population, where the analysis assumes that patients with missing data at Week 12 are considered treatment failures).

Summary of the primary and secondary endpoint results are as follows:


	B-SIMPLE4
	SB206 (N=444)	Vehicle (N=447)	p-value
Primary Endpoint: Complete Clearance of All Lesions at Week 12	32.4%	19.7%	p<0.0001

Secondary Endpoint: Proportion Achieving a Lesion Count of 0 or 1 at Week 12	43.5%	24.6%	p<0.0001

Secondary Endpoint: Proportion Achieving >90% Clearance of Lesions at Week 12	43.0%	23.9%	p<0.0001

Secondary Endpoint: Complete Clearance of All Lesions at Week 8	19.6%	11.6%	p=0.0014

Consistent with results from the Company’s Phase 2 and earlier Phase 3 studies, SB206 was found to be safe and well tolerated. No treatment-related serious adverse events (“TEAE”) were reported.

Tomoko Maeda-Chubachi, M.D., Ph.D., M.B.A., Senior Vice President, Medical at Novan added, “This is an exciting day for both Novan, the treatment landscape of molluscum and the millions of people, primarily children, affected every year. These results are a testament to Novan’s solid execution of the SB206 clinical program and strategy, and our belief in the potential of SB206 to provide patients with treatment benefit. With 32% of patients experiencing total clearance at Week 12 and 43% of patients with total clearance or one remaining lesion at Week 12, I am pleased to say the data demonstrate SB206 can be a powerful treatment option to shorten the duration of this contagious disease with visible skin lesions that worry parents and caregivers.”

“I am proud to have been an investigator in this pivotal study. The results are better than I could have imagined. I am excited to potentially have a topical treatment that is safe and effective in treating molluscum for my patients,” stated John Browning, M.D., F.A.A.D, F.A.A.P., MBA, Adjunct Associate Professor of Pediatrics and Dermatology at UT Health San Antonio and Baylor College of Medicine, and a Principal Investigator in the B-SIMPLE4 study.

There are currently no U.S. Food and Drug Administration (“FDA”) approved therapies for the treatment of molluscum. The Company believes that SB206 as a topical, at-home, self or caregiver-applied therapy with a rapid treatment benefit, if approved, would satisfy 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.

Conference Call and Webcast Details

The Novan management will host a video webcast presentation for investors, analysts, and other interested parties today, Friday, June 11, 2021, at 8:00 a.m. ET. 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.

Novan, Inc. is a clinical development-stage biotechnology company focused on leveraging its proprietary nitric oxide (NO) based technology platform, NITRICIL™ to generate macromolecular New Chemical Entities (NCEs) to treat multiple indications in dermatology, men’s and women’s health, infectious diseases and gastroenterology conditions with significant unmet needs. The Company’s lead product candidate, SB206, a topical antiviral gel, for the treatment of molluscum contagiosum, is currently being evaluated in the B-SIMPLE4 pivotal Phase 3 clinical study. The Company believes that SB206 as a topical, at-home, caregiver-applied therapy with a rapid treatment benefit, if approved, would address an important patient-care need for the treatment of molluscum.

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,” “intends” 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, and the potential timing of an NDA submission. 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; the Company’s ability to obtain additional funding or enter into strategic or other business relationships necessary or useful for the further development or, following regulatory approval, commercialization of the Company’s product candidates; 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; any operational or other disruptions as a result of the COVID-19 pandemic; 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:

Nitric Oxide-Based Medicine novan.com NASDAQ: NOVN SB206: B-SIMPLE4 Top-Line Results June 11, 2021 Exhibit 99.2

Forward-Looking Statements This presentation contains forward-looking statements including, but not limited to, statements related to the potential therapeutic value of our NITRICIL™ platform technology, our pharmaceutical development of nitric oxide-releasing product candidates, including SB206, the potential timing of an NDA submission, the commercial prospects of SB206, our expected cash runway and our intention to partner with third parties. These forward-looking statements are included throughout this presentation. We have used the words “anticipate,” “assume,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “future,” “will,” “seek,” “foreseeable,” “targeted” and similar terms and phrases to identify forward- looking statements in this presentation. Forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from our 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 our approach a potential NDA submission, our product candidates may not be approved or that additional studies may be required for approval or other delays may occur, that we may not have sufficient quantities of drug substance and/or drug product to support regulatory submissions and that we may not obtain funding sufficient to complete the regulatory or development process; our limited experience as a company in obtaining regulatory approvals and commercializing pharmaceutical products; our ability to obtain additional funding or enter into strategic or other business relationships necessary or useful for the further development or, following regulatory approval, commercialization of our product candidates; our ability to enter into arrangements with third parties to support our development or commercialization efforts on terms that are acceptable to us or at all; risks and uncertainties in the clinical development process, including, among others, length, expense, ability to enroll patients, potential for delays or other impacts, whether as a result of the COVID-19 pandemic or other factors, and that results of earlier research and preclinical or clinical trials may not be predictive of results, conclusions or interpretations of later research activities or additional trials; any operational or other disruptions as a result of the COVID-19 pandemic; risks related to the manufacture of raw materials, including our 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 us in connection with the upfit of our new facility) to obtain approval of and maintain compliance with the FDA or comparable regulatory authorities; our reliance on arrangements with third parties to support our operations and development efforts and the risk that such parties will not successfully carry out their contractual duties or meet expected deadlines; volatility in the price of our common stock; and other risks and uncertainties described in our annual report filed with the SEC on Form 10-K for the twelve months ended December 31, 2020, and in our subsequent filings with the SEC. These 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. 2

Agenda 3 • B-SIMPLE4: study design and demographics • Top-line efficacy: B-SIMPLE4 primary and secondary results • SB206 and molluscum indication: B-SIMPLE4 and B-SIMPLE2 • Molluscum market overview and commercial strategy

Treatment 12 Weeks Follow-up at Week 24 4 B-SIMPLE4 Pivotal Phase 3 Study Design in Molluscum Study Design Based on Learnings from B-SIMPLE1 and B-SIMPLE2: One and two-subject household stratification Inflammation of molluscum lesions added as a stratification factor1 Additional patient and caregiver training and retention efforts 1. As measured by BOTE (beginning of the end). Multi-center, double-blind, randomized, vehicle-controlled study Randomization891 Subjects (Aged 6-mos and older) Primary endpoint: Complete clearance of all treatable molluscum lesions Commenced Study in September 2020 With Last Week-12 Visit April 2021

Study Demographics and Disposition1 5 The B-SIMPLE4 pivotal trial was balanced across treatment arms and consistent with B-SIMPLE2 1. This table will be updated post completion of Week 24 data analysis and study closeout. 2. Intent-to-Treat Population (ITT): consists of all subjects who were randomized. SB206 Vehicle ITT Population2 444 447 Completed the 12 Week Treatment Period 394 400 Week 12 Premature Discontinuation 11.3% 10.5% Number of Sites (n=55) % Dermatologists 58.6% 59.3% Age (years) Mean 6.6 6.5 % Ages 2 to 17 95.0% 96.0% Gender Female 51.4% 47.7% Male 48.6% 52.3% Baseline Lesion Count Mean (Median) 23.1 (18.5) 20.5 (15.0)

B-SIMPLE4: ITT Population1 6 Positive study with robust clinical evidence of efficacy Primary Endpoint: Complete Clearance of All Lesions at Week 12 Secondary Endpoint: Proportion Achieving a Lesion Count of 0 or 1 at Week 12 SB206 (N=444) B-SIMPLE4 19.6% 11.6% Secondary Endpoint: Complete Clearance of All Lesions at Week 8 Secondary Endpoint: Proportion Achieving >90% Clearance of Lesions at Week 12 p=0.0014 43.0% 32.4% 19.7% p<0.0001 43.5% 24.6% p<0.0001 p<0.000123.9% Vehicle (N=447) p-value 1. Intent-to-Treat Population (ITT): consists of all subjects who were randomized.

Two Phase 3 Trials: Complete Clearance at Week 121 7 Approximately a 31% increase in treatment difference from B-SIMPLE2 to B-SIMPLE4 1. Intent-to-Treat Population (ITT): consists of all subjects who were randomized. 20.3% 19.7% 30.0% 32.4% 0.0% 5.0% 10.0% 15.0% 20.0% 25.0% 30.0% 35.0% 40.0% B-SIMPLE2 B-SIMPLE4 Vehicle SB206 p<0.0001 12.7% (N=355) (N=891) % o f p at ie nt s w ith c om pl et e cl ea ra nc e of a ll tr ea ta bl e m ol lu sc um le si on s at W ee k 12 9.7%

Summary of Adverse Events During 12-Week Treatment1 8 B-SIMPLE4 B-SIMPLE2 SB206 (N=444) Vehicle (N=447) SB206 (N=237) Vehicle (N=117) Subjects with at least one Treatment Emergent Adverse Event (TEAE) 189 (42.6%) 103 (23.0%) 120 (50.6%) 29 (24.8%) Subjects with at least one Serious TEAE 0 1 (0.2%) 1 (0.4%) 1 (0.9%) Subjects with at least one TEAE leading to Study Drug Discontinuation 17 (3.8%) 3 (0.7%) 17 (7.2%) 1 (0.9%) Maximum Severity Mild 106 (23.9%) 75 (16.8%) 51 (21.5%) 18 (15.4%) Moderate 79 (17.8%) 26 (5.8%) 64 (27.0%) 10 (8.5%) Severe 4 (0.9%) 2 (0.4%) 5 (2.1%) 1 (0.9%) 1. Safety Population consists of all patients who received drug any time during the treatment phase of the study. Note: results provided through Week 12 visit, final safety profile will be updated through Week 24 and is targeted to be released in 3Q 2021.

Summary of Treatment-Emergent Adverse Events 9 Note: through Week 12 visit, final safety profile will be updated through Week 24 and is targeted to be released in 3Q 2021. B-SIMPLE4 B-SIMPLE2 SB206 (N=444) Vehicle (N=447) SB206 (N=237) Vehicle (N=117) System Organ Class/Preferred Term Subjects[1] Subjects[1] Subjects[1] Subjects[1] Subjects with at least one TEAE 189 (42.6%) 103 (23.0%) 120 (50.6%) 29 (24.8%) General disorders and administration site conditions 169 (38.1%) 66 (14.8%) 85 (35.9%) 17 (14.5%) Application site pain 83 (18.7%) 23 (5.1%) 36 (15.2%) 2 (1.7%) Application site erythema 51 (11.5%) 6 (1.3%) 26 (11.0%) 0 Application site pruritus 33 (7.4%) 5 (1.1%) 8 (3.4%) 2 (1.7%) Application site exfoliation 26 (5.9%) 0 9 (3.8%) 0 Application site dermatitis 25 (5.6%) 3 (0.7%) 11 (4.6%) 1 (0.9%) [1] At each level of summation (overall, system organ class, preferred term), subjects reporting more than one adverse event are counted only once.

SB206: Summary of B-SIMPLE Results 10 B-SIMPLE4 was a positive Phase 3 study with robust clinical data SB206 demonstrates clinical evidence of efficacy B-SIMPLE2 will be included as the confirmatory trial per FDA guidance received in April 2020 We have confidence to move forward with NDA preparation and potential submission ✓ ✓ ✓ ✓

SB206: Next Steps 11 All safety data including the prospectively planned safety evaluation through Week 24, targeted to be available in 3Q 2021 Intend to utilize B-SIMPLE4 as the pivotal Phase 3 trial and B-SIMPLE2 as the confirmatory trial for New Drug Application ("NDA") submission1 Potential NDA submission remains consistent with previous timelines and targeted no later than 3Q 2022 1. Subject to discussions with the U.S. Food and Drug Administration (FDA).

Molluscum: The Unmet Medical Need 12 No FDA-Approved Treatments ~3.4 million prevalence in the U.S.1 ~1.3 million diagnosed per annum1 ~70% of patients below the age of 10 Average time to resolution 13 Months SB206: Potential to be the First FDA Approved Patient or Caregiver Administered Topical Therapy for Molluscum Contagiosum 1. Syneos Health Consulting Primary (n=40 Pediatricians, n=39 Dermatologists, n=4 Pediatric Dermatologists) and Secondary Research (2019).

SB206 Commercialization Strategy 13 Evaluating All Strategic Options Goal: Maximize Value Novan Commercializes Secure Commercialization Partner Co-Commercialize with Partner

THANK YOU!!! 14 Employees Patients Investigators Partners InvestorsCROs

Q&A 15

Nitric Oxide-Based Medicine Investor Relations JTC Team 833.475.8247 novn@jtcir.com novan.com NASDAQ: NOVN


			(d)			Exhibits