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): February 6, 2020
 _____________________
Novan, Inc.
(Exact name of registrant as specified in its charter) 
 _____________________
 
 
 
 
 
 
 
 
Delaware
 
001-37880
 
20-4427682
 
 
(State or other jurisdiction of
incorporation or organization)
 
(Commission
File Number)
 
(I.R.S. Employer
Identification No.)
 
4105 Hopson Road, Morrisville, North Carolina 27560
(Address of principal executive offices) (Zip Code)
(919) 485-8080
(Registrant’s telephone number, include 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 Class
Trading Symbol(s)
Name of Each Exchange on Which Registered 
Common Stock, $0.0001 par value
NOVN
Nasdaq Global Market
Indicate by check mark whether the registrant is an emerging growth company as defined in 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 8.01. Other Events.

On February 6, 2020, Novan, Inc. (the “Company”) issued a press release providing a SB206 program and business update. 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.
On February 6, 2020 the Company also published a corporate presentation on its website at www.Novan.com. The corporate presentation is furnished herewith as Exhibit 99.2 to this Current Report and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.

 
(d)
Exhibits
 
EXHIBIT INDEX
 
 
 
 
Exhibit No.
 
Description
 
 
99.1
 
 
 
 
99.2
 
 
 
 

 
The inclusion of Novan’s 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 Novan’s website are 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: February 6, 2020
 
 
 
By:
 
/s/ John M. Gay
 
 
 
 
 
 
John M. Gay
 
 
 
 
 
 
Vice President, Finance
 



Exhibit 99.1

Novan Provides SB206 Program and Business Update
FDA grants Type C meeting for SB206 to be held on April 1, 2020
Last subject completes last visit, Week 24 safety evaluation
Additional 12-week efficacy and safety data provided
MORRISVILLE, N.C. - February 06, 2020 - Novan, Inc. (“the Company” or “Novan”) (Nasdaq:NOVN) today provided an update on several aspects of its Phase 3 B-SIMPLE program (B-SIMPLE1 and B-SIMPLE2).
Novan has been granted a Type C meeting with the U.S. Food and Drug Administration (“FDA”) on April 1, 2020. The Type C Meeting is to seek FDA feedback on the proposal to conduct one additional, well-controlled confirmatory study of SB206 to support a future New Drug Application (“NDA”).
In the Company’s Phase 3 B-SIMPLE program with SB206 for the treatment of molluscum contagiosum, the last subject completed their final visit as part of the ongoing safety evaluation through Week 24. Top-line efficacy results from this program were announced on January 2, 2020, and full efficacy and safety data, including data from the safety evaluation through Week 24, are targeted to be available in March 2020.
The safety profile of SB206 through the Week 12 visit was found to be favorable. Adverse events experienced in the B-SIMPLE program were primarily mild to moderate and the only treatment emergent adverse events (TEAE) reported in greater than 5% of subjects in the SB206 treatment arm were application site pain and application site erythema. There were no treatment-related serious adverse events reported in B-SIMPLE1 or B-SIMPLE2.
 
B-SIMPLE1
B-SIMPLE2
 
SB206 (n=235)
Vehicle (n=116)
SB206 (n=237)
Vehicle (n=117)
Subjects with at least one…
TEAE
115 (48.9%)
36 (31.0%)
120 (50.6%)
29 (24.8%)
TEAE leading to study drug discontinuation
7 (3.0%)
1 (0.9%)
17 (7.2%)
1 (0.9%)
Maximum severity of TEAE at any visit
Mild
60 (25.5%)
25 (21.6%)
51 (21.5%)
18 (15.4%)
Moderate
50 (21.3%)
10 (8.6%)
64 (27.0%)
10 (8.5%)
Severe
5 (2.1%)
1 (0.9%)
5 (2.1%)
1 (0.9%)
Subjects treated with SB206 (n=472, integrated safety population) experienced a lower occurrence of scarring (3.8%), as determined by the investigator, through the Week 12 visit when compared to vehicle (n=233, integrated safety population; 7.3%). Final safety profile and scarring assessments will be updated through Week 24 and are targeted to be released in March 2020.
Additional post-hoc analyses of efficacy data were performed and identified discordant data in two-subject households (two subjects randomized to the same treatment arm within one household) in both studies. In two-subject households, a greater clearance response rate in vehicle was experienced when compared to SB206 in both B-SIMPLE1 and B-SIMPLE2. Both B-SIMPLE studies were stratified across treatment groups by household, two-subject or one-subject. The post-hoc analyses of the one-subject households are summarized below:






Complete Clearance of all Molluscum Lesions at Week 12 (ITT, One-Subject Households Only)
Pivotal Study
SB206
Vehicle
p-Value
B-SIMPLE1
28.7%
(n=181)
19.1%
(n=89)
0.116
B-SIMPLE2
29.0%
(n=193)
16.7%
(n=96)
0.025

In the integrated primary analysis (combining data from B-SIMPLE1 and B-SIMPLE2), a treatment effect of 7.0% was observed, which includes subjects from one and two-subject households. When looking at one-subject households only (excluding the data from the discordant two-subject households), the treatment effect increases to 11.1%.

Primary Endpoint: Complete Clearance of all Molluscum Lesions at Week 12 (ITT)
Integrated Analysis
SB206
Vehicle
p-Value
One and Two-Subject Households
27.9%
(n=473)
20.9%
(n=234)
0.049
One-Subject Households Only
28.9%
(n=374)
17.8%
(n=185)
0.005

Management, along with the Board of Directors, continues to explore both financial as well as strategic options in order to continue operations and to progress SB206 for the molluscum indication, subject to funding and FDA feedback. The Company intends to pursue financing, which may be dilutive, non-dilutive or both, in the near future and intends to engage one or more financial advisors to assist in this financial and strategic process.
About Novan
Novan, Inc. is a clinical development-stage biotechnology company focused on leveraging nitric oxide’s naturally occurring anti-microbial and immunomodulatory mechanisms of action to treat a range of diseases with significant unmet needs. We believe that our ability to deploy nitric oxide in a solid form, on demand and in localized formulations allows us the potential to improve patient outcomes in a variety of dermatology, women’s health and gastrointestinal diseases.
Forward-Looking Statements
This press release contains forward-looking statements including, but not limited to, statements related to pharmaceutical development of nitric oxide-releasing product candidates and our intention to advance development of certain product candidates, including the timing of full results of our Phase 3 program to evaluate SB206 for the treatment of molluscum, the outcome of discussions with the FDA regarding our B-SIMPLE program, the timing for a third Phase 3 trial, the timing of potential regulatory submissions, our needs for funding and our intention to pursue financing and strategic alternatives. 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, the risk that full results of the Phase 3 program will not be received timely or will not be consistent with our expectations; the risk that the FDA will not agree with our position that the B-SIMPLE2 results can be used to support an NDA alongside results of a third confirmatory trial; the risk that results from a third Phase 3 trial will not be received timely or will not achieve significance sufficient to support an NDA; our ability to obtain funding or enter into strategic relationships on a timely basis, or at all, to enable or complete a third Phase 3 trial and to continue operations; our ability to reduce cash expenditures; our ability to utilize the stock purchase agreement previously entered with Aspire Capital Fund, LLC; risks and uncertainties in the clinical development process, including, among others, length, expense, ability to enroll patients, reliance on third parties, potential for delays 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; risks related to the regulatory approval process, which is lengthy, time-consuming and inherently unpredictable, including the risk that our product candidates may not be approved or that additional studies may be required for approval or other delays may occur and that we may not obtain funding sufficient to complete the regulatory or development process; risks related to the manufacture of clinical trial materials; our ability to obtain additional funding or complete other strategic alternatives necessary to continue our business and/or the further development of our product candidates; 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, 2018, and in our subsequent filings with the SEC. These 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.
CONTACT:
(Investors & Media)
Cole Ikkala
Director, Investor Relations, Communications & Business Development
cikkala@novan.com


# # #



Exhibit 99.2 Corporate Overview February 2020 1


 
Forward-Looking Statements This presentation includes forward-looking statements that reflect our current views with respect to, among other things, our plans to develop and commercialize our product candidates, including our interpretation of preclinical and clinical studies and the success and timing of our product development activities and clinical trials, such as the timing of full results of our Phase 3 program to evaluate SB206 for the treatment of molluscum contagiosum, the outcome of discussions with the U.S. Food and Drug Administration (“FDA”) regarding our B-SIMPLE program, the timing for a third Phase 3 trial, the timing of potential regulatory submissions, and our needs for funding and our intention to pursue financing and strategic alternatives. 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. The forward-looking statements contained in this presentation are based on management’s current expectations and are subject to substantial risks, uncertainty and changes in circumstances. Actual results may differ materially from these expectations due to risks and uncertainties including, but not limited to: the risk that full results of the Phase 3 program will not be received timely or will not be consistent with our expectations; the risk that the FDA will not agree with our position that the B-SIMPLE2 results can be used to support an NDA alongside results of a third confirmatory trial; the risk that results from a third Phase 3 trial will not be received timely or will not achieve significance sufficient to support an NDA; our ability to obtain funding or enter into strategic relationships on a timely basis, or at all, to enable or complete a third Phase 3 trial and to continue operations; our ability to reduce cash expenditures; our ability to utilize the stock purchase agreement previously entered with Aspire Capital Fund, LLC; risks and uncertainties in the clinical development process, including, among others, length, expense, ability to enroll patients, reliance on third parties, potential for delays 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; risks related to the regulatory approval process, which is lengthy, time-consuming and inherently unpredictable, including the risk that our product candidates may not be approved or that additional studies may be required for approval or other delays may occur and that we may not obtain funding sufficient to complete the regulatory or development process; risks related to the manufacture of clinical trial materials; our ability to obtain additional funding or complete other strategic alternatives necessary to continue our business and/or the further development of our product candidates; and other risks and uncertainties described in our annual report filed with the SEC on Form 10-K for the twelve months ended Dec. 31, 2018, and in any subsequent filings with the SEC. Any forward-looking statement made by us in this presentation speaks only as of the date of this presentation. We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. 2


 
Proprietary Nitricil™ Technology Creation of macromolecular New Chemical Entities (NCEs) that possess unique nitric oxide (NO) release profiles that can be tailored to different therapeutic uses Analytical Therapeutic Engineered Stable Science Quantities “Tunability” Macromolecule Storage Targeted delivery of Coupling NO Precision release High load capacity NO: minimizes Druggable knowledge with profile unlocks solved: previous systemic exposure formulation of NO toolbox of desired MOA chemistry hurdle and reduces with stability chemistries + disease target backbone toxicity 3


 
Proprietary Nitricil™ Technology NO NO NO NO NCE NO H20 NO NO NO NO NO NO NO 4


 
Tunability and Release Profiles Generic Examples Novan Specific NCEs Burst Phase Time NO Time - Real Sustained Phase Release (nmol) Release Time NO Release NO Time - Real Time (Hr) Maximum Sustained Phase Released Burst % of Total NO ofTotal % NO Released NO Phase Cumulative Quantity Cumulative of Time (Hr) 5


 
Science & Technology Macromolecular platform to achieve stable, tunable and druggable delivery of nitric oxide Stable Tunable Druggable Real-Time Nitric Oxide Release Extended Tail Initial Burst New Chemical Entity (NCE) Proprietary platform enabling development of NCEs with Proprietary formulations, Multiple drug candidates with sustained delivery of nitric targeted to each indication, unique nitric oxide delivery and oxide enable tunable dosing proven target engagement 6


 
Development Pipeline Product Indication Preclinical Phase 1 Phase 2 Phase 3 Candidates DERMATOLOGY SB206 Molluscum Current focus, progression subject to additional funding and FDA feedback Atopic Dermatitis SB414 Psoriasis SB204 Acne Vulgaris SB208 Tinea Pedis MEN’S AND WOMEN’S HEALTH SB206 Genital Warts WH504 High-Risk HPV Supported by U.S. DoD CDMRP grant WH602 High-Risk HPV Supported by NIH grant GASTROENTEROLOGY Undisclosed Various On Hold 7


 
Value of Extensive Human Clinical Data SB204 SB206 SB208 SB414 Phase 3 (MC), Phase 2 (TP), Clinical Progress Phase 3 Phase 1b Phase 2 (EGW) Phase 1 (Nail) Tinea pedis, nail Atopic dermatitis, Indications Acne vulgaris Molluscum, EGW growth psoriasis Anti-bacterial, Anti-bacterial, Mechanism of Action Anti-viral Anti-fungal anti-inflammatory anti-inflammatory Peer-Reviewed 2 2 2 0 Clinical Publications Total # of Patients 2410 774 191 58 Treated ~3,400 patients of clinical efficacy/safety data 8


 
SB206 Phase 3 Study Design (B-SIMPLE1, B-SIMPLE2) • Multi-center, randomized, double-blind, vehicle-controlled, parallel trials to evaluate the efficacy and Description safety of SB206 12% QD for the treatment of molluscum contagiosum (“molluscum” or “MC”) • ~340 subjects per pivotal trial • 2:1 (active:vehicle) randomization • Stratified by investigator type and subjects per household Trial Design • Subjects or their caregivers will apply SB206 12% or Vehicle Gel once daily for a minimum of 4 weeks and up to 12 weeks to all treatable lesions (baseline and new) • Visits at Screening/Baseline, Week 2, Week 4, Week 8, Week 12 and safety follow-up at Week 24 • Males and females, 6 months of age and older Key Inclusion Criteria • 3-70 lesions at baseline Primary Endpoint • Proportion of subjects with complete clearance of all treatable molluscum lesions at Week 12 Secondary Endpoint • Proportion of subjects with complete clearance of all treatable molluscum lesions at Week 8 • Proportion of subjects with complete clearance of all treatable molluscum lesions at each visit • Proportion of subjects achieving clearance of ≥95%, 90% and 75% of molluscum lesions at Week 12 Exploratory • Percent change from baseline in number of molluscum lesions at every visit Endpoints1 • Time to complete clearance • Proportion of subjects who have a recurrence of MC after first visit of complete clearance • Proportion of subjects developing scar(s) after clearance of lesions at each visit Links to clinicaltrials.gov: B-SIMPLE1 & B-SIMPLE2 1. Additional exploratory and sensitivity analysis were defined in the statistical analysis plan 9


 
Study Demographics1 B-SIMPLE1 B-SIMPLE2 SB206 Vehicle SB206 Vehicle ITT Population2 236 116 237 118 PP Population3 192 109 194 103 Prematurely Discontinued Prior to Week 12 (%) 37 (15.7%) 4 (3.4%) 37 (15.6%) 14 (11.9%) Number of Sites 33 33 % Dermatologists 66.7% 69.7% Age (years) Mean 7.3 6.7 6.3 6.8 % Ages 2 to 17 94.1% 97.4% 97.9% 96.6% Sex Female 50.4% 42.2% 46.4% 52.5% Male 49.6% 57.8% 53.6% 47.5% Baseline Lesion Count Mean 17.8 18.6 18.9 17.1 Median 13.0 13.0 15.0 13.0 Time Since Clinical Diagnosis of Current Episode (Months) Mean 7.1 8.8 7.0 7.2 Median 4.1 5.3 4.6 4.7 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 3. Per Protocol (PP): all patients in the ITT population who completed the 12-week treatment period and had no significant protocol deviations that impacted the analyses of 10 efficacy endpoints


 
Stratification at Randomization1,2 B-SIMPLE1 B-SIMPLE2 SB206 Vehicle SB206 Vehicle # of Subjects Randomized per Household 1 Subject 76.7% 81.4% 2 Subject 23.3% 18.6% # of Subjects Randomized by Investigator Type Dermatologists 60.2% 59.5% 59.9% 61.0% Other 39.8% 40.5% 40.1% 39.0% The Phase 3 B-SIMPLE pivotal trials were well balanced across both studies 1. This table will be updated post completion of Week 24 data analysis and study closeout 11 2. Intent-to-Treat Population (ITT): consists of all subjects who were randomized


 
Study Disposition1,2 B-SIMPLE1 B-SIMPLE2 SB206 Vehicle SB206 Vehicle Prematurely Discontinued Treatments - Reasons 18.2% 5.2% 19.8% 11.9% Adverse Events 3.0% 0.9% 8.0% 0.8% Lost to Follow Up 8.5% 1.7% 5.9% 8.5% Lack of Efficacy 0.0% 0.0% 0.0% 0.0% Physician Decision 0.0% 0.0% 0.4% 0.0% Withdrawal by Subject Caregiver 5.9% 1.7% 5.1% 2.5% Worsening of Molluscum 0.0% 0.0% 0.0% 0.0% Other 0.8% 0.9% 0.4% 0.0% 1. This table will be updated post completion of Week 24 data analysis and study closeout 12 2. Intent-to-Treat Population (ITT): consists of all subjects who were randomized


 
B-SIMPLE1 & B-SIMPLE2 Top-Line Results: ITT Population1 B-SIMPLE1 B-SIMPLE2 SB206 Vehicle SB206 Vehicle p-value p-value (n=236) (n=116) (n=237) (n=118) Primary Endpoint: Complete Clearance of 25.8% 21.6% p=0.375 30.0% 20.3% p=0.062 All Lesions at Week 12 Secondary Endpoint: Complete Clearance of 15.3% 10.3% p=0.202 13.9% 5.9% p=0.028 All Lesions at Week 8 SB206 was nearly statistically significant for the primary endpoint compared to vehicle in B-SIMPLE2, and was statistically significant for the secondary endpoint 1. Intent-to-Treat Population (ITT): consists of all subjects who were randomized, and missing data imputed as treatment failures. 13


 
Complete Clearance of All Lesions (ITT1) by Week B-SIMPLE1 B-SIMPLE2 Percentage of Patients with Complete Clearance at Percentage of Patients with Complete Clearance at Week 12 Week 12 35.0% 35.0% 30.0% 30.0% 30.0% 25.8% 25.0% 25.0% 21.6% 20.3% 20.0% 20.0% 15.3% 15.0% 15.0% 13.9%* 10.3% 10.0% 10.0% 5.9% 4.3% 4.7% 5.0% 5.0% 3.4% 1.3% 1.7% 0.0% 0.4% 0.0% 0.0% 0.0% Week 2 Week 4 Week 8 Week 12 Week 2 Week 4 Week 8 Week 12 Vehicle SB206 Vehicle SB206 * p-value <0.05 1. Intent-to-Treat Population (ITT): consists of all subjects who were randomized, and missing data imputed as treatment failures. 14


 
Percent Change from Baseline Lesion Count B-SIMPLE1 B-SIMPLE2 10% 10% 0% 0% Week 2 Week 4 Week 8 Week 12 Week 2 Week 4 Week 8 Week 12 -10% -10% -20% -20% * -30% * -30% * -40% -40% -50% -50% * * -60% -60% Vehicle SB206 Vehicle SB206 * * p-value <0.05 15


 
Sensitivity Analyses and Exploratory Endpoints B-SIMPLE1 B-SIMPLE2 SB206 Vehicle SB206 Vehicle p-value p-value (n=192) (n=109) (n=194) (n=103) PP Primary Endpoint: Complete Population1 Clearance of All Lesions at Week 12 31.3% 21.1% p=0.074 36.1% 23.3% p=0.028 SB206 Vehicle SB206 Vehicle p-value p-value (n=236) (n=116) (n=237) (n=118) Primary Endpoint: Complete Clearance of All Lesions at Week 12 26.7% 21.6% p=0.292 30.8% 20.3% p=0.044 Exploratory Endpoint4: Clearance ITT of 95% Lesions at Week 12 28.0% 22.4% p=0.217 33.8% 20.3% p=0.013 Population2, LOCF3 Exploratory Endpoint4: Clearance of 90% Lesions at Week 12 33.9% 25.0% p=0.079 38.4% 20.3% p<0.001 Exploratory Endpoint4: Clearance of 75% Lesions at Week 12 44.5% 31.9% p=0.028 48.5% 32.2% p=0.004 1. Per Protocol (PP): all patients in the ITT population who completed the 12-week treatment period and had no significant protocol deviations that impacted the analyses of efficacy endpoints 2. Intent-to-Treat Population (ITT): consists of all subjects who were randomized. 3. Last Observation Carried Forward (LOCF) method for handling missing data: all patients randomized (ITT population) and where a patient missed their Week 12 visit their last visit lesion count is included in the analysis as complete/95%/90% clearance at Week 12 16 4. Exploratory endpoints were pre-specified in the statistical analysis plan


 
Complete Clearance Count at Week 12 (ITT1) by Household Stratification Factor B-SIMPLE1 B-SIMPLE2 SB206 Vehicle SB206 Vehicle p-value p-value n=236 n=116 n=237 n=118 One-Subject Household 28.7% 19.1% p=0.116 29.0% 16.7% p=0.025 n=181 n=89 n=193 n=96 Two-Subject Household 16.4% 29.6% - 34.1% 36.4% - Discordant data was identified in two-subject households across both studies. Subjects from one-subject households contributed to approximately 80% to the overall population. 1. Intent-to-Treat Population (ITT): consists of all subjects who were randomized, and missing data imputed as treatment failures. 17


 
B-SIMPLE1 & B-SIMPLE2: Consistent and Supportive • Statistical test of heterogeneity evaluated the consistency across B-SIMPLE1, B-SIMPLE2 and the integrated data • Overlap of 95% confidence intervals (interval that one can be 95% confident contains the true value of the population) for the primary endpoint between studies • Similar standard errors (a measure of the statistical accuracy of the estimate of interest) for both studies • An improvement of the odds ratio when data are evaluated for one-subject households: BSIMPLE Primary Analysis ITT Population Results BSIMPLE Primary Analysis ITT Population Subjects from a 1 subject Household Results BSIMPLE1 P-value=0.1155 BSIMPLE1 P-value=0.3752 BSIMPLE2 P-value=0.0250 BSIMPLE2 P-value=0.0624 Integrated P-value=0.0487 Integrated P-value=0.0054 0.5 1.0 1.5 2.0 2.5 3.0 1 2 3 4 Odds Ratio Odds Ratio 18


 
Overall Summary of AEs (Safety Population) at Week 12 B-SIMPLE1 B-SIMPLE2 SB206 Vehicle SB206 Vehicle (N=235) (N=116) (N=237) (N=117) Subjects with at least one Treatment Emergent 115 (48.9%) 36 (31.0%) 120 (50.6%) 29 (24.8%) Adverse Event (TEAE) Subjects with at least one Serious TEAE 0 0 1 (0.4%) 1 (0.9%) Subjects with at least one TEAE leading to Study 7 (3.0%) 1 (0.9%) 17 (7.2%) 1 (0.9%) Drug Discontinuation Subjects with a TEAE leading to Death 0 0 0 0 Maximum Severity Mild 60 (25.5%) 25 (21.6%) 51 (21.5%) 18 (15.4%) Moderate 50 (21.3%) 10 (8.6%) 64 (27.0%) 10 (8.5%) Severe 5 (2.1%) 1 (0.9%) 5 (2.1%) 1 (0.9%) Note: through Week 12 visit, final safety profile will be updated through Week 24 and is targeted to be released in March 2020. 19


 
Summary of Treatment-Emergent Adverse Event (Safety Population) B-SIMPLE1 B-SIMPLE2 SB206 Vehicle SB206 Vehicle (N=235) (N=116) (N=237) (N=117) System Organ Class/Preferred Term Subjects[1] Events Subjects[1] Events Subjects[1] Events Subjects[1] Events Subjects with at least one TEAE 115 (48.9%) 259 36 (31.0%) 63 120 (50.6%) 304 29 (24.8%) 53 General disorders and administration site 88 (37.4%) 183 22 (19.0%) 34 85 (35.9%) 203 17 (14.5%) 27 conditions Application site pain 51 (21.7%) 65 8 (6.9%) 10 36 (15.2%) 56 2 (1.7%) 7 Application site erythema 28 (11.9%) 40 3 (2.6%) 3 26 (11.0%) 43 0 0 Pyrexia 11 (4.7%) 12 3 (2.6%) 4 7 (3.0%) 7 2 (1.7%) 4 Application site exfoliation 10 (4.3%) 16 0 0 9 (3.8%) 17 0 0 Application site pruritus 10 (4.3%) 11 0 0 8 (3.4%) 8 2 (1.7%) 3 Application site swelling 6 (2.6%) 8 1 (0.9%) 1 7 (3.0%) 9 0 0 Application site dermatitis 5 (2.1%) 7 1 (0.9%) 1 11 (4.6%) 12 1 (0.9%) 1 Application site discolouration 5 (2.1%) 5 0 0 3 (1.3%) 3 1 (0.9%) 1 Application site irritation 4 (1.7%) 4 0 0 4 (1.7%) 5 0 0 [1] At each level of summation (overall, system organ class, preferred term), subjects reporting more than one adverse event are counted only once. Note: through Week 12 visit, final safety profile will be updated through Week 24 and is targeted to be released in March 2020. 20


 
SB206 Impact on Scarring Number of Subjects (%) with Scarring by Visit (ITT Population) B-SIMPLE1 B-SIMPLE2 SB206 Vehicle SB206 Vehicle (N=236) (N=116) (N=237) (N=118) Week 4 0 0 8 (3.4%) 6 (5.1%) Week 8 7 (3.0%) 8 (6.9%) 7 (3.0%) 8 (6.8%) Week 12 6 (2.5%) 5 (4.3%) 12 (5.1%) 12 (10.2%) Week 24 Data to follow In the integrated safety population, subjects treated with SB206 experienced a lower occurrence of scarring (3.8%) through the Week 12 visit when compared to vehicle (7.3%) Note: scarring was determined by the investigator and the definition of scar comprises any size scar including molluscum pitted scars/indentations that are natural course of resolution. 21


 
Summary of SB206 B-SIMPLE Program & Path Forward • Top-line efficacy results announced January 2020 − SB206 failed to achieve statistically significant results for the primary endpoint − B-SIMPLE2 was statistically significant for multiple pre-specified sensitivity analyses − Similar analyses with B-SIMPLE1 demonstrated the trial is reasonably consistent and supportive of B-SIMPLE2 • All efficacy and safety data (both trials) including the prospectively planned safety evaluation through Week 24, targeted to be available in March 2020 • FDA Type C Meeting scheduled for April 1, 2020, to seek feedback on the proposal to conduct one additional, well-controlled confirmatory study of SB206 to support a future NDA • Currently no FDA-approved out-of-office treatments indicated for molluscum 22


 
Funding and Operations Commentary • Management, along with the Board of Directors, continues to explore both financial as well as strategic options in order to continue operations and to progress SB206 for the molluscum indication, subject to funding and FDA feedback. • The Company intends to pursue financing, which may be dilutive, non- dilutive or both, in the near future and intends to engage one or more financial advisors to assist in this financial and strategic process. • The Company is working to action a number of operational adjustments in order to reduce cash utilization over the near term. • Substantial additional funding will be required in order to continue to sustain business operations. 23