UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
FORM 6-K
 
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
Under the Securities Exchange Act of 1934
 
For the month of July 2019
 
Commission File Number 001-38367
 
SOL-GEL TECHNOLOGIES LTD.
(Translation of registrant’s name into English)
 
7 Golda Meir Street
Ness Ziona 7403650, Israel
(Address of principal executive offices)
 
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
 
Form 20-F ☒           Form 40-F ☐
 
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):  ☐
 
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):  ☐


INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K
 
On July 25, 2019, Sol-Gel Technologies Ltd. (the “Company”) issued a press release announcing the hosting of an Analyst and Investor Day in New York, a Notice of Allowance for a U.S. patent application covering TWIN and a clinical study for SGT-210 in palmoplantar keratoderma (PPK) intended to begin in early 2020.  The Company is also posting on its website a presentation titled “Investor & Analyst Day”.
 
Attached hereto and incorporated by reference in this Report on Form 6-K are the following exhibits:
 
Exhibit 99.1: Press Release titled “Sol-Gel Technologies Hosting Analyst & Investor Day”.
 
Exhibit 99.2: Corporate presentation titled “Investor & Analyst Day”.

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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, thereunto duly authorized.

 
SOL-GEL TECHNOLOGIES LTD.
 
 

 
 
Date:  July 25, 2019
By:
/s/ Gilad Mamlok
 
 
 
Gilad Mamlok
 
 
 
Chief Financial Officer
 

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Exhibit 99.1

Sol-Gel Technologies Hosting Analyst & Investor Day

Notice of allowance for U.S. patent application extends TWIN patent protection to 2038
Clinical study for SGT-210 in palmoplantar keratoderma (PPK) intended to begin in early 2020
Webcast of Analyst & Investor Day today at 8:30 a.m. ET

NESS ZIONA, Israel, July 25, 2019 – Sol-Gel Technologies, Ltd. (NASDAQ: SLGL) will host an Analyst and Investor Day today in New York beginning at 8:30 a.m. ET. During the meeting, the company will review the recently announced, positive Phase III EPSOLAY® data in papulopustular rosacea; preliminary U.S. commercial plans; a planned clinical study for SGT-210 in PPK intended to begin in early 2020; and the new allowed patent for TWIN in acne.

Agenda

Introduction and Company Overview

o
Alon Seri-Levy, PhD, Chief Executive Officer

Current Challenges in Acne and Rosacea Treatment

o
Linda Stein Gold, MD, Director of Dermatology Clinical Research at Henry Ford Health System

EPSOLAY® Phase III Clinical Study Results

o
Jeffrey Sugarman, MD, Ph.D., Medical Director Northern California Medical Associates, Assoc. Clinical Professor, University of California, San Francisco

Technology Overview

o
Ofer Toledano, VP, Research and Development

Commercial Overview

o
John Vieira, U.S. Head of Commercialization

Pipeline and Active Research Areas

o
Mori Arkin, Chairman of The Board of Directors

Financial Overview

o
Gilad Mamlok, Chief Financial Officer

Closing Statements and Q&A

o
Alon Seri-Levy, PhD, Chief Executive Officer

Intellectual Property Update
Sol-Gel received Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a patent covering TWIN, a once daily topical cream containing a fixed-dose combination of encapsulated benzoyl peroxide and encapsulated tretinoin using Sol-Gel’s proprietary microencapsulation platform. 
The patent allowance includes the use of a BPO/tretinoin combination at 3%/0.1% respectively, for the treatment of acne vulgaris. The method includes the stability and release profile of the combination, and their synergistic efficacy and improved safety profile. The newly granted patent will extend protection to July 2038 which the company believes will prevent the launch of any AB-rated generic of TWIN during the life of the patent.


Sol-Gel’s current patent estate includes 38 granted and allowed patents and 26 pending US and global patent applications regarding the company’s silica-based proprietary processes and methods of use.

Pipeline Additions
SGT-210, a topical epidermal growth factor receptor inhibitor, has been added to the company’s development pipeline.  SGT-210 is in development for the treatment of PPK and non-melanoma skin cancer (NMSC). PPK is a group of skin conditions characterized by thickening of the skin on the hands and soles of the feet. Basal cell carcinoma and squamous cell carcinoma are collectively referred to as NMSC.

SGT-210 is designed to be used alone or in combination for the treatment of hyperproliferation and hyperkeratinization disorders, including PPK and NMSC. A 12-week proof of concept study of SGT-210 in PPK is planned to begin in early 2020.

Webcast
A live webcast of the event can be accessed on the Events & Presentations section of the company’s website at http://ir.sol-gel.com. Analysts and Institutional Investors can register for the event at solgel.troutgroup.com.

About Sol-Gel Technologies

Sol-Gel is a clinical-stage dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases. Sol-Gel’s current product candidate pipeline consists of late-stage branded product candidates that leverage the company’s proprietary, silica-based microencapsulation technology platform, and several generic product candidates across multiple indications. For additional information, please visit www.sol-gel.com.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements. These forward-looking statements include information about possible or assumed future results of our business, financial condition, results of operations, liquidity, plans and objectives. In some cases, you can identify forward-looking statements by terminology such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. Forward-looking statements are based on information we have when those statements are made or our management’s current expectation, and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Important factors that could cause such differences include, but are not limited to: (i) the adequacy of our financial and other resources, particularly in light of our history of recurring losses and the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives; (ii) our ability to complete the development of our product candidates; (iii) our ability to find suitable co-development partners; (iv) our ability to obtain and maintain regulatory approvals for our product candidates in our target markets and the possibility of adverse regulatory or legal actions relating to our product candidates even if regulatory approval is obtained; (v) our ability to commercialize our pharmaceutical product candidates; (vi) our ability to obtain and maintain adequate protection of our intellectual property; (vii) our ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; (viii) our ability to establish adequate sales, marketing and distribution channels; (ix) acceptance of our product candidates by healthcare professionals and patients; (x) the possibility that we may face third-party claims of intellectual property infringement; (xi) the timing and results of clinical trials that we may conduct or that our competitors and others may conduct relating to our or their products; (xii) intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; (xiii) potential product liability claims; (xiv) potential adverse federal, state and local government regulation in the United States, Europe or Israel; and (xv) loss or retirement of key executives and research scientists. These and other important factors discussed in the company's Annual Report on Form 20-F filed with the Securities and Exchange Commission (“SEC”) on March 21, 2019 and our other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. Except as required by law, we undertake no obligation to update publicly any forward-looking statements after the date of this press release to conform these statements to changes in our expectations.


For further information, please contact:
Sol-Gel Contact:
Gilad Mamlok
Chief Financial Officer
+972-8-9313433

Investor Contact:
Chiara Russo
Solebury Trout
+1-617-221-9197
crusso@soleburytrout.com


Source: Sol-Gel Technologies Ltd.



Exhibit 99.2

 INVESTOR & ANALYST DAYJuly 25, 2019 
 

 This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “future,” “outlook,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential,” “continue,” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. The forward-looking statements in this presentation relate to, among other things, statements regarding the commencement of our planned bioequivalence study for a generic product candidate, our expected date to report top-line data from our pivotal Phase III clinical program for TWIN, our anticipated NDA submission dates for Epsolay and TWIN, and estimated sales of our product candidates. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties, and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statement, including but not limited to the following: the fact that we have and expect to continue to incur significant losses; our need for additional funding, which may not be available; our ability to complete the development of our product candidates; our ability to obtain and maintain regulatory approvals for our product candidates in our target markets and the possibility of adverse regulatory or legal actions relating to our product candidates even if regulatory approval is obtained; our ability to commercialize our product candidates; our ability to obtain and maintain adequate protection of our intellectual property; our ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; our ability to establish adequate sales, marketing, and distribution channels; acceptance of our product candidates by healthcare professionals and patients; the possibility that we may face third-party claims of intellectual property infringement; the timing and results of clinical trials that we may conduct or that our competitors and others may conduct relating to our or their products; intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing, and sales, distribution and personnel resources than we do; potential product liability claims; potential adverse federal, state, and local government regulation in the United States, Europe, or Israel; and loss or retirement of key executives and research scientists. These and other important factors discussed in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission (“SEC”) on March 21, 2019, and our other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this presentation. While we may elect to update such forward-looking statements at some point in the future, unless required by applicable law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Thus, one should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this presentation. This presentation contains trademarks, trade names, and service marks of other companies, which are the property of their respective owners. We do not intend our use or display of other parties' trademarks, trade names, or service marks to imply, and such use or display should not be construed to imply a relationship with, or endorsement or sponsorship of us by, these other parties.  Forward-looking statements 
 

 Agenda  TOPIC  SPEAKER  Introduction and Company Overview  Alon Seri-LevyCEO, Sol-Gel   Current Challenges in Acne and Rosacea Treatment  Dr. Linda Stein GoldDirector of Dermatology Clinical Research,Henry Ford Health Systems, Michigan  EPSOLAY® Phase III Clinical Studies  Dr. Jeff SugarmanMedical Director, Northern California Medical AssociatesAssociate Clinical Professor, University of California, SF  Commercial Overview  John VieiraUS Head of Commercialization   Technology Overview  Ofer ToledanoVP, Research and Development   Pipeline and Active Research Areas  Mori ArkinChairman, Sol-Gel   Financial overview  Gilad MamlokCFO, Sol-Gel   Closing Statements and Q&A  Alon Seri-LevyCEO, Sol-Gel 
 

 THREE-FOLD STRATEGY  Leverage on our capabilities to generate significant non-dilutive funding  Identify targeted opportunities, in other areas of high unmet need, where we can bring innovation and exceed current standard-of-care treatments  Successfully commercialize best-in-class dermatology brands in acne and rosacea, and maintain a leadership position in these indications 
 

     Pipelines & upcoming milestones      BRANDED CANDIDATES  EPSOLAY®Papulopustular rosacea  TWINAcne vulgaris  Research  Preclinical  Phase II  Phase III  NDA submission  1H/2020  2H/2020  Top-lineresultsin Q4/2019      GENERIC PRODUCTS/CANDIDATES  Ivermectin cream, 1%(RLD: Soolantra®)  Acyclovir cream, 5%(RLD: Zovirax®)  5-Fluorouracil cream, 5%(RLD: Efudex®)  TENTATIVE APPROVAL AS OF JANUARY 29, 2018  APPROVAL & SALES AS OF FEBRUARY 2019   BE STUDY RESULTS IN 2019        Research  Filed  Bioequivalence                       
 

 Current challengesin Acne Vulgaris  Dr. Linda Stein GoldDirector of Dermatology Clinical Research, Henry Ford Health Systems   
 

 Collier CN, et al. J Am Acad Dermatol. 2008;58:56-59.Zaenglein AL. N Engl J Med. 2018;379:1343-1352.AAD 2016 Burden of Disease Report, https://www.aad.org/media/stats/conditions.   Percent  Age Group  PRESENTATION2  Moderate  Mild  Severe  aCNE: PREVALENCE & PRESENTATION  PREVALENCE1,3Acne is the most common skin condition in the USA,affecting up to 50 million Americans annuallyAbout 85% of people between the ages of 12 and 24 experience at least minor acne More than 5.1 million people sought medical treatment for acne in 2013, primarily children and young adults3 
 

 The impact of acne  In addition to physical effects such as permanent scarring and disfigurement,acne has long-lasting psychosocial effects that affect the patient's quality of lifeDepression, social isolation and suicidal ideation are frequent comorbidities of acnethat should not be neglected in the therapy of acne patientsResearch evidence suggests that the impairment of quality of life can be alleviatedby appropriate topical acne treatment    Gieler U, et al., J Eur Acad Dermatol Venereol. 2015 Jun;29 Suppl 4:12-4. 
 

 Treatment  Mild Acne  Moderate Acne  Severe Acne  First-line Treatment  Benzoyl peroxide, topical retinoid, or topical combination therapy  Topical combination therapy; oral antibiotic, topical retinoid, and benzoyl peroxide; oral antibiotic plus topical retinoid; or benzoyl peroxide plus topical antibiotic  Oral antibiotic plus either topical combination therapy or oral isotretinoin  Alternative Treatment  Add topical retinoid or benzoyl peroxide (if not using already), or consider alternative retinoid, or consider topical dapsone  Consider alternative combination therapy, or consider change in oral antibiotic, or add combined oral contraceptive or oral spironolactone (in female patients), or con- sider oral isotretinoin  Consider change in oral antibiotic, or add combined oral contraceptive or oral spironolactone (in female patients), or consider oral isotretinoin  Zaenglein AL, et al. J Am Acad Dermatol. 2016;74:945-73.e33.Zaenglein AL. N Engl J Med. 2018;379:1343-1352.  Treatment algorithm for the management ofacne vulgaris in adolescents & young adults1,2  The multi-faceted nature of acne pathogenesis often requires a combination therapy approach 
 

 Unmet need  There is a strong trend toward and professional recommendation to avoid or be more discerning with antibiotics use in dermatology whenever possible1Combination products or use of multiple products/modalities is common2,3 Benzoyl peroxide and tretinoin have both been shown to be effective2,3 Unable to combine benzoyl peroxide with tretinoin until now   Sixty-seventh World Health Assembly - Antimicrobial resistance (WHA67.25). 24 May 2014.Zaenglein AL, et al. J Am Acad Dermatol. 2016;74:945-73.e33.Zaenglein AL. N Engl J aMed. 2018;379:1343-1352. 
 

 Benzoyl peroxide in acne  Benzoyl radicals kill bacteria and inflammatory cellsBenzoic acid promotes the opening of clogged poresBenzoyl peroxide combines with other treatments for synergistic effects  Benzoyl peroxide  White blood cells  Bacteria  Benzoic acid  Benzoyl radicals  Seth V, et al. Int J Adv Med. 2015;2:1-5.          
 

 Elevated sebum production  C. acnes colonization  Tretinoin  Inflammation            Seth V, et al. Int J Adv Med. 2015;2:1-5.       Tretinoin in acne  Hyperkeratosis (keratin plug) 
 

 Elevated sebum production  C. acnes colonization  Tretinoin  Hyperkeratosis (keratin plug)  Inflammation            TRETINOIN AND BENZOYL PEROXIDE IN ACNE  Benzoyl Peroxide  Seth V, et al. Int J Adv Med. 2015;2:1-5.        
 

 Treatment to date…  Preference for dual action, but preferred products unable to be combined until now…Encapsulation permits storage and delivery of benzoyl peroxide with tretinoin in strengths repeated shownto be efficacious in patients of acne vulgaris  SEM Encapsulated Tretinoin  SEM Encapsulated Benzoyl Peroxide*  *Freeze fracture preparation 
 

 TWIN low and TWIN high demonstratedsignificant improvements in moderate to severe acne vulgaris after 12 weeks of treatment:Statistically significant (P <0.006) improvements were observed in both the IGA and lesion counts (inflammatory and noninflammatory) over vehicle aloneTWIN low and TWIN high had similar effects on outcome variables. However, at week 12, a higher proportion of subjects (39.7%) achieved clear or almost clear with TWIN high, compared to the TWIN low treatment (27.4%)TWIN low and TWIN high were safe and well tolerated with expected dermal incidences of application site dryness, exfoliation (scaling) and pain (mild burning and stinging) typical for the individual components of the two formulations  summary 
 

 Current challengesin Rosacea 
 

 Blount BW, Pelletier AL. Am Fam Physician. 2002;66:435-440. National Rosacea Society. http://www.rosacea.org/rr/2010/winter/article_1.php. Moustafa F. J Am Acad Dermatol. 2014;71:973-980.Gether L, et al. Br J Dermatol. 2018;179:282-289Wilkin J, et al. J Am Acad Dermatol. 2004;50:907-912  Erythematous  Phymatous  Ocular  Papulopustular  Rosacea is a chronicinflammatory skin disease1  Affects approximately 16 millionAmericans2Very high emotional and psychological impact35.46% of the adult general population is affected by rosacea4No latitude-dependent gradient in rosacea prevalence observed4Multiple subtypes/phenotypes often seen in a single patient4,5 
 

 Rosacea pathophysiology is complex  Pathogenesis of rosacea is thought to be an immune detection dysfunction  *TLR-2 – Toll-like receptor-2Yamasaki K et al. Nature Medicine. 2007;13:975-980.Yamasaki K et al J Dermatol Sci. 2009;55:77-81.Fleischer AB. J Drugs Dermatol. 2011;10:614-620.Yamasaki K et al. J Invest Dermatol. 2011;131:688-697.Yamasaki K et al. J Invest Dermatol. 2011;15:12-15. (slide courtesy of James Del Rosso, DO, Las Vegas, NV)   ROSACEA Inflammation / Neurovascular Effects / Vascular Changes / Fixed Physical Changes in Cutaneous Vasculature     Increased LL-37 + Variant Peptides    Elevated Cathelicidin Precursor(hCAP18)  Elevated Serine Protease(Kallikrein-5 [KLK-5])    Increase in TLR-2* on Keratinocytes(Augmented Immune “Danger” Recognition)  TRIGGER     
 

 National Rosacea Society. http://www.rosacea.org/press/new-rosacea-survey-shows-emotional-toll-facial-redness-equals-impact-bumps-pimples. Accessed November 7, 2016. Moustafa F, et al. J Am Acad Dermatol. 2014;71(5):973-980.  Patients with rosacea suffer psychologicalconsequences that impact their everyday lives 
 

 DLQI=Dermatology Life Quality Index; QOL=quality of life. Tan J, et al. Rosacea. Beyond the visible. 2018. Available at https://hosted.bmj.com/rosaceabeyondthevisible. Accessed October 15, 2018.  Clearer skin reduces impact onrosacea patient qol  Data from an online global survey of 710 rosacea patients 
 

 Same woman, different impressions   
 

 ROSACEA IS A LARGELY UNTAPPED MARKET  Of the approximate 16 million rosacea sufferers in the US: Only 10% seek treatment1 Misdiagnosis is common1,2 There is a clearly understood medical need for effective treatment options   Our goal is to address the underdiagnosis and to offer a safe and effective option to manage rosacea symptoms in order to give patients a better quality of life  National Rosacea Society. www.rosacea.org. Accessed October 10, 2016. Prevalence of rosacea. http://www.rosacea.org/rr/index.php. Accessed April 2015. 
 

 WHY NOT BENZOYL PEROXIDE FOR ROSACEA?  The skin of patients with rosacea is extremely sensitive and hyper-reactive to dietary, environmental, and topical factors1The use of topical retinoids and benzoyl peroxide has shown to be beneficial in treating rosaceain smaller case series2Data suggest that topical preparations containing benzoyl peroxide may be effective in rosacea, but that they may be poorly tolerated with frequent itching and burning at treatment sites3  Draelos ZD, J Drugs Dermatol. 2005 Sep-Oct;4(5):557-62.Two AM, et al. J Am Acad Dermatol. 2015;72:761-770.Goldgar C, et al. Am Fam Physician. 2009;80:461-468.  …Until Now 
 

 EPSOLAY® phase III clinical study results  Dr. Jeff SugarmanMedical Director, Northern California Medical AssociatesAssociate Clinical Professor, University of California, San Francisco  
 

 Male and female ≥18 years of age Clinical diagnosis of moderate to severe rosacea≥15 inflammatory lesions≤2 nodules  2:1  EPSOLAY® cream, 5% (once daily)  Vehicle cream (once daily)  54 Total Sites— RandomizationStudy 54-01: 361Study 54-02: 372  12 weeks of treatment  Baseline 2 4 8 12   Weeks  Inclusion criteria  Two phase III, double-blind, randomized, vehicle-controlled studies  Study design  PRIMARY ENDPOINTS:Proportion of patients with the primary measure of success "Clear" (0) or "Almost clear" (1) in the Investigator Global Assessment (IGA) relative to Baseline at Week 12Absolute change in inflammatory lesion counts from baseline to Week 12SECONDARY ENDPOINT:Percent change in inflammatory lesion count at Week 12 
 

 STUDY POPULATIONS & DISCONTINUATION  Study 54-02  Study 54-01  Percent of patients  EPSOLAY®  Vehicle  Randomized (n = 243), Safety (n = 239),Per Protocol (n=190)  Randomized (n = 118), Safety (n = 113),Per Protocol (n=93)    Randomized (n = 250), Safety (n = 249),Per Protocol (n=235)    Percent of patients  Randomized (n = 122), Safety (n = 120),Per Protocol (n=113)  Intent-to-treat population 
 

   Study 54-01    Study 54-02    CHARACTERISTIC  EPSOLAY ®(n = 243)  Vehicle(n = 118)   EPSOLAY ®(n = 250)  Vehicle(n = 122)   Age, yearsMean (SD)Median (range)  52.8 (13.21)54.0 (19-81)  52.4 (13.26)52.5 (24-85)  49.5 (14.04)50.0 (18 to 79)  51.5 (12.55)50 (22 to 84)  Sex, n (%)MaleFemale  60 (24.7)183 (75.3)  35 (29.7)83 (70.3)  69 (27.6)181 (72.4)  35 (28.7)87 (71.3)  Race, n (%)Amer. Indian/Alaska Nat.AsianBlack/African AmericanNat. Hawaiian/Pac. IslanderWhiteMultiple/0ther  09 (3.7)00233 (95.9)1 (0.4)  02 (1.7)00 116 (98.3)0  020 (8.0)2 (0.8)3 (1.2)220 (88.0)5 (2.0)  2 (1.6)8 (6.6)02 (1.6)110 (90.2)0  Ethnicity, n (%)Hispanic/LatinoNot Hispanic or LatinoUnknown  86 (35.4)156 (64.2)1 (0.4)  39 (33.1)77 (65.3)2 (1.7)  55 (22.0)195 (78.0)0   30 (24.6)92 (75.4)0   IGA Severity (%)ModerateSevere  210 (86.4)33 (13.6)  104 (88.1)14 (11.9)  227 (90.8)23 (9.2)  112 (91.8)10 (8.2)  Lesion CountMean (SD)Median (range)  25.7 (11.07)22.0 (15-69)  26.3 (12.45)21.0 (15-70)  29.8 (14.00)25.0 (15-70)  27.5 (13.04)22.5 (15-70)  PATIENT CHARACTERISTICS  Intent-to-treat population 
 

 P<0.001  P<0.001  Success in IGA at Week 12  Study 54-02  Study 54-01  Primary endpoint (igA)  Success in IGA at Week 12  Intent-to-treat population 
 

 Study 54-02  Study 54-01  P<0.001  P<0.001  Primary endpoint (change in lesion count)  Inflammatory lesion count change from baseline at Week 12  Inflammatory lesion count change frombaseline at Week 12  Intent-to-treat population 
 

 SECONDARY ENDPOINT (% CHANGE IN LESIONS)  Study 54-02  Study 54-01  Inflammatory lesion percent change from baseline at Week 12  P<0.001  P<0.001  Inflammatory lesion percent change frombaseline at Week 12  Intent-to-treat population 
 

 Study 54-02  Study 54-01  Success in IGA at Week 2  Inflammatory lesion count change from baseline at Week 2  P = 0.009  P = 0.017  P < 0.001  P < 0.001  Study 54-02  Study 54-01  * Intent-to-treat population  Exploratory endpoint (efficacy at 2 weekS)  Intent-to-treat population  Intent-to-treat population 
 

 SUCCESS in IGA OVER TIME  Percent Achieving Clear or Almost Clear  *  #  †  *  *  *  ₳  #  Intent-to-treat population  †P = 0.017, #P = 0.009, ₳ P =0.006, *P <0.001 vs corresponding vehicle 
 

 ABSOLUTE change in inflammatory lesioncount from baseline over time  Week  Inflammatory lesion count change from baseline  †  †  †  †  †  †  †  †  †P < 0.001 vs corresponding vehicle  Intent-to-treat population 
 

 IMPROVEMENT OVER TIME  4 0 0 0 1  3 2 1 0 0  IGA  IGA 
 

 3 0 0 0 0  4 3 3 3 2  IMPROVEMENT OVER TIME  IGA  IGA 
 

 SKIN TOLERABILITY  Safety population  Dryness  Scaling  Burning/Stinging  Itching  Percent Reporting Any…  Study 54-01  Percent Reporting Any…  Study 54-02  Dryness  Scaling  Burning/Stinging  Itching 
 

 No. (%) of Subjects  Study 54-01    Study 54-02    TEAEs, n (%)  EPSOLAY ®(n = 239)  Vehicle(n = 113)  EPSOLAY ®(n = 249)  Vehicle (n = 120)  Any TEAE  49 (20.5%)  17 (15.0%)  50 (20.2%)  22 (18.2%)  Serious TEAE  0  1 (0.4%)1  1 (0.4%)2  0  Severe TEAE  2 (0.8%)  0  2 (0.8%)3  0  Discontinuation  5 (2.1%)  1 (0.9%)  4 (1.6%)  1 (0.8%)4  Treatment-related  14 (5.9%)  3 (2.7%)  9 (3.6%)  0  1Femur fracture2Spinal compression fracture3One subject with spinal compression fracture4Urinary Tract Infection—Discontinuation classified as “other reason”   TEAEs, Treatment-Emergent Adverse Events  Safety population  TEAE summary 
 

 Baseline Characteristics of Active Arm  IGA  Severe  33  23  82  113  26  65  0  51  71  52  48      Moderate  210  227  369  346  172  418  557  444  443  67  77      Mild  0  0  0  0  0  0  0  0  0  8  17    Inflammatory Lesions    25.7  29.8  31.0  33.3  21.6  21.7  18.3  28.5  30.0  19.5  20.5  Inflammatory Lesions–Mean Percent Change from Baseline   Success in IGA  Difference from Vehicle  FMX103  Minocycline foam, 1.5%  10-week study  EPSOLAY ®  Oral administration  16-week study  Side-by-side with other historicaltrial results(*)   (*) Sol-Gel did not conduct a head-to-head comparison trial or study. The results described above are for illustrative purposes only and should not be construedas conclusions to be drawn as if we conducted a head-to-head comparison trial or study  12-week study  12-week study  12-week study  12-week study 
 

 Commercial Overview   John Vieira, US Head of Commercialization 
 

 THREE-FOLD STRATEGY  Leverage on our capabilities to generate significant non-dilutive revenues  Identify targeted opportunities, in other areas of high unmet need, where we can bring innovation and exceed current standard-of-care treatments  Successfully commercialize best-in-class dermatology brands in acne and rosacea, and maintain a leadership position in these indications 
 

 ROSACEA   ACNE  50 million people suffer from acne in the US(ages 12-24 years)$1.8 billion branded topical market (WAC)* Treated with topicals 56% of the time, remaining is oral*Dermatologists account for ~60% of acne treatment(higher for branded products)Combining treatments is the bestway to combat acne for the majority of patients1  Approximately 16 million people in the US suffer from rosacea 5-6 million type 2 ( >30 years)$478 million branded topical market (WAC)*Treated with topical products 76% of the time*Dermatologists account for 80% of treatmentsMany patients are misdiagnosed or do not seek treatment at all, creating a large underserved patient population  Market potential for acne & rosacea      *Sources: Symphony Health; Syneos Research & Insights ”Treatment Answers”; June 2019 MAT.  1. https://www.aad.org/practicecenter/quality/clinical-guidelines/acne/topical-therapies 
 

 24 month Launch aligned performance  Select ACNE brands  Select ROSACEA brands  Fixed dose combination—21% of topical acne market Tretinoin is ~25% of all retinoids used in acne~ 20% of all acne treatments involve benzoyl peroxide  TRx /month (000’s)  TRx /month (000’s)  Rosacea market has grown ~4% (MAT June 2019) Topicals constitute a steady 80% of market share  1. Syneos Health. Data on file. 
 

 EPSOLAY®  Advanced technology platform Trusted API Topical creamNon-systemicAntibiotic-freeComplimentary mechanism  Potential to advance rosacea treatment  Demonstrated strong efficacy  Demonstrated fast onset of action       Observed favorable tolerability profile 
 

 Capture significant opportunity in rosacea  Rosacea subtype II treatments by phase & severity  Note: *Branded products may have generic equivalentSource: L.E.K. interviews and analysis; company websites                     OTC  Generic  Branded*  Laser treatment  Intense pulsed light                                          Mild  Moderate  Severe  OTC products typically not used  Oralisotretinoin  Generic antibiotics(doxycycline, minocycline,  Generic metronidazole  Generic clindamycin        EPSOLAY® 
 

       DENSITY &PRODUCTIVITY METRICS            MARKET FACTORS    APPROACH TO building a commercialorganization—Efficient and effectivE      PRESCRIBER VALUE            ~15,000 Dermatologists  ~6500 Decile3-10  ~6000 NP/PAs  FlexibleScalableHighly efficient  SALES FORCE  3280 Target offices~45-62 sales representatives 
 

   Scalable marketing investment  An integrated approach built from the ground up      GEO-TARGETING& NONPERSONAL  HIGH TOUCHPOINTS  NONPERSONAL  Access services   Digital  CRM  Social media  Patient activation   SalesReps 
 

 COMPETITIVE PRICING   Addressing access & UM for epsolay®1,2,3  Positive payer response to EPSOLAY®—Competitive pricing likelyequals parity access in rosacea  ~70%  Most would cover at preferred or non-preferred level dependingon cost  PAYER RESPONSE TO CLINICAL PROFILE  LIKELY:Step-through genericsQuantity limits  POSSIBLE:Prior authorizationto label       “If priced like Finacea, it would get parity access; 15%-20% rebate expected with WAC at parity to Finacea.”  State      AIS Health, 2019. http://www.aishealth.com/about.MMIT Network, 2019. http://www.mmitnetwork.comData on file. NPG Health primary market research, 2019.  PAYER UM POSITION BASED ON HIGHERNET-TO-PLAN PRICE*   COMPELLING TO DRIVE FORUMLARY CONSIDERATION    COVERED OR BETTER3:92% Commercial40% Part D74% Medicaid      Based on~107 MILLION LIVES1 
 

 Symphony Health IDV Vantage, 10/18  Commercial approach  Efficient reach to 80% dermatology market for acne and rosacea  Targeted high-value and focus use of resources and effort   Build a highly effective organizational model that is flexible and scalable   Exploit Innovative channel and payment strategies to reduce access hurdles and ensure pull-through  Leverage consumer activation in high patient-engagement categories  Significant potential for sales force efficiency and addressing a challenging reimbursement environment 
 

 Technology overview  Ofer Toledano, VP Research and Development  
 

 WHY SILICA?   FDA approved for topical useSmooth, no-grit feel for userPhysical properties of silica shell tuned to modify release of active ingredientStrong IP protection to 2032 (Epsolay®) and 2038 (TWIN)Proprietary process produces high encapsulation efficiency    1  Silica monomers and drug substance are emulsified together   Silica monomers migrate to the oil/water interface in a well-controlled process  A silica shell, microcapsuleis formed   SOL-GEL PROCESS    2  If approved, will be first core-shell encapsulation system for topical dermatology productsAPIs stabilized via microencapsulation, allowing for novel combinationsBarrier between entrapped API and skin may reduce irritation and improve complianceHurdle for generics to demonstrate similar release profile  POTENTIAL BENEFITS    3  Foundation forbranded product pipeline 
 

 SEM PICTURE  SEM PICTURE  Encapsulated Tretinoin (E-ATRA)      High encapsulation efficiency protects tretinoin  Encapsulated tretinoin is stable in the presence of benzoyl peroxide  High encapsulation efficiency enhances stability 
 

 CRYO-SEM PICTURE  ENERGY-DISPERSIVE X-RAY SPECTROSCOPY MAPPING  Encapsulated Benzoyl Peroxide (E-BPO)  Skin lipids migrate through the silica shell to promote solubilization of BPO. Dissolved BPO then migrates to skin’s sebaceous follicles  Silica shell wraps BPO crystals and serves as a barrier between benzoyl peroxide crystals and skin, leading to less irritation      Controlled release improves tolerability 
 

 Patents and Trademarks  # of Patents Related to Company Products  4  14  29  16  4 in US, IL, CA, EP  EPSOLAY®  5 in US, CA, EP, IL  TWIN  US Patents  Granted/Allowed  Pending  Foreign Patents  Granted/Allowed  Pending  Trademarks  Registered/Allowed  Registered/Allowed  Our intellectual property is protected through a series of patent families, describing and claiming our proprietary processes, formulations, and methods of use  IP, Expiry  Product/Indication  IP Protection for Our Branded Products (US)  NEWLY GRANTED/ALLOWED PATENT EXTENSION 2038Pending, 2040  Granted/Allowed, 2032Pending, 2040  TWINacne vulgaris  EPSOLAY®subtype II rosacea      Intellectual property estate 
 

 Pipeline Lifecycle & active research areas  Mori Arkin, Chairman  Investor and Analyst Day, July 2019  
 

 Lifecycle  PROJECT  DESCRIPTION   SGT-129  EPSOLAY® + alpha agonist for the treatmentof rosacea type I and II  SGT-138  TWIN + immune modulator for the treatment of severe acne —Hydradenitis Suppurativa   Investor and Analyst Day, July 2019  
 

 Pipeline and Early research   PROJECT  DESCRIPTION    SGT-210   Topical treatment of hyper-keratinization disorders—Palmoplantar Keratoderma    Non-melanoma skin cancer NMSC (BCC/SCC)  Investor and Analyst Day, July 2019  
 

 A group of skin conditions characterized by thickening of the skin on the hands and soles of the feet1Can be a manifestation of various syndromes2Inherited:Due to mutations that result in keratin abnormalitiesCan be autosomal recessive or autosomal dominantAcquired due to1,2:Drugs, malnutrition, chemicals, systemic disease, cancer, infectionTreatment options are very limited and of limited effectiveness.3,4 (Topical keratolytics, Benzoic acid, oral retinoids, topical calcipotriol)  Palmoplantar keratoderma (PPK)  Genetic and Rare Diseases Information Center. 2019. https://rarediseases.info.nih.gov/diseases/8167/.Charny JW, James WD. 2019. https://emedicine.medscape.com/article/1108406-overview#a6.FIRST. 2019. http://www.firstskinfoundation.org/types-of-ichthyosis/palmoplantar-keratodermasSkaljic M. 2019. https://emedicine.medscape.com/article/1108406-overview  Investor and Analyst Day, July 2019   Topical treatment ofhyperkeratinization disorders 
 

 Financial overview  Gilad Mamlok, CFO 
 

 In January 2018, Perrigo received tentative approval from the FDA for ivermectin cream,1%, developed in collaboration with Sol-Gel. Perrigo was second to file and, as of today,there is no public disclosure of a third filer to the FDA. Sales of RLD reached $175 million in 2018In February 2019, Perrigo received approval from the FDA and launched the sale of acyclovir cream,5%, developed in collaboration with Sol-Gel. As of today, there is no public disclosure of anotherfiler to the FDA. The sales of the RLD were ~$92 million in 2018  Bioequivalence (BE) study results for 5-fluorouracil cream, 5%, expected in 2H2019  A portfolio of generic product candidates with favorable commercial agreementsthat supplement our branded pipelineSeven collaborations with Perrigo and one with Douglas Pharmaceuticalswith 50/50 gross profit sharing    FDA Approvals   Recent Developments  Multiple Collaborations      Revenue-generating generics partnerships 
 

 Financial profile  Gross proceeds of $86.3 million raised in IPO of 7,187,500 ordinary shares on February 5, 201818,949,968 shares outstanding as ofJune 30, 2019$49.8 million of cash and investmentsas of June 30, 2019Approximately $7.0 million in revenue from acyclovir cream in Q2/2019Cash runway expected to be sufficient to fund Phase III clinical programs for TWIN, regulatory activities for EPSOLAY®, a bioequivalence study,and our activities until the end of Q3/2020 
 

 Summary   Alon Seri-Levy, CEO 
 

 Advancements to Topical Therapies  Effective and efficient commercial organization on trackHighly positive Phase III results imply EPSOLAY®as best-in-classNew patent allowance extends value for TWINfrom 2032 to 2038Phase III topline results for TWIN on track in 4Q/19NDA submissions for EPSOLAY® and TWIN plannedfor 2020Lifecycle extension projects for acne and rosaceaR&D exploratory projects in areas of high unmet needsSignificant non-dilutive revenues ahead of plan 
 

 Q&A