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 February 2020
 
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
 
Sol-Gel Technologies Ltd. (the “Company”) is posting on its website a corporate presentation.
 
Attached hereto and incorporated by reference in this Report on Form 6-K is the following exhibit:
 
 

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:  February 5, 2020
By:
/s/ Gilad Mamlok  
    Gilad Mamlok  
   
Chief Financial Officer
 



Exhibit 99.1
 NASDAQ: SLGL 
 

 FORWARD-LOOKING STATEMENTS  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, our anticipated NDA submission dates for Epsolay and Twyneo, estimated timing for the approval and launch of Epsolay and Twyneo, 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 presentation. 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.Before you invest, you should read the prospectus in the registration statement and other documents we have filed with the SEC for more complete information about the issuer and this offering. You may get these documents for free by visiting EDGAR on the SEC web site at http://www.sec.gov. Alternatively, we, any underwriter or any dealer participating in the offering will arrange to end you the prospectus if you request it from Jefferies, Attention Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, via telephone at (877) 821-7388, or email at: [email protected] or from BMO Capital Markets, Attention: Syndicate Department, 3 Times Square, 25th Floor, New York, New York 10036 or by telephone at (800) 414-3627 or by email [email protected].  
 

 THREE-FOLD STRATEGY  Leverage 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 
 

 NOVEL DELIVERY SYSTEMFOR BEST-IN-CLASS TOPICAL DRUGS  Proprietarysilica-based microencapsulation topical delivery platform for dermatology indications   Positive phase III results from EPSOLAY® clinical trial in papulopustular rosacea in July 2019NDA submission anticipated in 1H/2020  Positive phase III results from TWYNEO® in acne vulgaris in December 2019NDA submission anticipated in 2H/2020  Completed follow-on offering of $11.5 million in August 2019Successfully raised $86.3 million in IPO in February 2018  Non-dilutive revenues of $18.8 million from generic pipeline in the first 9 months  Seasoned management team with proven track record and broad dermatologic experience    1    2    3    4    5    6 
 

                       Pipelines & upcoming milestones    BRANDED CANDIDATES  EPSOLAY®Papulopustular rosacea  TWYNEO®Acne vulgaris  Research/Preclinical  Phase I  Phase II  Phase III  NDA Submission 1H/2020  NDA Submission 2H/2020  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   BIOEQUIVALENCE ACHIEVED IN DEC 2019        Research  Filed  Bioequivalence                    SGT-210Palmoplantar keratoderma  Anticipated Milestones  RLD, reference listed drug.  Data in 1H/2021  TapinarofPsoriasis & other derm indications      RoflumilastPsoriasis & other derm indications  Formulation  Formulation 
 

 WHY SILICA?   FDA approved for topical useProprietary process produces high encapsulation efficiencyPhysical properties of silica shell tuned to modify release of active ingredientSmooth, no-grit feel for userStrong IP protection to 2032 (EPSOLAY®) and 2038 (TWYNEO®)    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  Barrier between entrapped API and skin may reduce irritation and improve complianceAPIs stabilized via microencapsulation, allowing for novel combinationsHurdle for generics to demonstrate similar release profileIf approved, will be first core-shell encapsulation system for topical dermatology products  POTENTIAL BENEFITS    3  Foundation forbranded product pipeline 
 

 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 BPO crystals and skin, leading to less irritation      Controlled release improves tolerability 
 

 Patents and Trademarks  # of Patents Related to Company Products  5  11  34  15  4 in US, IL, CA, EP  EPSOLAY®  5 in US, CA, EP, IL  TWYNEO®  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)  Granted 2038Pending 2040  Granted 2032Pending 2040  TWYNEO®acne vulgaris  EPSOLAY®subtype II rosacea      Intellectual property estate 
 

   A multifactorial disease of the pilosebaceous unit, involving abnormalities in sebum production, follicular epithelial desquamation, bacterial proliferation, and inflammation  Topical BPO, retinoids, antibiotics, and their combinations; isotretinoin and antibiotics are mainstays of systemic therapy   Insufficient efficacy negatively affects self-esteem; contributes to antibiotic resistance; systemic side effects  What isacne vulgaris?  How is it treated?  What are the current treatment shortfalls?  Acne vulgaris  Multifactorial disease requiring powerful combination treatments    Our solution: TWYNEO®E-BPO + E-ATRA Cream  Encapsulation allows combining 2 highly effective APIs, BPO and ATRA, that have complementary mechanisms of actionEncapsulation may reduce the irritation of both BPO and ATRAPotential to be more effective than existing topical treatments 
 

 Co-Primary EndpointsProportion of subjects with an assessment of clear or almost clear and with at least a 2-grade improvement in IGA from baseline at Week 12Absolute change in inflammatory lesion counts from baseline at Week 12Absolute change in non-inflammatory lesion counts from baseline at Week 12Safety EndpointsCutaneous safety assessment, local tolerability assessment, adverse event reporting  QD, Self-applied  Twyneo® cream(3% E-BPO, 0.1% E-ATRA)   Vehicle cream  Age ≥9 years≥20 to ≤100 Inflammatory lesions  ≥30 to ≤150 Non-inflammatory lesionsIGA grade 3 (Moderate) or grade 4 (Severe)Cysts/nodules ≤2  2:1  Randomization  Inclusion criteria  12 weeks of treatment  E-ATRA=microencapsulated tretinoin; E-BPO=microencapsulated benzoyl peroxide; IGA=Investigator's Global Assessment; QD=once daily;   Baseline 2 4 8 12   Weeks  63 Total SitesStudy 65-04: 424Study 65-05: 434   Twyne0® Study design  Two Phase 3, Double-blind, Randomized, Vehicle-controlled Studies 
 

   Study 65-04    Study 65-05    Number of sites  32    31      Twyneo®(n=281)  Vehicle (n=143)   Twyneo®(n=290)  Vehicle (n=144)   Age, yearsMean (SD)Median (range)  20.9 (8.48)18.0 (11-67)  21.4 (8.62)18.0 (10-57)  20.1 (6.96)18.0 (10-51)  20.3 (6.67)18.5 (9-42)  Sex, n (%)MaleFemale  106 (37.7%)175 (62.3%)  60 (42.0%)83 (58.0%)  117 (40.3%)173 (59.7%)  67 (46.5%)77 (53.5%)  Ethnicity, n (%)Hispanic/LatinoNot Hispanic or LatinoUnknown/Not Reported  102 (36.3%)178 (63.3%)1 (0.4%)  44 (30.8%)98 (68.5%)1 (0.7%)  85 (29.3%)204 (70.3%)1 (0.3%)  56 (38.9%)87 (60.4%)1 (0.7%)   IGA severity Moderate Severe  251 (89.3%)30 (10.7%)  132 (92.3%)11 (7.7%)  262 (90.3%)28 (9.7%)  133 (93.0%)10 (7.0%)  Inflammatory lesion countMean (SD)Median (range)  33.5 (14.62)28.0 (20-92)  33.5 (14.69)28.0 (20-90)  28.2 (8.70)25.0 (20-62)  27.5 (8.52)25 (20-75)  Non-inflammatory lesion countMean (SD)Median (range)  48.6 (20.24)42.0 (30-148)  47.1 (19.97)41.0 (30-140)  44.6 (18.03)39.0 (23-149)  44.9 (18.82)38.0 (30-123)  Well-balanced studies at Baseline (ITT)   
 

 Low discontinuation rate across studies    Study 65-04    Study 65-05      Twyneo®(n=281)  Vehicle (n=143)  Twyneo®(n=290)  Vehicle (n=144)  Randomized Subjects          Discontinued  32  12  48  12  Adverse events  4 (1.4%)​  0​  12 (4.1%)​  0  Lost to follow-up​  10 (3.6%)​  7 (4.9%)​  15 (5.2%)​  7 (4.9%)​  Lack of efficacy​  0​  0​  0​  0​  Pregnancy​  1 (0.4%)​  0​  1 (0.3%)​  0 ​  Protocol violation​  2 (0.7%)​  0​  0​  0 ​  Withdrawal by parent/guardian​  4 (1.4%)​  1 (0.7%)​  4 (1.4%)​  0 ​  Withdrawal by patient​  9 (3.2%)​  4 (2.8%)​  14 (4.8%)​  5 (3.5%)​  Physician decision​  1 (0.4%)​  0​  1 (0.3%)​  0​  Condition worsened​  0​  0​  0​  0​  Other ​  1 (0.4%)​  0   1 (0.3%)​  0​  Completed  249 (88.6%)  131 (91.6%)  242 (83.4%)   132 (91.7%)  
 

 Co-primary endpoint (itt)  IGA Treatment Success at Week 12  Percent of subjects achieving IGA success at Week 12  P<0.001  Study 65-04  Vehicle(n=143)  Vehicle  P=0.017  Study 65-05  (n=290)  (n=144)  (n=281) 
 

 Co-primary endpoint (itt)  Absolute Mean Change From Baseline in Inflammatory Lesions at Week 12  P<0.001  P=0.018  Study 65-04  Study 65-05  Mean reduction in inflammatory lesion count from baseline at Week 12  Vehicle(n=143)  (n=281)  (n=290)  Vehicle(n=144) 
 

 Co-primary endpoint (itt)  Absolute Mean Change From Baseline in Non-Inflammatory Lesions at Week 12  Mean reduction in non-inflammatory lesion count from baseline at Week 12  Study 65-04  Study 65-05  P<0.001  P<0.001  Vehicle(n=143)  Vehicle(n=144)  Twyneo®(n=281)  Twyneo®(n=290) 
 

 SUCCESS IN IGA IN RECENT ACNE TRIALS*  Trials With Highest Difference in IGA Between the Active Arm and the Vehicle Arm   *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 construed as conclusions to be drawn as if we conducted a head-to-head comparison trial or study  Percent of subjects achieving IGA success at Week 12 normalized to vehicle    Twyneo®  Winlevi®  Seysara® 
 

 SUCCESS IN IGA IN MODERATE Subjects*  Trials With Highest Difference in IGA Between the Active Arm and the Vehicle ArmModerate Subjects at Baseline Only  Percent of subjects achieving IGA success at Week 12 normalized to vehicle    Twyneo®   *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 construed as conclusions to be drawn as if we conducted a head-to-head comparison trial or study 
 

 Twyneo®(n=281)  Supportive efficacy analysis*(itt)  IGA Treatment Success Over Time  Percent of subjects achieving IGA success  Week  Week  Study 65-04  Study 65-05  ​  *Percent of subjects with an assessment of clear or almost clear and with at least a 2-grade improvement in IGA from baseline, at Weeks 2, 4 and 8  Vehicle(n=143)  Twyneo®(n=290)  Vehicle(n=144) 
 

 Supportive efficacy analysis* (itt)  Mean Reduction in Non-Inflammatory Lesion Count Over Time  Mean change from baseline in non-inflammatory lesion count  Study 65-04  Study 65-05  Week  Week  Mean change from baseline in inflammatory lesion count  Study 65-04  Study 65-05  Week  Week  Mean Reduction in Inflammatory Lesion Count Over Time  *Mean change from baseline in inflammatory and non-inflammatory lesion counts from baseline to Week 2  Twyneo®  Twyneo® 
 

 Safety & tolerability  Nearly all AEs were mild or moderate in severityTotal of 18 subjects discontinued from Studies 65-04 and 65-05 due to a TEAE: 18 (2%) in Twyneo® and 0 in vehicle No treatment-related SAEs were identified in either study2 subjects reported SAEs in Study 65-05; (1) Twyneo® subject reported depression        Study 65-04    Study 65-05    Most frequent non-cutaneous TEAEs (≥1% in any treatment arm), n (%)  Twyneo®  Vehicle   Twyneo®  Vehicle   Safety population  n=274  n=139  n=281  n=138  Upper respiratory tract infection  6 (2.2%)  3 (2.2%)  1 (0.4%)  2 (1.4%)  Headache  3 (1.1%)  1 (0.7%)  1 (0.4%)  0  Nasopharyngitis  1 (0.4%)  0  4 (1.4%)  0  Attention deficithyperactivity disorder  0  2 (1.4%)  0  0  Viral upper respiratorytract infection  0  0  1 (0.4%)  2 (1.4%)  SAE=serious adverse event; TEAE=treatment-emergent adverse event 
 

 Local Skin Tolerability assessment* at week 12  *Safety population  Study 65-04  Study 65-05     
 

 Local skin tolerability assessments over time   Safety population for Study 65-04 (n=274). Safety population for Study 65-04 (n=281). BL=baseline; 12W=12 weeks   Erythema Scaling Pigmentation Dryness Itching Burning Stinging   Percent of subjects  BL 12W  BL 12W  BL 12W  BL 12W  BL 12W  BL 12W  BL 12W  BL 12W  BL 12W  BL 12W  BL 12W  Study 65-05  Study 65-04  BL 12W  BL 12W  BL 12W 
 

 Encapsulation aims to reduce irritation of BPOPotential to be more effective than existing treatmentsPotential to be first FDA-approved single-agent BPO Rx drug product     Chronic, inflammatory condition that primarily affects the face and is often characterized by flushing, redness, inflamed bumps, and pustules  Topical antimicrobials (metronidazole, clindamycin); topical anti-mite (ivermectin); systemic antibiotics (minocycline, doxycycline)  Insufficient efficacy resulting in poor adherence, contributing to antibiotic resistance; systemic side effects  What ispapulopustular rosacea?  How is it treated?  What are the current treatment shortfalls?  Papulopustular rosacea  Inflammatory condition with poor adherence to current treatments    Our solution: EPSOLAY®Encapsulated benzoyl peroxide (E-BPO) 
 

 Male and female ≥18 years of age Clinical diagnosis of moderate to severe rosacea≥15 to ≤70 inflammatory lesions≤2 nodules  2:1  EPSOLAY® cream, 5% (once daily)  Vehicle cream (once daily)  54 Total SitesStudy 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  EPSOLAY® Study design  PRIMARY ENDPOINTS:Proportion of patients with the primary measure of success, "Clear" (0) or "Almost clear" (1), in the Investigator GlobalAssessment (IGA) relative to baseline at Week 12Absolute mean change in inflammatory lesion counts from baseline to Week 12  Randomization 
 

 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. 
 

 Patient severity at baseline    Study 54-01    Characteristic  EPSOLAY®  Vehicle   IGA “Moderate”IGA “Severe”  210 (86.4%)33 (13.6%)  104 (88.1%)14 (11.9%)  Mean lesion count (SD)Median lesion count (range)  25.7 (11.07)22.0 (15-69)  26.3 (12.45)21.0 (15-70)  Study 54-02    EPSOLAY®  Vehicle   227 (90.8%)23 (9.2%)  112 (91.8%)10 (8.2%)  29.8 (14.00)25.0 (15-70)  27.5 (13.04)22.5 (15-70) 
 

 Primary endpoints (itt)  Study 54-02  Study 54-01  P<0.001  P<0.001  Success in IGA at Week 12  Inflammatory Lesion Count Change From Baseline at Week 12  P<0.001  P<0.001  Study 54-02  Study 54-01  ITT, intent-to-treat.  
 

 Secondary endpoint (itt)  Inflammatory Lesion Percent Change From Baseline to Week 12  P<0.001  P<0.001  Study 54-02  Study 54-01 
 

 Success in iga (itt)  Week 2Exploratory Endpoint  P=0.009  P=0.017  Study 54-02  Study 54-01  Week 4Secondary Endpoint  P<0.001  P=0.009  Study 54-02  Study 54-01  Week 8Secondary Endpoint  P<0.001  P=0.006  Study 54-02  Study 54-01 
 

 Inflammatory lesion Count Change from Baseline (itt)  Study 54-02  Study 54-01  P<0.001  P<0.001  Week 2Exploratory Endpoint  Week 4Secondary Endpoint  Week 8Secondary Endpoint  Study 54-02  Study 54-01  P<0.001  P<0.001  Study 54-02  Study 54-01  P<0.001  P<0.001 
 

 Comparison of Onset of action tohistorical soolantra® results*  Rapid Onset of EPSOLAY®  *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. 
 

 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 
 

 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 
 

   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 (0.4%)†  0  Severe TEAE  2 (0.8%)  0  2 (0.8%)‡  0  Discontinuation  5 (2.1%)  1 (0.9%)  4 (1.6%)  1 (0.8%)§  Treatment-related  14 (5.9%)  3 (2.7%)  9 (3.6%)  0  *Femur fracture.†Spinal compression fracture.‡One subject with spinal compression fracture.§Urinary tract infection—Discontinuation classified as “other reason.”  Safety population.  Treatment-emergent adverse events(TEAEs) summary 
 

 ROSACEA   ACNE  Approximately 16 million people in the US suffer from rosacea; 5-6 million have type 2 (age >30 years)~$800 million branded topical market (WAC)1Treated with topical products 76% of the time1Dermatologists 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      1. Symphony Health. Syneos Research & Insights ”Treatment Answers”; June 2019 MAT.  50 million people suffer from acne in the US(ages 12-24 years)~$1.9 billion branded topical market (WAC)1 Treated with topicals 56% of the time;remaining is oral1Dermatologists account for ~60% of acne treatments(higher for branded products)Combining treatments is the bestway to combat acne for the majority of patients2  2. American Academy of Dermatology. https://www.aad.org/practicecenter/quality/clinical-guidelines/acne/topical-therapies.. 
 

 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 
 

       DENSITY &PRODUCTIVITY METRICS            MARKET FACTORS    APPROACH TO building a commercialorganization—Efficient and effectivE      PRESCRIBER VALUE            ~12,000 Dermatologists  ~6,500 Decile3-10  ~6,000 NP/PAs  FlexibleScalableHighly efficient  SALES FORCE  3,280 target offices~45-62 sales representatives 
 

 COMPETITIVE PRICING   Addressing access & UM for epsolay®1-3  ~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.com.Data on file. NPG Health primary market research, 2019.  PAYER UM POSITION BASED ON HIGHERNET-TO-PLAN PRICE   COMPELLING TO DRIVE FORMULARY CONSIDERATION    COVERED OR BETTER3:92% Commercial40% Part D74% Medicaid      Based on~107 MILLION LIVES1  Positive payer response to EPSOLAY®—Competitive pricing likelyequals parity access in rosacea 
 

 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. In February 2019, Perrigo received approval from the FDA and launched the sale of acyclovir cream,5%, developed in collaboration with Sol-Gel. An authorized generic product entered the market in the third quarter of 2019.   Bioequivalence achieved for generic 5-fluorouracil cream, 5%, for actinic keratosis, submission of abbreviated New Drug Application expected in 1H 2021.  A portfolio of generic product candidates with favorable commercial agreementsthat supplement our branded pipelineSeven collaborations with Perrigo and 1 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, 2018Gross proceeds of $11.5 million raised in a public follow-on offering on August 12, 201920,387,468 shares outstanding as ofSeptember 30, 2019$57.7 million of cash and investmentsas of September 30, 2019$18.8 million in generic product revenue in the first 9 months of 2019 Cash resources expected to be sufficient to fund operational and capital expenditure requirements into the first quarter of 2021 
 

 2021  File NDA for EPSOLAY® in 1H/2020   File NDA for TWYENO® in 2H/2020  2019  2020  Obtained ANDA approval for acyclovir cream (collaboration with Perrigo)  Reported positive phase III results for EPSOLAY® in papulopustular rosacea  Reported positive phase III results for TWYNEO® in acne vulgaris at end of 2019  Bioequivalence achieved for generic 5-fluorouracil cream, 5%       Recent milestones & next steps  US pre-launch commercial preparations     File ANDA for 5-fluorouracil cream, 5% in 1H/2021 (collaboration with Douglas)     Approval and launch of EPSOLAY®    US commercial organization fully operational    TWYNEO® granted market protection out to 2038  Approval and launch of TWYNEO® following EPSOLAY®     Recognized non-dilutive revenues early from launch of acyclovir cream (by Perrigo)  Initiated phase I PoC for SGT-210 in palmoplantar keratoderma     Top-line data expected in phase I PoC for SGT-210 in 1H/2021 
 

 NASDAQ: SLGLwww.sol-gel.com  ©2019 Sol-Gel Technologies Ltd. All Rights Reserved. EPSOLAY® is a registered trademark of Sol-Gel Technologies Ltd. All other trademarks are the property of their respective owners.