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
of the Securities Exchange Act of 1934
 
For the month of July 2019

Commission File No.: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
 
The Company is posting on its website the Sol-Gel Technologies Ltd. Corporate Presentation.
 
Attached hereto and incorporated by reference in this Report on Form 6-K is the following exhibit:
 

2

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 23, 2019
By:
/s/ Gilad Mamlok
 
 
Gilad Mamlok
 
 
Chief Financial Officer
 
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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, 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. 
 

 NOVEL DELIVERY SYSTEMFOR BEST-IN-CLASS TOPICAL DRUGS  Proprietary silica-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  TWIN Phase III data in acne vulgaris expected in Q4/2019  Successfully raised $86.3 million in IPO in February 2018  Non-dilutive revenues from generic pipeline as of 1H/2019  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  TWINAcne vulgaris  Research  Preclinical  Phase II  Phase III  NDA submission  1H/2020  2H/2020  Top-lineresultsin Q4/2019        GENERIS 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                        Company and Products Overview | July 2019  
 

 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, microcapsule is 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)  Granted/Allowed, 2038Pending, 2040  Granted/Allowed, 2032Pending, 2040  TWINacne vulgaris  EPSOLAY®subtype II rosacea      Intellectual property estate  Company and Products Overview | July 2019  
 

 Chronic, inflammatory condition that primarily affects the face, and is often characterized by flushing, redness, inflamed bumps, and pustulesAffects approximately 16 million in the United States1 — ~5 million have papulopustular2  Topical antimicrobials or anti-mites (metronidazole, clindamycin, ivermectin)and systemic antibiotics (minocycline, doxycycline)  Insufficient efficacy resulting in poor adherence; contributing to antibiotic resistance; systemic side effects; misdiagnosis is common1,3  What ispapulopustular rosacea?  How is it treated?  What are the current treatments shortfalls?  Papulopustular rosacea—inflammatory condition with pooradherence to current treatments  Erythematotelangiectatic  Papulopustular  Phymatous  Ocular  National Rosacea Society. www.rosacea.org.Berg, M. and Liden, S, Acta Derm Venereol. 1989;69: 419–423Prevalence of rosacea. http://www.rosacea.org/rr/index.php.Gether L et al. Br J Dermatol. 2018;179:282-289.Wilkin J et al. J Am Acad Dermatol. 2004;50:907-912  Multiple subtypes/phenotypes often seen in a single patient4,5 
 

 Epsolay®Microencapsulated BPO cream, 5%  Encapsulation may reduce the irritation of BPOPotential to be more effective than existing treatmentsPotential to be the first FDA-approved single-active BPO Rx drug product 
 

 Male and female ≥18 years of age Clinical diagnosis of moderate to severe rosacea≥15 ≤ 70 inflammatory lesions≤2 nodules  2:1  EPSOLAY® cream, 5% (once daily)  Vehicle cream (once daily)  54 Total Sites - Study 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 Global Assessment (IGA) relative to Baseline at Week 12Absolute mean change in inflammatory lesion counts from baseline to Week 12SECONDARY ENDPOINTS:Inflammatory lesion percentage change from baseline to Week 12Absolute mean change in inflammatory lesion counts from baseline at Week 8 and Week 4Proportion 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 8 and Week 4  Randomization 
 

 Study population & discontinuation   Study 54-02  Study 54-01  # of Patients  Epsolay®  Vehicle  # of Patients 
 

 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-value < 0.001  P-value < 0.001  Success in IGA @ Week 12  Inflammatory Lesion Count Change from Baseline @ Week 12  P-value < 0.001  P-value < 0.001  Study 54-02  Study 54-01 
 

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

 Exploratory endpoints (itt)  Study 54-02  Study 54-01  Success in IGA @ Week 2  Inflammatory Lesion Count Change from Baseline @ Week 2  P-value = 0.009  P-value = 0.017  P-value < 0.001  P-value < 0.001  Study 54-02  Study 54-01 
 

 Secondary endpoints (itt)  Success in IGA @ Week 4  Inflammatory Lesion Count Change from Baseline @ Week 4  P-value < 0.001  P-value = 0.009  P-value < 0.001  P-value < 0.001  Study 54-02  Study 54-01  Study 54-02  Study 54-01 
 

 Secondary endpoints (itt)  Success in IGA @ Week 8  Inflammatory Lesion Count Change from Baseline @ Week 8  P-value < 0.001  P-value = 0.006  P-value < 0.001  P-value < 0.001  Study 54-02  Study 54-01  Study 54-02  Study 54-01 
 

  absolute change IN Inflammatory lesion count from baseline over time (itt)  Demonstrated statistical significant improvement in reducing inflammatory lesions as of Week 2  P<0.001 vs corresponding vehicle  †  †  †  †  †  †  †  †  † 
 

 Success in iga over time (itt)  Statistical significant improvement in getting patients to the stage of “clear” or “almost clear”  †P < 0.05, #P < 0.01, *P < 0.001 vs corresponding vehicle  *  #  †  *  *  *  #  # 
 

 Comparison of Onset of action tohistorical soolantra® results(†)   Rapid Efficacy 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 construed as 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  Primary endpoints historical comparisons(†)   (†) 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 
 

 Skin tolerability  Study 54-01  Study 54-02      Itching Burning/Stinging Dryness Scaling  Percent of Patients                  Epsolay®      Vehicle              Percent of Patients  Itching Burning/Stinging Dryness Scaling     
 

 Treatment emergent adverse events (†)Safety population  No. (%) of Subjects  Study 54-01      Epsolay®  Vehicle  Subjects reporting any TEAE  49 (20.5%)  17 (15.0%)  Serious TEAE    1 (0.4%)1  Severe TEAE  2 (0.8%)    Discontinuation  5 (2.1%)  1 (0.9%)  Treatment-related  14 (5.9%)  3 (2.7%)  Study 54-02    Epsolay®  Vehicle  50 (20.2%)  22 (18.2%)  1 (0.4%)2    2 (0.8%)3    4 (1.6%)  1 (0.8%)4  9 (3.6%)    1 Femur fracture2 Spinal compression fracture3 One subject with spinal compression fracture4 Urinary tract infection – Discontinuation defined as “other” reason 
 

 A multifactorial disease of the pilosebaceous unit, involving abnormalitiesin sebum production, follicular epithelial desquamation, bacterial proliferation,and inflammation  BPO, retinoids, antibiotics and their combinations are the mainstays of Rx topical therapies. Isotretinoin and antibiotics are the mainstays of Rx systemic therapies   Insufficient efficacy negatively affects self-esteem; contributes toantibiotic resistance; systemic side effects  Encapsulation allows combining two highly effective APIs, BPO & ATRA,that have a complementary mechanism of actionEncapsulation may reduce the irritation of both BPO and ATRAPotential to be more effective than existing topical treatments  What isacne vulgaris?  How is it treated?  What are the current treatments shortfalls?  TWIN:E-ATRA/E-BPO cream  Acne vulgaris—multifactorial disease requiringpowerful combination treatments 
 

 Number of Patients  Severe  0    0  1  0    Moderate  102    111  1,043  1,118    Mild  0    0  0  0  Average Baseline # of Lesions  Inflamed  25.9    ~29.7  28.8  29.6    Noninflamed  42.1    ~53.7  46.9  46.7  Non-Inflammatory Lesions—Mean Percent Change from Baseline at Week 12  Success in IGA at Week 12  Inflammatory Lesions—Mean Percent Change from Baseline at Week 12  Difference From Vehicle  Phase II  Phase II  Phase II  TWIN  Active Treatment 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  Acne trials efficacy results*: moderate patients 
 

 Number of Patients  Severe  14    61  64  37  118  70  79    Moderate  102    292  305  296  620  413  440    Mild  0    0  0  0  0  0  0  Average Baseline # of Lesions  Inflamed  26.7    42.4  42.9  31.6  30.7  29.7  30.3    Noninflamed  42.9    59.1  62.8  50.5  49.7  42.4  42.3  Non-Inflammatory Lesions—Mean Percent Change from Baseline at Week 12  Success in IGA at Week 12  Inflammatory Lesions—Mean Percent Change from Baseline at Week 12  Active Treatment Arm  Difference From Vehicle  Winlevi™  FMX101  Minocycline foam, 4%  Clascoterone cream, 1%  Oral sarecycline  Seysara™  Noninflammatory lesions not a co-primary endpoint  Phase II  Phase II  Phase II  Noninflammatory lesions not in label  TWIN   *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.  Efficacy results of recent acne trials* 
 

     Week 12  Week 6  0      2-1 Randomization    Screening  Encapsulated BPO vs. Topical vehicle Placebo-controlled  Two 12-week, randomized, double-blind, vehicle controlled studies in patients with acne vulgarisEnrollment of ~420 subjects per study at a ratio of 2:1, yielding 99% powering  PRIMARY ENDPOINTS: Proportion of patients in active treatment versus vehicle cream with an assessment of clear or almost clear with at least a 2-grade improvement in IGA at Week 12Absolute change from Baseline in inflammatory and non-inflammatory lesion count at Week 12 TOPLINE RESULTS EXPECTED IN Q4 2019  Twin phase III trial designs  Male and female patients ≥ 9 years of ageIGA score of moderate or severeA diagnosis of facial acne ≥30 and ≤150 non-inflammatory lesions ≥20 and ≤100 inflammatory lesions including in the nose 
 

 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 (rest oral)*Dermatologists account for ~60% of acne treatment(higher for branded products)Tretinoin is prescribed at 5x the rate of any other retinoid,and no combination of benzoyl peroxide and tretinoinis available or currently possible  Approximately 16 million people in the US suffer from rosacea(5-6 million type 2) (>30 years)Many patients are misdiagnosed or do not seek treatment at all, creating a large underserved patient population$478 million branded topical market (WAC)*Treated with topical products 76% of the time (rest oral)*  Market potential for acne & rosacea        *Sources: Symphony Health; Syneos Research & Insights ”Treatment Answers”; June 2019 MAT. 
 

 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 commercial organization - 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 
 

 COMPETITIVE PRICING   Addressing access & UM for epsolay®1,2,3  Positive payer response to EPSOLAY® - Competitive pricing likely equals 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 HIGHER NET-TO-PLAN PRICE   COMPELLING TO DRIVE FORUMLARY CONSIDERATION    COVERED OR BETTER:92% Commercial40% Part D74% Medicaid     
 

 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 
 

 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 2018.In 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 
 

 2021  File NDA for EPSOLAY® in 1H/2020   File NDA for TWIN in 2H/2020  2019  2020  Obtained ANDA approvalfor acyclovir cream (sponsored by Perrigo)  Reported positive Phase III results for EPSOLAY® in papulopustular rosacea  Plans to report Phase III results for TWIN in acne vulgaris End of 2019  Plans to report BE study results for 5-fluorouracil cream, 5%           Recent milestones & next steps  US pre-launch commercial preparations     (Collaboration with Perrigo) ANDA for 5-fluorouracil cream, 5% filed in 1H/2020    Approval and launch of EPSOLAY® first in 2021    US commercial organization fully operational    Receive notice of allowance extending TWIN market protection from 2032  2038  Start PoC for Palmoplantar Keratoderma Q4/2019     Approval and launch of TWIN product second in 2021    Recognized non-dilutive revenues early form launch of acyclovir cream (by Perrigo) 
 

 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.