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 January, 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):  
 
Attached hereto and incorporated by reference herein are the following documents:
 
Exhibit 99.1: Sol-Gel Technologies Ltd. Corporate Presentation

SIGNATURES

 
SOL-GEL TECHNOLOGIES LTD.
 
 
 
 
 
Date:  January 7, 2019
By:
/s/ Gilad Mamlok
 
 
 
Gilad Mamlok
 
 
 
Chief Financial Officer
 
 
 



Exhibit 99.1

   NASDAQ: SLGL 
 

 Cautionary Note on 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 clinical trials for TWIN, 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 programs 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 rely on data from our Phase II TWIN trial to advance the development of SIRS-T; 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 26, 2018 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. 
 

 Seven established collaborations with two strategic partners on generic candidates   Tentative approval for 1st generic drug product  Complementary combination of branded and generic topical drugs pipelines  Proprietary topical microencapsulation delivery system   Significant inflection points expected from Phase III trials as early as 2019   Proven track record combined with broad dermatological knowhow  Primed to become a global dedicated dermatological company   Our Dermatology Company 
 

     A disease of the pilosebaceous unit, involving abnormalities in sebum production, follicular epithelial desquamation, bacterial proliferation and inflammationBenzoyl peroxide (BPO) and tretinoin are mainstay therapiesTretinoin is the most widely used Rx topical retinoid, but is rapidly decomposed by BPO and causes irritationBPO/tretinoin combination does not currently exist on the market~$2.7 billion sales in the U.S. in 2017 of several promoted topical brands and many generics, of which fixed-dose combination drugs account for ~$900 millionDermatologists often prefer branded topical drugs even though cheaper generics and OTC alternatives exist  Papulopustular Rosacea  Acne Vulgaris  A chronic, inflammatory skin condition affecting nearly 5 million people in the US~$395 million sales in the U.S. in 2017 of topical products: Soolantra®, Finacea® and generic metronidazolePoor patient adherence to current drugs  Sources: IQVIA (IMS); T. Pigeon, Practical Dermatology, July 2010   Common Indications Requiring Better Therapies 
 

 (†) Our estimation takes into consideration current payers’ requirements and tier 3 limitations        SIRS-Tacne vulgaris  TWINacne vulgaris  Epsolay®papulopustular rosacea  A cream containing encapsulated benzoyl peroxide, 5%Encapsulation was designed to reduce irritation caused by benzoyl peroxidePotential to be the 1st FDA-approved single-active benzoyl peroxide prescription drug productWe estimate peak annual sales of $75M - $100M(†)  A cream containing a fixed-dose combination of encapsulated tretinoin and encapsulated benzoyl peroxideMajor challenges were the instability of tretinoin in the presence of benzoyl peroxide and irritationEncapsulation allows stabilization and is also expected to contribute to patient complianceOpportunity exists for shift from prescribing tretinoin and existing combinations to prescribing TWINWe estimate peak annual sales of $350M - $400M(†).   A topical formulation containing encapsulated tretinoinCommon side effects of tretinoin include itching, redness, swelling, dryness, peeling and scaling Encapsulation was designed to reduce irritation and is therefore expected to contribute to patient compliancePotential to be the 1st FDA-approved encapsulated tretinoin and more tolerable than currently available tretinoin drugs  Our Branded Drug Product Candidates 
 

 Our Microencapsulation Platform  SEM pictures of our silica-based encapsulated tretinoin  Encapsulated tretinoin microcapsule  Encapsulated tretinoin crystals inside broken microcapsule 
 

 Positive TWIN Factorial Phase II Results (ITT)(†)  Inflammatory Lesion Mean Absolute Change from Baseline at Week 12  <0.001  <0.001  P-value vs. vehicle  0.060  0.003  Non-Inflammatory Lesion Mean Absolute Change from Baseline at Week 12  <0.001  <0.001  P-value vs. vehicle  0.002  <0.001  Success in Dichotomized IGA at Week 12  <0.001  P-value vs. vehicle  0.015  0.001  0.006  N=115  N=116  N=117  N=118  N=118  N=118   (†) The above calculations were made using Markov Chain Monte Carlo multiple imputation method for handling missing data and without data from one center that discontinued the study. Analyses without imputation (with or without the discontinued center) were highly consistent with the above 
 

 Number of Patients  Severe  0    0  1  0    Moderate  102    111  1,043  1,118    Mild  0    0  0  0  Baseline # of Lesions  Inflamed  25.9    ~29.7  28.8  29.6    Non-inflamed  42.1    ~53.7  46.9  46.7  Non-Inflammatory Lesions – Mean Percent Change from Baseline at Week 12  Acne Trials Efficacy Results(†): Moderate Patients  Success in IGA at Week 12  Inflammatory Lesions – Mean Percent Change from Baseline at Week 12   (†) 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 conducteda head-to-head comparison trial or study  Treatment Arm:  Difference from Vehicle  Phase II  Phase II  TWIN  Phase II 
 

 Phase II Cutaneous Tolerability of TWIN    Mild    Moderate    Severe  Erythema  Scaling  Pigmentation  Itching  Burning  Stinging  Proportion of Subjects with Post-Baseline Worsening of Cutaneous Side Effects (Safety Population)  Max. Post-Baseline > Baseline  22%  31%  26%  22%  42%  41%  15%  14%  14%  19%  25%  28%  12%  38%  45%  14%  30%  36% 
 

 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  Baseline # of Lesions  Inflamed  26.7    42.4  42.9  31.6  30.7  29.7  30.3    Non-inflamed  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  Efficacy Results of Recent Acne Trials(†)  Success in IGA at Week 12  Inflammatory Lesions – Mean Percent Change from Baseline at Week 12   (†) 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 conducteda head-to-head comparison trial or study  Treatment Arm:  Difference from Vehicle  Winlevi™  FMX101  Minocycline foam, 4%  Clascoterone cream, 1%  Oral sarecycline  Seysara™  Non-inflammatory lesions not a co-primary endpoint  TWIN  Phase II  Phase II  Phase II  Non-inflammatory lesions not in label 
 

 Supportive SIRS-T Clinical Results (ITT)  Success in Dichotomized IGA at Week 12  P-value vs. vehicle  0.015  0.001  Non-Inflammatory Lesion Mean Percent Change from Baseline at Week 12  Inflammatory Lesion Mean Percent Change from Baseline at Week 12  N=115  N=118  N=118  P-value vs. vehicle  0.060  0.003  P-value vs. vehicle  0.002  <0.001 
 

 Positive Epsolay® Phase II Results (ITT)  Success in Dichotomized IGA at Week 12 (†)  0.0013  P-value vs. vehicle  Inflammatory Lesion Count – Change from Baseline at Week 12    Median    Mean   (†) The FDA required a modification to our definition of “clear” on the IGA scale such that the category of “clear” represented the absence of the disease. Out of the 11 subjects that were defined as “mild” at baseline, there was only one subject that was treated with Epsolay® 5% and reached “clear” at the end of the trial  N=30  N=32  N=30 
 

 Phase II Cutaneous Tolerability of Epsolay®  Dryness  Scaling  Pruritus  Burning  Stinging  Increase from Baseline of Cutaneous Side Effects at Week 12 (Safety Population)  Increase from Baseline  2/30  2/32  3/30  1/30  2/32  2/30  1/32  3/30  1/32  3/30 
 

 Number of Patients  Severe  5    82  113  26  65  0  51  71    Moderate  21    369  346  172  418  557  444  443    Mild  4    0  0  0  0  0  0  0  Baseline # of Inflammatory Lesions    22.9    31.0  33.3  21.6  21.7  18.3  28.5  30.0  Papulopustular Rosacea Trials Results(†) (ITT)  Success in IGA at Week 12  Inflammatory Lesions – Mean Percent Change from Baseline at Week 12  Difference from Vehicle  Treatment Arm:  Phase II  Phase II  (1)  Epsolay®  (2)   (†) 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 conducteda head-to-head comparison trial or study  (1) "clear" definition: "no inflammatory lesions present with no or very mild erythema immediately localized to and around where inflammatory lesions were present”(2) 10-week study  FMX103  Minocycline foam, 1.5% 
 

 Only TWIN and vehicle are required for the pivotal trials, as the requirements of the combination rule act were satisfied in our Phase II trial Each pivotal trial is planned to enroll 420 subjects in a 2:1 ratio, with a power of 99%No LTSS is required to support our future marketing application, as long as we demonstrate that the systemic exposure of our product is comparable to our reference-listed drug (RLD)No pediatric clinical studies are required to support our future marketing applicationSubject to favorable results from our Phase III clinical program, we plan to submit an NDA in 2020      Each pivotal trial is planned to enroll 350 subjects in a 2:1 ratio, with a power > 99%Long-term safety study (LTSS) was initiated in September 2018No pediatric and no Phase I clinical trials are required to support our future marketing applicationSubject to favorable results from our Phase III clinical program, we plan to submit an NDA in 2020  TWIN  Epsolay®  Highly-Powered Phase III Trials and Mitigated Risks 
 

 Bioequivalence study results for 5-fluorouracil cream, 5%, in 2019        1st Fruition  A portfolio of generic product candidates with favorable commercial agreements that supplement our branded pipeline and potentially make a meaningful contribution to operating incomeSix collaborations with Perrigo and one with Douglas Pharmaceuticals with 50/50 gross profit sharing  Last January Perrigo received tentative approval from the FDA for ivermectin cream, 1%, developed in collaboration with Sol-GelPerrigo was second to file and, as of today, there is no public disclosure of another tentative approval or a third filer to the FDASales of RLD reached $150M in the 12 months ending May 2018(†), and are expected to exceed $200M annually by 2020  News Flow  Lucrative Pipeline  (†) Source: IQVIA (IMS)  Our Generic Pipeline 
 

 Gross proceeds of $86.3 million raised in IPO of 7,187,500 ordinary shares on February 5, 2018  Cash runway expected to be sufficient to fund Phase III clinical programs for TWIN and Epsolay® and a bioequivalence study  $73.5 million of cash and investments as of September 30, 2018  18,949,968 shares outstanding as of September 30, 2018  Financial Profile 
 

 Our Upcoming Milestones  FPFV: First Patient First Visit; EoPII: End of Phase II          Preclinical  Phase II  Phase III  Research  Branded Candidates  TWIN  SIRS-T  Epsolay®  Generic Candidates  Bioequivalence  Filed    Research  Ivermectin cream, 1%    Tentative approval as of January 29, 2018    Based on TWIN Phase II        5-Fluorouracil cream, 5%  acne vulgaris  papulopustular rosacea    Readoutsin Q4/2019  EoPII meeting in 2019  Readoutsin 2019      Readoutsin mid-2019  actinickeratosis 
 

 2017     Reported positive results from TWIN Phase II trial in acne vulgaris     Had an EoPII meeting with the FDA about Epsolay®  2018  Had an EoPII meeting with the FDA about TWIN and addressed the combination rule act  Initiated a bioequivalence study for5-fluorouracil cream, 5% in actinic keratosis  Hired U.S. commercialization leader for the launches of TWIN and Epsolay®  2019    Plans to have EoPII meeting with the FDA for SIRS-T    Plans to report Phase III results for Epsolay® in papulopustular rosacea    Plans to report Phase III results for TWIN in acne vulgaris    Plans to report bioequivalence study results for 5-fluorouracil cream, 5%   Recent Milestones and Next Steps  Submitted a Paragraph IV ANDA, for ivermectin cream, 1% (sponsored by Perrigo)     Initiated TWIN Phase III program in acne vulgaris  Obtained tentative ANDA approval for ivermectin cream (sponsored by Perrigo)  Initiated Epsolay® Phase III program in papulopustular rosacea           Initiated LTSS for Epsolay®             
 

 Seven 50/50 gross profit sharing partnerships regarding generics including tentative ANDA approval for ivermectin cream. As of today we are the only ones to have tentative approval and no 3rd filing exists with the FDA  TWIN combination of BPO/tretinoin does not currently exist on the market. Pivotal trials are planned for Q4/2018. Opportunity exists for shift from prescribing tretinoin and existing combinations to prescribing TWIN. We estimate peak annual sales of $350M - $400M  SIRS-T has the potential to be more tolerable than currently available tretinoin drugs and the 1st encapsulated tretinoin on the market. EoPII meeting is planned for 2019  Epsolay® has the potential to be more effective than existing drugs and the 1st FDA-approved single-active BPO prescription drug product. Topline results of pivotal trials are expected in mid-2019. We estimate peak annual sales of $75M - $100M  Wrap-Up