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 June 2021
 
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, including updates on its balance of $42.1 million in cash and investments as of May 31, 2021 and its estimate that cash resources will enable funding of the Company’s operational and capital expenditure requirements into the first quarter of 2023 (assuming FDA approval of both EPSOLAY® and TWYNEO® in 2021, and based on Galderma’s upfront and milestone payments).
 
Attached hereto and incorporated by reference in this Report on Form 6-K is the following exhibit:
 
Exhibit 99.1: Corporate Presentation.

This Form 6-K (without Exhibit 99.1) is hereby incorporated by reference into the Company's Registration Statement on Form S-8 (Registration No. 333-223915) and its Registration Statement on Form F-3 (Registration No. 333-230564).

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:  June 28, 2021
By:
/s/ Gilad Mamlok
 
 
 
Gilad Mamlok
 
 
 
Chief Financial Officer
 

3

Exhibit 99.1

            NASDAQ: SLGL  June 2021 
 

 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 PDUFA goal date for TWYNEO, approval and commercial launch of EPSOLAY and TWYNEO, the strategic partnership with Galderma, anticipated timing of the initiation of clinical trials for SGT-510, the intellectual property protection that would be provided by patents for SGT-210 and our tapinarof drug product, the timing of the launch of our tapinarof drug product, the future markets for various skin diseases, the timing of a test and a second POC study of erlotinib, projected profit margins, our expectations regarding our liquidity and ability to fund operational and capital expenditure requirements. 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: risks relating to the timing of the PDUFA action date for EPSOLAY, the timing of FDA approval, if any, of EPSOLAY and TWYNEO; the risk that we not receive any or all of the anticipated benefits of the strategic partnership with Galderma, the risk of a delay in the clinical trials for SGT-510; the risk that patents for SGT-210 and our tapinarof drug product will not provide the anticipated intellectual property protection; the risk of a delay in the launch of our tapinarof drug product; the risk that our estimate of the markets for psoriasis, atopic dermatitis and for hyperkeratotic skin diseases are inaccurate; the risk that our tapinarof drug product will not be the only other player besides the brand for a number of years; the risk of a delay in the timing of a test of erlotinib with a much higher concentrations in an animal model and the risk of a delay of a second POC study on PPK patients; 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, and obtain marketing approval for, 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 and launch our product candidates at all or on a timely basis; 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; 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; delays in the launch of product candidates and generic drugs; intense competition in our industry; potential product liability claims; potential adverse federal, state, and local government regulation in the United States, Europe, or Israel; the impact of pandemics, such as COVID-19 (coronavirus); 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 4, 2021, and in 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. 
 

                           ROFLUMILAST (SGT-510)Our innovative investigational topical formulation of roflumilast (SGT-510) was found to be more effective than roflumilast cream, 0.3%, that was formulated by Sol-Gel according to conventional methods of cream formulation, in a human xenograft psoriasis animal model​    IPO$86.3M raised in February 2018            PERRIGO PARTNERSHIPTwelve 50/50 gross profit-sharing collaborations  TAPINAROF (SGT-310)We are currently developing an innovative investigational formulation of tapinarof (SGT-310) aiming to offer product formulation innovations and increased affordability for patients compared to the brand expected to be launched  ERLOTINIB (SGT-210)Our proof-of-concept study for erlotinib gel (SGT-210) in palmoplantar keratoderma patients was completed and indicated a possible modest improvement. We plan to investigate higher concentrations of erlotinib              GALDERMA PARTNERSHIP5-year license, with option to regain brands. EPSOLAY PDUFA goal date was set for April 26, 2021 (awaiting FDA’s pre-approval inspection). TWYNEO  PDUFA goal date set for August 1, 2021  Our Pipeline  OUR DERMATOLOGY COMPANY  OVERVIEW   
 

 STRATEGIC PARTNERSHIP WITH GALDERMA  RECENT UPDATES          Option to regain commercialization rights 5 years following first saleWe expect that by then markets will be well-established  EPSOLAY and TWYNEO are patent protected until 2040 and 2038, respectively  Deal is immediately cash flow positive, with capital to be redeployed towards our pipeline      Exclusive commercialization agreements in the US for TWYNEO and EPSOLAYUp to $15 million in upfront and product approval payments (assuming 2021 approvals of both products)Tiered double-digit royalties (mid- to high-teen percentage) of net salesUp to an additional $9 million in sales milestone payments 
 

     Aiming to provide effective and tolerable topical therapies to achieve local action  THE SCIENCE BEHIND OUR PROPRIETARY TECHNOLOGY 
 

   Silica-based shell wraps the BPO crystal and is intended to serve as a barrier between the BPO crystals and the skin  CRYO-SEM PICTURE    After application onto skin, BPO slowly migrates through the shell resulting in a continuous flow of BPO for up to 24 hours  ENERGY-DISPERSIVE X-RAY SPECTROSCOPY MAPPING  ENCAPSULATED BENZOYL PEROXIDE (E-BPO)  ENCAPSULATION IS DESIGNED TO ALLOW FOR CONTINUOUS FLOW   
 

   Complete encapsulation allows stabilization of tretinoin in the presence of BPO  SEM PICTURE    Silica-based shell allows for slow delivery of tretinoin to the skin over time   SEM PICTURE  ENCAPSULATED TRETINOIN (E-TRETINOIN)  ENCAPSULATION IS DESIGNED TO ENHANCE STABILITY   
 

         Papulopustular RosaceaChronic, inflammatory condition that primarily affects the face and is often characterized by flushing, redness, inflamed bumps, and pustules  How is it Treated?Topical antimicrobials (metronidazole, clindamycin)Topical anti-mite (ivermectin)Systemic antibiotics (minocycline, doxycycline)  Current Treatment ShortfallsInsufficient efficacy resulting in poor adherenceSystemic side effectsContributing to antibiotic resistance  UNMET NEED IN PAPULOPUSTULAR ROSACEA    CHRONIC CONDITION WITH POOR ADHERENCE TO CURRENT TREATMENTS  THE CHALLENGE 
 

       Encapsulation was designed to allow the BPO to slowly migrate from the microcapsules to help reduce irritationPDUFA goal date was set for April 26, 2021. Awaiting FDA’s pre-approval inspectionPotential to be the first single-active BPO approved by the FDA as a prescription drug product   Benzoyl Peroxide Cream, 5%  SOL-GEL SOLUTION*EPSOLAY®     * EPSOLAY is investigational. Safety and efficacy have not been established 
 

       Two Parallel, Multicenter, Double-Blinded, Randomized, Vehicle-Controlled Studies, 2:1 Ratio, QD  EPSOLAY® PHASE III STUDIES   
 

 P<0.001  P<0.001  Change from Baseline in Inflammatory Lesion Count  Success in IGA  Week 12Success in IGA (ITT)  Week 12Inflammatory Lesion Count Change from Baseline (ITT)  Study 54-01  Study 54-02  SUCCESS IN PRIMARY ENDPOINTS  PHASE III RESULTS    P<0.001  P<0.001  Study 54-01  Study 54-02 
 

 Success in IGA  Week 2Exploratory Endpoint (ITT)  Week 8Secondary Endpoint (ITT)  P<0.009  P<0.017  Study 54-01  Study 54-02  P<0.001  P<0.009  Study 54-01  Study 54-02  P<0.001  P<0.006  Study 54-01  Study 54-02  Week 4Secondary Endpoint (ITT)  IMPROVEMENT AS OF WEEK 2  SUCCESS IN IGA   
 

 Week 2Exploratory Endpoint (ITT)  Week 4Secondary Endpoint (ITT)  Week 8Secondary Endpoint (ITT)  Change from Baseline in Inflammatory Lesion Count  P<0.001  P<0.001  Study 54-01  Study 54-02  P<0.001  P<0.001  Study 54-01  Study 54-02  P<0.001  P<0.001  Study 54-01  Study 54-02  IMPROVEMENT AS OF WEEK 2  REDUCTION OF LESIONS   
 

    * Individual results vary  BASELINE  “Severe”; 31 inflamed lesions  WEEK 2  “Clear”; No inflamed lesions  WEEK 4  “Clear”; No inflamed lesions  WEEK 12  “Almost Clear”; 1 inflamed lesion  WEEK 8  “Clear”; No inflamed lesions  ONSET OF ACTION AS OF WEEK 2  SUBJECT 116-009 || 41 YEARS OLD | FEMALE | WHITE | NOT HISPANIC OR LATINO*   
 

 Phase III Studies Followed by 40 Weeks Long-Term Safety Study Extension  Percentage of Subjects  IMPROVEMENT IN IGA*  LONG-TERM SAFETY STUDY     * This study was not designed for efficacy; however, efficacy was evaluated. Interpret results with caution 
 

   MULTIFACTORIAL DISEASE REQUIRING POWERFUL COMBINATION TREATMENTS        Acne VulgarisA multifactorial disease of the pilosebaceous unit, involving abnormalities in sebum production, follicular epithelial desquamation, bacterial proliferation, and inflammation  How is it Treated?Topical BPO, retinoids (such as tretinoin, adapalene), antibiotics, and their combinationsOral Isotretinoin and antibiotics  Current Treatment ShortfallsInsufficient efficacy negatively affects self-esteemSystemic side effectsContributes to antibiotic resistance  UNMET NEED IN ACNE VULGARIS    LONG-TERM SAFETY STUDY 
 

       Benzoyl Peroxide 3% & Tretinoin 0.1%, Cream  SOL-GEL SOLUTION*TWYNEO®   * TWYNEO is investigational. Safety and efficacy have not been established  Encapsulation was designed to stabilize tretinoin and to enable both tretinoin and BPO to slowly migrate from their microcapsules to help reduce irritationPDUFA goal date set for August 1, 2021Potential to be first FDA-approved acne treatment that contains fixed-dose combination of BPO and tretinoin   
 

     Two Parallel, Multicenter, Double-Blinded, Randomized, Vehicle-Controlled Studies, 2:1 Ratio, QD  TWYNEO® PHASE III STUDIES   
 

 Success in IGA  Week 12Success in IGA (ITT)  P<0.001  Study 65-04  P<0.017  Study 65-05  SUCCESS IN IGA  PHASE III RESULTS   
 

 Week 12Inflammatory Lesion Count Change From Baseline  Change from Baseline in Inflammatory Lesion Count  P<0.001  Study 65-04  P=0.018  Study 65-05  P<0.001  Study 65-04  P<0.001  Study 65-05  Week 12Non-Inflammatory Lesion Count Change From Baseline  SUCCESS IN REDUCING LESIONS  PHASE III RESULTS   
 

    * Individual results vary  BASELINE  “Severe”; 29 inflamed lesions31 non-inflamed lesions; 1 nodule  WEEK 12  “Moderate”; 9 inflamed lesions5 non-inflamed lesions; No nodules  IMPROVEMENT IN SEVERE PATIENT  SUBJECT 507-003 || 18 YEARS OLD | FEMALE | WHITE | NOT HISPANIC OR LATINO*   
 

   BROAD LONG-TERM INTELLECUAL PROPERTYESTATE        TWYNEO is protected until 2038 by granted patents and until 2041 by a pending patent application        EPSOLAY is protected until 2040 by granted patents and until 2041 by a pendingpatent application      25 patent applications for erlotinib, tapinarof and roflumilast in various skin conditions (as of February 26, 2021) 
 

 LUCRATIVE GENERIC PRODUCTS AND PIPELINE    Source: 1 IQVIA sale data              12 collaborations with Perrigo with 50/50 gross profit sharing   2015    In March 2017, Perrigo filed a Paragraph IV Certification for SOOLANTRA®  March 2017    In February 2019, Perrigo launched acyclovir cream, 5%, developed in collaboration with Sol-Gel. This product generated $22.8 million in net revenues in 2019, $8.7 million in net revenues in 2020 and $0.7 million in net revenues in 1Q/21  February 2019  13:00 - 14:00            In January 2020, Perrigo filed a Paragraph IV Certification for BRYHALI®  January 2020    In June 2020, Perrigo was first-to-file a Paragraph IV Certification for DUOBRII®  June 2020    In June 2021, Perrigo began selling a generic ivermectin cream, 1% product.  In 2019, sales of the brand name product amounted to $1921 million in the U.S.  June 2021  13:00 - 14:00         
 

     Our innovative investigational topical formulation of roflumilast (SGT-510) was found to be more effective than roflumilast cream, 0.3%, that was formulated by Sol-Gel according to conventional methods of cream formulation, in a human xenograft psoriasis animal model      We are currently developing an innovative investigational formulation of tapinarof (SGT-310) aiming to offer product formulation innovations and increased affordability for patients compared to the brand expected to be launched      Our proof-of-concept study for erlotinib gel (SGT-210) in palmoplantar keratoderma patients was completed and indicated a possible modest improvement. We plan to investigate higher concentrations of erlotinib​                PIPELINE PROGRESS   RECENT UPDATES   
 

       REVENUE STREAM FROM PARTNERSHIPS WILL SUPPORT DEVELOPMENT OF OUR INNOVATIVE PIPELINE  EPSOLAY®(benzoyl peroxide) Cream, 5%Papulopustular Rosacea  TWYNEO® (benzoyl peroxide and tretinoin) Cream, 3%/0.1%Acne Vulgaris  SGT-210 (erlotinib)Palmoplantar Keratoderma  SGT-310 (tapinarof)Psoriasis & Other Dermatologic Indications  SGT-510 (roflumilast)Psoriasis & Other Dermatologic Indications  Galderma Partnership – U.S.  Galderma Partnership – U.S.  research  pre-clinical  phase II  phase III  filed            research  pre-clinical  phase II  phase III  filed            research  non-clinical  phase II  phase III  filed            research  non-clinical  phase II  phase III  filed  research  non-clinical  phase II  phase III  filed  EPSOLAYPDUFA  GOAL date was set for April 26.  Awaiting FDA's pre-approval inspection.TWYNEOPDUFA goal date set for August 1, 2021                      A DIVERSE PIPELINE OF TOPICAL SKIN MEDICATIONS   
 

               01  Gross proceeds of $86.3 million raised in IPO on February 5, 2018  02  Gross proceeds of $11.5 and $23 million raised in public follow-on offerings on August 12, 2019 and February 13, 2020, respectively  03  Additional $5 million investment by controlling shareholder in April 2020  04  23,028,264 Ordinary Shares as of March 31, 2021  05  $8.7 million net revenues from generic products in 2020 and $0.7 million net revenues from generic products in 1Q/21  06  $42.1 million in cash and investments as of May 31, 2021  07  Based on Galderma’s upfront and milestone payments, we expect that our cash resources will enable funding of operational and capital expenditure requirements into the first quarter of 2023 (assuming timely approval of both products in 2021)  FINANCIAL PROFILE  RECENT UPDATES   
 

            NASDAQ: SLGL