Sol-Gel Technologies Ltd 6-K, filed Mar 1, 2021
Sol-Gel Technologies Ltd. (SLGL)
6-K
2021-03-01
For: 2021-03-01
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About this 6-K
Sol-Gel Technologies Ltd filed this 6-K on March 1, 2021.
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 March 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 net revenues for year ended December 31, 2020 and cash and cash equivalents as of December
31, 2020.
Attached hereto and incorporated by reference in this Report on Form 6-K is the following exhibit:
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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.
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SOL-GEL TECHNOLOGIES LTD.
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Date: March 1, 2021
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By:
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/s/ Gilad Mamlok
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Gilad Mamlok
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Chief Financial Officer
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Exhibit 99.1
NASDAQ: SLGL March 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 dates for EPSOLAY and TWYNEO, approval and
commercial launch of EPSOLAY and TWYNEO, anticipated timing of results of the ongoing Phase 1 clinical trial of SGT-210, the expectation to launch a partnered generic drug starting in the second quarter of 2021, our expectations regarding our
liquidity and ability to fund operational and capital expenditure requirements, 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: risks relating to the timing of the PDUFA action dates for EPSOLAY and TWYNEO; 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; 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; 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 24, 2020, 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.
Pending patent applications for tapinarof and roflumilast in various skin conditions EARLY
STAGE Ongoing Phase I proof-of-concept study for erlotinib gel in palmoplantar keratoderma SGT-210 Twelve 50/50 gross profit-sharing collaborations with Perrigo$8.7 million in net revenues last year GENERICS PDUFA goal date set for
August 1, 2021Potential to be first FDA-approved acne treatment that contains fixed-dose combination of BPO and tretinoin TWYNEO® Proprietary silica-based microencapsulation technology TECHNOLOGY PDUFA goal date set for April 26,
2021Potential to be the first single-active BPO approved by the FDA as a prescription drug product EPSOLAY® OUR DERMATOLOGY COMPANY OVERVIEW
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
CHRONIC CONDITION WITH POOR ADHERENCE TO CURRENT TREATMENTS THE CHALLENGE 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
Encapsulation was designed to allow the BPO to slowly migrate from the microcapsules to help
reduce irritationPDUFA goal date was set by the FDA for April 26, 2021Potential 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
ONSET OF ACTION AS OF WEEK 2 Subject 116-009 || 41 years old | Female | White | Not Hispanic or
Latino* * 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
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 THE CHALLENGE 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
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 was set
by the FDA 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
IMPROVEMENT IN SEVERE PATIENT Subject 507-003 || 18 years old | Female | White | Not Hispanic or
Latino* * Individual results vary BASELINE “Severe”; 29 inflamed lesions31 non-inflamed lesions; 1 nodule WEEK 12 “Moderate”; 9 inflamed lesions5 non-inflamed lesions; No nodules
EPSOLAY is protected until 2032 by granted patents, and until 2040 by allowed patentsTWYNEO is
protected until 2038 by granted patents and until 2041 by pending patent applications25 provisional patent applications for erlotinib, tapinarof and roflumilast in various skin conditions (as of February 26, 2021) BROAD LONG-TERM INTELLECUAL
PROPERTYESTATE
Sources: NaviSync LLC (Morristown, NJ), Sol-Gel Managed Market Access for Acne and
Rosacea, July 2019 NaviSync LLC (Morristown, NJ), Twyneo Payer Market Research Topline Summary, February 2020 TWYNEO® EPSOLAY® “All respondents recognized the product as a unique molecule for rosacea”“Near unanimous recognition as
additional option for rosacea”“If priced and rebated similarly to the covered products, coverage seems likely” “Unique MOA will qualify it for formulary addition, price will determine its position”“If you price it like Epiduo, it will be
managed like Epiduo”“If similarly priced with better tolerability, it would become preferred brand” EPSOLAY & TWYNEO ARE COMPELLING ENOUGH TO DRIVE PAYOR COVERAGE
We are in discussions with potential partners regarding the commercialization of EPSOLAY and TWYNEO in
the US* 45-62Sales Reps 3,300Dermatology Offices 6,500Dermatologists 80%Potential Market Value 6,000NPs/PAs Source: Syneos Health (Morrisville, NC), Sol-Gel Market Analysis, June 2019 PRUDENT COMMERCIALIZATION APPROACH
12 collaborations with Perrigo with 50/50 gross profit sharing In March 2017, Perrigo filed a
Paragraph IV Certification for Soolantra®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 and $8.7 million in net revenues in
2020In January 2020, Perrigo filed a Paragraph IV Certification for Bryhali®In June 2020, Perrigo was first-to-file a Paragraph IV Certification for Duobrii®The launch of a partnered generic drug is expected in 2Q/21. In 2019, sales of the
brand name product exceeded $180 million in the US LUCRATIVE GENERIC PIPELINE
Gross proceeds of $86.3 million raised in IPO on February 5, 2018Gross proceeds of $11.5 and $23
million raised in public follow-on offerings on August 12, 2019 and February 13, 2020, respectivelyAdditional $5 million investment by controlling shareholder in April 202023,000,782 Ordinary Shares as of December 31, 2020$8.7 million net
revenues from generic products in 2020$50.2 million in cash and investments as of December 31, 2020Under our operational model which assumes collaborations with third parties with sales and marketing experience, we expect that our cash
resources will enable funding of operational and capital expenditure requirements into the third quarter of 2022 FINANCIAL PROFILE
PALMOPLANTAR KERATODERMA SGT-210 WHAT’S AHEAD Palmoplantar keratoderma (PPK) is a group of
skin conditions characterized by thickening of the skin on the palms of the hands and soles of the feetPhase I proof-of-concept study for erlotinib gel in PPK is ongoing
2019 2020 2021 Potential FDA approvaland launch of EPSOLAY Potential FDA approvaland launch
of TWYNEO Revenues from generics DONE Phase III results for EPSOLAY DONE Granted patent forTWYNEO until 2038 DONE Phase I studyfor SGT-210 IN PROGRESS Phase III results for TWYNEO DONE RECENT MILESTONES& NEXT STEPS NDA
for EPSOLAY was accepted for filing DONE DONE NDA for TWYNEO was accepted for filing
NASDAQ: SLGL