Sol-Gel Technologies Ltd 6-K, filed Mar 3, 2020
Sol-Gel Technologies Ltd. (SLGL)
6-K
2020-03-03
For: 2020-03-03
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About this 6-K
Sol-Gel Technologies Ltd filed this 6-K on March 3, 2020.
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 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.
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SOL-GEL TECHNOLOGIES LTD.
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Date: March 3, 2020
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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
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 our anticipated NDA submission dates for EPSOLAY and TWYNEO, estimated timing for the approval and
commercial 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. FORWARD-LOOKING STATEMENTS
OUR DERMATOLOGY COMPANY Positive Phase III results in papulopustular rosaceaNDA submission
expected in 1H/20Potential to be first-in-class and to work faster and better than current drugs EPSOLAY® Positive Phase III results in acne vulgaris NDA submission expected in 2H/20Potential to be
best-in-class TWYNEO® Ongoing Phase I proof-of-concept study for erlotinib gel in punctuate palmoplantar keratoderma type IResults expected early next year SGT-210 Microencapsulation in silica platform
technology Technology 15 provisional patent applications for tapinarof and roflumilast in various skin conditions Early Stage Seven 50/50 gross profit sharing collaborations with Perrigo$22.8 million in net revenues last
year Generics
Encapsulated Benzoyl Peroxide (E-BPO) ENCAPSULATION Improves tolerability CRYO-SEM
PICTURE ENERGY-DISPERSIVE X-RAY SPECTROSCOPY MAPPING Silica shell wraps BPO crystals and serves as a barrier between BPO and skin, leading to less irritation Skin lipids migrate through the silica shell to promote solubilization of BPO
Encapsulated Tretinoin (E-ATRA) encapsulation enhances stability Encapsulated tretinoin is stable in
the presence of E-BPO High encapsulation efficiency protects tretinoin SEM PICTURE SEM PICTURE
What isPapulopustular Rosacea? UNMET NEED IN Papulopustular rosacea Chronic Condition with Poor
Adherence to Current Treatments 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 Our solution: EPSOLAY®E-BPO Cream,
5% Chronic, 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) Insufficient efficacy resulting in poor adherence, contributing to antibiotic resistance; systemic side effects What are the Current Treatment Shortfalls?
“Clear”: Skin clear of inflammatory papules or pustules“Almost Clear”: Very few small papules or pustules
and very mild dull erythema is present“Mild”: Few small papules or pustules and mild dull or light pink erythema is present“Moderate”: Several to many small or larger papules or pustules and moderate light to bright red erythema is
present“Severe”: Numerous small and/or larger papules or pustules and severe erythema that is bright red to deep red is present Primary Endpoints EPSOLAY® PHASE III STUDIES DESIGN Two Parallel, Multicenter, Double-Blinded, Randomized,
Vehicle-Controlled Studies, 2:1 Ratio, QD Weeks 2, 4, 8, 12 (end of study) Visits Proportion of patients with IGA “Clear” or “Almost Clear” relative to baseline at Week 12Absolute mean change in inflammatory lesion counts from baseline to
Week 12 ≥18 years old; “Moderate” or “Severe” acne; ≥15 to ≤70 inflammatory lesions; ≤2 nodules Inclusion Criteria Investigator Global Assessment (IGA) Definition
WELL-BALANCED EPSOLAY® PHASE III STUDIES
SUCCESS IN Primary endpoints Study 54-02 Study 54-01 P<0.001 P<0.001 Success in IGA @ Week 12
(ITT) Inflammatory Lesion Count Change from Baseline @ Week 12 (ITT) P<0.001 P<0.001 Study 54-02 Study 54-01 Change from Baseline in Inflammatory Lesion Count Success in IGA
IMPROVEMENT AS OF WEEK 2 P=0.009 P=0.017 Study 54-02 Study 54-01 P<0.001 P=0.009 Study
54-02 Study 54-01 P<0.001 P=0.006 Study 54-02 Study 54-01 Week 2Exploratory Endpoint (ITT) Week 4Secondary Endpoint (ITT) Week 8Secondary Endpoint (ITT) Success in IGA
IMPROVEMENT AS OF WEEK 2 P<0.001 P<0.001 P<0.001 Week 2Exploratory Endpoint (ITT) Week
4Secondary Endpoint (ITT) Week 8Secondary Endpoint (ITT) Study 54-02 Study 54-01 Study 54-02 Study 54-01 Study 54-02 Study 54-01 Change from Baseline in Inflammatory Lesion Count P<0.001 P<0.001 P<0.001
RAPID ONSET OF ACTION Baseline Week 2 Week 4 Week 8 Week 12 Subject 116-009; 41 years old; Female;
White; Not Hispanic or Latino
SUBSTANTIAL IMPROVEMENT CONTINUES Results after 12 Weeks Phase III Studies Followed by 40 Weeks
Long-Term Safety Study Extension Percentage of Subjects
RAPID Onset of action SIDE-BY-SIDE WITH historical 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 Success in IGA
Success in IGA 10-week study EPSOLAY® 16-week study, Per os 12-week study 12-week study 12-week
study Inflammatory Lesion Percent Change from Baseline EPSOLAY® PHASE IIISide-by-side with historical 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 Baseline Characteristics of Active
Arm IGA Severe 33 23 82 113 26 65 0 52 48 51 71 Moderate 210 227 369 346 172 418 557 67 77 444 443 Mild 0 0 0 0 0 0 0 8 17 0 0 Inflammatory
Lesions 25.7 29.8 31.0 33.3 21.6 21.7 18.3 19.5 20.5 28.5 30.0 FMX103 Minocycline foam, 1.5% 12-week study
TREATMENT-EMERGENT Adverse events
EPSOLAY® WAS WELL-TOLERATED % of Subjects Week 12 % of
Subjects Dryness Scaling Itching Burning/Stinging None Mild Moderate Severe Baseline Safety population: n=239 Fewer Local Skin Reactions at Week 12 than at Baseline Study 54-01
EPSOLAY® WAS WELL-TOLERATED Dryness Scaling Itching Burning/Stinging None Mild Moderate
Severe Safety population: n=249 Low Rate of Local Skin Reactions – Comparable to Vehicle Study 54-02 % of Subjects Week 12 % of Subjects Baseline
Encapsulation allows combining BPO and ATRAEncapsulation is aimed to reduce the irritation of both BPO
and ATRAPotential to be more effective than existing topical treatments Our solution: TWYNEO®E-BPO 3% + E-ATRA 0.1% Cream 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? UNMET NEED IN ACNE VULGARIS Multifactorial Disease Requiring Powerful Combination Treatments
Proportion 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 12 Primary Endpoints “Clear”: Normal, clear skin with no
evidence of acne vulgaris“Almost Clear”: Rare non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving and may be hyperpigmented, though not pink-red) “Mild”: Some non-inflammatory lesions are present, with
few inflammatory lesions (papules/pustules only; no nodulo-cystic lesions)“Moderate”: Multiple Non-inflammatory lesions and, inflammatory lesions are evident (several to many comedones and papules/pustules, and there may or may not be one small
nodulo-cystic lesion)“Severe”: Inflammatory lesions are more apparent, many comedones and papules/pustules, there may or may not be a few nodulo-cystic lesions Inclusion Criteria Investigator Global Assessment (IGA) Definition TWYNEO® PHASE
III STUDIES DESIGN Two Parallel, Multicenter, Double-Blinded, Randomized, Vehicle-Controlled Studies, 2:1 Ratio, QD Weeks 2, 4, 8, 12 (end of study) ≥9 years old; “Moderate” or “Severe” acne; ≥20 to ≤100 inflammatory lesions; ≥30 to ≤150
non-inflammatory lesions; ≤2 cysts/nodules Visits
WELL-BALANCED TWYNEO® PHASE III STUDIES
SUCCESS IN IGA PRIMARY endpoint Study 65-05 P<0.001 Success in IGA @ Week 12 (ITT) Success in IGA
@ Week 12 (ITT) Study 65-04 Success in IGA Success in IGA P=0.017
SUCCESS IN LESION COUNT PRIMARY endpoints Study 65-05 Study
65-04 P<0.001 P=0.018 Non-Inflammatory Lesion Count Change from Baseline @ Week 12 (ITT) P<0.001 P<0.001 Study 65-05 Study 65-04 Change from Baseline in Non-Inflammatory Lesion Count Inflammatory Lesion Count Change from
Baseline @ Week 12 (ITT) Change from Baseline in Inflammatory Lesion Count
IMPROVEMENT IN SEVERE PATIENT Baseline Week 12 Subject 507-003; 18 years old; Female; White; Not
Hispanic or Latino
TWYNEO® PHASE IIISide-by-side with historical 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 Trials with Highest Difference in IGA
Between the Active Arm and the Vehicle Arm Success in IGA Normalized to Vehicle TWYNEO®
TWYNEO® PHASE IIISide-by-side with historical results* 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 construedas conclusions to be drawn as if we conducted a head-to-head comparison trial or study Trials with Highest Difference in IGA
Between the Active Arm and the Vehicle ArmModerate Subjects at Baseline Only Success in IGA Normalized to Vehicle
TREATMENT-EMERGENT Adverse events
Dryness Scaling Itching Burning None Mild Moderate Severe TWYNEO® WAS
WELL-TOLERATED Erythema Pigmentation Stinging % of Subjects Week 12 Study 65-04 The Majority of Local Skin Reactions, when Reported, were Mild and Improved Over Time % of Subjects Week 2 % of Subjects Baseline
Dryness Scaling Itching Burning None Mild Moderate Severe TWYNEO® WAS
WELL-TOLERATED Erythema Pigmentation Stinging Study 65-05 % of Subjects Week 12 % of Subjects Week 2 % of Subjects Baseline The Majority of Local Skin Reactions, when Reported, were Mild and Improved Over Time
LEAN COMMERCIALIZATION APPROACH Efficiently Reaching 80% Dermatology TRx in Acne and
Rosacea 6,500Dermatologists 6,000NPs/PAs Source: Syneos Health (Morrisville, NC), Sol-Gel Market Analysis, June 2019
INSURERS’ FORMULARY “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” EPSOLAY® “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” TWYNEO® EPSOLAY® and TWYNEO® are Compelling Enough to Drive Formulary
Consideration Sources: NaviSync LLC (Morristown, NJ), Sol-Gel Managed Market Access for Acne and Rosacea, July 2019; Twyneo Payer Market Research Topline Summary, February 2020
Punctuate palmoplantar keratoderma type 1 (PPKP1) is a very rare autosomal dominant hereditary skin
disease characterized by multiple hyperkeratotic centrally indented papules that develop in early adolescence or later and are irregularly distributed on the palms and solesPhase I proof-of-concept study for erlotinib gel in PPKP1 is
ongoing SGT-210
EPSOLAY® is protected until 2032 by granted patents and until 2040 by pending patentTWYNEO® is protected
until 2032 by granted patents and until 2040 by pending patent19 pending patent applications for erlotinib, tapinarof and roflumilast in various skin conditions (as of March 1, 2020) BROAD LONG-TERM INTELLECUAL PROPERTY ESTATE
Seven collaborations with Perrigo with 50/50 gross profit sharingIn February 2019, Perrigo launched
acyclovir cream, 5%, developed in collaboration with Sol-Gel. As of today this is the only generic product on the market other than an authorized generic. This product generated more than $22 million in net revenues in 2019In 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 LUCRATIVE GENERIC
PIPELINE
$22.8 million net revenues from generic products in 2019 $50.3 million in cash and investments as of
December 31, 2019. Gross proceeds of $23 million raised in our underwritten offering in February 2020. Additional $5 million investment by controlling shareholder is subject to shareholders’ approval22,494,707 outstanding Ordinary Shares as of
February 19, 2020Cash resources are expected to enable funding of operational and capital expenditure requirements into the middle of 2Q/2021Sol-Gel does not plan to raise additional dilutive capital to fund pre-commercialization
activities STRONG FINANCIAL PROFILE
Recent milestones & next steps 2019 Recognized revenues from launch of generic acyclovir cream, 5%
(by Perrigo) Granted patent for TWYNEO® until 2038 Reported positive phase III results for TWYNEO® in acne vulgaris Reported positive phase III results for EPSOLAY® in papulopustular rosacea 2020 NDA submission for EPSOLAY® NDA submission
for TWYNEO® Initiated phase I PoC for SGT-210 in palmoplantar keratoderma 2021 Phase I results for SGT-210 in punctuate palmoplantar keratoderma type 1 NDA approval and commercial launch of TWYNEO® NDA approval and commercial launch
of EPSOLAY®
©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. WWW.SOL-GEL.COM