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 July 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): ☐
INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K
On July 25, 2019, Sol-Gel Technologies Ltd. (the “Company”) issued a press release announcing the hosting of an Analyst and Investor Day in New York, a Notice of Allowance for a U.S. patent
application covering TWIN and a clinical study for SGT-210 in palmoplantar keratoderma (PPK) intended to begin in early 2020. The Company is also posting on its website a presentation titled “Investor & Analyst Day”.
Attached hereto and incorporated by reference in this Report on Form 6-K are the following exhibits:
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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: July 25, 2019
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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
Sol-Gel Technologies Hosting Analyst & Investor Day
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Notice of allowance for U.S. patent application extends TWIN patent protection to 2038
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Clinical study for SGT-210 in palmoplantar keratoderma (PPK) intended to begin in early 2020
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Webcast of Analyst & Investor Day today at 8:30 a.m. ET
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NESS ZIONA, Israel, July 25, 2019 – Sol-Gel Technologies, Ltd. (NASDAQ: SLGL) will host an Analyst and Investor Day today in New York beginning at 8:30 a.m. ET. During the meeting, the company will review the recently announced, positive Phase III EPSOLAY® data in papulopustular rosacea; preliminary U.S. commercial plans; a planned clinical study for SGT-210 in PPK intended to begin in early 2020; and the new allowed patent for TWIN in acne.
Agenda
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Introduction and Company Overview
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Alon Seri-Levy, PhD, Chief Executive Officer
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Current Challenges in Acne and Rosacea Treatment
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Linda Stein Gold, MD, Director of Dermatology Clinical Research at Henry Ford Health System
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EPSOLAY® Phase III Clinical Study Results
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Jeffrey Sugarman, MD, Ph.D., Medical Director Northern California Medical Associates, Assoc. Clinical Professor, University of California, San Francisco
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Technology Overview
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Ofer Toledano, VP, Research and Development
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Commercial Overview
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John Vieira, U.S. Head of Commercialization
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Pipeline and Active Research Areas
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Mori Arkin, Chairman of The Board of Directors
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Financial Overview
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Gilad Mamlok, Chief Financial Officer
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Closing Statements and Q&A
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Alon Seri-Levy, PhD, Chief Executive Officer
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Intellectual Property Update
Sol-Gel received Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a patent covering TWIN, a once daily
topical cream containing a fixed-dose combination of encapsulated benzoyl peroxide and encapsulated tretinoin using Sol-Gel’s proprietary microencapsulation platform.
The patent allowance includes the use of a BPO/tretinoin combination at 3%/0.1% respectively, for the treatment of acne vulgaris. The
method includes the stability and release profile of the combination, and their synergistic efficacy and improved safety profile. The newly granted patent will extend protection to July 2038 which the company believes will prevent the launch of any
AB-rated generic of TWIN during the life of the patent.
Sol-Gel’s current patent estate includes 38 granted and allowed patents and 26 pending US and global patent applications regarding the
company’s silica-based proprietary processes and methods of use.
Pipeline Additions
SGT-210, a topical epidermal growth factor receptor inhibitor, has been added to the company’s development pipeline. SGT-210 is in
development for the treatment of PPK and non-melanoma skin cancer (NMSC). PPK is a group of skin conditions characterized by thickening of the skin on the hands and soles of the feet. Basal cell carcinoma and squamous cell carcinoma are
collectively referred to as NMSC.
SGT-210 is designed to be used alone or in combination for the treatment of hyperproliferation and hyperkeratinization disorders,
including PPK and NMSC. A 12-week proof of concept study of SGT-210 in PPK is planned to begin in early 2020.
Webcast
A live webcast of the event can be accessed on the Events & Presentations section of the company’s website at http://ir.sol-gel.com. Analysts and Institutional Investors can register for the event at solgel.troutgroup.com.
About Sol-Gel Technologies
Sol-Gel is a clinical-stage dermatology company focused on identifying, developing and commercializing branded and generic topical drug
products for the treatment of skin diseases. Sol-Gel’s current product candidate pipeline consists of late-stage branded product candidates that leverage the company’s proprietary, silica-based microencapsulation technology platform, and several
generic product candidates across multiple indications. For additional information, please visit www.sol-gel.com.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All
statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements. These forward-looking statements include information about possible or assumed future results of our
business, financial condition, results of operations, liquidity, plans and objectives. In some cases, you can identify forward-looking statements by terminology such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,”
“plan,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. Forward-looking statements are based on information we have when those statements are made or our management’s current expectation, and are
subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Important factors that could cause such differences include, but are not
limited to: (i) the adequacy of our financial and other resources, particularly in light of our history of recurring losses and the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives; (ii) our ability to
complete the development of our product candidates; (iii) our ability to find suitable co-development partners; (iv) 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; (v) our ability to commercialize our pharmaceutical product candidates; (vi) our ability to obtain and maintain adequate protection of
our intellectual property; (vii) our ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; (viii) our ability to establish adequate sales, marketing and distribution channels; (ix)
acceptance of our product candidates by healthcare professionals and patients; (x) the possibility that we may face third-party claims of intellectual property infringement; (xi) 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; (xii) 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; (xiii) potential product liability claims; (xiv) potential adverse federal, state and local government regulation in the United States, Europe or Israel; and (xv)
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 press
release. Except as required by law, we undertake no obligation to update publicly any forward-looking statements after the date of this press release to conform these statements to changes in our expectations.
For further information, please contact:
Sol-Gel Contact:
Gilad Mamlok
Chief Financial Officer
+972-8-9313433
Investor Contact:
Chiara Russo
Solebury Trout
+1-617-221-9197
Source: Sol-Gel Technologies Ltd.
Exhibit 99.2
INVESTOR & ANALYST DAYJuly 25, 2019
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. Forward-looking statements
Agenda TOPIC SPEAKER Introduction and Company Overview Alon Seri-LevyCEO, Sol-Gel Current
Challenges in Acne and Rosacea Treatment Dr. Linda Stein GoldDirector of Dermatology Clinical Research,Henry Ford Health Systems, Michigan EPSOLAY® Phase III Clinical Studies Dr. Jeff SugarmanMedical Director, Northern California Medical
AssociatesAssociate Clinical Professor, University of California, SF Commercial Overview John VieiraUS Head of Commercialization Technology Overview Ofer ToledanoVP, Research and Development Pipeline and Active Research Areas Mori
ArkinChairman, Sol-Gel Financial overview Gilad MamlokCFO, Sol-Gel Closing Statements and Q&A Alon Seri-LevyCEO, Sol-Gel
THREE-FOLD STRATEGY Leverage on our capabilities to generate significant non-dilutive
funding Identify targeted opportunities, in other areas of high unmet need, where we can bring innovation and exceed current standard-of-care treatments Successfully commercialize best-in-class dermatology brands in acne and rosacea, and
maintain a leadership position in these indications
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 GENERIC 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
Current challengesin Acne Vulgaris Dr. Linda Stein GoldDirector of Dermatology Clinical Research,
Henry Ford Health Systems
Collier CN, et al. J Am Acad Dermatol. 2008;58:56-59.Zaenglein AL. N Engl J Med. 2018;379:1343-1352.AAD
2016 Burden of Disease Report, https://www.aad.org/media/stats/conditions. Percent Age Group PRESENTATION2 Moderate Mild Severe aCNE: PREVALENCE & PRESENTATION PREVALENCE1,3Acne is the most common skin condition in the
USA,affecting up to 50 million Americans annuallyAbout 85% of people between the ages of 12 and 24 experience at least minor acne More than 5.1 million people sought medical treatment for acne in 2013, primarily children and young adults3
The impact of acne In addition to physical effects such as permanent scarring and disfigurement,acne
has long-lasting psychosocial effects that affect the patient's quality of lifeDepression, social isolation and suicidal ideation are frequent comorbidities of acnethat should not be neglected in the therapy of acne patientsResearch evidence
suggests that the impairment of quality of life can be alleviatedby appropriate topical acne treatment Gieler U, et al., J Eur Acad Dermatol Venereol. 2015 Jun;29 Suppl 4:12-4.
Treatment Mild Acne Moderate Acne Severe Acne First-line Treatment Benzoyl peroxide, topical
retinoid, or topical combination therapy Topical combination therapy; oral antibiotic, topical retinoid, and benzoyl peroxide; oral antibiotic plus topical retinoid; or benzoyl peroxide plus topical antibiotic Oral antibiotic plus either
topical combination therapy or oral isotretinoin Alternative Treatment Add topical retinoid or benzoyl peroxide (if not using already), or consider alternative retinoid, or consider topical dapsone Consider alternative combination therapy,
or consider change in oral antibiotic, or add combined oral contraceptive or oral spironolactone (in female patients), or con- sider oral isotretinoin Consider change in oral antibiotic, or add combined oral contraceptive or oral
spironolactone (in female patients), or consider oral isotretinoin Zaenglein AL, et al. J Am Acad Dermatol. 2016;74:945-73.e33.Zaenglein AL. N Engl J Med. 2018;379:1343-1352. Treatment algorithm for the management ofacne vulgaris in
adolescents & young adults1,2 The multi-faceted nature of acne pathogenesis often requires a combination therapy approach
Unmet need There is a strong trend toward and professional recommendation to avoid or be more
discerning with antibiotics use in dermatology whenever possible1Combination products or use of multiple products/modalities is common2,3 Benzoyl peroxide and tretinoin have both been shown to be effective2,3 Unable to combine benzoyl
peroxide with tretinoin until now Sixty-seventh World Health Assembly - Antimicrobial resistance (WHA67.25). 24 May 2014.Zaenglein AL, et al. J Am Acad Dermatol. 2016;74:945-73.e33.Zaenglein AL. N Engl J aMed. 2018;379:1343-1352.
Benzoyl peroxide in acne Benzoyl radicals kill bacteria and inflammatory cellsBenzoic acid promotes
the opening of clogged poresBenzoyl peroxide combines with other treatments for synergistic effects Benzoyl peroxide White blood cells Bacteria Benzoic acid Benzoyl radicals Seth V, et al. Int J Adv Med. 2015;2:1-5.
Elevated sebum production C. acnes colonization Tretinoin Inflammation Seth V, et al. Int
J Adv Med. 2015;2:1-5. Tretinoin in acne Hyperkeratosis (keratin plug)
Elevated sebum production C. acnes colonization Tretinoin Hyperkeratosis (keratin
plug) Inflammation TRETINOIN AND BENZOYL PEROXIDE IN ACNE Benzoyl Peroxide Seth V, et al. Int J Adv Med. 2015;2:1-5.
Treatment to date… Preference for dual action, but preferred products unable to be combined until
now…Encapsulation permits storage and delivery of benzoyl peroxide with tretinoin in strengths repeated shownto be efficacious in patients of acne vulgaris SEM Encapsulated Tretinoin SEM Encapsulated Benzoyl Peroxide* *Freeze fracture
preparation
TWIN low and TWIN high demonstratedsignificant improvements in moderate to severe acne vulgaris after
12 weeks of treatment:Statistically significant (P <0.006) improvements were observed in both the IGA and lesion counts (inflammatory and noninflammatory) over vehicle aloneTWIN low and TWIN high had similar effects on outcome variables.
However, at week 12, a higher proportion of subjects (39.7%) achieved clear or almost clear with TWIN high, compared to the TWIN low treatment (27.4%)TWIN low and TWIN high were safe and well tolerated with expected dermal incidences of
application site dryness, exfoliation (scaling) and pain (mild burning and stinging) typical for the individual components of the two formulations summary
Current challengesin Rosacea
Blount BW, Pelletier AL. Am Fam Physician. 2002;66:435-440. National Rosacea Society.
http://www.rosacea.org/rr/2010/winter/article_1.php. Moustafa F. J Am Acad Dermatol. 2014;71:973-980.Gether L, et al. Br J Dermatol. 2018;179:282-289Wilkin J, et al. J Am Acad Dermatol.
2004;50:907-912 Erythematous Phymatous Ocular Papulopustular Rosacea is a chronicinflammatory skin disease1 Affects approximately 16 millionAmericans2Very high emotional and psychological impact35.46% of the adult general population is
affected by rosacea4No latitude-dependent gradient in rosacea prevalence observed4Multiple subtypes/phenotypes often seen in a single patient4,5
Rosacea pathophysiology is complex Pathogenesis of rosacea is thought to be an immune detection
dysfunction *TLR-2 – Toll-like receptor-2Yamasaki K et al. Nature Medicine. 2007;13:975-980.Yamasaki K et al J Dermatol Sci. 2009;55:77-81.Fleischer AB. J Drugs Dermatol. 2011;10:614-620.Yamasaki K et al. J Invest Dermatol.
2011;131:688-697.Yamasaki K et al. J Invest Dermatol. 2011;15:12-15. (slide courtesy of James Del Rosso, DO, Las Vegas, NV) ROSACEA Inflammation / Neurovascular Effects / Vascular Changes / Fixed Physical Changes in Cutaneous Vasculature
Increased LL-37 + Variant Peptides Elevated Cathelicidin Precursor(hCAP18) Elevated Serine Protease(Kallikrein-5 [KLK-5]) Increase in TLR-2* on Keratinocytes(Augmented Immune “Danger” Recognition) TRIGGER
National Rosacea Society.
http://www.rosacea.org/press/new-rosacea-survey-shows-emotional-toll-facial-redness-equals-impact-bumps-pimples. Accessed November 7, 2016. Moustafa F, et al. J Am Acad Dermatol. 2014;71(5):973-980. Patients with rosacea suffer
psychologicalconsequences that impact their everyday lives
DLQI=Dermatology Life Quality Index; QOL=quality of life. Tan J, et al. Rosacea. Beyond the visible.
2018. Available at https://hosted.bmj.com/rosaceabeyondthevisible. Accessed October 15, 2018. Clearer skin reduces impact onrosacea patient qol Data from an online global survey of 710 rosacea patients
Same woman, different impressions
ROSACEA IS A LARGELY UNTAPPED MARKET Of the approximate 16 million rosacea sufferers in the US: Only
10% seek treatment1 Misdiagnosis is common1,2 There is a clearly understood medical need for effective treatment options Our goal is to address the underdiagnosis and to offer a safe and effective option to manage rosacea symptoms in order
to give patients a better quality of life National Rosacea Society. www.rosacea.org. Accessed October 10, 2016. Prevalence of rosacea. http://www.rosacea.org/rr/index.php. Accessed April 2015.
WHY NOT BENZOYL PEROXIDE FOR ROSACEA? The skin of patients with rosacea is extremely sensitive and
hyper-reactive to dietary, environmental, and topical factors1The use of topical retinoids and benzoyl peroxide has shown to be beneficial in treating rosaceain smaller case series2Data suggest that topical preparations containing benzoyl
peroxide may be effective in rosacea, but that they may be poorly tolerated with frequent itching and burning at treatment sites3 Draelos ZD, J Drugs Dermatol. 2005 Sep-Oct;4(5):557-62.Two AM, et al. J Am Acad Dermatol.
2015;72:761-770.Goldgar C, et al. Am Fam Physician. 2009;80:461-468. …Until Now
EPSOLAY® phase III clinical study results Dr. Jeff SugarmanMedical Director, Northern California
Medical AssociatesAssociate Clinical Professor, University of California, San Francisco
Male and female ≥18 years of age Clinical diagnosis of moderate to severe rosacea≥15 inflammatory
lesions≤2 nodules 2:1 EPSOLAY® cream, 5% (once daily) Vehicle cream (once daily) 54 Total Sites— RandomizationStudy 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 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 change in inflammatory lesion counts from baseline to Week 12SECONDARY ENDPOINT:Percent change in inflammatory lesion count at Week 12
STUDY POPULATIONS & DISCONTINUATION Study 54-02 Study 54-01 Percent of
patients EPSOLAY® Vehicle Randomized (n = 243), Safety (n = 239),Per Protocol (n=190) Randomized (n = 118), Safety (n = 113),Per Protocol (n=93) Randomized (n = 250), Safety (n = 249),Per Protocol (n=235) Percent of
patients Randomized (n = 122), Safety (n = 120),Per Protocol (n=113) Intent-to-treat population
Study 54-01 Study 54-02 CHARACTERISTIC EPSOLAY ®(n = 243) Vehicle(n = 118) EPSOLAY ®(n =
250) Vehicle(n = 122) Age, yearsMean (SD)Median (range) 52.8 (13.21)54.0 (19-81) 52.4 (13.26)52.5 (24-85) 49.5 (14.04)50.0 (18 to 79) 51.5 (12.55)50 (22 to 84) Sex, n (%)MaleFemale 60 (24.7)183 (75.3) 35 (29.7)83 (70.3) 69
(27.6)181 (72.4) 35 (28.7)87 (71.3) Race, n (%)Amer. Indian/Alaska Nat.AsianBlack/African AmericanNat. Hawaiian/Pac. IslanderWhiteMultiple/0ther 09 (3.7)00233 (95.9)1 (0.4) 02 (1.7)00 116 (98.3)0 020 (8.0)2 (0.8)3 (1.2)220 (88.0)5
(2.0) 2 (1.6)8 (6.6)02 (1.6)110 (90.2)0 Ethnicity, n (%)Hispanic/LatinoNot Hispanic or LatinoUnknown 86 (35.4)156 (64.2)1 (0.4) 39 (33.1)77 (65.3)2 (1.7) 55 (22.0)195 (78.0)0 30 (24.6)92 (75.4)0 IGA Severity (%)ModerateSevere 210
(86.4)33 (13.6) 104 (88.1)14 (11.9) 227 (90.8)23 (9.2) 112 (91.8)10 (8.2) Lesion CountMean (SD)Median (range) 25.7 (11.07)22.0 (15-69) 26.3 (12.45)21.0 (15-70) 29.8 (14.00)25.0 (15-70) 27.5 (13.04)22.5 (15-70) PATIENT
CHARACTERISTICS Intent-to-treat population
P<0.001 P<0.001 Success in IGA at Week 12 Study 54-02 Study 54-01 Primary endpoint
(igA) Success in IGA at Week 12 Intent-to-treat population
Study 54-02 Study 54-01 P<0.001 P<0.001 Primary endpoint (change in lesion
count) Inflammatory lesion count change from baseline at Week 12 Inflammatory lesion count change frombaseline at Week 12 Intent-to-treat population
SECONDARY ENDPOINT (% CHANGE IN LESIONS) Study 54-02 Study 54-01 Inflammatory lesion percent change
from baseline at Week 12 P<0.001 P<0.001 Inflammatory lesion percent change frombaseline at Week 12 Intent-to-treat population
Study 54-02 Study 54-01 Success in IGA at Week 2 Inflammatory lesion count change from baseline at
Week 2 P = 0.009 P = 0.017 P < 0.001 P < 0.001 Study 54-02 Study 54-01 * Intent-to-treat population Exploratory endpoint (efficacy at 2 weekS) Intent-to-treat population Intent-to-treat population
SUCCESS in IGA OVER TIME Percent Achieving Clear or Almost
Clear * # † * * * ₳ # Intent-to-treat population †P = 0.017, #P = 0.009, ₳ P =0.006, *P <0.001 vs corresponding vehicle
ABSOLUTE change in inflammatory lesioncount from baseline over time Week Inflammatory lesion count
change from baseline † † † † † † † † †P < 0.001 vs corresponding vehicle Intent-to-treat population
IMPROVEMENT OVER TIME 4 0 0 0 1 3 2 1 0 0 IGA IGA
3 0 0 0 0 4 3 3 3 2 IMPROVEMENT OVER TIME IGA IGA
SKIN TOLERABILITY Safety population Dryness Scaling Burning/Stinging Itching Percent Reporting
Any… Study 54-01 Percent Reporting Any… Study 54-02 Dryness Scaling Burning/Stinging Itching
No. (%) of Subjects Study 54-01 Study 54-02 TEAEs, n (%) EPSOLAY ®(n = 239) Vehicle(n =
113) EPSOLAY ®(n = 249) Vehicle (n = 120) Any TEAE 49 (20.5%) 17 (15.0%) 50 (20.2%) 22 (18.2%) Serious TEAE 0 1 (0.4%)1 1 (0.4%)2 0 Severe TEAE 2 (0.8%) 0 2 (0.8%)3 0 Discontinuation 5 (2.1%) 1 (0.9%) 4 (1.6%) 1
(0.8%)4 Treatment-related 14 (5.9%) 3 (2.7%) 9 (3.6%) 0 1Femur fracture2Spinal compression fracture3One subject with spinal compression fracture4Urinary Tract Infection—Discontinuation classified as “other reason” TEAEs,
Treatment-Emergent Adverse Events Safety population TEAE summary
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 Side-by-side with other historicaltrial 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 12-week study 12-week study 12-week study 12-week study
Commercial Overview John Vieira, US Head of Commercialization
THREE-FOLD STRATEGY Leverage on our capabilities to generate significant non-dilutive
revenues Identify targeted opportunities, in other areas of high unmet need, where we can bring innovation and exceed current standard-of-care treatments Successfully commercialize best-in-class dermatology brands in acne and rosacea, and
maintain a leadership position in these indications
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, remaining is oral*Dermatologists account for ~60% of acne treatment(higher for branded products)Combining treatments is the bestway to combat acne for the majority of
patients1 Approximately 16 million people in the US suffer from rosacea 5-6 million type 2 ( >30 years)$478 million branded topical market (WAC)*Treated with topical products 76% of the time*Dermatologists account for 80% of
treatmentsMany patients are misdiagnosed or do not seek treatment at all, creating a large underserved patient population Market potential for acne & rosacea *Sources: Symphony Health; Syneos Research & Insights ”Treatment
Answers”; June 2019 MAT. 1. https://www.aad.org/practicecenter/quality/clinical-guidelines/acne/topical-therapies
24 month Launch aligned performance Select ACNE brands Select ROSACEA brands Fixed dose
combination—21% of topical acne market Tretinoin is ~25% of all retinoids used in acne~ 20% of all acne treatments involve benzoyl peroxide TRx /month (000’s) TRx /month (000’s) Rosacea market has grown ~4% (MAT June 2019) Topicals
constitute a steady 80% of market share 1. Syneos Health. Data on file.
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
Capture significant opportunity in rosacea Rosacea subtype II treatments by phase &
severity Note: *Branded products may have generic equivalentSource: L.E.K. interviews and analysis; company websites OTC Generic Branded* Laser treatment Intense pulsed
light Mild Moderate Severe OTC products typically not used Oralisotretinoin Generic antibiotics(doxycycline, minocycline, Generic metronidazole Generic clindamycin EPSOLAY®
DENSITY &PRODUCTIVITY METRICS MARKET FACTORS APPROACH TO building a
commercialorganization—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
Scalable marketing investment An integrated approach built from the ground
up GEO-TARGETING& NONPERSONAL HIGH TOUCHPOINTS NONPERSONAL Access services Digital CRM Social media Patient activation SalesReps
COMPETITIVE PRICING Addressing access & UM for epsolay®1,2,3 Positive payer response to
EPSOLAY®—Competitive pricing likelyequals 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 HIGHERNET-TO-PLAN PRICE* COMPELLING TO DRIVE FORUMLARY CONSIDERATION COVERED OR BETTER3:92% Commercial40% Part D74%
Medicaid Based on~107 MILLION LIVES1
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
Technology overview Ofer Toledano, VP Research and Development
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, microcapsuleis 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) NEWLY GRANTED/ALLOWED PATENT EXTENSION 2038Pending,
2040 Granted/Allowed, 2032Pending, 2040 TWINacne vulgaris EPSOLAY®subtype II rosacea Intellectual property estate
Pipeline Lifecycle & active research areas Mori Arkin, Chairman Investor and Analyst Day, July
2019
Lifecycle PROJECT DESCRIPTION SGT-129 EPSOLAY® + alpha agonist for the treatmentof rosacea type I
and II SGT-138 TWIN + immune modulator for the treatment of severe acne —Hydradenitis Suppurativa Investor and Analyst Day, July 2019
Pipeline and Early research PROJECT DESCRIPTION SGT-210 Topical treatment of
hyper-keratinization disorders—Palmoplantar Keratoderma Non-melanoma skin cancer NMSC (BCC/SCC) Investor and Analyst Day, July 2019
A group of skin conditions characterized by thickening of the skin on the hands and soles of the
feet1Can be a manifestation of various syndromes2Inherited:Due to mutations that result in keratin abnormalitiesCan be autosomal recessive or autosomal dominantAcquired due to1,2:Drugs, malnutrition, chemicals, systemic disease, cancer,
infectionTreatment options are very limited and of limited effectiveness.3,4 (Topical keratolytics, Benzoic acid, oral retinoids, topical calcipotriol) Palmoplantar keratoderma (PPK) Genetic and Rare Diseases Information Center. 2019.
https://rarediseases.info.nih.gov/diseases/8167/.Charny JW, James WD. 2019. https://emedicine.medscape.com/article/1108406-overview#a6.FIRST. 2019. http://www.firstskinfoundation.org/types-of-ichthyosis/palmoplantar-keratodermasSkaljic M.
2019. https://emedicine.medscape.com/article/1108406-overview Investor and Analyst Day, July 2019 Topical treatment ofhyperkeratinization disorders
Financial overview Gilad Mamlok, CFO
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 2018In 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
Summary Alon Seri-Levy, CEO
Advancements to Topical Therapies Effective and efficient commercial organization on trackHighly
positive Phase III results imply EPSOLAY®as best-in-classNew patent allowance extends value for TWINfrom 2032 to 2038Phase III topline results for TWIN on track in 4Q/19NDA submissions for EPSOLAY® and TWIN plannedfor 2020Lifecycle extension
projects for acne and rosaceaR&D exploratory projects in areas of high unmet needsSignificant non-dilutive revenues ahead of plan
Q&A