Sol-gel Technologies Ltd. · NASDAQ:SLGL
Sol-gel Technologies — Investor Presentation (June 2021)
27 slides from Sol-gel Technologies's investor presentation, Jun 28, 2021
Slide 1: Sol-Gel Advanced Topical Therapy
Sol-Gel _, Advanced Topical Therapy NASDAQ: SLGL June 2021
Slide 2: Forward-Looking Statements
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 statem
Slide 3: Our Dermatology Company Overview
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
Slide 4: Strategic Partnership with Galderma
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 capi
Slide 5: The Science Behind Our Proprietary Technology
Aiming to provide effective and tolerable topical therapies to achieve local action THE SCIENCE BEHIND OUR PROPRIETARY TECHNOLOGY
Slide 6: Encapsulated Benzoyl Peroxide (E-BPO)
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 MAPPI
Slide 7: Encapsulated Tretinoin (E-Tretinoin)
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
Slide 8: Unmet Need in Papulopustular Rosacea
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, do
Slide 9: EPSOLAY Benzoyl Peroxide Cream, 5%
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 Perox
Slide 10: EPSOLAY Phase III Studies
Two Parallel, Multicenter, Double-Blinded, Randomized, Vehicle-Controlled Studies, 2:1 Ratio, QD EPSOLAY® PHASE III STUDIES
Slide 11: Phase III Results: Success in Primary Endpoints
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
Slide 12: Improvement as of Week 2: Success in IGA
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
Slide 13: Improvement as of Week 2: Reduction of Lesions
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
Slide 14: Onset of Action as of Week 2
* 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 H
Slide 15: Long-Term Safety Study
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
Slide 16: Unmet Need in Acne Vulgaris
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
Slide 17: TWYNEO Benzoyl Peroxide 3% & Tretinoin 0.1% Cream
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 irritationP
Slide 18: TWYNEO Phase III Studies
Two Parallel, Multicenter, Double-Blinded, Randomized, Vehicle-Controlled Studies, 2:1 Ratio, QD TWYNEO® PHASE III STUDIES
Slide 19: Phase III Results: Success in IGA
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
Slide 20: Phase III Results: Success in Reducing Lesions
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
Slide 21: Improvement in Severe Patient
* 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*
Slide 22: Broad Long-Term Intellectual Property Estate
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
Slide 23: Lucrative Generic Products and Pipeline
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
Slide 24: Pipeline Progress Recent Updates
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 i
Slide 25: A Diverse Pipeline of Topical Skin Medications
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 Dermat
Slide 26: Financial Profile Recent Updates
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 Ordin
Slide 27: Sol-Gel Advanced Topical Therapy
- “ J Sol-Gel _, Advanced Topical Therapy NASDAQ: SLGL
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