Sol-gel Technologies Ltd. · NASDAQ:SLGL
Sol-gel Technologies — Investor Presentation (August 2021)
25 slides from Sol-gel Technologies's investor presentation, Aug 4, 2021
Slide 1: Sol-Gel Advanced Topical Therapy
Sol-Gel _, Advanced Topical Therapy NASDAQ: SLGL August 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 Global Leader Galderma
$8 million upfront payment received. Additional regulatory milestone payments of up to $7 millionTiered double-digit royalties (mid- to high-teen percentage) of net salesUp to an additional $9 million in sales milestone paymentsOption to regain commercialization rights 5 years following first sale a
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: TWYNEO: First Proprietary Drug Approval
TWYNEO: FIRST PROPRIETARY DRUG APPROVAL U.S. COMMERCIAL PARTNERSHIP FOR EPSOLAY® AND TWYNEO® WITH GALDERMA
Slide 9: 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 10: TWYNEO: Our First Branded Product Approval
(Tretinoin and Benzoyl Peroxide) Cream, 0.1%/3% TWYNEO®: OUR FIRST BRANDED PRODUCT APPROVAL Indication: for the treatment of acne vulgaris in adults and pediatric patients nine years of age and olderFirst acne treatment that contains a fixed‑dose combination of tretinoin and benzoyl peroxide, which
Slide 11: 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 12: 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 13: EPSOLAY: Sol-Gel Solution
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 14: EPSOLAY Phase III Studies
Two Parallel, Multi-Center, Double-Blinded, Randomized, Vehicle-Controlled Studies, 2:1 Ratio, QD EPSOLAY® PHASE III STUDIES
Slide 15: 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 16: 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 17: 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 18: 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 19: 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 20: 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 21: 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 22: 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 23: Innovative Pipeline of Topical Skin Medications
Pipeline focused on large and attractive categories and two active moieties that already demonstrated positive Phase 3 results 4/26/21 PDUFA EPSOLAY ®(benzoyl peroxide) Cream, 5%Papulopustular Rosacea Galderma Partnership – U.S. research pre-clinical phase II phase III filed SGT-210 (erlotinib)Palmo
Slide 24: Financial Profile: Recent Updates
> Gross proceeds of $86.3 million raised in IPO on February 5, 2018 > Gross proceeds of $11.5 and $23 million raised in public follow-on offerings on August 12, 2019 and February 13, 2020, respectively > Additional $5 million investment by controlling shareholder in April 2020 > 23,029,953 Ordinary
Slide 25: Sol-Gel Advanced Topical Therapy
- “ J Sol-Gel _, Advanced Topical Therapy NASDAQ: SLGL
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