Sol-gel Technologies Ltd. · NASDAQ:SLGL
Sol-gel Technologies — Investor Presentation (March 2020)
33 slides from Sol-gel Technologies's investor presentation, Mar 26, 2020
Slide 1: Advanced Topical Therapy
Advanced Topical Therapy $5 50l-Gel NASDAQ: SLGL
Slide 2: 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,
Slide 3: Timelines for Epsolay and TWYNEO
Timelines for Epsolay® and TWYNEO® We completed the clinical programs required for the submission of our NDAs for Epsolay® and Twyneo®We also met with the FDA (physically and through telecoms) for pre-NDA meetings Exhibit batches for Epsolay® were produced at full commercial scale and the next produ
Slide 4: Current Modus Operandi (COVID-19)
CURRENT MODUS OPERANDI (COVID-19) Company is following all restrictions published by the Israeli Ministry of Health (IMOH) and therefore no more than 30% of employees work at our facilities at any one time – primarily employees working in the labs, production, maintenance, warehouse and housekeeping
Slide 5: Our Dermatology Company
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-cla
Slide 6: Encapsulated Benzoyl Peroxide (E-BPO)
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 sol
Slide 7: Encapsulated Tretinoin (E-ATRA)
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
Slide 8: Unmet Need in Papulopustular Rosacea
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
Slide 9: Epsolay Phase III Studies Design
“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 mod
Slide 10: Well-Balanced Epsolay Phase III Studies
WELL-BALANCED EPSOLAY® PHASE III STUDIES
Slide 11: Success in Primary Endpoints
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
Slide 12: Improvement as of Week 2: 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
Slide 13: Improvement as of Week 2: Lesion Count
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
Slide 14: Rapid Onset of Action
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
Slide 15: Substantial Improvement Continues
SUBSTANTIAL IMPROVEMENT CONTINUES Results after 12 Weeks Phase III Studies Followed by 40 Weeks Long-Term Safety Study Extension Percentage of Subjects
Slide 16: Rapid Onset of Action Side-by-Side with Historical Results
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 st
Slide 17: Epsolay Phase III Side-by-Side with Historical Results
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 abov
Slide 18: Treatment-Emergent Adverse Events
TREATMENT-EMERGENT Adverse events
Slide 19: Epsolay Was Well-Tolerated (Study 54-01)
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
Slide 20: Epsolay Was Well-Tolerated (Study 54-02)
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
Slide 21: Unmet Need in Acne Vulgaris
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
Slide 22: Twyneo Phase III Studies Design
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 Endpo
Slide 23: Well-Balanced Twyneo Phase III Studies
WELL-BALANCED TWYNEO® PHASE III STUDIES
Slide 24: Success in IGA Primary Endpoint
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
Slide 25: Success in Lesion Count Primary Endpoints
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
Slide 26: Improvement in Severe Patient
IMPROVEMENT IN SEVERE PATIENT Baseline Week 12 Subject 507-003; 18 years old; Female; White; Not Hispanic or Latino
Slide 27: Twyneo Phase III Side-by-Side with Historical Results
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 T
Slide 28: Twyneo Phase III Side-by-Side (Moderate Subjects)
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
Slide 29: Lean Commercialization Approach
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
Slide 30: Insurers' Formulary
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, pric
Slide 31: Strong Financial Profile
$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’ approval
Slide 32: Recent Milestones & Next Steps
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 s
Slide 33: All Rights Reserved. EPSOLAY® is a registered trademark of Sol-Gel Technologies Ltd. All other
©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
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