Sol-gel Technologies Ltd. · NASDAQ:SLGL
Sol-gel Technologies — Investor Day (October 2026)
93 slides from Sol-gel Technologies's investor day presentation, Oct 14, 2026
Slide 1: Investor KOL Event – Phase III SGT-610: Patidegib Gel, 2%
Investor KOL Event – Phase III SGT-610: PATIDEGIB GEL, 2% 14 October 2026
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 contained in this presentation that do not relate to matters of historical fact should be considered forward-looking statement
Slide 3: Agenda
Mori Arkin 1. WELCOME REMARKS Chief Executive Officer, Chairman Mori Arkin 2. SGT-610: PATIDEGIB GEL, 2% Chief Executive Officer, Chairman 3. GORLIN SYNDROME ALLIANCE INTRODUCTION Julie Breneiser, PA-C THE STORY OF HEDGEHOG SIGNALING AND HH 4. Ervin Epstein Jr., MD INHIBITORS VS. BCCS Agenda 5. GORL
Slide 4: Focus on Skin Diseases with No Approved Treatments
Focus on Skin Diseases with No Approved Treatments Leading the way in Dermatological Advancements Sol-Gel Technologies is an experienced dermatology company that leverages innovative approaches to develop advanced treatments for patients with severe skin conditions Sol-Gel KOL EVENT | 14 OCTOBER 202
Slide 5: Management Team
Management Team EYAL BEN-OR MORI ARKIN MICHAEL GLEZIN Chief Financial Officer Chief Executive Officer, Chairman Chief Business Officer DR. OFRA LEVY-HACHAM DR. ITZIK YOSEF DR. OFER TOLEDANO VP, Clinical and Regulatory Affairs Chief Operating Officer VP, Research and Development KOL EVENT | 14 OCTOBE
Slide 6: SGT-610 in Gorlin Syndrome
SGT-610 in Gorlin Syndrome An investigational topical approach to preventing Basal Cell Carcinoma (BCC) Target population Adult patients with Gorlin syndrome Mechanism Patidegib is designed to block the Hedgehog signaling pathway Development history Patidegib gel, 2% (SGT-610) was acquired from Pell
Slide 7: PellePharm Phase III: Number of New BCCs
PellePharm Phase III 1. At least 3 BCCs at baseline in patients with Gorlin syndrome 2. Confirmation of PTCH1 mutation was not mandatory New BCCs, by Month ITT, Observed 8 6 Number of New BCC 4 4.03 3.25 2.84 2.27 2.56 2 1.00 1.92 0.80 Vehicle 86 64 63 65 Number of Patidegib 0 82 59 63 58 Patients 3
Slide 8: What Did We Learn From the PellePharm Study?
What Did We Learn From the PellePharm study? 1. In the post hoc analysis, patients with Gorlin syndrome without a PTCH1 mutation showed no greater response to patidegib gel than to vehicle. Number of new BCCs, Observed, >10 BCCs at Baseline with or without PTCH1 mutation 10 8 Number of New BCC 6.67
Slide 9: What Did We Learn From the PellePharm Study?
What Did We Learn From the PellePharm study? 2. In the post hoc analysis, a greater number of BCCs at baseline was associated with a larger treatment effect favoring patidegib over vehicle Patidegib Vehicle Population – Month 121 % reduction P-value Mean ± SD (N) Mean ± SD (N) Baseline Total Lesions
Slide 10: Post-hoc Analysis Findings Led to Current Study Design
Post-hoc Analysis Findings Led to Current Study Design New BCCs, by Month New BCCs by Month ITT, Observed Observed >10 BCCs at baseline with PTCH1 mutation 8 8 The previous study did not meet its PellePharm’s Phase III findings informed primary endpoint patient selection for the current study 6.38 6
Slide 11: FDA Feedback on Prior Study
FDA Feedback on Prior Study (FDA response, May 2021): “We recommend conducting a new adequately-powered randomized, vehicle-controlled trial to support the efficacy of your product. However, it may be possible to identify study design elements from the completed trial that could be modified in a fut
Slide 12: How We Applied These Findings in the New Phase III Study
Summary: How We Applied These Findings in the New Phase III Study? Conducted a more focused Phase III Study Patient Selection Operational Improvements Previous study Current study Criterion Dermoscopic assessment Facial BCCs ≥31 ≥10 Patients without Only patients with the Central photography review
Slide 13: SGT-610 Study Design - Update
SGT-610 Study Design - Update Study Recruitment Summary: 41 sites 184 Patients Screened U.S., E.U. & U.K. 113 Enrolled Study design 102 Completed SGT-610 (patidegib gel, 2%), BID More than 90% of enrolled On-site visit patients completed the study Remote visit Screening 1:1 M-0 M-3 M-6 M-9 M-12 Clin
Slide 14: SGT-610 Upcoming Milestones for the U.S. Market
SGT-610 Upcoming Milestones for the U.S. Market 2026 2027 2028 Q4 Q1 Q2 Q3 Q4 Q1 Topline Results NDA submission NDA Approval Launch Future milestones are company targets, subject to regulatory review. KOL EVENT | 14 OCTOBER 2026 14
Slide 15: Strong IP Protection Until at Least 2044 of SGT-610
Strong IP Protection Until at Least 2044 of SGT-610 Patent and Regulatory Exclusivity Oct, 2034 Orphan Drug Exclusivity Apr, 2035 NCE Exclusivity with a 30-month stay (longer than ODE) Jun, 2041 Formulation patent describing SGT-610 gel composition (granted) including 5 years PTE Jan, 2044 Method of
Slide 16: Gorlin Syndrome SGT-610 Market Opportunity
Gorlin Syndrome SGT-610 Market Opportunity ~$860M1 U.S. only ~$270K Assessed by Estimated peak sales opportunity Expected annual net price of SGT-610 11,000 estimated U.S. patients with Gorlin syndrome2 Comparative WAC benchmarks Estimated patients at peak Patients $600K U.S. 4,000 $500K $583K $400K
Slide 17: SGT-610: Lean, Focused, Cost-Effective U.S. S&M Platform
SGT-610: Lean, Focused, Cost-Effective U.S. S&M Platform Sol-Gel is expected to be launch-ready with a dedicated SGT-610 team, supported by a third-party commercialization service provider with proven rare-disease capabilities, while retaining full strategic control and economics Operating Approach1
Slide 18: New Commercialization Initiatives at Sol-Gel
New Commercialization initiatives at Sol-Gel: 1. Applied for an ICD-10 Code 2. Collaboration with GSA to Create Centers of Excellence For the First Time: Sol-Gel applied for ICD-10 Code for Gorlin Patient partnership Syndrome Patient education and navigation Referral gaps and patient Sol-Gel plan to
Slide 19: Future Development Opportunities
Future Development Opportunities SGT-620 Prevention of new BCCs in 124,000 patients in the U.S.1 patients with HF-BCC Potential SGT-630 Reduction in BCC size 100,000 patients in the U.S.2 Expansion SGT-910 Scalp BCC in Gorlin syndrome 5,170 patients in the U.S.3 Beyond the initial Gorlin program 1 J
Slide 20: Julie Breneiser, Gorlin Syndrome Alliance
Julie Breneiser, Associate Director Gorlin Syndrome Alliance Affected mother of two adults with Gorlin Syndrome Retired Physician Assistant © Gorlin Syndrome Alliance. All rights reserved.
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Slide 22: Gorlin Syndrome Fact Sheet
Gorlin Syndrome Fact Sheet ➢ Aka - Basal Cell (Carcinoma) Nevus Syndrome. ➢ Incidence: 1 in 31,000. ➢ Autosomal dominant genetic disorder (50% chance of passing it along). ~31 % spontaneous mutation rate. ➢ Can affect every organ system in the human body with over 100 possible manifestations. ➢ Most
Slide 23: Odontogenic Keratocysts (OKCs)
Odontogenic Keratocysts (OKCs) Boney cysts of the jaw bones with a >40% recurrence rate To reduce recurrences, surgical removal is extensive & aggressive. Permanent teeth may be lost. Lip numbness may result. Historically, cavity packed with gauze saturated with Carnoy Solution (now banned), current
Slide 24: Months Later: Recurrence + More OKCs
18 Months Later: Recurrence + 2 more OKCs
Slide 25: Beware: Images May Be Disturbing
BEWARE: Some may find images on the next three slides to be disturbing.
Slide 26: © Gorlin Syndrome Alliance. All rights reserved.
26 © Gorlin Syndrome Alliance. All rights reserved.
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Slide 28: © Gorlin Syndrome Alliance. All rights reserved.
© Gorlin Syndrome Alliance. All rights reserved.
Slide 29: BCC Burden on Face and Body
BCCs on face / neck / scalp: BCCs on other parts of their body 45% of respondents >50 BCCs 42% respondents > 50, 5% had OVER 1,000 20% Lifetime Lifetime # of BCCs # of BCCs 0 1-5 14% 14% 14% 6-15 13% 13% 13% 16-30 12% 10% 11% 11% 11% 31-50 10% 10% 51-100 9% 9% 100-200 8% 8% 201-500 6% 6% 501-1000 5%
Slide 30: Current Treatment Options
CURRENT TREATMENT OPTIONS: Surgical: All cause pain, permanent scarring and disfigurement. Topical: May cause pain, scabbing, scarring, treatment course lasts weeks. Oral: Significant side effects (hair loss, muscle cramps,…) may lead to early termination. BCCs return after medication stopped. Immun
Slide 31: Patient Survey on BCC Reduction
The Gorlin Syndrome Alliance has surveyed our member community three times over the last five years. Externally Led Patient Focused Drug Development Meeting for the FDA in 2021, patient audience response question: A patient preferred and clinically meaningful reduction of the volume of BCCs by 30% i
Slide 32: We desperately need something that slows the tide of BCC development
We desperately need something that slows / interrupts the constant tide of BCC development and reduces the size of those present. We will never be cancer survivors. We live with it every day. We are considered NEVER cancer free and NEVER in remission. “We can never ring the bell” indicating our trea
Slide 33: Thank You
THANK YOU for helping us to keep scars OFF these smiling faces. E-mail: [email protected]
Slide 34: Ervin Epstein
Ervin Epstein Research Dermatologist/Cin Prof Dermatology UCSF (ret) Sr Scientist Children’s Hospital Oakland Res Inst (ret) Co-Founder and Consultant (PellePharm)/Consultant (SGT) [email protected] 510-502-6144 SOL-Gel Technologies NYC October 14, 2026
Slide 35: My Topic
My Topic Overall: The story of Hedgehog signaling and HH Inhibitors vs. BCCs Specifically: BCCs are driven by Excess Hedgehog Signaling PTCH1-mutant BCCs are Susceptible to SMO-Binding Hedgehog Inhibitors (e.g. Patidegib gel) SOL-Gel Technologies NYC October 14, 2026
Slide 36: Hedgehog Signaling and HH Inhibitors vs. BCCs
Hedgehog signaling and HH Inhibitors vs. BCCs 1. How did we get from Gorlin syndrome to Hedgehog Signaling as the Driver of all BCCs?? i. 1960: Robert Gorlin DDS The Gorlin Syndrome - Phenotype: Basal Cell Carcinomas (NEJM) ii. 1980: Nüsslein-Volhard/Wieschaus Fruit fly mutagenesis –> Hedgehog pheno
Slide 37: Hedgehog Signaling Pathway
Hedgehog Signaling Pathway Hedgehog signalling pathway. In the absence of ligand, the HH signalling pathway is inactive (left). In this case, the transmembrane protein receptor Patched (PTCH1) inhibits the activity of Smoothened (SMO) Nature Reviews Cancer volume 3, pages903–911 (2003) SOL-Gel Techn
Slide 38: Hedgehog Signaling Pathway
Hedgehog Signaling Pathway Organization and Function of Hedgehog Signaling Complexes HH signaling leads to the accumulation In the absence of HH, (PTCH1) of Smo and increases the translocation of localizes to and prevents (SMO) SUFU-Gli complexes to the tip of the from entering primary cilia. primar
Slide 39: BCCs Are Driven by Excess Hedgehog Signaling
BCCs are driven by Excess Hedgehog Signaling (i) Familial linkage analysis: 1996 Global Village identified PTCH1 as the gene whose mutations underly Gorlin syndrome (H Hahn Cell; R Johnson Science) USA/EU: 85% of clinically-diagnosed GS pts have detectable PTCH1 mutation in histologically Normal tis
Slide 40: BCCs Are Driven by Excess Hedgehog Signaling
BCCs are driven by Excess Hedgehog Signaling (i) Familial linkage analysis: 1996 Global Village identified PTCH1 as the gene whose mutations underly Gorlin syndrome (H Hahn Cell; R Johnson Science) USA/EU: 85% of clinically-diagnosed GS pts have detectable PTCH1 mutation in histologically Normal tis
Slide 41: BCCs Are Driven by Excess Hedgehog Signaling
BCCs are driven by Excess Hedgehog Signaling (i) Familial linkage analysis: 1996 Global Village identified PTCH1 as the gene whose mutations underly Gorlin syndrome (H Hahn Cell; R Johnson Science) USA/EU: 85% of clinically-diagnosed GS pts have detectable PTCH1 mutation in histologically Normal tis
Slide 42: BCCs Are Driven by Excess Hedgehog Signaling
BCCs are driven by Excess Hedgehog Signaling (i) Familial linkage analysis: 1996 Global Village identified PTCH1 as the gene whose mutations underly Gorlin syndrome (H Hahn Cell; R Johnson Science) USA/EU: 85% of clinically-diagnosed GS pts have detectable PTCH1 mutation in histologically Normal tis
Slide 43: Oral HH Inhibitor vs. Gorlin Patient BCCs
Oral HH Inhibitor vs. Gorlin Patient BCCs Prevent Appearance Shrink Existing BCCs New Eng J Med 2012 Tang JY et al. N Engl J Med 2012;366:2180-2188 SOL-Gel Technologies NYC October 14, 2026
Slide 44: BCCs Are Driven by Excess Hedgehog Signaling
BCCs are driven by Excess Hedgehog Signaling (i) Familial linkage analysis: 1996 Global Village identified PTCH1 as the gene whose mutations underly Gorlin syndrome (H Hahn Cell; R Johnson Science) USA/EU: 85% of clinically-diagnosed GS pts have detectable PTCH1 mutation in histologically Normal tis
Slide 45: Small Molecules Can Inhibit HH Signaling
Small Molecules Can INHIBIT HH Signaling California Corn Lily Veratrum californicum Phase 2 trials: 1960’s: Lynn James and Richard Keeler H • BCNS 1996: Phil Beachy and James Chen H O patients: NH NH O H NCT02762084 H H • Nodular, O H H H H3C S N sporadic H H O H H BCC: Cyclopamine HO NCT02828111 SO
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Slide 47: The Cyclops Polyphemus
The Cyclops Polyphemus
Slide 48: Small Molecules Can Inhibit HH Signaling
Small Molecules Can INHIBIT HH Signaling California Corn Lily Veratrum californicum Phase 2 trials: 1960’s: Lynn James and Richard Keeler H • BCNS 1996: Phil Beachy and James Chen H O patients: NH NH O H NCT02762084 H H • Nodular, O H H H H3C S N sporadic H H O H H BCC: Cyclopamine HO NCT02828111 Cy
Slide 49: Reducing the Burden of BCCs
Reducing the BURDEN of BCCs SOL-Gel Technologies NYC October 14, 2026
Slide 50: Normal Skin to BCCs: Prevention and Interception
Normal Skin -> HH Up-Regulation -> Clonal Growth -> BCCs Prevention Achieving Skin Normality e.g. with Gene Therapy -> NO BCCs Interception: Stopping Clonal Growth Before it is Clinically Evident with Patidegib -> NO BCCs After: E Blackburn Cancer Prevention 2011
Slide 51: BCCs Are Driven by Excess Hedgehog Signaling
BCCs are driven by Excess Hedgehog Signaling (i) Familial linkage analysis: 1996 Global Village identified PTCH1 as the gene whose mutations underly Gorlin syndrome (H Hahn Cell; R Johnson Science) USA: 85% of clinically-diagnosed GS pts have detectable PTCH1 mutation in histologically Normal tissue
Slide 52: Gorlin Syndrome Diagnosis and Management
Gorlin Syndrome Diagnosis and Management Kavita Y. Sarin, MD, PhD Director Skin Cancer Genetics Program, Stanford Cancer Institute Department of Dermatology, Stanford University School of All clinical photographs are of my own patients, used with permission. Medicine Sol-Gel investigator meeting Oct
Slide 53: Gorlin Syndrome: A Genetic Tumor Predisposition Syndrome
Gorlin syndrome: a genetic tumor predisposition syndrome • Autosomal dominant tumor predisposition syndrome • Estimated prevalence 1:31,000 to 1:256,000; 20–40% of cases are de novo. • Tumors appear on sun-exposed and sun-protected skin, span every histologic subtype, are frequently pigmented, and s
Slide 54: Diagnostic Clinical Criteria
Diagnostic clinical criteria: In practice Diagnosis is established by 2 major criteria, or by 1 major + 2 minor criteria, or by 1 major criterion plus a pathogenic germline variant. Major criteria Minor criteria BCC before age 20, or multiple BCCs Rib anomalies — bifid, fused or splayed Odontogenic
Slide 55: New Presentation of Gorlin Syndrome
New Presentation of Gorlin Syndrome Small pigmented papules, face Shoulder — sun-protected skin Plantar pits Prevalence figures: Verkouteren BJA, et al. Br J Dermatol. 2022;186:215–226. Clinical images: patient of K. Sarin, used with permission. 4
Slide 56: Confirming the Diagnosis
Confirming the diagnosis Panoramic radiograph: odontogenic keratocyst, right mandible Biopsy: basaloid nests, peripheral palisading, stromal retraction – Odontogenic keratocyst on the panorex — a second major criterion. Oral surgeons and orthodontists often see these years before dermatology does. –
Slide 57: Genetic Testing
Genetic testing Who I test Why the gene matters: • Any BCC before age 20, or multiple BCCs before roughly age 40 Jaw surveillance • BCCs arising on sun-protected skin PTCH1: orthopantomogram every 2 years from age 8, annually after the first cyst, through about age 22. SUFU: no routine jaw screening
Slide 58: Monitoring Gorlin
Monitoring Gorlin – Full skin examination every 3 to 6 months with discussion of photoprotection – Total body photography and lesion mapping with numbered lesions – Triage rather than treat-everything. – The 2026 guideline severity assessment: number, size, growth rate, rate of new lesions, aggressi
Slide 59: Imiquimod, 5-Fluorouracil, and Photodynamic Therapy
Imiquimod, 5-fluorouracil, and photodynamic therapy Imiquimod 5% 5-fluorouracil 5% Photodynamic therapy • 5 nights per week for 6 weeks for a biopsy- • Twice daily for 4 weeks. • Single treatment with 5-ALA proven superficial BCC. • Easier to tolerate across a large field • 16 minutes under a blue l
Slide 60: Procedural Therapies for BCC
Procedural therapies for BCC Electrodesiccation and curettage Excision and Mohs micrographic Radiation therapy surgery • Relatively contraindicated. Irradiated skin in a patient with a germline PTCH1 defect develops dense fields of new BCCs within the treatment port. • Absolutely contraindicated in
Slide 61: The Role of Oral Hedgehog Inhibitors
The role of oral hedgehog inhibitors March 2022 · baseline September 2022 · 6 months July 2023 · 16 months 10
Slide 62: Oral Hedgehog Inhibitors Have High Efficacy
Oral hedgehog inhibitors have high efficacy High Efficacy Poor tolerability with continuous dosing 2 29 vs 54% new surgically eligible BCCs per patient-year on vismodegib versus of patients discontinued vismodegib because of adverse events in that placebo, in the randomized trial of 41 patients with
Slide 63: Intermittent Dosing: The MIKIE Trial
Intermittent dosing of hedgehog inhibitors: the MIKIE trial Randomized, double-blind, regimen-controlled phase 2 trial · 229 patients, 52 centers, 10 countries · 85 with Gorlin syndrome · both arms received identical total drug exposure (48 weeks of drug, 24 of placebo) on drug off drug (placebo) Re
Slide 64: Overview of the Current State of the Art
Overview of the current state of the art Surveillance and photography Every patient, indefinitely Detects; does not prevent Topical 5-FU, imiquimod, PDT Biopsy-proven superficial tumors, field disease Lesion-directed; weeks of local reaction Electrodesiccation and curettage Low-risk nodular and supe
Slide 65: Elizabeth M. Billingsley, MD
Elizabeth M. Billingsley, MD FACMS, FAAD, FASDS Professor of Dermatology Penn State University College of Medicine Penn State Health
Slide 66: Disclosure
Disclosure Clinical Investigator/Principal Investigator Regeneron Pharmaceuticals Sol Gel Technologies Consultant Inhibitor Therapeutics Phio Pharmaceuticals
Slide 67: Gorlin Syndrome
Gorlin Syndrome - • Tens to Hundreds of Basal Cell Carcinomas • Lifelong condition with continual need for more treatment • Numerous surgeries can lead to significant disfigurement • Patients often give up/surgical fatigue leading to neglect and eventually larger more invasive procedures
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Slide 71: Gorlin Syndrome Management
Gorlin Syndrome Management • Goal – prevent BCC development, growth, and need for surgery • Topical treatments • Oral medications • Photodynamic therapy • Surgery – gold standard • Sun Prevention and Education • Support
Slide 72: Gorlin Syndrome – Surgical Approach
Gorlin Syndrome – Surgical Approach Curettage ( +/- electrodessication) Excision Mohs Surgery
Slide 73: Curettage
Curettage
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Slide 76: Surgical Excision
Surgical Excision
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Slide 78: Mohs Micrographic Surgery
Mohs Micrographic Surgery • Excision technique with frozen section analysis of surgical margins • Allows 100% margin assessment • Higher cure rate and tissue sparing • Indications – recurrent lesions, tumors where tissue conservation is critical – eyelid,nose, lip, ear, etc, aggressive histology, Go
Slide 79: Tissue Conservation
Tissue Conservation
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Slide 82: Gorlin Syndrome – Surgeon’s Perspective
Gorlin Syndrome – Surgeon’s perspective • Decrease the number and extent/size of surgeries • Smaller lesions require less extensive surgeries • Patients have different goals • Team approach
Slide 83: Meaningful Efficacy Outcome
Meaningful efficacy outcome • Prevention of new lesions • Cure of small lesions • Reduction in size of larger lesions • Fewer surgeries per patient • Fewer scars, smaller scars • Optimism and motivation for patients • Decreasing the number of surgeries a patient needs by 30% would have significant i
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Slide 85: Surgeon’s Point of View
Surgeon’s point of view • Sometimes so numerous, many small lesions can run into each other – creating large defects • Some tumors will not respond to this – some require surgery • If can prevent small lesions/ shrink some lesions/ or cure some lesions – More normal skin preservation • Allows easier
Slide 86: Why Is This Treatment Important?
Why is this treatment important? • One more option to decrease the number of surgeries, number of scars • Easy and well-tolerated – patient motivation • Builds into regimen of awareness and increased efforts • Prevention, size reduction, and slowing progression are all meaningful outcomes
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Slide 91: Gorlin Syndrome Management and Care
Gorlin Syndrome Management and Care Optimize quality of life Prevent need for so many surgeries Decrease scarring and disfigurement Multiple treatment options are needed to have long lasting impact
Slide 92: Panel Discussion
Panel Discussion 14 October 2026
Slide 93: Question and Answer Session
Question and Answer Session 14 October 2026