Sol-gel Technologies Ltd. · NASDAQ:SLGL
Sol-gel Technologies — Investor Presentation (January 2019)
21 slides from Sol-gel Technologies's investor presentation, Jan 7, 2019
Slide 1: Sol-Gel Advanced Topical Therapy
Sol-Gel Advanced Topical Therapy NASDAQ; SLGL
Slide 2: Cautionary Note on Forward-Looking Statements
Cautionary Note on 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 for
Slide 3: Our Dermatology Company
Seven established collaborations with two strategic partners on generic candidates Tentative approval for 1st generic drug product Complementary combination of branded and generic topical drugs pipelines Proprietary topical microencapsulation delivery system Significant inflection points expected fr
Slide 4: Acne vulgaris and papulopustular rosacea market overview
A disease of the pilosebaceous unit, involving abnormalities in sebum production, follicular epithelial desquamation, bacterial proliferation and inflammationBenzoyl peroxide (BPO) and tretinoin are mainstay therapiesTretinoin is the most widely used Rx topical retinoid, but is rapidly decomposed by
Slide 5: SIRS-T, TWIN and Epsolay product candidates
(†) Our estimation takes into consideration current payers’ requirements and tier 3 limitations SIRS-Tacne vulgaris TWINacne vulgaris Epsolay®papulopustular rosacea A cream containing encapsulated benzoyl peroxide, 5%Encapsulation was designed to reduce irritation caused by benzoyl peroxidePotential
Slide 6: Our Microencapsulation Platform
Our Microencapsulation Platform SEM pictures of our silica-based encapsulated tretinoin Encapsulated tretinoin microcapsule Encapsulated tretinoin crystals inside broken microcapsule
Slide 7: Positive TWIN Factorial Phase II Results (ITT)
Positive TWIN Factorial Phase II Results (ITT)(†) Inflammatory Lesion Mean Absolute Change from Baseline at Week 12 <0.001 <0.001 P-value vs. vehicle 0.060 0.003 Non-Inflammatory Lesion Mean Absolute Change from Baseline at Week 12 <0.001 <0.001 P-value vs. vehicle 0.002 <0.001 Success in Dichotomiz
Slide 8: Acne Trials Efficacy Results: Moderate Patients
Number of Patients Severe 0 0 1 0 Moderate 102 111 1,043 1,118 Mild 0 0 0 0 Baseline # of Lesions Inflamed 25.9 ~29.7 28.8 29.6 Non-inflamed 42.1 ~53.7 46.9 46.7 Non-Inflammatory Lesions – Mean Percent Change from Baseline at Week 12 Acne Trials Efficacy Results(†): Moderate Patients Success in IGA
Slide 9: Phase II Cutaneous Tolerability of TWIN
Phase II Cutaneous Tolerability of TWIN Mild Moderate Severe Erythema Scaling Pigmentation Itching Burning Stinging Proportion of Subjects with Post-Baseline Worsening of Cutaneous Side Effects (Safety Population) Max. Post-Baseline > Baseline 22% 31% 26% 22% 42% 41% 15% 14% 14% 19% 25% 28% 12% 38%
Slide 10: Efficacy Results of Recent Acne Trials
Number of Patients Severe 14 61 64 37 118 70 79 Moderate 102 292 305 296 620 413 440 Mild 0 0 0 0 0 0 0 Baseline # of Lesions Inflamed 26.7 42.4 42.9 31.6 30.7 29.7 30.3 Non-inflamed 42.9 59.1 62.8 50.5 49.7 42.4 42.3 Non-Inflammatory Lesions – Mean Percent Change from Baseline at Week 12 Efficacy R
Slide 11: Supportive SIRS-T Clinical Results (ITT)
Supportive SIRS-T Clinical Results (ITT) Success in Dichotomized IGA at Week 12 P-value vs. vehicle 0.015 0.001 Non-Inflammatory Lesion Mean Percent Change from Baseline at Week 12 Inflammatory Lesion Mean Percent Change from Baseline at Week 12 N=115 N=118 N=118 P-value vs. vehicle 0.060 0.003 P-va
Slide 12: Positive Epsolay Phase II Results (ITT)
Positive Epsolay® Phase II Results (ITT) Success in Dichotomized IGA at Week 12 (†) 0.0013 P-value vs. vehicle Inflammatory Lesion Count – Change from Baseline at Week 12 Median Mean (†) The FDA required a modification to our definition of “clear” on the IGA scale such that the category of “clear” r
Slide 13: Phase II Cutaneous Tolerability of Epsolay
Phase II Cutaneous Tolerability of Epsolay® Dryness Scaling Pruritus Burning Stinging Increase from Baseline of Cutaneous Side Effects at Week 12 (Safety Population) Increase from Baseline 2/30 2/32 3/30 1/30 2/32 2/30 1/32 3/30 1/32 3/30
Slide 14: Papulopustular Rosacea Trials Results
Number of Patients Severe 5 82 113 26 65 0 51 71 Moderate 21 369 346 172 418 557 444 443 Mild 4 0 0 0 0 0 0 0 Baseline # of Inflammatory Lesions 22.9 31.0 33.3 21.6 21.7 18.3 28.5 30.0 Papulopustular Rosacea Trials Results(†) (ITT) Success in IGA at Week 12 Inflammatory Lesions – Mean Percent Change
Slide 15: Phase III pivotal trial design and NDA plans
Only TWIN and vehicle are required for the pivotal trials, as the requirements of the combination rule act were satisfied in our Phase II trial Each pivotal trial is planned to enroll 420 subjects in a 2:1 ratio, with a power of 99%No LTSS is required to support our future marketing application, as
Slide 16: Our Generic Pipeline
Bioequivalence study results for 5-fluorouracil cream, 5%, in 2019 1st Fruition A portfolio of generic product candidates with favorable commercial agreements that supplement our branded pipeline and potentially make a meaningful contribution to operating incomeSix collaborations with Perrigo and on
Slide 17: Financial Profile
Gross proceeds of $86.3 million raised in IPO of 7,187,500 ordinary shares on February 5, 2018 Cash runway expected to be sufficient to fund Phase III clinical programs for TWIN and Epsolay® and a bioequivalence study $73.5 million of cash and investments as of September 30, 2018 18,949,968 shares o
Slide 18: Our Upcoming Milestones
Our Upcoming Milestones FPFV: First Patient First Visit; EoPII: End of Phase II Preclinical Phase II Phase III Research Branded Candidates TWIN SIRS-T Epsolay® Generic Candidates Bioequivalence Filed Research Ivermectin cream, 1% Tentative approval as of January 29, 2018 Based on TWIN Phase II 5-Flu
Slide 19: Recent Milestones and Next Steps
2017 Reported positive results from TWIN Phase II trial in acne vulgaris Had an EoPII meeting with the FDA about Epsolay® 2018 Had an EoPII meeting with the FDA about TWIN and addressed the combination rule act Initiated a bioequivalence study for5-fluorouracil cream, 5% in actinic keratosis Hir
Slide 20: Seven 50/50 gross profit sharing partnerships
Seven 50/50 gross profit sharing partnerships regarding generics including tentative ANDA approval for ivermectin cream. As of today we are the only ones to have tentative approval and no 3rd filing exists with the FDA TWIN combination of BPO/tretinoin does not currently exist on the market. Pivotal
Slide 21: Sol Gel www.sol-gel.com
NASDAQ: SLGL www.sol-gel.com Sol Gel Advanced Topical Therapy
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