Sol-gel Technologies Ltd. · NASDAQ:SLGL
Sol-gel Technologies — Investor Presentation (March 2019)
20 slides from Sol-gel Technologies's investor presentation, Mar 22, 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
Expecting results during 2019 from pivotal trials of two branded pipeline candidates, based on a proprietary topical microencapsulation delivery system Proven track record combined with broad dermatological knowhow Primed to become a global dedicated dermatological company by developing a combinatio
Slide 4: Acne vulgaris and papulopustular rosacea market overview
Sources: IQVIA (IMS); T. Pigeon, Practical Dermatology, July 2010 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
Slide 5: Our Branded Drug Product Candidates
(†) Our estimation takes into consideration current payers’ requirements and tier 3 limitations Our Branded Drug Product Candidates TWINacne vulgaris Epsolay®papulopustular rosacea A cream containing encapsulated benzoyl peroxide, 5%Encapsulation was designed to reduce irritation caused by benzoyl p
Slide 6: Our Microencapsulation Platform
Our Microencapsulation Platform SEM pictures of our silica-based encapsulated tretinoin Encapsulated tretinoin (E-ATRA) Broken microcapsule containing multiple tretinoin (ATRA) crystals crystals
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: 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 12: 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 13: 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 14: 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 15: Our Generic Pipeline
1st Fruitions Upcoming Milestones Multiple Collaborations (†) Source: IQVIA (IMS) Our Generic Pipeline In February 2019, Perrigo received approval from the FDA and launched the sale of acyclovir cream, 5%, developed in collaboration with Sol-Gel. As of today, there is no public disclosure of another
Slide 16: 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®, a bioequivalence study, and our activities until the end of Q2/2020 $63.0 million of cash and investments as
Slide 17: Our Upcoming Milestones
Our Upcoming Milestones Preclinical Phase II Phase III Research Branded Candidates Generic Candidates Bioequivalence Filed Research Ivermectin cream, 1% Tentative approval as of January 29, 2018 Acyclovir cream, 5% Epsolay® TWIN Top-line resultsin Q4/2019 BE study resultsin 2019 5-Fluorouracil cream
Slide 18: 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 Initiated a bioequivalence study for5-fluorouracil cream, 5% in actinic keratosis Hired U.S. commercialization leader for the launches of TWIN and Epsolay® 2019 Launched
Slide 19: Wrap-Up
Wrap-Up Seven 50/50 gross profit sharing partnerships regarding generics including an ANDA approval for acyclovir cream and a tentative ANDA approval for ivermectin cream. Acyclovir cream is generating revenues as of February 2019 TWIN combination of BPO/tretinoin does not currently exist on the mar
Slide 20: NASDAQ: SLGL www.sol-gel.com
NASDAQ: SLGLwww.sol-gel.com
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