Exhibit 99.2
EPSOLAY® PHASE 3 RESULTS
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EPSOLAY® PHASE 3 STUDY DESIGN Multicenter, parallel, double-blind, randomized, vehicle-controlled, 2:1 ratio, QDInclusion criteria:Male & female ≥ 18 years of age IGA score “moderate” to “severe”≥ 15 ≤ 70 inflammatory lesions≤ 2 nodules IGA Definition:“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 moderate light to bright red erythema is present“Severe”: Numerous small and/or larger papules or pustules and severe erythema that is bright red to deep red is present
STUDY POPULATION & DISCONTINUATION Study 54-02 Study 54-01 # of Patients Epsolay® Vehicle # of Patients
PATIENT SEVERITY AT BASELINE Study 54-01 Characteristic Epsolay® Vehicle IGA “Moderate”IGA “Severe” 210 (86.4%)33 (13.6%) 104 (88.1%)14 (11.9%) Mean lesion count (SD)Median lesion count (range) 25.7 (11.07)22.0 (15-69) 26.3 (12.45)21.0 (15-70) Study 54-02 Epsolay® Vehicle 227 (90.8%)23 (9.2%) 112 (91.8%)10 (8.2%) 29.8 (14.00)25.0 (15-70) 27.5 (13.04)22.5 (15-70)
PRIMARY ENDPOINTS (ITT) Study 54-02 Study 54-01 P-value < 0.001 P-value < 0.001 Success in IGA @ Week 12 Inflammatory Lesion Count Change from Baseline @ Week 12 P-value < 0.001 P-value < 0.001 Study 54-02 Study 54-01
SECONDARY ENDPOINT (ITT) Study 54-02 Study 54-01 Inflammatory Lesion Percent Change from Baseline @ Week 12 P-value < 0.001 P-value < 0.001
EXPLORATORY ENDPOINTS (ITT) Study 54-02 Study 54-01 Success in IGA @ Week 2 Inflammatory Lesion Count Change from Baseline @ Week 2 P-value = 0.009 P-value = 0.017 P-value < 0.001 P-value < 0.001 Study 54-02 Study 54-01
Success in IGA @ Week 4 Inflammatory Lesion Count Change from Baseline @ Week 4 P-value < 0.001 P-value = 0.009 P-value < 0.001 P-value < 0.001 SECONDARY ENDPOINTS (ITT) Study 54-02 Study 54-01 Study 54-02 Study 54-01
SECONDARY ENDPOINTS (ITT) Success in IGA @ Week 8 Inflammatory Lesion Count Change from Baseline @ Week 8 P-value < 0.001 P-value = 0.006 P-value < 0.001 P-value < 0.001 Study 54-02 Study 54-01 Study 54-02 Study 54-01
ABSOLUTE REDUCTION IN LESION COUNT OVER TIME Statistical significant improvement in reducing inflammatory lesions as of Week 2 P-value < 0.001 P-value < 0.001
SUCCESS IN IGA OVER TIME (ITT) Statistical significant improvement in in getting patients to the stage of “clear” or “almost clear” P-value < 0.001 P-value < 0.001
Rapid efficacy of Epsolay® (†) 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 construed as conclusions to be drawn as if we conducted a head-to-head comparison trial or study SIDE-BY-SIDE WITH HISTORICAL SOOLANTRA® RESULTS(†)
Baseline Characteristics of Active Arm IGA Severe 33 23 82 113 26 65 0 51 71 Moderate 210 227 369 346 172 418 557 444 443 Mild 0 0 0 0 0 0 0 0 0 Inflammatory Lesions 25.7 29.8 31.0 33.3 21.6 21.7 18.3 28.5 30.0 Inflammatory Lesions – Mean Percent Change from Baseline @ Week 12 SIDE-BY-SIDE WITH OTHER HISTORICAL TRIAL RESULTS(†) Success in IGA @ Week 12 Difference from Vehicle FMX103 Minocycline foam, 1.5% 10-week study Epsolay® (†) 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 construed as conclusions to be drawn as if we conducted a head-to-head comparison trial or study
LESION COUNT IMPROVEMENT OVER TIME
SKIN TOLERABILITY (SAFETY POPULATION) Study 54-01 Study 54-02 Itching Burning/Stinging Dryness Scaling Percent of Patients Epsolay® Vehicle Percent of Patients Itching Burning/Stinging Dryness Scaling
No. (%) of Subjects Study 54-01 Epsolay® Vehicle Subjects reporting any TEAE 49 (20.5%) 17 (15.0%) Serious TEAE 1 (0.4%)1 Severe TEAE 2 (0.8%) Discontinuation 5 (2.1%) 1 (0.9%) Treatment-related 14 (5.9%) 3 (2.7%) Study 54-02 Epsolay® Vehicle 50 (20.2%) 22 (18.2%) 1 (0.4%)2 2 (0.8%)3 4 (1.6%) 1 (0.8%)4 9 (3.6%) 1 Femur fracture2 Spinal compression fracture3 One subject with spinal compression fracture4 Subject with urinary tract infection – Discontinuation defined as “other” reason (†)TEAE = Treatment-Emergent Adverse Events TEAEs (†) (SAFETY POPULATION)
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