EX-99.2 3 exhibit_99-2.htm EXHIBIT 99.2


Exhibit 99.2

 EPSOLAY® PHASE 3 RESULTS 
 

 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,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “future,” “outlook,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential,” “continue,” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties, and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statement, including but not limited to the following: the fact that we have and expect to continue to incur significant losses; our need for additional funding, which may not be available; our ability to complete the development of our product candidates; our ability to obtain and maintain regulatory approvals for our product candidates in our target markets and the possibility of adverse regulatory or legal actions relating to our product candidates even if regulatory approval is obtained; our ability to commercialize our product candidates; our ability to obtain and maintain adequate protection of our intellectual property; our ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; our ability to establish adequate sales, marketing, and distribution channels; acceptance of our product candidates by healthcare professionals and patients; the possibility that we may face third-party claims of intellectual property infringement; the timing and results of clinical trials that we may conduct or that our competitors and others may conduct relating to our or their products; intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing, and sales, distribution and personnel resources than we do; potential product liability claims; potential adverse federal, state, and local government regulation in the United States, Europe, or Israel; and loss or retirement of key executives and research scientists. These and other important factors discussed in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission (“SEC”) on March 21, 2019, and our other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this presentation. While we may elect to update such forward-looking statements at some point in the future, unless required by applicable law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Thus, one should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this presentation. This presentation contains trademarks, trade names, and service marks of other companies, which are the property of their respective owners. We do not intend our use or display of other parties' trademarks, trade names, or service marks to imply, and such use or display should not be construed to imply, a relationship with, or endorsement or sponsorship of us by, these other parties. 
 

 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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