•Section 6.1 Overall Study Design and Plan was edited to provide a rationale for the dose level and frequency of the topical gel, based on nonclinical data and the known characteristics of the oral formulation. Patidegib 2% and 4% gel applied twice daily was predicted to be effective while providing a large safety margin for both dermal and systemic safety. •Table 2 Schedule of Assessments footnote e was expanded to specify that the following clinical laboratory tests would be performed: chemistry (AST, total bilirubin, BUN, calcium, carbon dioxide, chloride, creatinine, glucose, potassium, protein, sodium), hematology (WBC, RBC, hemoglobin, hematocrit, MCV, MCH, MCHC, Red Cell Distribution Width, Platelets, Mean Platelet Volumes, Absolute/Percent Neutrophil Count, Absolute/Percent Lymphocyte count, Absolute/Percent Monocyte count, Absolute/Percent Eosinophil Count, Absolute/Percent Basophil Count), and urinalysis (including reflex microscopic examination). •Appendix 16.4 Safety Laboratory Tests was newly added to provide a detailed list of clinical laboratory assessments to be collected. •Section 8.3 Unblinding was edited to clarify that, in the case of a medical emergency, the Investigator could break the blind for the subject involved without first discussing the situation with the Medical Monitor.

. •Section 1 Synopsis and Section 7.1 Subject Inclusion Criteria were edited per feedback from the MHRA to specify 2 acceptable methods of contraception: 1) barrier method in association with bilateral tubal ligation, combined oral contraceptives, or implanted or injectable contraceptives with a stable dose for at least 1 month prior to Baseline; or 2) hormonal intrauterine device inserted at least 1 month prior to Baseline. •Section 10.1.1 Screening Visit and Section 10.1.5 Week 26 were edited. Previously, subject height assessment was erroneously included at these visits; it was removed. •Section 10.1.2 Baseline Visit (Day 1) was edited. Height and weight assessments were erroneously included in item 4; they were removed as they already were present in item 5.

•Synopsis/Section 7.1 Inclusion Criteria 8-Female subjects must have a negative serum pregnancy test at Screening. 9-If the subject is a male with a female sexual partner who is of childbearing potential the couple is willing to use two effective methods of birth control during the duration of the trial and for one month after the last application of the gel. A female of childbearing potential is a sexually mature woman who has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months), must agree to use two effective methods of contraception for the duration of the study and at least 1 month after the last study drug application. The two forms of birth control authorized are defined as the use of a barrier method of contraception (condom with spermicide) in association with one of the following methods of birth control: bilateral tubal ligation; combined oral contraceptives (estrogens and progesterone) or implanted or injectable contraceptives with a stable dose for at least 1 month prior to Baseline; hormonal intra-uterine device (IUD) inserted at least 1 month prior to Baseline. •Synopsis/Section 7.2 Exclusion Criteria 1-The subject is a woman of childbearing potential. (based on the key role of the HH pathway in embryogenesis, the known preclinical teratogenic effects of systemic cyclopamine, a naturally occurring inhibitor of SMO, and the unknown level of systemic exposure following topical application of patidegib in humans) A female of childbearing potential is a sexually mature woman who has not undergone a hysterectomy or bilateral oophorectomy or has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months. 10-Female sexual partner(s) of male subjects unwilling/unable to comply with pregnancy prevention measures.

•Synopsis Safety Measurements /Section 10.3.1 Dermal Safety and Tolerability were amended to specify that safety and tolerability would be evaluated, and that each of the 5 baseline treatment-targeted tumor sites, as well as the face in general, would be evaluated separately for these signs and symptoms of application site reactions. Scales for assessing local skin reactions were clarified to specify that the subjects should rate the symptoms experienced at the application site(s). •Synopsis Statistical Methods /Section 11 Statistics were edited to add that if determined appropriate by the Sponsor, limited efficacy analysis on tumor shrinkage and biomarkers might have been performed after the last subject completed 14 weeks of treatment. •Table 2 Schedule of Assessments was edited to indicate that at Baseline and Week 6, a BCC was to be identified for biopsy, and that visible BCCs were to be measured at Baseline and at Weeks 2, 6, 10, 14, 18, 22, and 26/ET. Footnote f was added: Tumors to be measured and mapped included the 5 baseline treatment-targeted tumors as well as all other facial tumors including those on the eyelids and the nose. In addition, up to 10 non treatment-targeted non-facial tumors also were measured and mapped. •Section 10 Study Procedures and Evaluations was edited to indicate that a physician must identify the treatment targeted tumor to be biopsied.

•Section 10.1.2 Baseline Visit (Day 1) was edited to clarify the following procedures: 7. The Investigator will perform the clinical evaluation to identify BCCs including the 5 baseline treatment-targeted tumors, as well as, all other facial tumors (including those on the eyelids and the nose). In addition, up to 10 non treatment-targeted non facial tumors will also be clinically classified as superficial, nodular, infiltrative, morpheic or sclerosing, pigmented, or micronodular/morpheaform, circle each tumor in ink, photographed, measured, and recorded on a body diagram. The 5 baseline treatment-targeted tumors will also be evaluated based on the ISGTA. 8. Obtain 2 mm punch biopsy from the baseline treatment targeted SEB that has been designated for biomarker evaluation. The 2 mm punch biopsies can be performed by the Investigator or designee as allowed by the clinical site's normal policies and procedures. 9. The Investigator or designee will assess each of the areas to be treated by observations and questioning the subjects as necessary for the signs and symptoms of irritation including pain/burning, pruritus, erythema, edema, and scabbing/crusting. Each of the 5 treatment targeted-tumors, as well as the face in general, will be evaluated separately.

•Section 10.1.3 Weeks 2, 10, 18, and 22; Section 10.1.4 Weeks 6, 14, and 26; and Section 10.1.5 Week 26 (Day 183 ± 3 Days) / Early Termination were edited to clarify the following procedures: -The Investigator will perform the clinical evaluation of the 5 baseline treatment targeted tumors, as well as, all other facial tumors (including those on the eyelids and the nose). In addition, up to 10 non treatment-targeted non-facial tumors will be circled in ink, photographed, measured, and recorded on a body diagram. The 5 baseline treatment-targeted tumors will be evaluated based on the ISGTA. -The Investigator or designee will assess each of the treated areas by observations and questioning the subjects as necessary for the signs and symptoms of irritation including pain/burning, pruritus, erythema, edema, and scabbing/crusting. Each of the 5 treatment-targeted tumors, as well as the face in general, will be evaluated separately. Section 10.1.4 Weeks 6, 14, and 26 was edited to clarify the following procedure: -Obtain a biopsy with a 2 mm punch at Week 6 from the single SEB designated as the biomarker treatment targeted tumor and previously biopsied at baseline. The 2 mm punch biopsies can be performed by the Investigator or designee as allowed by the clinical site's normal policies and procedures. •Section 10.1.5 Week 26 (Day 183 ± 3 Days) / Early Termination was edited to remove the 2 mm punch biopsy of non-responding tumors for subjects considered to be non responders. •Section 10.2 (Evaluation of Efficacy) renamed, “Evaluation of Tumors.” •Section 11 Statistics and Section 11.6 Interim Analyses were edited to remove the sentence, “No interim analyses are planned.” Text was added to Section 11.6: “If determined appropriate by the Sponsor, limited efficacy analysis on tumor shrinkage and biomarkers may be performed after the last subject completes 14 weeks of treatment.” •Section 13 (Data Monitoring Committee) was renamed, “Data Safety Monitoring Committee.”