Sienna Biopharmaceuticals Inc · OTC:SNNAQ
Sienna Biopharmaceuticals — Corporate Update (July 2018)
11 slides from Sienna Biopharmaceuticals's corporate update, Jul 30, 2018
Slide 1: SNA-001 Acne Pivotal Trials: Results with 1064 nm and 810 nm Lasers
SNA-001 Acne Pivotal Trials: Results with 1064 nm and 810 nm Lasers July 30, 2018 March 2017 Exhibit 99.2
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation contains forward-looking statements. All statements other than descriptions of historical facts contained in this presentation, including statements regarding future operational and financial results and positions, business strategy, prospective products,
Slide 3: Topical Photoparticle Therapy Platform (SNA-001)
Topical Photoparticle TherapyTM Platform (SNA-001)
Slide 4: SNA-001 Acne Pivotal Trials with 1064 nm & 810 nm Lasers: Trial Design
Enrollment Primary Endpoint Secondary Endpoints Independent, multicenter, randomized, double-blind, split-face (within subject vehicle controlled) trials Three treatments over two weeks (7 + 1 days apart), each side of the face with laser and either SNA-001 or Vehicle Three separate clinical trials
Slide 5: Primary Endpoint Results: Percentage Lesion Change (810 nm)
Primary Endpoint Data – 810 nm Laser Endpoint/Analysis Mean (SD1) Percentage Change from Baseline LS2 Mean in Treatment Difference p-value SNA-001 + Laser (N = 78) Vehicle + Laser (N = 78) Percentage change in inflammatory lesion count from baseline at 12 weeks post final treatment -37.4 (45.54) -36
Slide 6: Primary Endpoint Results: Percentage Lesion Change (1064 nm)
Primary Endpoint Data – 1064 nm Laser Endpoint/Analysis Mean (SD1) Percentage Change from Baseline LS2 Mean in Treatment Difference p-value SNA-001 + Laser (N = 89) Vehicle + Laser (N = 89) Percentage change in inflammatory lesion count from baseline at 12 weeks post final treatment -38.7 (47.89) -4
Slide 7: Secondary Endpoint Results (810 nm)
Secondary Endpoint Data – 810 nm Laser Endpoint/Analysis SNA-001 + Laser Vehicle + Laser LS1 Mean (SEM2) in Treatment Difference p-value Absolute change in inflammatory Lesion count from baseline at 12 weeks post final treatment Mean (SD3) -7.3 (8.36) -7.1 (7.03) -0.483 (0.774) 0.534 IGA4 success5 a
Slide 8: Secondary Endpoint Results (1064 nm)
Secondary Endpoint Data – 1064 nm Laser Endpoint/Analysis SNA-001 + Laser Vehicle + Laser LS1 Mean (SEM2) in Treatment Difference p-value Absolute change in inflammatory Lesion count from baseline at 12 weeks post final treatment Mean (SD3) -7.9 (9.67) -8.2 (9.56) 0.265 (0.724) 0.716 IGA4 success5 a
Slide 9: Safety Summary
Safety Summary – 810 nm Laser Type of Event SNA-001 + Laser n (%) [Events] Vehicle + Laser n (%) [Events] Bilateral n (%) [Events] Treatment emergent adverse event (TEAE) 11 (14.1) [14] 5 (6.4) [8] 10 (12.8) [15] Serious adverse event (SAE) 0 (0) 0 (0) 0 (0) TEAE related to investigational device 5
Slide 10: Safety Summary – 1064 nm
Safety Summary – 1064 nm Laser Type of Event SNA-001 + Laser n (%) [Events] Vehicle + Laser n (%) [Events] Bilateral n (%) [Events] Treatment emergent adverse event (TEAE) 0 (0) [0] 1 (1.1) [1] 17 (19.1) [33] Serious adverse event (SAE) 0 (0) 0 (0) 0 (0) TEAE related to investigational device 0 (0)
Slide 11: Regulatory Pathways and Anticipated Milestones
Regulated as a drug pursuant to a new drug application (NDA) regulatory pathway Regulated as a Class II medical device under 510(k) marketing clearance pathway TrkA = tropomyosin receptor kinase A JAK3 = Janus kinase 3 Technology Platform Research Pre-clinical Phase 1 Phase 2 Phase 3 Anticipated Mil
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