Sienna Biopharmaceuticals Inc · OTC:SNNAQ
Sienna Biopharmaceuticals — Investor Presentation (January 2019)
53 slides from Sienna Biopharmaceuticals's investor presentation, Jan 2, 2019
Slide 1: Company Overview January 2019
Company Overview January 2019 Exhibit 99.1
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: The Sienna Opportunity
The Sienna® Opportunity Addressing the Innovation Gap in Medical Dermatology Accomplished, Credible Management Team Recent advances in dermatology have mostly benefited the more severe patient populations Opportunity to leverage biotechnology and well-understood pathways to develop novel, targeted t
Slide 4: The Sienna Opportunity (cont.)
The Sienna® Opportunity (cont.) Proprietary Platforms and Multiple Clinical Stage Assets Large Markets Global Medical Dermatology Prescription Market Global Non-Surgical Aesthetic Procedure Market Topical by Design™ Topical Photoparticle Therapy™ Designed to enable chronic administration with low sy
Slide 5: Pipeline 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 Top-line acne data for 1064 nm and 810 nm did not show statistical significance
Slide 6: Opportunity to Address Large Underserved Markets in Medical Dermatology and Aesthetics
Opportunity to Address Large Underserved Markets in Medical Dermatology and Aesthetics Atopic Dermatitis Psoriasis Pruritus SNA-125 Psoriasis and Associated Pruritus SNA-120 Topical By Design™ Platform Topical Photoparticle Therapy™ Platform Light-pigmented Hair Reduction MARKET EXPANSION $3+ billio
Slide 7: Topical by Design Platform (SNA-120 & SNA-125)
Topical by Design™ Platform (SNA-120 & SNA-125)
Slide 8: Topical by Design Molecule Components
Topical by Design Molecule Components Optimizes small molecules for topical administration High local drug concentration Low systemic exposure Ability to create new chemical entities (NCEs) with the Topical by Design platform Targeting surfaces such as the skin, the eye, the gastrointestinal tract a
Slide 9: SNA-120: A Novel Topical Non-Steroidal Psoriasis Drug in Phase 3
SNA-120: A Novel Topical Non-Steroidal Psoriasis Drug in Phase 3 Before Treatment After 12 weeks Treatment with SNA-120 0.05% in Recent Phase 2b Trial Data on file, Sienna Biopharmaceuticals, Inc.: Study SNA-120-201. Subject 08005. Responder Analyses - Composite IGA: Yes; PASI 50: Yes; PASI 75: Yes.
Slide 10: SNA-120: $1B+ Global Opportunity in Mild to Moderate Psoriasis
7.5 million Total psoriasis patient population1 6.0 million Mild-to moderate psoriasis patients1 $500-$950/month Price range for 60-gram tube of current topical psoriasis therapies3 American Academy of Dermatology. Skin conditions by the numbers. Accessed November 2018. Stinco et al. Acta Dermatoven
Slide 11: SNA-120 Inhibits TrkA, the High Affinity Receptor for NGF
SNA-120 Inhibits TrkA, the High Affinity Receptor for NGF1, Particularly Important in Psoriasis SNA-120 Attenuation of NGF-driven: Neurogenic inflammation Keratinocyte hyperproliferation Itch signaling through TRPV12 NGF = nerve growth factor TRPV1 = transient receptor potential cation channel subfa
Slide 12: TrkA-Positive Nerve Fibers are Prevalent in Psoriatic Skin
TrkA-Positive Nerve Fibers are Prevalent in Psoriatic Skin epidermis dermis TrkA-Positive Nerve Fiber TrkA-Positive Nerve Fiber epidermis dermis Modified from Roblin et al. Acta Derm Venereol 2015;95:542-48 (Fig. 2). Human skin sections showing TrkA-positive intra-epidermal nerve fibers (arrow, left
Slide 13: NGF is Highly Expressed in Epidermis of Psoriatic Skin
NGF is Highly Expressed in Epidermis of Psoriatic Skin Healthy human skin Psoriatic skin Modified from Kou et al. Acta Derm Venereol 2012;92:521-28 (Fig. 2). Skin samples from healthy volunteer (left photo) and patient with psoriasis (right photo) were immunostained for NGF. NGF expression was incre
Slide 14: Cutaneous Nerves Play a Role in Psoriasis Pathogenesis
Cutaneous Nerves Play a Role in Psoriasis Pathogenesis Plaque remission on right hand following nerve injury to right hand Beginning of plaque reappearance on right hand with nerve recovery in right hand at four months Modified from Azimi et al. Br J Dermatol 2015;172:988-93 (Fig. 1).
Slide 15: Clear Iterative Development of SNA-120 to Phase 3
Clear Iterative Development of SNA-120 to Phase 3, A Novel Topical Non-Steroidal Psoriasis Drug Recent Phase 2b (Study SNA-120-201)1 Only itchy psoriatics Statistically significant efficacy in psoriasis regulatory endpoint (IGA 2-grade composite2) ~60% improvement from baseline in pruritus Maximal U
Slide 16: NGF Expression is Greater in Pruritic Psoriatic Skin
NGF Expression is Greater in Pruritic Psoriatic Skin Pruritic psoriasis skin Non-pruritic psoriasis skin Modified from Nakamura et al. Br J Dermatol 2003;149:718-30 (Fig. 3). Marked diminution of NGF immunoreactivity in the epidermis of a non-pruritic lesion (left photo). Strong expression of NGF th
Slide 17: TrkA Expression is Greater in Pruritic Psoriatic Skin
TrkA Expression is Greater in Pruritic Psoriatic Skin Modified from Nakamura et al. Br J Dermatol 2003;149:718-30 (Fig. 4). Immunostaining for TrkA in psoriatic lesional skin. Virtual absence of TrkA expression in the epidermal basal layer in a non-pruritic lesion (left photo); note the few fine ner
Slide 18: Key Learnings from CT327-2003 Study
SNA-120 improved both psoriasis and pruritus Greater impact in itchy patients on both psoriasis and pruritus Pruritus may be a clinical biomarker for NGF-mediated psoriasis, which SNA-120 affects as a TrkA inhibitor Treatment effect appeared to increase with time Low dose appeared similar to or more
Slide 19: Rationale Behind SNA-120-201 Study Design
Confirm positive effect on both psoriasis and pruritus in larger and longer (12 week) Phase 2b study Pruritus as primary endpoint based on CT327-2003 data FDA prefers I-NRS1 (versus I-VAS2) as primary measure for pruritus Needed to test I-NRS measure before Phase 3 Demonstrate maximum impact on psor
Slide 20: SNA-120-201 Study Design
Multicenter, randomized, double-blind, placebo-controlled study N = 208 ³18 years of age Mild-to-moderate psoriasis At least moderate pruritus Twice daily treatment for 12 weeks with either SNA-120 (0.05% or 0.5%) or Vehicle SNA-120-201 Study Design
Slide 21: Demographics and Baseline Characteristics
Characteristic SNA-120 (0.05%) n=70 SNA-120 (0.5%) n=69 Vehicle n=69 Age, mean (years) 49.5 53.8 49.7 Male (%) 50.0 49.3 42.0 Race (%) Black/African American White Other 5.7 84.3 10.0 5.8 85.5 8.7 1.4 89.9 8.7 I-NRS weekly mean 7.3 7.4 7.4 BSA2 mean 6.0 5.7 5.5 IGA 2 – ‘mild’ (%) IGA 3 – ‘moderate’
Slide 22: SNA-120 (0.05%) Showed Statistical Significance on IGA 2-Grade Composite
SNA-120 (0.05%) Showed Statistical Significance on FDA Psoriasis Primary Endpoint for Topicals (IGA 2-Grade Composite1)2 Treatment Group Week 8 Week 12 PASI 50 SNA-120 (0.05%) Proportion of subjects P value vs vehicle 30 (49.2%) p=0.130 32 (54.2%) p=0.057 SNA-120 (0.5%) Proportion of subjects P valu
Slide 23: SNA-120 Efficacy Improved Throughout Trial on IGA Composite
Week 0.05% SNA-120 Vehicle SNA-120 (0.05%) Efficacy Improved Throughout Trial on FDA Psoriasis Primary Endpoint for Topicals (IGA 2-Grade Composite)1 Composite IGA Responder Rate, % (SEM2) End of Treatment p < 0.05 * 0.5% SNA-120 Data on file, Sienna Biopharmaceuticals, Inc.: Study SNA-120-201. SEM
Slide 24: Subject 08005 in SNA-120-201
SNA-120 (0.05%) Subject 08005 in SNA-120-201 Visible clearing of target lesion Responder on IGA 2-grade composite and PASI 75 Baseline IGA (2 or 3) 3 PASI (mean) 2.8 I-NRS (mean) 6.2 Responder Analyses IGA 2-grade Composite Yes PASI 50 Yes PASI 75 Yes Week 12 IGA 1 PASI (mean) 0 I-NRS (mean) 1.4 Dat
Slide 25: Published IGA Data for On-Market Psoriasis Therapies
mild to moderate moderate to severe Drug Active Vehicle N % N % Vanos (fluocinonide) Cream 0.1%2 107 18% QD 54 7% QD 107 31% BID 54 5% BID Otezla (apremilast) Tablets 30 mg3 562 22% 282 4% 272 20% 137 4% Taclonex (calcipotriene / betamethasone) Ointment4 Calc Arm 480 17% 157 8% Vectical ointment (ca
Slide 26: SNA-120 Statistically Significant on Both IGA Composite and PASI 75
SNA-120 (0.05%) Statistically Significant on Both IGA 2-Grade Composite and PASI 751,2 Treatment Group Week 8 Week 12 PASI 50 SNA-120 (0.05%) Proportion of subjects P value vs vehicle 30 (49.2%) p=0.130 32 (54.2%) p=0.057 SNA-120 (0.5%) Proportion of subjects P value vs vehicle 20 (31.7%) p=0.636 25
Slide 27: Efficacy Improved Throughout Trial on PASI 75
Week Vehicle PASI 75 Responder Rate, % (SEM) End of Treatment SNA-120 (0.05%) Efficacy Improved Throughout Trial on PASI 75, Similar to IGA 2-Grade Composite 0.05% SNA-120 p < 0.05 * 0.5% SNA-120 Data on file, Sienna Biopharmaceuticals, Inc.: Study SNA-120-201.
Slide 28: SNA-120 Reduced Disease Severity on PASI 50
Week Vehicle PASI 50 Responder Rate, % (SEM) End of Treatment SNA-120 (0.05%) Reduced Psoriasis Disease Severity on PASI 501 and Efficacy Improved Throughout Trial2 0.05% SNA-120 p = 0.057 PASI 50 = proportion of subjects achieving 50% reduction in Psoriasis Area and Severity Index score from baseli
Slide 29: Subject 02012 in SNA-120-201
SNA-120 (0.05%) Subject 02012 in SNA-120-201 Visible clearing of target lesion Non-responder on IGA 2-grade composite and PASI 75 Baseline IGA (2 or 3) 3 PASI (mean) 4.9 I-NRS (mean) 7 Responder Analyses IGA 2-grade Composite No PASI 50 Yes PASI 75 No Week 12 IGA 2 PASI (mean) 2.4 I-NRS (mean) 1.4 D
Slide 30: Consistent Psoriasis Results (PASI 50) in Both Studies
Week Vehicle Week 0.05% SNA-120 Vehicle Consistent Psoriasis Results (PASI 50) in Both CT327-2003 and SNA-120-201 for 0.05% Dose1 PASI 50 Responder Rate, % (SEM) Second Study: Itchy Subjects First Study: Itchy Subjects2 0.05% SNA-120 p > 0.05 Data on file, Sienna Biopharmaceuticals, Inc. Impact on p
Slide 31: Consistent Psoriasis Results (Mean PASI) in Both Studies
Week Vehicle Week Vehicle Consistent Psoriasis Results (Mean PASI) in Both CT327-2003 and SNA-120-201 for 0.05% Dose1 Mean PASI Reduction, % (SEM) Second Study: Itchy Subjects First Study: Itchy Subjects2 0.05% SNA-120 p = 0.001 * 0.05% SNA-120 p = 0.016 * Data on file, Sienna Biopharmaceuticals, In
Slide 32: Consistent Pruritus Results (I-VAS) in Both Studies
Week Vehicle Week Vehicle Consistent Pruritus Results (I-VAS) in Both CT327-2003 and SNA-120-201 for 0.05% Dose, Yet Different Vehicle Response1 I-VAS Change (SEM) Second Study: Itchy Subjects First Study: Itchy Subjects2 0.05% SNA-120 p < 0.05 * 0.05% SNA-120 p > 0.05 Data on file, Sienna Biopharma
Slide 33: Consistent Pruritus Results (I-VAS %) in Both Studies
Week Vehicle Week Vehicle Consistent Pruritus Results (I-VAS) in Both CT327-2003 and SNA-120-201 for 0.05% Dose, Yet Different Vehicle Response1 I-VAS Change, % (SEM) Second Study: Itchy Subjects First Study: Itchy Subjects2 0.05% SNA-120 p < 0.05 * 0.05% SNA-120 p > 0.05 Data on file, Sienna Biopha
Slide 34: SNA-120 Reduced Pruritus Severity on I-NRS
Week Vehicle I-NRS Change (SEM) End of Treatment SNA-120 (0.05%) Reduced Pruritus Severity on I-NRS ~60% from Baseline 0.05% SNA-120 0.5% SNA-120 Data on file, Sienna Biopharmaceuticals, Inc.: Study SNA-120-201.
Slide 35: Expectation Setting on Topical Pruritus Treatment Influences Placebo Effect
Modified from Smits et al. Exp Rev Clin Immunol 2018;14:761-70 (Fig. 1). Peerdeman et al. Eur J Pain 2018;22:774-83 (Fig. 1). Expectation Setting on Topical Pruritus Treatment is Known to Influence Placebo Effect Expectations Conditioning Psychological processes Biological mechanisms Itch is particu
Slide 36: SNA-120 Improved Psoriasis and Pruritus
Clinically and statistically significant psoriasis results in SNA-120-2011 Even better than CT327-20031, as expected with refined patient population On stringent FDA psoriasis primary endpoint for topicals (IGA 2-Grade Composite) Also on stringent PASI 75 = confidence in robustness of results Prurit
Slide 37: SNA-120 Was Well-Tolerated with No Serious Treatment-Related AEs
Treatment-related AEs were observed in only 2 subjects and included dermatitis (0.5% group) and pain and pruritus (Vehicle group) Most common AEs (≥ 2 subjects) in any group were nasopharyngitis, nausea, diarrhea, cellulitis and urinary tract infection Majority of treatment-emergent AEs were mild to
Slide 38: Better Efficacy with Low Dose (0.05%) Was Expected
Increasing dose results in broader, less targeted kinase inhibition Consistent better performance of low vs. high dose in both CT327-2003 and SNA-120-201 Similar effect observed in SNA-125 preclinical and Phase 1 studies Kinase inhibitors can have bell-shaped dose-response curves e.g., tofacitinib1,
Slide 39: More Is Not Always Better with Kinase Inhibitors: tofacitinib, ASN002
More Is Not Always Better with Kinase Inhibitors Pfizer’s tofacitinib (JAK) Bell-shaped dose-response curve in dose-ranging Phase 2 study in UC1 Similarly seen in RA2 and preclinical models for IBD3 Asana’s ASN002 (JAK/SYK4) Bell-shaped dose-response curve in Phase 1b study in AD5 Modified from Mukh
Slide 40: More Is Not Always Better with Kinase Inhibitors: upadacitinib
More Is Not Always Better with Kinase Inhibitors AbbVie’s upadacitinib (JAK) Bell-shaped dose-response curves in two Phase 2b studies in RA (left) In patients with RA and inadequate response to methotrexate1 (right) in patients with RA and inadequate response to anti-tumor necrosis factor therapy2 M
Slide 41: SNA-125: First-in-Class Topical JAK3/TrkA Inhibitor
SNA-125: A First-in-Class Topical JAK3/TrkA Inhibitor for Atopic Dermatitis, Psoriasis and Pruritus in Phase 2 Pfizer Labs. Xeljanz (tofacitinib) tablets. Full Prescribing Information. November 2012. Papp et al. BMC Dermatology 2016 April;16:15. Inhibitory Action of SNA-125 on JAK3 Pathway SNA-125 i
Slide 42: Atopic Dermatitis: Large Unmet Need for Safe Topical Non-steroidal Drug
One of the most common skin diseases: 2-3% of adults, up to 25% of children1 In 2017, the prevalence of Atopic Dermatitis in the United States was estimated at 28 million2 85% of Atopic Dermatitis patients in the United States have mild-to-moderate disease3 Large unmet need across the Atopic Dermati
Slide 43: Topical by Design Platform Represents Significant Upside
Opportunity for selective development of our current product candidates SNA-120 and SNA-125 in additional indications We have developed additional NCEs from our Topical by Design platform which have shown favorable data in early nonclinical studies We believe the Topical by Design technology may als
Slide 44: Topical Photoparticle Therapy Platform (SNA-001)
Topical Photoparticle TherapyTM Platform (SNA-001)
Slide 45: SNA-001: Topical Photoparticle Therapy for Unwanted Light-Pigmented Hair
Topical Photoparticle Therapy uses precisely engineered silver particles to facilitate local tissue injury (hair follicle) through a process called selective photothermolysis Ready-to-use topical suspension Particles are designed to work with current installed base of lasers in practices Multiple ad
Slide 46: SNA-001: Opportunity to Expand the Market for Laser Hair Removal
SNA-001: Opportunity to Expand the Market for Laser Hair Removal First effective hair removal solution for light-pigmented hair 1 2 Safe, similar to conventional laser hair removal treatment 3 Works with existing installed base of lasers and all skin and hair types PRODUCT VISION 4 Aligned with phys
Slide 47: SNA-001: Designed to Overcome Current Limitations
Laser hair removal is the highest volume aesthetic procedure performed globally1 Nevertheless, laser hair removal is largely ineffective for patients with light-pigmented hair (i.e., white, gray, blond, light brown and light red)2 As a result, patients are often turned away by healthcare practitione
Slide 48: SNA-001: Precisely Engineered Silver Particles Target Hair Follicles
SNA-001: Precisely Engineered Silver Particles Target Hair Follicles to Reduce Light-Pigmented Hair Thermally injures hair follicle for permanent reduction of unwanted, light-pigmented hair Number and timing of treatment sessions are same as current laser hair removal treatment Six in-office treatme
Slide 49: SNA-001: Feasibility Study Showed Reduction of Light-Pigmented Hair
SNA-001: Feasibility Study Showed Reduction of Light-Pigmented Hair Data on file, Sienna Biopharmaceuticals, Inc.: Interim analysis results. *SNA-001, baseline to 12 wks post Tx **SNA-001 - Vehicle at 12 wks post Tx Evaluator blinded, controlled study (N = 10) Randomized, in-subject design (L vs. R
Slide 50: SNA-001: Pivotal Studies Ongoing
SNA-001: Pivotal Studies Ongoing for Light-Pigmented Hair Reduction Evaluate safety and efficacy of SNA-001 to enhance the therapeutic results of laser hair reduction1 of light hair Primary Objectives Patients Trial Design Endpoints Timing1 Percentage change in hair count from baseline to month 3 an
Slide 51: SNA-001: Large U.S. Market Opportunity in Hair Removal
SNA-001: Large U.S. Market Opportunity in Hair Removal 3.3 million1 potential treatments 27% expansion of treatment volume from new patients 3.3 million1 potential treatments 28% of current treatments result in suboptimal outcomes Large portion of treatments performed by HCP/Laser Centers. Kalorama.
Slide 52: Patent Coverage & Regulatory Exclusivity
Patent Coverage & Regulatory Exclusivity Product Patent Term Patent Term Extension1 NCE-based Exclusivity2 International Patents Topical By DesignTM SNA-120 Compound US: 2032 EU: 2029 Yes US: 2037 EU: 2034 US: 5 years EU: 10 years Issued: Europe (38 countries), Australia, Canada, China, Hong Kong, I
Slide 53: Company Overview January 2019
Company Overview January 2019
Sienna Biopharmaceuticals — Investor Presentation (January 2019) on 6ix