Kiniksa Pharmaceuticals International, Plc · NASDAQ:KNSA
Kiniksa Pharmaceuticals International — J.P. Morgan Healthcare Conference 2020
25 slides from Kiniksa Pharmaceuticals International's conference presentation, Jan 13, 2020
Slide 1: J.P. Morgan Healthcare Conference January 13, 2020
J.P. Morgan Healthcare Conference January 13, 2020 Every Second Counts!™
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation (together with any other statements or information that we may make in connection herewith) contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 with respect to Kiniksa Pharmaceuticals, Ltd. (and i
Slide 3: Building Value
Building Value Focused on unmet need in autoimmune and autoinflammatory diseases Product candidates based on validated mechanisms and/or strong biologic rationale Target underserved conditions and offer potential differentiation Allocate capital across portfolio relative to opportunity Second Counts
Slide 4: Pipeline: Multiple Clinical Stage Assets
Pipeline: Multiple Clinical Stage Assets 1) Rilonacept (ARCALYST®) is approved and marketed for cryopyrin-associated periodic syndrome, in the United States by Regeneron Pharmaceuticals, Inc. BLA transfers to Kiniksa after receipt of positive Phase 3 clinical data; 2) Chronic Idiopathic Pruritus, Ch
Slide 5: Clinical-Stage Assets Based on Validated Mechanisms and/or Strong Biologic Rationale
Clinical-Stage Assets Based on Validated Mechanisms and/or Strong Biologic Rationale recurrences while on treatment, and biopsies of giant cell arteritis patients vs. normal lesional biopsies of prurigo nodularis subjects vs. autoimmune diseases8 1) Dinarello CA, et al. Nat Rev Drug Discov 2012;11:6
Slide 6: Clinical-Stage Assets Target Underserved Diseases and Offer Potential Differentiation
Clinical-Stage Assets Target Underserved Diseases and Offer Potential Differentiation •Estimated U.S. prevalence ~40K patients seeking and receiving medical treatment1 • Potentially first FDA-approved therapy Recurrent Peri arditis •Rilonacept: IL-1α and IL-1β cytokine trap offers potential dosing,
Slide 7: Multiple Clinical Data Readouts Expected in 2020
Multiple Clinical Data Readouts Expected in 2020 Prurigo Nodularis (Top-line Phase 2 Data) KPL-716 – Phase 2 (monoclonal antibody inhibitor targeting OSMRβ) 1H 2020 KPL-716 – Phase 2 (monoclonal antibody inhibitor targeting OSMRβ) Diseases Characterized by Chronic Pruritus (Interim Phase 2 Data in L
Slide 8: Rilonacept – Phase 3
Rilonacept – Phase 3 Rilonacept Mavrilimumab KPL-716 KPL-404 developed by Regeneron and approved for CAPS4 Worldwide (excluding MENA); BLA transfers to Kiniksa after receipt of positive Phase 3 clinical data Rights 1) Brucato et al. JAMA. 2016, 316 (18): 1906-1912; Arcalyst Prescribing Information;
Slide 9: Recurrent Pericarditis Patients Currently Have Limited Treatment Options
Recurrent Pericarditis Patients Currently Have Limited Treatment Options Patients deemed recurrent if symptomatic after symptom-free period of 4-6 weeks; 20-30% recurrent NSAID +/-Colchicine 1st Line Steroid-Sparing Opportunity Recurrent Pericarditis Current Standard Clinical Practice Systemic Corti
Slide 10: Recurrent Pericarditis Episodes: Painful, Debilitating and Disruptive to Quality of Life
Recurrent Pericarditis Episodes: Painful, Debilitating Key areas of unmet need patients are seeking to address and Disruptive to Quality of Life Prevention of Future Episodes1 Steroid-Sparing Disease Control Resolution of Episodes Quality of Life 50% Annual Recurrence Rate Unable to Wean off Steroid
Slide 11: Clinical Development Plan for Rilonacept in Recurrent Pericarditis
Clinical Development Plan for Rilonacept in Recurrent Designed to generate data on clinically meaningful outcomes Pericarditis Phase 2 Phase 3 (RHAPSODY) Rilonacept in Recurrent Pericarditis is for Investigational Use Only; Kiniksa Clinical Protocols, Phase 2: KPL-914-C001, Phase 3: KPL-914-C002; NC
Slide 12: Final Phase 2 Rilonacept Data: Resolution of Pericarditis Episodes in Symptomatic Patients
Final Phase 2 Rilonacept Data: Resolution of Pericarditis Episodes in Symptomatic Patients Rapid and sustained reduction in reported pain and inflammation after first dose; persistent and clinically meaningful response throughout 6-month study Symptomatic Recurrent Pericarditis Patients with Elevate
Slide 13: Phase 2 Rilonacept Data: Discontinuation of Corticosteroids, Decrease in Episodes
Phase 2 Rilonacept Data: Discontinuation of Corticosteroids, Decrease in Incidence of Pericarditis Episodes While on Treatment and Improvement in Quality of Life Scores Discontinuation of Corticosteroids Without Pericarditis Recurrence Decrease in Annualized Incidence of Pericarditis Episodes While
Slide 14: Commercial Opportunity: U.S. Prevalence Estimated to be ~40K RP Patients
Commercial Opportunity: U.S. Prevalence Estimated to be ~40K RP Patients Addressable U.S. opportunity for rilonacept estimated to be ~14K patients Multiple Unmet Needs Rapid Resolution of Episodes Group Size1,2 Patient fails to respond, or is intolerant, to NSAIDs, colchicine, and steroids (~3K) Ref
Slide 15: Commercial Strategy
Commercial Strategy Focus on high-volume specialists Commercialization Plan Linked to Opportunity Recurrent Pericarditis Patient Volume by Account • Specialty cardiology sales force of ~30 reps to call on high volume specialists • Supported by current Kiniksa MSL team • Efficient digital marketing t
Slide 16: Mavrilimumab – Phase 2
Mavrilimumab – Phase 2 Rilonacept Mavrilimumab KPL-716 KPL-404 1) Sources: Wicks, Roberts, Nature Review Immunology, 2015; Hamilton, Expert Review of Clinical Immunology, 11:4, 457-465; 2) Lemaire et al. Journal of Leukocyte Biology, 1996; 60(4):509-18; 3) Wicks & Roberts. Nature Reviews. Rheumatolo
Slide 17: 2019 Preclinical Data Support the Mechanistic Rationale of Targeting GM-CSF in GCA
2019 Preclinical Data Support the Mechanistic Rationale of Targeting GM-CSF in GCA EULAR June 2019: GM-CSF and its receptor shown to be elevated in GCA biopsies compared to control1 ACR Nov 20 Mavrilimumab reduced arterial inflammation in an ino model of vasculitis compared to control2 1) Poster pre
Slide 18: Clinical Development Plan for Mavrilimumab
Clinical Development Plan for Mavrilimumab Phase 2 Relapsed/Refractory Large B-Cell Lymphoma Phase 2 Giant Cell Arteritis efficacy 18 | January 13, 2020 • Target enrollment achieved • 26-week, double-blind, randomized, placebo-controlled clinical trial of mavrilimumab with a corticosteroid taper in
Slide 19: KPL-716 – Phase 2
KPL-716 – Phase 2 Rilonacept Mavrilimumab KPL-716 KPL-404 by chronic pruritus 1) Trinity Qualitative Interviews; 2) Dillon SR, Sprecher C, Hammond A, Bilsborough J, Rosenfeld-Franklin M, Presnell SR, et al. Interleukin 31, a cytokine produced by activated T cells, induces dermatitis in mice. Nat Imm
Slide 20: Preclinical, Clinical and External Data Support Further Development of KPL-716
Preclinical, Clinical and External Data Support Further Phase 1b data showed rapid and sustained anti-pruritic effect Development of KPL-716 Repeated-Single-Dose Phase 1b2 Single-Dose Phase 1b1 -30.9% -55.0% *P-value <0.05 ** P-value<0.01 1) Oral presentation at the 27th European Academy of Dermatol
Slide 21: Clinical Development Plan for KPL-716
Clinical Development Plan for KPL-716 Phase 2 Prurigo Nodularis Phase 2 Multiple Chronic Pruritic Diseases plaque psoriasis 21 | January 13, 2020 • Enrolling 8-week, double-blind, randomized, placebo-controlled clinical trial of KPL-716 in subjects with prurigo nodularis • Primary efficacy endpoint
Slide 22: KPL-404 – Phase 1
KPL-404 – Phase 1 Rilonacept Mavrilimumab KPL-716 KPL-404 systemic lupus, rheumatoid arthritis, solid organ transplant and Graves’ disease1 1) National Center for Biotechnology Information - Targeting the CD40-CD154 Signaling Pathway for Treatment of Autoimmune Arthritis: https://www.ncbi.nlm.nih.go
Slide 23: Multiple Key Clinical Data Readouts Expected in 2020
Multiple Key Clinical Data Readouts Expected in 2020 Prurigo Nodularis (Top-line Phase 2 Data) KPL-716 – Phase 2 (monoclonal antibody inhibitor targeting OSMRβ) 1H 2020 KPL-716 – Phase 2 (monoclonal antibody inhibitor targeting OSMRβ) Diseases Characterized by Chronic Pruritus (Interim Phase 2 Data
Slide 24: Rare Diseases with Unmet Medical Need Potentially Attractive Commercial Opportunities
Rare Diseases with Unmet Medical Need Potentially Attractive Commercial Opportunities YE 2019 ~$233M Cash Balance Extends into 2H 20211 Multiple Clinical Data Readouts Expected in 2020 Autoimmune and Autoinflammatory Pipeline 1) Cash, Cash Equivalents and short-term investments as of 12/31/19 (unaud
Slide 25: Every Second Counts!™
Every Second Counts!™
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