Chemocentryx Inc. · NASDAQ:CCXI
Chemocentryx — Investor Presentation (January 2020)
38 slides from Chemocentryx's investor presentation, Jan 16, 2020
Slide 1: New Ideas. Better Medicines. Presentation to Investors January 2020
Exhibit 99.1 New Ideas. Better Medicines. Presentation to Investors January 2020Exhibit 99.1 New Ideas. Better Medicines. Presentation to Investors January 2020
Slide 2: Forward-Looking Statements
Forward‐Looking Statements This presentation contains forward‐looking statements that involve substantial risks and uncertainties. In some cases, you can identify forward‐looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “
Slide 3: ChemoCentryx (CCXI): Inhibiting Disease-Driving Chemoattraction
ChemoCentryx (CCXI): Inhibiting Disease‐Driving Chemoattraction § Chemoattractant receptors (chemokine receptors and complement receptors) attract and Chemoattractant Extracellular activate destructive inflammatory (e.g. C5a, chemokine MCP‐1) cells in disease § CCXI platform: inhibition a given chem
Slide 4: CCXI Value Creation: From Basic Science to Commercialization
CCXI Value Creation: From Basic Science to Commercialization Advanced Establishing Precision Broad Pipeline of Programs Strong Global Approach Unique, Orally‐ Leads to Better Focused on Commercial Administered, Small Orphan Diseases Capabilities Medicines Molecule Therapeutics CCXI owns commercial T
Slide 5: ADVOCATE Phase III Data for ANCA Vasculitis: A Defining Moment for CCXI in 2019
ADVOCATE Phase III Data for ANCA Vasculitis: A Defining Moment for CCXI in 2019 § Data demonstrate avacopan’s superiority to standard of care in treating patients with ANCA vasculitis o NDA / EMA submissions planned for 2020 § Avacopan is the first chemoattractant inhibitor for autoimmune and inflam
Slide 6: CCXI Broad Pipeline from Novel Discovery Platform
CCXI Broad Pipeline from Novel Discovery Platform DRUG/ THERAPEUTIC AREA TARGET INDICATION PRECLINICAL PHASE I PHASE II PHASE III NDA ANCA‐ASSOCIATED VASCULITIS Avacopan Complement (formerly Inhibition in C3 GLOMERULOPATHY CCX168) / Orphan Diseases C5aR HIDRADENITIS SUPPURATIVA ORPHAN KIDNEY DISEASE
Slide 7: Beyond ADVOCATE - 2020 4-Sight: Four Data Readouts Anticipated in 2020
Beyond ADVOCATE ‐ “2020 4‐Sight”: Four Data Readouts Anticipated in 2020 1 1 1 1 1 2 3 4 FSGS FSGS Hidradenitis C3G Suppurativa No Approved No Approved No Approved Treatment Treatment Approved Treatment Options Treatment Has Options Options Large Controlled Limited Efficacy CCX140 LUMINA‐2 ‘Phase II
Slide 8: Avacopan (CCX168): A Unique Orally Administered Inhibitor of C5aR
Avacopan (CCX168) A Unique Orally Administered Inhibitor of the Complement 5a Receptor (C5aR) 8Avacopan (CCX168) A Unique Orally Administered Inhibitor of the Complement 5a Receptor (C5aR) 8
Slide 9: Avacopan: Unique Orally Administered C5aR Inhibitor
Avacopan: Unique Orally Administered C5aR Inhibitor We believe avacopan avoids long‐term biological 1 consequences of ‘upstream’ complement inhibition 1 Avacopan does not block C5b‐9 production; leaving host defense 2 C5a Antibodies mechanism (MAC) in place Avacopan preserves beneficial Avacopan 3 f
Slide 10: Avacopan Targets Only C5aR; Why Preserving C5L2 is Important
Avacopan Targets Only C5aR (C5aR1 / CD88); Why Preserving C5L2 (C5aR2) is Important • An Anti‐inflammatory Function for the Complement Anaphylatoxin C5a‐binding Protein, C5L2. Gerard et al, J. Biol Chem, 2005 • Disruption of the Complement Anaphylatoxin Receptor C5L2 Exacerbates Inflammation in Alle
Slide 11: ANCA Vasculitis: A Complement C5a Activated Neutrophil-Driven Disease
Anti‐Neutrophil Cytoplasmic Auto‐antibody (ANCA) Vasculitis: A Complement C5a Activated Neutrophil‐Driven Disease Overview • Highly inflammatory and progressive autoimmune disease caused by the over‐activation of the complement system; generation of C5a • Kidney is a major target organ • Characteriz
Slide 12: ANCA Vasculitis: A Complement C5a Activated Neutrophil-Driven Disease
Anti‐Neutrophil Cytoplasmic Auto‐antibody (ANCA) Vasculitis: A Complement C5a Activated Neutrophil‐Driven Disease Overview • Highly inflammatory and progressive autoimmune disease caused by the over‐activation of the complement system; generation of C5a • Kidney is a major target organ • Characteriz
Slide 13: The Time for an ANCA Vasculitis Treatment Paradigm Shift Has Arrived
The Time for an ANCA Vasculitis Treatment Paradigm Shift Has Arrived Major Unmet Needs – Current ANCA Vasculitis Chronic High‐Dose Steroid SOC Traditional Therapy is: Not Safe With Current SOC: • Prevent glucocorticoid‐related Steroids for 6 Months § 11‐16% die within 1st year of diagnosis* toxicity
Slide 14: Avacopan's Value Proposition: A Superior Profile in Treating ANCA Vasculitis
Avacopan’s Value Proposition: A Superior Profile in Treating ANCA Vasculitis Stop active Eliminate current Stop accumulated Improve patient vasculitis therapy‐ induced organ damage quality of life illness (as soon as possible) Reduction in vasculitis From chronic steroids, From both vasculitis and V
Slide 15: Avacopan ADVOCATE Pivotal Phase III Trial Design
Avacopan ADVOCATE Pivotal Phase III Trial Design BVAS Remission* BVAS Remission* Two primary endpoints: 1 2 at 26 Weeks at 52 Weeks (both analyzed after 52 weeks) Avacopan, 30 mg twice daily Dummy prednisone taper Test Group over 21 weeks (N=165) RTX, 4 weeks or CYC, 12 weeks followed by AZA Screeni
Slide 16: Primary and Key Secondary Endpoints and Statistical Design of ADVOCATE Trial
Primary and Key Secondary Endpoints and Statistical Design of ADVOCATE Trial Two Primary Endpoints (not Co‐Primaries) Secondary Endpoints ‐‐ Evaluated at Weeks 26 and 52 ‐‐ ‐‐Reduce the Total Burden of Disease ‐‐ Remission = BVAS score of zero and off steroids 4 weeks prior • Change in health‐relate
Slide 17: ADVOCATE Demonstrates Avacopan's Superiority Over Standard of Care
ADVOCATE Demonstrates Avacopan’s Superiority Over Standard of Care Primary Endpoints: Can avacopan therapy fulfill the pre‐specified statistical null hypothesis for the primary BVAS endpoints of vasculitis Stop Stop active active vasculitis vasculitis remission at week 26 and sustained remission at
Slide 18: Avacopan Superior in Reducing Steroid-Related Toxicities
Avacopan Superior in Reducing Steroid‐Related Toxicities Glucocorticoid Related Toxicity GlucocorticoidToxicity Avacopan Control P Value Stop Stop active active vasculitis vasculitis Index (GTI) v2 (SOC) ✔ GTI Cumulative Worsening 39.7 56.6 p=0.0002 Score Eliminate Eliminate current current therapy
Slide 19: Avacopan Demonstrates Significant Improvement in Renal Function
Avacopan Demonstrates Significant Improvement in Renal Function Stop Stop active active vasculitis vasculitis Estimated Glomerular Filtration Rate (eGFR) ✔ Mean Change Expressed Avacopan Control P Value 2 in ml/min/1.73m (SOC) Eliminate Eliminate current current therapy therapy‐ ‐ Baseline change to
Slide 20: Avacopan: Marked Improvements in Kidney Function
Avacopan: Marked Improvements in Kidney Function Change from Baseline in eGFR in Patients with Renal Change from Baseline in eGFR in Patients with eGFR Disease at Baseline (Pre‐specified) <30 at Baseline (Pre‐specified) Baseline eGFR ~21 in (Baseline eGFR ~45) in 20Avacopan: Marked Improvements in K
Slide 21: Improving Kidney Function with Avacopan: Underserved Complement-driven Kidney Disease
Improving Kidney Function with Avacopan: Examples of Underserved Complement‐driven Kidney Disease Other Renal / Complement Lupus Nephritis Polycystic Kidney Disease Disorders • Uncontrolled complement system activation • PKD is a cystic renal disease characterized by • Several proteinuric disorders
Slide 22: ADVOCATE Demonstrates Improvements in Validated Health-Related Quality of Life Metrics
ADVOCATE Demonstrates Improvements in Validated Health‐Related Quality of Life Metrics § Avacopan group scored higher in all (10 of 10) measured domains and categories of the SF‐36 QOL instrument at both weeks 26 and 52 Stop Stop active active vasculitis vasculitis ✔ § Avacopan group statistically s
Slide 23: ADVOCATE Demonstrates Avacopan's Superiority Over Standard of Care
ADVOCATE Demonstrates Avacopan’s Superiority Over Standard of Care… Numerically superior, statistically significant non‐inferior at Stop Stop active active vasculitis vasculitis 26 weeks Result ✔ Statistically superior sustained remission at 52 weeks Statistically significant reduction in Glucocorti
Slide 24: ...and Provides Potential Path to Regulatory Approval
…and Provides Potential Path to Regulatory Approval § Statistical superiority over standard of care opens pathway to potential FDA and EMA regulatory approval § Data addressing total burden of disease further enhances value proposition o Improved renal function parameters (eGFR) o Reduced steroid‐in
Slide 25: Avacopan's Potential Multi-Billion Commercial Opportunity Starts with ANCA Vasculitis
̴ ̴ Avacopan’s Potential Multi‐Billion Commercial Opportunity Starts with ANCA Vasculitis ADVOCATE established 52 weeks as a reasonable minimum treatment Illustrative Example of Potential Annual Sales at Orphan Drug Pricing Prevalence of ANCA vasculitis 6,000 $200K/Pt/Year 5,000 40-75K 50-100K 4,000
Slide 26: Preparing for U.S. Commercialization
Preparing for U.S. Commercialization § Rheumatologists and nephrologists Market Penetration primarily manage ANCA vasculitis § Medical Science Liaisons (MSLs) to perform education and awareness role KOLs 30% of Market § Field Force of approximately 50‐75 to < 250 Top 80% of Market account for 80% of
Slide 27: Summary: Avacopan for ANCA Vasculitis
Summary: Avacopan for ANCA Vasculitis § ADVOCATE trial demonstrates avacopan’s superiority over standard of care: o Fulfills pre‐specified primary endpoint null hypothesis of statistical non‐inferiority of remission of acute vasculitis at week 26 vs. standard of care o Demonstrates 52 week sustained
Slide 28: Avacopan for C3 Glomerulopathy (C3G)
Avacopan for C3 Glomerulopathy (C3G) 28Avacopan for C3 Glomerulopathy (C3G) 28
Slide 29: Avacopan: Clinical Development in C3G
Avacopan: Clinical Development in C3G Study Design Overview • Randomized (1:1), double‐blind, placebo controlled clinical trial in patients with a confirmed diagnosis of C3G • Uncontrolled activation of complement system leading to • Two strata: C5b‐9 level >244 ng/mL and C5b‐9 level ≤244 ng/mL comp
Slide 30: Avacopan for Hidradenitis Suppurativa (HS)
Avacopan for Hidradenitis Suppurativa (HS) 30Avacopan for Hidradenitis Suppurativa (HS) 30
Slide 31: Abundant Data on Complement in Hidradenitis Suppurativa (HS)
Abundant Data on Complement in Hidradenitis Suppurativa (HS) 31Abundant Data on Complement in Hidradenitis Suppurativa (HS) 31
Slide 32: Avacopan for HS: AURORA Trial Data Read-out Expected in Q3 2020
Avacopan for HS: AURORA Trial Data Read‐out Expected in Q3 2020: >300 Patients Enrolled Study Design Overview • Double‐blind, placebo controlled Phase IIb trial • Chronic, disabling autoimmune skin disease featuring • ~390 moderate to severe HS patients randomized (1:1:1) across ~100 sites painful,
Slide 33: CCR2 Inhibitor CCX140: Targeted Approach to Chronic and Orphan Kidney Diseases
CCR2 Inhibitor CCX140 Targeted Approach to Chronic and Orphan Kidney Diseases CCX140 for Focal Segmental Glomerulosclerosis (FSGS) 33CCR2 Inhibitor CCX140 Targeted Approach to Chronic and Orphan Kidney Diseases CCX140 for Focal Segmental Glomerulosclerosis (FSGS) 33
Slide 34: CCR2 Inhibitor CCX140 in FSGS: LUMINA-1 Data Expected in Q2 2020
CCR2 Inhibitor CCX140 in FSGS: LUMINA‐1 Data Expected in Q2 2020 LUMINA‐2: Nephrotic Range Proteinuria Primary FSGS Overview • ≥3 gram/day baseline proteinuria • Orphan indication ‐ kidney’s filtering units (glomeruli) have scarring • First presentation or new flare following prior effective treatme
Slide 35: Avacopan and CCX140: Potential for Paradigm Shift in Orphan Inflammatory Diseases
Avacopan and CCX140 – Potential for Paradigm Shift in Orphan Inflammatory Diseases Avacopan (C5aR Inhibitor): • Success in pivotal Phase III ADVOCATE trial in ANCA lays foundation for potential approval • First chemoattractant inhibitor to achieve pivotal trial success in autoimmune / inflammatory d
Slide 36: History of Capital Efficiency and Current Strong Financial Position
History of Capital Efficiency and Current Strong Financial Position Financial Highlights End of Quarter Cash and Investments $205.8M cash and investments at September 30, 2019 Excludes $100M credit facility secured in 2020 History of non‐dilutive funding from successful partnering strategy / funding
Slide 37: What's Next? A Historic Year for CCXI: 2020 4-Sight
What’s Next? A Historic Year for CCXI ‘2020 4‐SIGHT’ Avacopan in ANCA Vasculitis 4 Topline Readouts Expected in 2020 1. LUMINA‐1 trial of CCX140 in Sub‐ • Full analysis of ADVOCATE data Nephrotic Primary Focal Segmental and publication Glomerulosclerosis (FSGS) in Q2 • Regulatory filings to FDA and
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