Vera Therapeutics, Inc. · NASDAQ:VERA
Vera Therapeutics — Investor Day (October 2024)
41 slides from Vera Therapeutics's investor day presentation, Oct 2, 2024
Slide 1: R&D Day October 2, 2024
Exhibit 99.2 R&D Day October 2, 2024 © 2024 VERA THERAPEUTICS, INC.
Slide 2: Forward-looking statements
Forward-looking statements Disclaimer This material has been made available to you with the consent of Vera Therapeutics, Inc. ( we , us , our , or the Company ). Statements in this presentation that are not statements of historical fact are forward-looking statements within the meaning of the Priva
Slide 3: Agenda
Agenda Marshall Fordyce, MD Opening Remarks Founder and CEO, Vera Therapeutics Robert Brenner, MD Vera Expansion Strategy Chief Medical Officer, Vera Therapeutics Q&A Panel Jonathan Barratt, MD, PhD, FRCP Mayer Professor of Renal Medicine, University of Leicester Richard Lafayette, MD, FACP Professo
Slide 4: Atacicept potentially best and first-in-class dual BAFF/APRIL B cell modulator in IgAN
Atacicept potentially best and first-in-class dual BAFF/APRIL B cell modulator in IgAN, with pipeline-in-a-product opportunity IgAN Potential Best-in-Class Indication Expansion Resourced for Potential Launch • eGFR normalization may suggest • B cell modulation represents a • Regulatory exclusivity e
Slide 5: Cumulative Atacicept data offers best-in-class potential
Cumulative Atacicept data offers best-in-class potential 1 2 3 Atacicept Sibeprenlimab Povetacicept Zigakibart Mechanism BAFF/APRIL inhibition APRIL inhibition only BAFF/APRIL inhibition APRIL inhibition only 25/75/150 mg SC QW (Ph2) 2/4/8 mg/kg IV (Ph2) 450 mg IV Q2W (Ph2) Dosing & 80/240 mg SC QM
Slide 6: Vera optionality to expand in autoimmune kidney disease & beyond
Vera optionality to expand in autoimmune kidney disease & beyond US prevalence estimates ~230K Potential Future Indications 1-10 + ~70K Hematology ITP, AIHA, CAD, APS 1 ~160K Rheumatology Non-IgAN SLE, Sjogren’s, Long COVID autoimmune Neurology kidney disease MG pMN, FSGS, MCD and Metabolism Expande
Slide 7: Vera financial position is strong
Vera financial position is strong ~$384M ~54.8M Cash, cash equivalents, Shares outstanding (as of 8.5.24) and marketable securities (as of 6.30.24) 7 © 2024 VERA THERAPEUTICS, INC.
Slide 8: Atacicept: previously shared projected catalysts
Atacicept: previously shared projected catalysts Catalyst 2024 2025 2026 Phase 3 primary endpoint cohort full enrollment 3Q Phase 2b 96-week results 4Q Phase 3 top-line results 2Q (IgAN) BLA submission 2H Projected US launch Vera holds worldwide, exclusive rights to develop and commercialize atacice
Slide 9: Atacicept: additional projected catalysts
Atacicept: additional projected catalysts Catalyst 2024 2025 2026 Phase 3 primary endpoint cohort full enrollment 3Q Phase 2b 96-week results 4Q Phase 3 top-line results 2Q (IgAN) BLA submission 2H Projected US launch Initiation New clinical trial Initial data available Initiation New clinical trial
Slide 10: Agenda
Agenda Marshall Fordyce, MD Opening Remarks Founder and CEO, Vera Therapeutics Robert Brenner, MD Vera Expansion Strategy Chief Medical Officer, Vera Therapeutics Q&A Panel Jonathan Barratt, MD, PhD, FRCP Mayer Professor of Renal Medicine, University of Leicester Richard Lafayette, MD, FACP Professo
Slide 11: Atacicept has broad therapeutic potential in autoimmune disease
Atacicept has broad therapeutic potential in autoimmune disease Immunity in health BAFF Antibodies bind to foreign antigens B cell APRIL Autoimmune disease Autoantigens and autoantibodies mediate autoimmune disease BAFF Autoantibodies bind to autoantigens B cells are the source of autoantibodies → B
Slide 12: Lead indication: IgAN is a disease of B cell origin with kidney pathology
Lead indication: IgAN is a disease of B cell origin with kidney pathology B Cell Activation Formation of Circulating Immune Complexes Immune Complex Deposition Leading to Glomerulonephritis and Kidney Damage Autoantigen (Gd-IgA1) BAFF B cell Glomerulus APRIL Autoantibody (anti-Gd-IgA1) 1 2 3 4 6 BAF
Slide 13: Atacicept is an example of rational drug design
Atacicept is an example of rational drug design Native TACI-Fc fusion: Soluble protein binds both BAFF and APRIL with nanomolar potency Atacicept BAFF APRIL BAFF APRIL 1 t =35 days 1/2 Kd Kd 2 2 1.45 nM 0.672 nM TACI TACI receptor receptor B cell B cell Fc domain of IgG1 Fc = fragment crystallizable
Slide 14: An ideal IgAN disease modifying therapy would be expected to…
An ideal IgAN disease modifying therapy would be expected to… Reduce Reduce Reduce Convert eGFR profile to Gd-IgA1 hematuria proteinuria general population 14 © 2024 VERA THERAPEUTICS, INC.
Slide 15: ORIGIN Phase 2b 72-week results consistent with IgAN disease modification
ORIGIN Phase 2b 72-week results consistent with IgAN FDA Breakthrough disease modification Therapy Designation Including eGFR Profile consistent with the general population of -1 mL/min/year Reduction in Reduction in Reduction in eGFR profile consistent Gd-IgA1 hematuria proteinuria with general pop
Slide 16: Atacicept eGFR slope profile consistent with general population
Atacicept treated participants have an eGFR slope profile consistent with general population without kidney disease 4 All atacicept → 150 mg 0 Slope General population 1 ~ -1 estimate -4 1 mL/min/y IgAN natural history including supportive -8 2 CKD therapy Slope ~ -6 2 mL/min/y -12 0 4 12 24 36 48 6
Slide 17: 2024 Draft KDIGO IgAN guidelines call for target eGFR slope ≤ -1 mL/min/year
2024 Draft KDIGO IgAN guidelines call for target eGFR slope ≤ -1 mL/min/year 1 % patients who will reach kidney failure 0 25 50 75 100 -0.1 0 0 2 2 1 1 -0.5 25 17 19 15 6 8 -1 56 40 38 40 23 16 -2 100 89 80 78 60 26 2 Filspari ~ -3 -3 100 100 100 91 85 46 3 4 SGLT2i , Tarpeyo ~ -4 -5 100 100 100 100
Slide 18: 5-year mean mortality in ESKD comparable to cancer in US
5-year mean mortality in ESKD comparable to cancer in US 80 72 60 59 40 36 20 9 0 Lung Cancer ESKD Colorectal Cancer Breast Cancer ESKD = end-stage kidney disease. 1. US CDC Cancer Statistics; 2. Thurlow JS, et al. Am J Nephrol 2021. 18 © 2024 VERA THERAPEUTICS, INC. 1,2 5-Year % Mortality in US
Slide 19: ORIGIN Phase 2b long-term data at ASN Kidney Week
ORIGIN Phase 2b long-term data will be revealed in late breaking oral presentation during ASN Kidney Week Double-Blind Treatment Open-label Extension Placebo n=30 Atacicept 25 mg QW n=15 Atacicept 150 mg QW Atacicept 75 mg QW n=30 Atacicept 150 mg QW n=30 Week 0 24 36 72 96 1° Endpoint 2° Endpoint I
Slide 20: Consistency with ORIGIN 2b instills great confidence in ORIGIN 3
Consistency with ORIGIN 2b instills great confidence in ORIGIN 3 Double-Blind Treatment Open-label Extension Placebo Atacicept 150 mg QW Atacicept 150 mg QW 156 Week 0 36 104 Fully enrolled 2° Endpoint 1° Endpoint for 1° endpoint eGFR: n=376 UPCR: n=200 September 12, 2024 2Q 2025 Inclusion Criteria
Slide 21: Atacicept expansion roadmap
Atacicept expansion roadmap US prevalence estimates 1 ~160K and Expanded IgAN Atacicept 1. Vera Therapeutics corporate estimates for peak year prevalence based on ClearView Healthcare Partners Analysis. 21 © 2024 VERA THERAPEUTICS, INC.
Slide 22: ORIGIN Extend: long-term access to atacicept for all ORIGIN participants
ORIGIN Extend: Commitment to providing long-term access to atacicept for all ORIGIN participants Off treatment ORIGIN 2b Group 1 Atacicept 150 mg QW ORIGIN 3 Group 2 Week 0 156/Beyond • Phase 2 extension study in participants who complete ORIGIN 2b/3; initiating Q4 2024 • Objectives: 1. Provide pati
Slide 23: Atacicept at home, self-administered QW dosing highly attractive
Atacicept at home, self-administered QW dosing highly attractive; QM program begins in 2025 • Biologic therapies utilizing at home, self-administered, vs SC 1 mL QW dosing widely used and accepted t 1/2• This dosing paradigm has the potential to support atacicept as 1 35 days a foundational therapy
Slide 24: PIONEER: Phase 2 basket study in expanded IgAN cohorts
PIONEER: Phase 2 basket study in expanded IgAN cohorts Patients ineligible for ORIGIN 3 will have an opportunity to enroll in PIONEER at same clinical sites Expanded IgAN populations, n ≤120 Atacicept 150 mg qwk 1 1 Adult IgAN with low kidney function , n ≤20 2 2 Adult IgAN with low proteinuria , n
Slide 25: Atacicept expansion roadmap
Atacicept expansion roadmap US prevalence estimates ~230K 1-10 + ~70K 1 ~160K Non-IgAN autoimmune kidney disease pMN, FSGS, MCD and Expanded IgAN Atacicept Vera Therapeutics corporate estimates for peak year prevalence based on 1. ClearView Healthcare Partners Analysis; 2. US Census 2023; 3. McGroga
Slide 26: Autoimmune glomerular disease: podocyte injury drives proteinuria
Autoimmune glomerular disease: podocyte injury and cytoskeletal derangement drives proteinuria and progressive disease Healthy Podocyte Foot Processes Disrupted Podocyte Foot Processes Podocyte foot process Urinary Foot process effacement space Podocyte Protein Endothelial cell GBM Glomerulus Vascul
Slide 27: Atacicept mechanism of action in membranous nephropathy
Atacicept mechanism of action has broad potential in autoimmune glomerular disease including membranous nephropathy B Cell Activation Autoantibody Production Autoantibodies Bind to Glomerular Antigens, Driving Kidney Injury BAFF Anti-PLA2R antibodies PLA2R Cytoskeletal B dysregulation cell APRIL Pod
Slide 28: Atacicept expansion roadmap
Atacicept expansion roadmap US prevalence estimates ~195K 1-5 + ~35K 1 ~160K Anti-PLA2R podocytopathy pMN and Expanded IgAN Atacicept Vera Therapeutics corporate estimates for peak year prevalence based on 1. ClearView Healthcare Partners Analysis; 2. US Census 2023; 3. McGrogan A. Nephrol Dial Tran
Slide 29: PIONEER: basket study in expanded IgAN and anti-PLA2R podocytopathy
PIONEER: Operationally efficient Phase 2 basket study in expanded IgAN and anti-PLA2R podocytopathy (PMN) Atacicept 150 mg qwk Population 1, n ≤120 Expanded IgAN populations Week 0 36 52 1° Endpoint 2° Endpoint Endpoints Population 2, n ≤20 • Primary: UPCR change at week 36 Anti-PLA2R podocytopathy
Slide 30: Atacicept expansion roadmap
Atacicept expansion roadmap US prevalence estimates ~230K 2,3,6-10 + ~35K ~195K 1-5 + ~35K 1 ~160K Anti-nephrin podocytopathy Anti-PLA2R FSGS, MCD podocytopathy and pMN Expanded IgAN Atacicept Vera Therapeutics corporate estimates for peak year prevalence based on 1. ClearView Healthcare Partners An
Slide 31: FSGS and MCD: anti-nephrin antibodies as one driver of disease
FSGS and MCD are histologic diagnoses with heterogeneous etiology; Autoimmunity, including anti-nephrin antibodies, is one driver of disease B Cell Activation Autoantibody Autoantibodies Bind to Glomerular Antigens, Production Leading to Kidney Injury FSGS MCD BAFF Fused foot processes Anti-nephrin
Slide 32: PIONEER: basket study in IgAN, anti-PLA2R & anti-nephrin podocytopathies
PIONEER: Operationally efficient Phase 2 basket study in expanded IgAN and anti-PLA2R & anti-nephrin podocytopathies Atacicept 150 mg qwk Population 1, n ≤120 Expanded IgAN populations Week 0 36 52 1° Endpoint 2° Endpoint Endpoints Population 2, n ≤20 • Primary: UPCR change at week 36 Anti-PLA2R pod
Slide 33: Targeting B cell autoantibodies offers additional kidney indications
Targeting B cell production of autoantibodies against glomerular antigens offers the promise of additional kidney indications B Cell Activation Autoantibody Production Immune Complex Deposition Leading to Glomerulonephritis and Kidney Damage BAFF Anti-Gd-IgA1 antibodies IgAN B cell Anti-PLA2R antibo
Slide 34: Vision for an evolved approach to autoimmune glomerular disease
Vision for an evolved approach to autoimmune glomerular disease Identification of autoantigen/autoantibody constructs that drive autoimmune glomerular diseases Gd-IgA1 & PLA2R & Nephrin & Future anti-Gd-IgA1 anti-PLA2R anti-nephrin autoantigen/autoantibody constructs identified 1 2 3 1999 2009 2022
Slide 35: Vera optionality to expand in autoimmune kidney disease & beyond
Vera optionality to expand in autoimmune kidney disease & beyond US prevalence estimates ~230K Potential Future Indications 1-10 + ~70K Hematology ITP, AIHA, CAD, APS 1 ~160K Rheumatology Non-IgAN SLE, Sjogren’s, Long COVID autoimmune Neurology kidney disease MG pMN, FSGS, MCD and Metabolism Expande
Slide 36: Atacicept projected catalysts
Atacicept projected catalysts Catalyst 2024 2025 2026 Phase 3 primary endpoint cohort full enrollment 3Q Phase 2b 96-week results 4Q Phase 3 top-line results 2Q (IgAN) BLA submission 2H Projected US launch Initiation (IgAN) Initial data available Initiation (IgAN, PMN, Initial data available FSGS, M
Slide 37: Agenda
Agenda Marshall Fordyce, MD Opening Remarks Founder and CEO, Vera Therapeutics Robert Brenner, MD Vera Expansion Strategy Chief Medical Officer, Vera Therapeutics Q&A Panel Jonathan Barratt, MD, PhD, FRCP Mayer Professor of Renal Medicine, University of Leicester Richard Lafayette, MD, FACP Professo
Slide 38: Q&A Panel
Q&A Panel Jonathan Barratt Richard Lafayette Brad Rovin MD, PhD, FRCP MD, FACP MD, FACP, FASN Dr. Barratt leads the Renal Research Group within the Dr. Lafayette is a Professor of Medicine (Nephrology) and Dr. Brad H. Rovin is the Lee A. Hebert Professor of Nephrology. Dr. Rovin College of Life Scie
Slide 39: Agenda
Agenda Marshall Fordyce, MD Opening Remarks Founder and CEO, Vera Therapeutics Robert Brenner, MD Vera Expansion Strategy Chief Medical Officer, Vera Therapeutics Q&A Panel Jonathan Barratt, MD, PhD, FRCP Mayer Professor of Renal Medicine, University of Leicester Richard Lafayette, MD, FACP Professo
Slide 40: Atacicept projected catalysts
Atacicept projected catalysts Catalyst 2024 2025 2026 Phase 3 primary endpoint cohort full enrollment 3Q Phase 2b 96-week results 4Q Phase 3 top-line results 2Q (IgAN) BLA submission 2H Projected US launch Initiation (IgAN) Initial data available Initiation (IgAN, PMN, Initial data available FSGS, M
Slide 41: © 2024 VERA THERAPEUTICS, INC.
© 2024 VERA THERAPEUTICS, INC.