Slide 1: Phase 2b Clinical Trial Data Update
© 2023 VERA THERAPEUTICS, INC. Phase 2b Clinical Trial Data Update January 30, 2023 Exhibit 99.1
Slide 2: Forward Looking Statements Disclaimer
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 contained in this presentation regarding matters, events or results that may occur in the future are “forward-looking state
Slide 3: Agenda for Today's Meeting
Agenda for Today’s Meeting Opening Remarks ORIGIN Phase 2b Results Takeaways and Phase 3 Plans Q&A Professor, University of Leicester Founder and CEO, Vera Therapeutics Founder and CEO, Vera Therapeutics CMO, Vera Therapeutics Professor, University of Leicester Founder and CEO, Vera Therapeutics Mar
Slide 4: Atacicept for IgA Nephropathy
Atacicept for IgA Nephropathy Self-administered subcutaneous biologic therapy in development for IgAN Targets the source of IgAN disease, Gd-IgA1 and its immune complexes, by inhibiting two cytokines, BLyS (also known as BAFF) and APRIL, important in B cell and plasma cell development and maturation
Slide 5: Prespecified Per-Protocol Analysis of ORIGIN Results
Intent-to-treat (ITT) Per-protocol (PP) Prespecified Per-Protocol Analysis of ORIGIN Results RAASi = renin-angiotensin-aldosterone system inhibitor; SGLT2 = sodium-glucose cotransporter-2; UPCR = urine protein:creatinine ratio. Jan 3 data disclosure of ORIGIN results reflected the ITT analysis of al
Slide 6: Summary of Positive Phase 2b Results
Stable eGFR through week 24 for patients on atacicept Atacicept safety profile in IgAN patients similar to placebo Gd-IgA1 reduction of 60% at week 24 with atacicept 150 mg Met primary endpoint, clinically & statistically significant UPCR reductions, deepening over time Summary of Positive Phase 2b
Slide 7: Atacicept: Potential Value Creation Over Next 18 Months
Catalyst 2022 2023 2024 2025 2026 Presented data on Gd-IgA1, anti-Gd-IgA1, and immune complexes from Phase 2a JANUS trial Completed enrollment in Phase 2b ORIGIN trial Present 24-week ITT and PP data from ORIGIN trial Present 36-week data from ORIGIN trial Initiate Phase 3 trial Present ongoing data
Slide 8: Table of Contents
Table of Contents Opening Remarks ORIGIN Phase 2b Results Takeaways and Phase 3 Plans Q&A Professor, University of Leicester Founder and CEO, Vera Therapeutics Founder and CEO, Vera Therapeutics CMO, Vera Therapeutics Professor, University of Leicester Founder and CEO, Vera Therapeutics Marshall For
Slide 9: ORIGIN Phase 2b IgAN Trial: Study Design and Objectives
ORIGIN Phase 2b IgAN Trial: Study Design and Objectives Multinational, randomized, placebo-controlled trial powered for 28% Δ between pooled 75/150 mg arms vs placebo ET = end of treatment. Week 0 24 1° Endpoint 36 2° Endpoint Atacicept 150 mg qwk n=30 Atacicept 75 mg qwk n=30 Atacicept 25 mg qwk n=
Slide 10: 30% Reduction in Proteinuria is Known to be Clinically Meaningful in IgAN Patients
30% Reduction in Proteinuria is Known to be Clinically Meaningful in IgAN Patients 1. Inker LA, et al. Am J Kidney Dis 2021;78:340-9.E1; 2. Barratt Lab, University of Leicester. ESRD = end stage renal disease. 30% reduction in proteinuria at week 36 is associated with improvement of renal function i
Slide 11: Randomized Patients
Randomized Patients Multinational, Randomized, Placebo-controlled Phase 2b Trial
Slide 12: Patient Disposition
Patient Disposition Safety data includes all post-week 24 visits available at data-cut December 23, 2022. ITT = intent to treat. PP = per protocol. 1. Discontinued to pursue elective surgery (1) and adverse event (1). 2. Initiated prohibited medication for concomitant disease. Screened, n=232 Random
Slide 13: Demographics and Baseline Characteristics
Demographics and Baseline Characteristics Mean ± SD or n (%) Overall n=116 Atacicept 25 mg n=16 Atacicept 75 mg n=33 Atacicept 150 mg n=33 Placebo n=34 Age, y 39 40 41 38 39 Male sex 69 (59) 9 (56) 19 (58) 22 (67) 19 (56) Race White 62 (53) 7 (44) 12 (36) 17 (52) 26 (76) Asian 51 (44) 7 (44) 20 (61)
Slide 14: Data Update: Prespecified PP Analysis
Data Update: Prespecified PP Analysis UPCR % Change in Atacicept 75 and 150 mg Through Week 36 p-values, percentage changes from baseline, and treatment differences are computed using FDA endorsed mixed-effects modeling which takes into account the effects of baseline UPCR and eGFR. -29% Δ 31% n= Pl
Slide 15: Data Update: Prespecified PP Analysis
Placebo Atacicept 75 mg Atacicept 150 mg % Patients Data Update: Prespecified PP Analysis 33% of Patients on 150 mg Had >50% UPCR Decrease at Week 24 7/32 9/27 4/29
Slide 16: Data Update: Prespecified PP Analysis
Data Update: Prespecified PP Analysis 43% of Patients on 150 mg with Baseline UPCR ≥1 g/g Achieved <1 g/g at Week 24 Placebo Atacicept 75 mg Atacicept 150 mg % Patients 5/20 8/26 9/21
Slide 17: ITT Analysis in Review
ITT Analysis in Review UPCR % Change in Atacicept 75 and 150 mg Through Week 36 p-values, percentage changes from baseline, and treatment differences are computed using FDA endorsed mixed-effects modeling which takes into account the effects of baseline UPCR and eGFR. -4% -36% Δ 33% -28% Δ 25% n= Pl
Slide 18: Atacicept P2 UPCR Data in Context – Best in Class Potential
Atacicept P2 UPCR Data in Context – Best in Class Potential, Derisked for P3 Multinational, Randomized, Placebo-controlled Trials in IgAN at Weeks 24 and 32 This data is based on a cross-trial comparison and not a head-to-head clinical trial, such data may not be directly comparable due to differenc
Slide 19: Atacicept P2 UPCR Data in Context – Best in Class Potential
Atacicept P2 UPCR Data in Context – Best in Class Potential, Derisked for P3 Multinational, Randomized, Placebo-controlled Trials in IgAN at Week 36 This data is based on a cross-trial comparison and not a head-to-head clinical trial, such data may not be directly comparable due to differences in st
Slide 20: eGFR Changes in Atacicept Through Week 36
eGFR Changes in Atacicept 75 and 150 mg Through Week 24 n= Placebo 29 29 29 29 29 Atacicept 75 mg 32 32 32 32 32 Atacicept 150 mg 27 27 27 27 27 Week 34 34 34 34 34 33 33 33 33 32 33 33 33 32 32 Week Mean ± SD Change from Baseline in eGFR, mL/min/1.73 m2 Data Update: Prespecified PP Analysis ITT Ana
Slide 21: Summary of Clinical Safety Data Through Week 24
ITT Analysis in Review Summary of Clinical Safety Data Through Week 24 Atacicept was generally well tolerated in IgAN patients, with no reported deaths, low rate (2%) of serious AEs overall, and 1 patient (1%) discontinued atacicept due to AE Infections were balanced between atacicept and placebo No
Slide 22: Table of Contents
Table of Contents Opening Remarks ORIGIN Phase 2b Results Takeaways and Phase 3 Plans Q&A Professor, University of Leicester Founder and CEO, Vera Therapeutics Founder and CEO, Vera Therapeutics CMO, Vera Therapeutics Professor, University of Leicester Founder and CEO, Vera Therapeutics Marshall For
Slide 23: Regulatory Update: Rapidly Advance Phase 3
Regulatory Update Rapidly Advance Phase 3 Atacicept 150 mg Dose Selection Met statistical significance in ORIGIN study Can leverage ORIGIN worldwide sites Derisked Phase 3 Same SC formulation and dose as used in Phase 2, similar study design as ORIGIN Phase 2 I © 2023 VERA THERAPEUTICS, INC. Atacice
Slide 24: ORIGIN Subgroup Analyses Will Inform Phase 3 Design
ORIGIN Subgroup Analyses Will Inform Phase 3 Design and Management to Maximize Competitive Positioning Tested atacicept’s anticipated commercial formulation and setting (at home SC self administration) in patients with wide-spectrum disease severity and racially diverse backgrounds Incorporated evol
Slide 25: Initiation of Phase 3 Pivotal Trial
Endpoints Primary efficacy: UPCR-24h at week 36 to support potential accelerated approval Key secondary: eGFR change up to week 104 Safety Initiation of Phase 3 Pivotal Trial Expected in 1H 2023 Atacicept Once Weekly SC Injection Formulation in Phase 3, Same as Phase 2b Week 0 Atacicept 150 mg qwk P
Slide 26: Atacicept in IgAN: Development Program Anticipated Timeline
Atacicept in IgAN: Development Program Anticipated Timeline 1. Reported original analysis at Barratt J, et al. Nephrol Dial Transplant 2020, abstr MO039 and Barratt J, et al. ASN Kidney Week 2020, abstr SU-OR35; conducted by Merck KGaA. JANUS Phase 2a ORIGIN Phase 2b Trial Phase 3 Trial 2020 2023 20
Slide 27: Table of Contents
Table of Contents Opening Remarks ORIGIN Phase 2b Results Takeaways and Phase 3 Plans Q&A Professor, University of Leicester Founder and CEO, Vera Therapeutics Founder and CEO, Vera Therapeutics CMO, Vera Therapeutics Professor, University of Leicester Founder and CEO, Vera Therapeutics Marshall For
Slide 28: © 2023 VERA THERAPEUTICS, INC.
© 2023 VERA THERAPEUTICS, INC.