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2023 VERA THERAPEUTICS, INC.
Phase 2b Clinical Trial Data Update January 30, 2023 Exhibit 99.1
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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 Marshall Fordyce, MD Jonathan Barratt, PhD, FRCP Marshall Fordyce, MD Marshall Fordyce, MD Celia Lin, MD Jonathan Barratt, PhD, FRCP
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 Gd-IgA1 = galactose-deficient IgA1; BLyS = B lymphocyte stimulator; BAFF = B cell activating factor; APRIL = a proliferation-inducing ligand. Currently being studied in a Phase 2b multinational, 36-week randomized,
placebo-controlled, double-blind trial, with a 60-week open label extension January 2023, reporting positive week 24 and 36 prespecified per-protocol (PP) and intent-to-treat (ITT) results I 2023 VERA THERAPEUTICS, INC.
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 all randomized patients (n=116), which is a conservative assessment of efficacy ORIGIN benchmarked our primary endpoint to the Tarpeyo label to ensure a derisked Phase 3 In the prespecified PP analysis, the population was defined as
patients who had completed treatment according to protocol (n=102); 14 patients across all treatment arms who had protocol violations were identified by a blinded third-party CRO and excluded: 6 due to change in background RAASi post-randomization 3
due to inadequate time of SGLT2i stability (<8 weeks prior to screening) 3 due to missing UPCR data at week 24 1 due to prohibited medication 1 due to compliance <80% PP analysis was a planned and prespecified analysis, but not available at
the time of our ITT data disclosure We believe the PP analysis represents a more accurate assessment of treatment efficacy when compared to the ITT analysis because it minimizes potential confounders for proteinuria measure
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 Results Atacicept 150 mg dose selected for Phase 3 clinical trial, expected to initiate in 1H 2023 eGFR = estimated glomerular filtration rate. Week 24 full data Week 24 full data Week 36 interim data Atacicept 150 mg
Placebo Atacicept 150 mg Placebo PP analysis -41% -10% 34% -47% +3% 48% ITT analysis -33% -7% 28% -36% -4% 33%
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 from ORIGIN trial Present topline Phase 3 BLA submission Projected launch Atacicept: Potential Value Creation Over Next 18 Months Vera holds worldwide, exclusive rights to develop and commercialize atacicept
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 Fordyce, MD Jonathan Barratt, PhD, FRCP Marshall Fordyce, MD Marshall Fordyce, MD Celia Lin, MD Jonathan Barratt, PhD, FRCP
ORIGIN Phase 2b IgAN Trial: Study
Design and Objectives Multinational, randomized, placebo-controlled trial powered for 28% 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=15 Placebo n=30 Atacicept 150 mg qwk Double-Blind Treatment Open-label Extension (OLE) 96/ET Endpoints Primary efficacy: UPCR-24h at week 24 Key secondary: UPCR-24h at week 36 eGFR change up to week 96 Gd-IgA1 change
Safety Inclusion Criteria Patients 18 years old with IgAN on renal biopsy and high risk of disease progression Stable and optimized RAASi for 12 weeks UPCR-24h >0.75 g/g or UP >0.75 g per 24h eGFR 30 mL/min/1.73 m2 Blood pressure
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 in IgAN as measured by eGFR slope1 Reduction of 30% could delay ESRD by over 10 years2 Early change in proteinuria at week 36 is an approvable surrogate endpoint for FDA accelerated approval, based on precedent set by
Calliditas' Tarpeyo eGFR slope at 2 years is the key confirmatory endpoint for full approval
Randomized Patients Multinational,
Randomized, Placebo-controlled Phase 2b Trial
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 Randomized and Treated, n=116 Screen Failures, n=116 Discontinued n=2 (2%)1 Completed Week 24 n=80 (98%) All Atacicept, n=82 Placebo, n=34 Discontinued n=1 (3%)2 Completed Week 24 n=33 (97%) Safety and ITT population Prespecified PP
analysis Excludes patients with protocol violations as identified by blinded third-party CRO n=73 (89%) n=29 (85%) n=82 n=34
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) 16 (48) 8 (24) Other 3 (3) 2 (12) 1 (3) 0 0 eGFR, mL/min/1.73 m2 63 27.3 71 28.7 64 25.4 56 22.7 66 31.7 UPCR by 24h urine, g/g 1.6 0.9 1.6 0.8 1.7 0.9 1.7
1.0 1.6 0.8 SGLT2i use 16 (14) 3 (19) 3 (9) 4 (12) 6 (18)
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% 31% n= Placebo 29 29 29 9 Atacicept 75 mg 32 32 32 12 Atacicept 150 mg 27 27 27 10 Week Mean SE % Change from Baseline in UPCR-24h 3% -47% 48% -41% 34% p=0.025 -10% -28%
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
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
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% 33% -28% 25% n= Placebo 34 34 34 12 Atacicept 75 mg 33 33 32 12 Atacicept 150 mg 33 32 32 13 Week Mean SE % Change from Baseline in UPCR-24h -7% -33% 28% p=0.047 -28% 22%
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 differences in study protocols, conditions and patient populations. 1. Barratt J, et al. Kidney Int 2022;S0085-2538(22)00836-5; 2. Rovin BH, et al. ASN Kidney Week 2022, abstr FR-OR59; 3. Alnylam RNAi Roundtable 2022. FAS = full
analysis set; ITT = intent to treat; NR = not reported; PP = per protocol. -10% -41% -7% -33% 10% -31% Week 24 Week 32 Atacicept 150 mg (P3 dose) Tarpeyo1 Cemdisiran3 -41% -2% Iptacopan2 ~-4% ~-18% Placebo/control Active delta 34% 28%
NR NR 37% n= 29 27 34 32 94 90 10 11 8 22 p-value p=0.025 p=0.047 NR NR NR Analysis Type Prespecified PP (full data) ITT (full data) FAS (full data) Post-hoc, NR (interim data) NR (full data) SGLT2i use Yes No No No Mean UPCR % Change From
Baseline -40 -20 60 20 40 0
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 study protocols, conditions and patient populations. 1. Barratt J, et al. Kidney Int 2022;S0085-2538(22)00836-5; 2. Travere Corporate Overview January 2023; confidence intervals not available; 3. Kooienga L, et al. ASN Kidney
Week 2022. *Not a geometric mean, statistical analysis was not performed. FAS = full analysis set; ITT = intent to treat; NR = not reported; PP = per protocol. Mean UPCR % Change From Baseline -40 -20 60 20 40 0 Week 36 -5% -31% -15% -50% Tarpeyo1
Sibeprenlimab3 ~-1% ~-44% Atacicept 150 mg (P3 dose) 3% -47% -4% -36% Placebo/control Active delta 48% 33% 27% 41% 43%* n= 9 10 12 13 89 90 280 72 p-value NR NR p=0.0003 p<0.0001 NR Analysis Type Prespecified PP
(interim data) ITT (interim data) FAS (full data) NR (interim data) Descriptive only (interim data) SGLT2i use Yes No No No Sparsentan2 Confidence intervals (CIs) not reported 48% Background RAASi discontinued on Day 1
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 Analysis
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 serious AEs in atacicept 150 mg group No patient had study drug discontinuation or interruption due to hypogammaglobulinemia
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 Fordyce, MD Jonathan Barratt, PhD, FRCP Marshall Fordyce, MD Marshall Fordyce, MD Celia Lin, MD Jonathan Barratt, PhD, FRCP
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. Atacicept for IgAN FDA meeting in Q4 2022 enabled alignment on Phase 3 study design to accelerate Phase 3 start
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 evolving SOC SGLT2i use in a multinational RCT eGFR SGLT2i use Asian Region UPCR Proprietary subgroup analyses that will inform Phase 3 design and management include:
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 Placebo Atacicept 150 mg qwk Double-Blind Treatment Open-label Extension (OLE) 156 36 1 Endpoint 104 2 Endpoint Inclusion Criteria Patients 18 years old with IgAN on renal biopsy and high risk of disease
progression UPCR-24h 1.0 g/g or UP 1.0 g per 24h eGFR 30 mL/min/1.73 m2 Stable and optimized RAASi for 12 weeks Use of SGLT2i allowed Blood pressure 150/90 mmHg
Atacicept in IgAN: Development