Vera Therapeutics, Inc. · NASDAQ:VERA
Vera Therapeutics — Investor Day (January 2024)
50 slides from Vera Therapeutics's investor day presentation, Jan 25, 2024
Slide 1: R&D Day January 25, 2024
Exhibit 99.2 R&D Day January 25, 2024 © 2024 VERA THERAPEUTICS, INC.
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 statemen
Slide 3: Agenda
Agenda Marshall Fordyce, MD Opening Remarks Founder and CEO, Vera Therapeutics Jonathan Barratt, PhD, FRCP IgAN Disease State Professor, University of Leicester Richard Lafayette, MD, FACP Atacicept ORIGIN Phase 2b 72 Week Results Professor, Stanford University Robert Brenner, MD Closing Remarks Chi
Slide 4: Corporate Highlights
Corporate Highlights • Atacicept is a potential first-in-class dual BAFF/APRIL B cell modulator with pipeline-in-a-drug potential • Currently in Phase 3 pivotal trial for IgA Nephropathy (IgAN), a large potential market • Differentiation based on disease-modifying MOA, evident in long-term eGFR stab
Slide 5: Atacicept: Expected Value Creation Catalysts Over Next Months
Atacicept: Expected Value Creation Catalysts Over Next 18 Months Catalyst 2024 2025 2026 Jan 25 ORIGIN Phase 2b 72-week results 2H ORIGIN Phase 3 full enrollment 4Q ORIGIN Phase 2b 96-week results 1H ORIGIN Phase 3 top-line results 2H BLA submission Projected US launch Vera holds worldwide, exclusiv
Slide 6: Management Team: Successful Clinical and Commercial Track Record
Management Team: Successful Clinical and Commercial Track Record Marshall Fordyce, MD Sean Grant, MBA President and CEO Chief Financial Officer • >15 years drug dev leadership • >15 years in corporate strategy, • 7 new drug approvals, Project Lead for finance, and capital raising tenofovir alafenami
Slide 7: Strong Financial Position
Strong Financial Position Current capital position sufficient to ~$185M fund IgAN-focused ~44.4M Pro forma cash, cash operations to equivalents, and marketable Shares outstanding (as of 9.30.23) securities including $25M 2026 1 drawdown of credit facility 1. Unaudited; pro forma cash includes ~$160M
Slide 8: Vera Pipeline: Late-Stage Opportunities For Patient Benefit
Vera Pipeline: Compelling Late-Stage Opportunities For Patient Benefit Atacicept Phase 3 Ongoing Lead Indication: IgAN Phase 2/3 potential IgAN extended dosing Phase 3 ready LN SLE Phase 3 ready Phase 3 potential Sjogren’s syndrome Myasthenia gravis Phase 3 potential Phase 3 potential Membranous nep
Slide 9: MAU868: Novel Investigational Neutralizing Antibody Targeting BK Virus
MAU868: Novel Investigational Neutralizing Antibody Targeting BK Virus Phase 2 Trial in Kidney Transplantation: Markedly decreased BK viral load and stable eGFR MAU868 Placebo n=20 n=8 P-value Log reduction in BK viremia, median (IQR) DNA copies/mL -1.14 (-1.88, -0.50) 0.37 (-0.72, 0.04) 0.051 Patie
Slide 10: Atacicept Dual Cytokine Inhibition of BAFF and APRIL
Atacicept Dual Cytokine Inhibition of BAFF and APRIL: Superior Potential B cell Modulation vs Single Pathway Intervention Pre-Clinical Evidence: Clinical Evidence: Clinical Evidence: BAFF-APRIL >> BAFF or APRIL alone BAFF-APRIL >> BAFF or APRIL alone Improved kidney function in SLE SRI-4 Response at
Slide 11: Atacicept Phase 2b Results in SLE
Atacicept Phase 2 Results in SLE Potentially Best-In-Class Clinical Activity 1,2 3 SRI-6 Response in HDA Patients (n=158) HDA Patients Reaching LDA (n=158) 60 40 Atacicept 150 mg, n=51 Atacicept 150 mg, n=51 Atacicept 75 mg, n=55 Atacicept 75 mg, n=55 Placebo, n=52 Placebo, n=52 30 Δ 26.1 Δ 23.8 40
Slide 12: Attractive Target Commercial Atacicept Product Profile
Attractive Target Commercial Atacicept Product Profile • Self-administration (subcutaneous) of small volume (1 mL) once weekly via autoinjector at commercial launch • Smallest volume among B-cell modifying drugs in Phase 3 development (2–4 mL with APRIL-only) • Large subcutaneous injection volumes a
Slide 13: Atacicept PK/PD Supports Once-Monthly Dosing
Atacicept PK/PD Supports Once-Monthly Dosing Plan to Evaluate as Part of Life Cycle Management Exposure for Weeks 48–52 5,000 4,598 4,373 4,000 Atacicept 150 mg weekly (Phase 2/3 dosing) 3,000 52 Week Simulation 2,000 Atacicept 600 mg monthly 1,000 0 150 mg weekly 600 mg monthly 29% CV 32% CV Simula
Slide 14: IgAN: High Unmet Need and Significant Commercial Opportunity
IgAN: High Unmet Need and Significant Commercial Opportunity Serious and progressive autoimmune disease of ~$6–10B Annual Market Opportunity in 7 the kidney; average age of diagnosis ~35 years old, US, EU, and Japan for Novel IgAN Therapeutics 1 severely impacting quality of life ~136K ~130K ~126K 2
Slide 15: Thesis That Drove Vera Acquisition of Atacicept in 2020
Thesis That Drove Vera Acquisition of Atacicept in 2020… BAFF B cell Rationale for Dual Inhibition of Autoantibodies and immune complexes BAFF + APRIL Plasma with Atacicept cell APRIL Atacicept • Elevated BAFF plays key role in IgAN pathogenesis 1-3 – BAFF and APRIL levels are both elevated in patie
Slide 16: Bold Projections for IgAN Disease Modification
… Included Bold Projections for IgAN Disease Modification Atacicept Potential to Convert eGFR Rate of Decline to That of the General Population Supportive New approved non-disease 1 2 CKD therapy modifying therapies Atacicept eGFR slope, ~ -6 ~ -3 ~0 2 mL/min/1.73m /y 75 60 45 30 15 ESKD 0 0 10 20 3
Slide 17: Agenda
Agenda Marshall Fordyce, MD Opening Remarks Founder and CEO, Vera Therapeutics Jonathan Barratt, PhD, FRCP IgAN Disease State Professor, University of Leicester Richard Lafayette, MD, FACP Atacicept ORIGIN Phase 2b 72-week Results Professor, Stanford University Robert Brenner, MD Closing Remarks Chi
Slide 18: Jonathan Barratt, PhD, FACP
Jonathan Barratt, PhD, FACP Dr. Barratt leads the Renal Research Group within the College of Life Sciences, University of Leicester. His research is focused on a bench-to-bedside approach to improving our understanding of the pathogenesis of IgAN, a common global cause of kidney failure. Dr. Barratt
Slide 19: IgA Nephropathy Current Challenges and Unmet Needs
IgA Nephropathy Current Challenges and Unmet Needs Professor Jonathan Barratt University of Leicester & John Walls Renal Unit, Leicester
Slide 20: Agenda
Agenda Marshall Fordyce, MD Opening Remarks Founder and CEO, Vera Therapeutics Jonathan Barratt, PhD, FRCP IgAN Disease State Professor, University of Leicester Richard Lafayette, MD, FACP Atacicept ORIGIN Phase 2b 72-week Results Professor, Stanford University Robert Brenner, MD Closing Remarks Chi
Slide 21: Richard Lafayette, MD, FACP
Richard Lafayette, MD, FACP Dr. Lafayette is a Professor of Medicine (Nephrology) and Director of the Stanford Glomerular Disease Center at Stanford University Medical Center. Dr. Lafayette completed his medical education at New York Medical College and went on to complete his residency at the Long
Slide 22: ORIGIN Phase 2b IgAN Trial: Study Design and Objectives
ORIGIN Phase 2b IgAN Trial: Study Design and Objectives Multinational, randomized, placebo-controlled trial Double-Blind Treatment Open-label Extension Placebo n=30 Atacicept 25 mg qwk n=15 Atacicept 150 mg qwk Atacicept 75 mg qwk n=30 Atacicept 150 mg qwk n=30 Week 0 24 36 72 96/ET 1° Endpoint 2° E
Slide 23: Summary of Positive Phase 2b 72-Week Results
Summary of Positive Phase 2b Week 36 Results Gd-IgA1 reduction of 64% from baseline with atacicept 150 mg Hematuria resolution in 80% of participants on atacicept 150 mg vs 5% on placebo PP Analysis ITT Analysis Met primary endpoint, with statistically significant *p<0.05 UPCR reductions on atacicep
Slide 24: Disease Modification Observed in Phase 2b Results
Disease Modification Observed in Phase 2b Week 36 Results Placebo 1 1 Gd-IgA1 Reduction Hematuria Resolution Atacicept 150 mg 0 100 -7% 80% -15 80 -30 60 -45 40 -60 20 5% p<0.001 -64% -75 0 n=29 n=30 n=1/19 n=12/15 1 UPCR Reduction eGFR Stabilization 2 PP Analysis ITT Analysis 15 20 5.8 2 mL/min/1.7
Slide 25: ORIGIN 2b Participant Disposition
ORIGIN 2b Participant Disposition Screened, n=232 Screen Failures, n=116 Randomized and Treated, n=116 All Atacicept, n=82 Placebo, n=34 n=82 Safety and ITT population n=34 n=73 (89%) n=26 (76%) Prespecified Week 36 PP analysis Excludes participants with protocol violations as identified by blinded
Slide 26: ORIGIN 2b Demographics and Baseline Characteristics
ORIGIN 2b Demographics and Baseline Characteristics Overall Atacicept 25 mg Atacicept 75 mg Atacicept 150 mg Placebo Mean ± SD or n (%) n=116 n=16 n=33 n=33 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 (4
Slide 27: Consistent and Sustained Gd-IgA1 Reduction Through Week 72
Consistent and Sustained Gd-IgA1 Reduction Through Week 72 Placebo → Atacicept Switch Group Had Similar Reduction as Randomized Atacicept Group 15 Atacicept 150 mg OLE Switch Group 0 -7% -15 -30 -45 -59% -59% -60 -62% -75 0 4 8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 68 72 Week n= Placebo 33 33 33
Slide 28: Sustained Reductions in Percentage of Participants with Hematuria
Consistent and Sustained Reductions in Percentage of Participants with Hematuria Through Week 72 100 Atacicept 150 mg OLE Switch Group 95% 80 60 41% 40 33% 20 19% 0 0 12 24 36 48 60 72 Week n= Placebo 22 22 22 22 19 17 18 17 All atacicept 44 44 43 43 43 43 43 43 Percentages represent number of parti
Slide 29: Consistent and Sustained Reductions in UPCR Over 72 Weeks
Consistent and Sustained Reductions in UPCR Over 72 Weeks 1 ITT Analysis PP Analysis All Atacicept Placebo All Atacicept Placebo 20 Atacicept 150 mg Atacicept 150 mg Atacicept 150 mg Atacicept 150 mg OLE OLE OLE OLE 0 -20 -40 -45% -47% -47% -48% -60 0 12 24 36 48 60 72 0 12 24 36 48 60 72 0 12 24 36
Slide 30: Atacicept Resulted in eGFR Stabilization Through 72 Weeks
Atacicept Resulted in eGFR Stabilization Through 72 Weeks Atacicept Switch Halted eGFR Decline in Randomized Placebo Cohort All Atacicept Placebo 10 10 Atacicept 150 mg OLE Atacicept 150 mg OLE 5 5 0 0 0 -3.2 -5 -5 -4.9 -10 -10 0 4 8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 68 72 0 4 8 12 16 20 24
Slide 31: OLE Adverse Events Profile Consistent with Randomized Period
OLE Adverse Events Profile Consistent with Randomized Period 1 Double-Blind Data Through Week 36; OLE Data Through 12/2023 Double-blind BL to W36 W36 to W72 BL to W72 Atacicept Atacicept Atacicept Total OLE Atacicept Placebo 25 mg 75 mg 150 mg Atacicept 150 mg 150 mg Participants, n (%) n=34 n=16 n=
Slide 32: Summary of 72 Week Results
Summary of Week 72 Results • Participants treated with atacicept for 72 weeks demonstrated: – Consistent and sustained reductions in Gd-IgA1, hematuria and UPCR – Consistent and stable eGFR – In aggregate, these data provide evidence of long-term, comprehensive IgAN disease modification • Participan
Slide 33: Agenda
Agenda Marshall Fordyce, MD Opening Remarks Founder and CEO, Vera Therapeutics Jonathan Barratt, PhD, FRCP IgAN Disease State Professor, University of Leicester Richard Lafayette, MD, FACP Atacicept ORIGIN Phase 2b 72 Week Results Professor, Stanford University Robert Brenner, MD Closing Remarks Chi
Slide 34: IgAN Through the Ages
IgAN Through the Ages nephritis [Greek]: nephros “of the kidney” + -itis “inflammation” Evidence that IgAN is a 3 B-cell mediated disease 5 Discovery of BAFF Hippocratic Aphorism 7.34: 1 earliest description of proteinuria “When bubbles settle on the surface of the urine, they indicate disease of th
Slide 35: Review of the CKD Therapy History and Landscape
Providing Context: An Abbreviated Review of the CKD Therapy History and Landscape Lewis EJ, et al. N Engl J Med 1993. 2 Change from Baseline in eGFR Baseline (mL/min/1.73m ) Canagliflozin Placebo 56.4 56.0 0 -4 40 Canagliflozin -8 20 Placebo -12 0 Placebo -16 P<0.001 -20 -20 Losartan -40 0 3 6 12 18
Slide 36: IgAN is a Disease of B Cell Origin With Kidney Pathology
IgAN is a Disease of B Cell Origin With Kidney Pathology B Cell Maturation and Systemic Circulation Glomerulonephritis Class-Switching BAFF B Plasma cell Glomerulus APRIL 3 4 5 6 1 2 …autoantibodies bind …and form …which deposit …resulting in …and progressive In response to various stimuli to expose
Slide 37: An Ideal IgAN Disease Modifying Therapy Would be Expected To…
An Ideal IgAN Disease Modifying Therapy Would be Expected To… Reduce Gd-IgA1 Reduce hematuria Reduce proteinuria Stabilize eGFR 37 © 2024 VERA THERAPEUTICS, INC.
Slide 38: ORIGIN Phase 2b 72 Week Results Consistent With Disease Modifying Profile
… And the Atacicept ORIGIN Phase 2b 72 Week Results Are Consistent With a Disease Modifying IgAN Profile Reduction in Reduction in patients Reduction in Stabilization of Gd-IgA1 with hematuria proteinuria eGFR 0 100 0 20 150 mg OLE 150 mg OLE 150 mg OLE 150 mg OLE -15 80 -15 10 -30 60 -30 0 0 40 -45
Slide 39: Atacicept eGFR Profile Akin to the General Population
Atacicept Treated Participants Have an eGFR Profile Akin to the General Population; Dissimilar to Historical IgAN 4 0 -4 1 General population estimate -8 -12 0 4 12 24 36 48 60 72 82 96 Week This data is based on a cross-trial comparison and not a head-to-head clinical trial; such data may not be di
Slide 40: Atacicept eGFR Profile Akin to the General Population
Atacicept Treated Participants Have an eGFR Profile Akin to the General Population; Dissimilar to Historical IgAN 4 0 -4 1 General population estimate 2 -8 IgAN natural history inclusive of supportive CKD therapy -12 0 4 12 24 36 48 60 72 82 96 Week This data is based on a cross-trial comparison and
Slide 41: Atacicept eGFR Profile Akin to the General Population
Atacicept Treated Participants Have an eGFR Profile Akin to the General Population; Dissimilar to Historical IgAN 4 0 -4 1 General population estimate 2 -8 IgAN natural history inclusive of supportive CKD therapy 3 Tarpeyo Ph3 4 Filspari Ph3 -12 0 4 12 24 36 48 60 72 82 96 Week This data is based on
Slide 42: Atacicept eGFR Profile Akin to the General Population
Atacicept Treated Participants Have an eGFR Profile Akin to the General Population; Dissimilar to Historical IgAN 4 0 -4 1 General population estimate 2 -8 IgAN natural history inclusive of supportive CKD therapy 3 Tarpeyo Ph3 4 Filspari Ph3 All atacicept → 150 mg -12 0 4 12 24 36 48 60 72 82 96 Wee
Slide 43: Cumulative Atacicept Data Offers Promise For Best-In-Class Potential
Cumulative Atacicept Data Offers Promise For Best-In-Class Potential… …And Further Supports ORIGIN Phase 3 Design 1 2 3 4 Atacicept Sibeprenlimab Zigakibart Telitacicept Povetacicept Mechanism BAFF/APRIL inhibition APRIL inhibition only APRIL inhibition only BAFF/APRIL inhibition BAFF/APRIL inhibiti
Slide 44: Potential Framework for a Future Treatment Paradigm in IgAN
Potential Framework for a Future Treatment Paradigm in IgAN Patients with new Prevalent IgAN diagnosis IgAN patients IgAN-specific BAFF/APRIL B cell modulation with atacicept to modify disease ± supportive CKD therapy (ACEi, ARB, ERA, SGLT2i) • In prevalent IgAN patients, initiate disease modifying
Slide 45: Congruency with ORIGIN 2b Instills Greater Confidence in ORIGIN 3
Congruency with ORIGIN 2b Instills Greater Confidence in ORIGIN 3; Enrollment On Track Double-Blind Treatment Open-label Extension Placebo Atacicept 150 mg qwk Atacicept 150 mg qwk Initiated in 2023 Week 0 36 104 156 1° Endpoint 2° Endpoint UPCR: n=200 eGFR: n=376 Inclusion Criteria Endpoints • Pati
Slide 46: 2024 Poised To Be An Impactful Year Of Community Engagement
2024 Poised To Be An Impactful Year Of Community Engagement Q1 Q2 Q3 Q4 • Community engagement • Community engagement • Data submission • Community engagement • Sponsorship of GN CME course • Medical Affairs booth presence • Encore data accepted as posters • Data submission • Industry sponsored symp
Slide 47: Atacicept: Anticipated Clinical & Regulatory Catalysts Over Next 18 Months
Atacicept: Anticipated Clinical & Regulatory Catalysts Over Next 18 Months Catalyst 2024 2025 2026 Jan 25 ORIGIN Phase 2b 72-week results 2H ORIGIN Phase 3 full enrollment 4Q ORIGIN Phase 2b 96-week results 1H ORIGIN Phase 3 top-line results 2H BLA submission Projected US approval Based on managemen
Slide 48: Returning to Vienna in the late 18th Century
th Returning to Vienna in the late 18 Century… • We have record of a 35-year-old man living in Vienna, with a history of various infections, depression and headache • Not long before his death, he was noted to have skin rash, gastroenteritis and edema • He died on December 5, 1791 Hatzinger M, et al
Slide 49: Wolfgang Amadeus Mozart
Wolfgang Amadeus Mozart Perhaps the First Described Individual to Succumb to an IgA Mediated Death • Mozart displayed signs and symptoms of IgA Vasculitis, and it is believed he ultimately died due to kidney failure • He remained engaged and composing, working on the Lacrymosa of the Requiem, within
Slide 50: © 2024 VERA THERAPEUTICS, INC.
© 2024 VERA THERAPEUTICS, INC.