Vera Therapeutics, Inc. · NASDAQ:VERA

Vera Therapeutics — Investor Presentation (January 2024)

35 slides from Vera Therapeutics's investor presentation, Jan 8, 2024

  1. Slide 1: Corporate Presentation January 2024

    Exhibit 99.1 Corporate Presentation January 2024 © 2023 VERA THERAPEUTICS, INC.

  2. 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 in this presentation that are not statements of historical fact are forward-looking statements. Such forward-looking statement

  3. Slide 3: Corporate Highlights

    Corporate Highlights • Atacicept targets B cells and plasma cells, and has 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 stabilization • Phase 2b 72-we

  4. Slide 4: Atacicept: Potential Value Creation Over Next Months

    Atacicept: Potential Value Creation Over Next 18 Months Catalyst 2024 2025 2026 Present 72-week eGFR and proteinuria Jan 25 data from ORIGIN Phase 2b 2H Phase 3 estimated full enrollment Present 96-week eGFR and proteinuria 4Q data from ORIGIN Phase 2b 1H Present topline Phase 3 data 2H BLA submissi

  5. Slide 5: 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

  6. Slide 6: Financial Position

    Financial Position ~$160M $25M Cash, cash equivalents, Drawdown of and marketable securities credit facility (unaudited as of 9.30.23) (Dec 2023) Current capital position sufficient to fund IgAN-focused operations to ~44.4M Shares outstanding (as of 9.30.23) 2026 6 © 2023 VERA THERAPEUTICS, INC.

  7. Slide 7: Strategic Vision: Develop Transformative Therapeutics for Immunologic Diseases

    Strategic Vision: Develop Transformative Therapeutics for Immunologic Diseases Lead indications with large markets and validated clinical data Lead Indication IgAN Phase 3 initiated Potential Indication Expansion Phase 3 ready Lupus nephritis Phase 3 ready Systemic lupus erythematosus Phase 3 potent

  8. Slide 8: IgAN: Large Unmet Need and Significant Commercial Opportunity

    IgAN: Large Unmet Need and Significant Commercial Opportunity ~$6–10B Annual Market Opportunity in 5 US, EU, and Japan for Novel IgAN Therapeutics Serious and progressive autoimmune disease of the kidney; average age of diagnosis 30 years 1 old, severely impacting quality of life ~136K ~130K ~126K 2

  9. Slide 9: Atacicept Targets All Upstream Hits of IgAN Pathogenesis

    Atacicept Targets All Upstream Hits of IgAN Pathogenesis, Leading to Downstream Improvements B Cell Maturation and Class-Switching Systemic Circulation Glomerulonephritis Lymphoid tissue 2 6 Fewer plasma cells Atacicept Plasma cell Reduced circulating mistraffic to immune complexes systemic circulat

  10. Slide 10: Atacicept: Favorable MOA for Potential Disease Modifying Therapy

    Atacicept: Favorable MOA for Potential Disease Modifying Therapy Potential Disease Modifying Therapy for IgAN 1 2 3 4 Decrease Reduce Reduce Stabilize Gd-IgA1 & hematuria proteinuria eGFR immune complexes Dual blockade reduces long-term risk of single pathway intervention escape + Based on clinical

  11. Slide 11: Prospective IgAN Treatment Paradigm

    Prospective IgAN Treatment Paradigm B cell modulators have potential as front-line plus treatment based on unique eGFR stabilization Hemodynamic Disease-modifying Other immunomodulatory Nontargeted immunosuppressant 1L: RAASi (current SOC) 1L+: BAFF/APRIL (atacicept) ± other renal supportive care (R

  12. Slide 12: Rationale for Dual Inhibition of BAFF + APRIL with Atacicept

    Rationale for Dual Inhibition of BAFF + APRIL with Atacicept • Elevated BAFF plays key role in IgAN pathogenesis BAFF APRIL – BAFF and APRIL levels are both elevated in patients with IgAN and are 1-3 each associated with clinical severity – In preclinical models, overexpression of BAFF alone can lea

  13. Slide 13: Atacicept Binds BAFF and APRIL with Low Nanomolar Potency

    Atacicept Binds BAFF and APRIL with Low Nanomolar Potency BAFF APRIL Kd 1.45 nM Kd 0.672 nM 70 54 60 46 200 nM 50 38 100 nM 200 nM 50 nM 40 30 30 22 50 nM 20 14 10 nM 10 nM 10 2 nM 6 Buffer 0 -2 Buffer -10 -10 200 300 400 500 600 700 800 900 1000 200 280 360 440 520 600 680 760 840 920 1000 Time, s

  14. Slide 14: Summary of Positive Phase 2b Week 36 Results

    Summary of Positive Phase 2b Week 36 Results PP Analysis ITT Analysis Met primary endpoint, with statistically significant *p<0.05 UPCR reductions on atacicept 150 mg Δ 43%*Δ 35%* Stable eGFR observed for patients on atacicept, Mean eGFR % change with atacicept 150 mg vs placebo was 11% (p=0.038), a

  15. Slide 15: 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 96/ET 1° Endpoint 2° Endp

  16. Slide 16: 30% Placebo-Adjusted Reduction in Proteinuria Known to be Clinically Meaningful

    30% Placebo-Adjusted Reduction in Proteinuria Known to be Clinically Meaningful in IgAN Patients • 30% placebo-adjusted reduction in proteinuria at week 36 is associated with 1 improvement of renal function in IgAN as measured by eGFR slope 2 • Placebo-adjusted reduction of 30% could delay ESKD by o

  17. Slide 17: Patient Disposition

    Patient Disposition Screened, n=232 Screen Failures, n=116 Randomized and Treated, n=116 All Atacicept, n=82 Placebo, n=34 Safety and ITT population n=82 n=34 Prespecified Week 36 PP analysis n=73 (89%) n=26 (76%) Excludes patients with protocol violations as identified by blinded third-party CRO Di

  18. Slide 18: Demographics and Baseline Characteristics

    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 (44) 20 (61)

  19. Slide 19: UPCR % Change with Atacicept 150 mg at Week 36

    UPCR % Change with Atacicept 150 mg at Week 36 1 ITT Analysis PP Analysis 20 10 5% 3% 0 -10 -20 -30 Δ 35% -33% p=0.012 -40 Δ 43% -40% p=0.003 -50 Placebo Atacicept 150 mg Placebo Atacicept 150 mg n=26 n=26 n=34 n=33 p-values, percentage changes from baseline, and treatment differences were computed

  20. Slide 20: eGFR Change with Atacicept 150 mg Through Week 36

    eGFR Change with Atacicept 150 mg Through Week 36 15 10 5 1.6%Δ 11% p=0.038 0 5.8 2 mL/min/1.73 m -5 Absolute difference in mean change at week 36 -10 -8.5% -15 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 Week n= Placebo 34 34 34 34 34 30 Atacicept 150 mg 33 33 33 32 32 31 ITT analysis; p-va

  21. Slide 21: Atacicept Has Shown Stable and Persistent eGFR Trends in Multiple RCTs

    Atacicept Has Shown Stable and Persistent eGFR Trends in Multiple RCTs Placebo Atacicept 75 mg Atacicept 150 mg Phase 2a JANUS Phase 2b ORIGIN 1 2 eGFR Change through Week 72 eGFR Change through Week 36 30 30 2 5.8 mL/min/1.73 m Absolute difference in 20 20 mean change at week 36 10 10 Δ 11% 1.6% p=

  22. Slide 22: Hematuria Resolved in 80% of Patients on Atacicept 150 mg vs 5% on Placebo

    Hematuria Resolved in 80% of Patients on Atacicept 150 mg vs 5% on Placebo at Week 36 100 80% 80 • Hematuria represents active glomerulonephritis (inflammation of glomeruli), and resolution is 60 2,3 associated with improved renal outcomes 40 • Most patients receiving atacicept 150 mg with 4 hematur

  23. Slide 23: Dose-dependent Reductions Observed in Serum IgG, IgA, and IgM Through Week 36

    Dose-dependent Reductions Observed in Serum IgG, IgA, and IgM Through Week 36 IgG IgA IgM 0 0 0 0% -3% -4% * * * * * -14% * -20 * -20 -20 * * * * * * * * -32% -32% * -37% -40 -40 -40 * * * * * * * * * * -54% * * * -59% -60 -60 -60 -63% * * * * -70% * -73% * * -80 -80 -80 0 4 8 12 16 20 24 28 32 36 0

  24. Slide 24: Gd-IgA1 % Change Through Week 36

    Gd-IgA1 % Change Through Week 36 20 0 -7% * -20 * * * * -40 -39% * * * * -62% -60 * -64% * * -80 0 4 8 12 16 20 24 28 32 36 Week n= Placebo 33 33 33 33 29 Atacicept 25 mg 16 16 16 15 15 Atacicept 75 mg 33 33 33 33 33 Atacicept 150 mg 32 32 30 30 30 ITT analysis; *p<0.05 vs placebo. p-values, percent

  25. Slide 25: At Week 36, 82% of Patients Had Gd-IgA1 Reductions to the Lowest Risk Quartile

    At Week 36, 82% of Patients on Atacicept 150 mg Had 1 Gd-IgA1 Reductions to the Lowest Risk Quartile Placebo, n=34 Atacicept 150 mg, n=33 1.0 Baseline Week 4 Week 12 Week 24 Week 36 Baseline Week 4 Week 12 Week 24 Week 36 1 1 2 2 3 3 4 4 Group 1 5 5 0.8 6 6 7 7 8 8 9 9 10 10 11 11 0.6 12 12 Group 3

  26. Slide 26: Treatment-Emergent Adverse Events Through Week 36

    Treatment-Emergent Adverse Events Through Week 36 Atacicept 25 mg Atacicept 75 mg Atacicept 150 mg Placebo Patients, n (%) n=16 n=33 n=33 n=34 TEAEs 11 (69) 24 (73) 25 (76) 27 (79) 1 Study drug-related TEAEs 6 (38) 17 (52) 19 (58) 14 (41) 2 3 4 Serious TEAEs 0 1 (3) 1 (3) 3 (9) TEAEs leading to stud

  27. Slide 27: No Significant Change in Lymphocyte Counts at Week 36

    No Significant Change in Lymphocyte Counts at Week 36 Mean ± SD Atacicept 25 mg Atacicept 75 mg Atacicept 150 mg Placebo 9 Lymphocyte counts, 10 /L n=16 n=33 n=33 n=34 1.83 ± 0.66 1.76 ± 0.64 1.77 ± 0.58 1.7 ± 0.52 Baseline 1.93 ± 0.64 1.68 ± 0.60 2.00 ± 0.75 1.62 ± 0.36 Week 36 n=13 n=30 n=31 n=29

  28. Slide 28: Balanced Infections with Atacicept vs Placebo

    Balanced Infections with Atacicept vs Placebo Infections through Week 36 in ORIGIN Atacicept 25 mg Atacicept 75 mg Atacicept 150 mg Placebo Patients, n (%) n=16 n=33 n=33 n=34 1 Infections 6 (38) 16 (48) 13 (39) 11 (32) Occurring in >1 patient COVID-19 4 (25) 9 (27) 8 (24) 6 (18) Upper respiratory t

  29. Slide 29: Summary of Clinical Safety Data Through Week 36

    Summary of Clinical Safety Data Through Week 36 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, including COVID Low rate

  30. Slide 30: Enrolling Phase 3 Trial of Atacicept for IgAN

    Enrolling Phase 3 Trial of Atacicept for IgAN Regulatory FDA Type C meeting Q4’22 & written feedback received Q2’23 enabled Feedback alignment on Ph3 protocol to accelerate Ph3 trial start in early June Operational Ability to leverage ORIGIN worldwide sites and experience Efficiency Attractive trial

  31. Slide 31: Phase 2b Subgroup Analyses Informed Phase 3 Design

    Phase 2b Subgroup Analyses Informed Phase 3 Design • 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 Propr

  32. Slide 32: Initiated Phase 3 Pivotal Trial in June 2023

    Initiated Phase 3 Pivotal Trial in June 2023 Atacicept Once Weekly SC Injection Formulation in Phase 3, Same as Phase 2b Double-Blind Treatment Open-label Extension Placebo Atacicept 150 mg qwk Atacicept 150 mg qwk Week 0 36 104 156 1° Endpoint 2° Endpoint UPCR: n=200 eGFR: n=376 Inclusion Criteria

  33. Slide 33: Target Commercial Drug Product Profile

    Target Commercial Drug Product Profile • Self-administration of small volume (1 mL) via autoinjector at commercial launch • Smallest volume among B-cell modifying drugs in development (2–4 mL with APRIL-only) • Large subcutaneous injection volumes are associated with pain and may affect tolerability

  34. Slide 34: Atacicept: Potential Value Creation Over Next Months

    Atacicept: Potential Value Creation Over Next 18 Months Catalyst 2024 2025 2026 Present 72-week eGFR and proteinuria Jan 25 data from ORIGIN Phase 2b 2H Phase 3 estimated full enrollment Present 96-week eGFR and proteinuria 4Q data from ORIGIN Phase 2b 1H Present topline Phase 3 data 2H BLA submissi

  35. Slide 35: © 2023 VERA THERAPEUTICS, INC.

    © 2023 VERA THERAPEUTICS, INC.

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