Vaxcyte, Inc. · NASDAQ:PCVX

Vaxcyte — Technical Presentation (April 2023)

39 slides from Vaxcyte's technical presentation, Apr 17, 2023

  1. Slide 1: VAX-24 Phase 2 Program Results, Including Adult 65+ Data and Full Six-Month Safety Data

    VAX-24 Phase 2 Program Results, Including Adult 65+ Data and Full Six-Month Safety Data from Both Studies April 17, 2023 Exhibit 99.2

  2. Slide 2: Forward-Looking Statements

    April 2023 Forward-Looking Statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements related to the potential benefits of Vaxcyte’s vaccine candidates, incl

  3. Slide 3: Agenda

    Introduction and vax-24 Results Overview VAX-24 Phase 2 Study results in Adults Aged 65 and Older (65+) Disposition and Demographics Safety and Tolerability Data Immunogenicity Data Prespecified Pooled Immunogenicity Analyses of both Phase 2 Adult Studies Full Six-Month Safety Data from both Adult S

  4. Slide 4: Introduction and VAX-24 Results Overview

    Introduction and VAX-24 Results Overview April 2023

  5. Slide 5: Summary: VAX-24 Adult 65+ Study Results Confirm Prior Phase 2 Results

    Summary: VAX-24 Adult 65+ Study Results Confirm Prior Phase 2 Results Positive Results Support Best-in-Class Potential for VAX-24 and Set Stage for Phase 3 Design and Advancement April 2023 SAFETY: Full six-month safety data from Phase 2 study in adults aged 65+ and prior Phase 1/2 study in adults a

  6. Slide 6: Global Impact of Pneumococcal Disease Remains Significant

    April 2023 Streptococcus pneumoniae is the most common pathogen causing pneumococcal disease (PD). In the U.S. alone, there are ~320K pneumococcal pneumonia cases per year resulting in ~150K hospitalizations. Invasive pneumococcal disease (IPD) is a leading cause of invasive disease in children two

  7. Slide 7: Spectrum of Coverage Drives Adoption in PCV Segment

    April 2023 Spectrum of Coverage Drives Adoption in PCV Segment Significant Unmet Needs Remain Despite Available Vaccines Data in the US is for 2017, inclusive of those > 5 yrs of age. Varghese et al. Clin Micro and Infect (2020) 26(4): 512.e1-512.e10. PCV20 PCV15 PCV13 Designed to provide broadest c

  8. Slide 8: Carrier-Sparing Approach for PCV Franchise Validated By Phase 2 Program

    April 2023 Carrier-Sparing Approach for PCV Franchise Validated By Phase 2 Program Site-Specific Conjugation Using Cell-Free Platform to Go Beyond Limits of Conventional Chemistry Random conjugation masks “on-target” T-cell epitopes on the protein carrier Higher ratio of protein carrier to polysacch

  9. Slide 9: Global Pneumococcal Vaccine Market and Growth Drivers

    April 2023 ~$13B ~$7B Market Growth Pfizer (Prevnar Family – PCV13 & PCV20) Merck (PPV23 & PCV15) GSK (Synflorix) Billions Other Sources: Company websites; includes Merck’s PCV15 sales disclosed for Q4 2022. Global Pneumococcal Vaccine Market (2022-2027), Infogence Global Research. Shea KM, Edelsber

  10. Slide 10: VAX-24 Phase 2 Study in Adults 65+

    VAX-24 Phase 2 Study in Adults 65+ April 2023

  11. Slide 11: Study Design

    Study Design VAXCYTE April2023 | 12

  12. Slide 12: Overview of VAX-24 Phase 2 Clinical Study in Adults 65+

    Overview of VAX-24 Phase 2 Clinical Study in Adults 65+ April 2023 Design: Randomized, Observer-Blind, Dose-Finding, Controlled Clinical Study to Evaluate Safety, Tolerability & Immunogenicity of VAX-24 vs. Standard-of-Care (PCV20) in Healthy Adults Aged 65 and Older Day 1 Dose Blood Sample Phase 2

  13. Slide 13: Study Evaluated Three VAX-24 Doses Consistent with Prior Phase 2 Study

    Study Evaluated Three VAX-24 Doses Consistent with Prior Phase 2 Study April 2023 1 3 4 5 6A 6B 7F 8 9V 10A 11A 12F 14 15B 18C 19A 19F 22F 23F 33F 2 9N 17F 20 4.4 mcg 4.4 mcg 4.4 mcg 4.4 mcg 4.4 mcg 4.4 mcg 4.4 mcg 4.4 mcg Low Dose (1.1mcg) Middle Dose (2.2mcg) Mixed Dose (2.2mcg/ 4.4mcg) PCV20 VAX-

  14. Slide 14: Study Safety, Tolerability and Immunogenicity Key Outcome Measures

    Study Safety, Tolerability and Immunogenicity Key Outcome Measures April 2023 Safety and Tolerability Outcome Measures Immunogenicity Outcome Measures DAY 7 DAY 29 DAY 180 Solicited local reactions Solicited systemic events Unsolicited adverse events (AE) Serious adverse events (SAE) SAE, new onset

  15. Slide 15: Disposition and Demographics

    Disposition and Demographics April 2023

  16. Slide 16: Study Disposition Overall High Proportion of Subjects with Follow-Up

    Study Disposition Overall High Proportion of Subjects with Safety and Immunogenicity Follow-Up April 2023 Phase 2 Study in Adults 65+ 7 Subjects (3.4%) Discontinued Enrolled N = 207 Included in Safety Population N = 50 (98.0%) Included in Safety Population N = 53 (100.0%) Included in Safety Populati

  17. Slide 17: Demographic Population Generally Balanced Across Cohorts

    Demographic Population Generally Balanced Across Cohorts and Similar for the Safety and Immunogenicity Populations April 2023 VAX-24 Low Dose (1.1mcg) VAX-24 Middle Dose (2.2mcg) VAX-24 Mixed Dose (2.2mcg/4.4mcg) PCV20 Safety Immunogenicity Safety Immunogenicity Safety Immunogenicity Safety Immunoge

  18. Slide 18: Safety and Tolerability Data

    Safety and Tolerability Data April 2023

  19. Slide 19: Local Solicited AEs Similar to PCV20 and Across Cohorts Through Day 7

    Local Solicited AEs Similar to PCV20 and Across Cohorts Through Day 7 April 2023

  20. Slide 20: Systemic Solicited AEs Similar to PCV20 and Across Cohorts Through Day 7

    Systemic Solicited AEs Similar to PCV20 and Across Cohorts Through Day 7 April 2023 .

  21. Slide 21: Immunogenicity Data

    Immunogenicity Data April 2023

  22. Slide 22: Precedent Regulatory Criteria for Phase 2/3 PCV Immunogenicity Studies

    Criteria for FOUR Incremental Serotypes in VAX-24: Superiority: Lower bound of the 2-sided 95% CI of the difference in the proportions of participants with a ≥4-fold increase from Day 1 to Day 29 is greater than 10% Lower bound of the 2-sided 95% CI of the OPA GMR is greater than 2.0 Criteria for 20

  23. Slide 23: VAX-24 2.2mcg Dose Showed Robust Immune Responses for All Serotypes

    VAX-24 2.2mcg Dose Showed Robust Immune Responses for All 24 Serotypes April 2023 Met non-inferiority criteria for 18 of 20 common STs for the OPA GMR of VAX-24 : PCV20 (n~45) Met superiority criteria for all four incremental STs in VAX-24 based on 4-fold rise vs. PCV20 (n~45) Non-inferiority Criter

  24. Slide 24: 65+ Study Results Confirm 2.2mcg is Optimal Dose to Advance to Phase 3

    65+ Study Results Confirm 2.2mcg is Optimal Dose to Advance to Phase 3 Consistent with Prior Phase 2 Study, 2.2mcg Dose Demonstrated Higher OPA GMR for 16/20 Shared STs April 2023 X = 7 VAX-24 serotypes at the 4.4mcg dose; GMR = Geometric Mean Ratio; GMFR = Geometric Mean Fold Ratio GMR: GMFR:

  25. Slide 25: All Serotypes in VAX-24 Demonstrated Robust OPA GMT Immune Responses

    All 24 Serotypes in VAX-24 Demonstrated Robust OPA GMT Immune Responses Serotypes Contained in PCV20 April 2023 Non-PCV20 Serotypes OPA = Opsonophagocytic Activity; GMT = Geometric Mean Titer

  26. Slide 26: All Serotypes in VAX-24 Demonstrated Robust IgG GMC Responses

    All 24 Serotypes in VAX-24 Demonstrated Robust IgG GMC Responses Non-PCV20 Serotypes Serotypes Contained in PCV20 April 2023 0.1 1 10 IgG GMCs mcg/mLs (95% CI) IgG = Immunoglobulin G; GMC = Geometric Mean Concentration

  27. Slide 27: Prespecified Pooled Immunogenicity Analyses of Both VAX-24 Phase 2 Adult Studies

    Prespecified Pooled Immunogenicity Analyses of Both VAX-24 Phase 2 Adult Studies April 2023

  28. Slide 28: Phase 2 Program Confirms 2.2mcg as Optimal Dose in Adult Population

    ST GMR 95%CI 1 1.56 3.33 0.73 3 0.91 1.47 0.56 4 1.33 2.55 0.70 5 1.18 2.49 0.55 6A 1.96 4.93 0.78 6B 1.28 2.99 0.55 7F 0.90 1.60 0.51 8 1.32 2.34 0.74 9V 1.65 3.59 0.76 10A 1.17 2.39 0.58 11A 1.31 1.89 0.91 12F 1.6 3.77 0.68 14 1.31 2.42 0.70 15B 0.86 1.88 0.39 18C 1.69 3.20 0.89 19A 1.52 2.53 0.92

  29. Slide 29: Met Standard OPA Response Non-Inferiority Criteria for All 20 Common STs

    Met Standard OPA Response Non-Inferiority Criteria for All 20 Common STs Prespecified Pooled Analyses Support Advancement of VAX-24 to Phase 3 April 2023 Sample size of ~225 calculated as median between immunogenicity evaluable VAX-24 n=228 and PCV20 n=224 rounded to nearest 5 for 50+ and ~100 calcu

  30. Slide 30: Full Six-Month Safety and Tolerability Data from Both VAX-24 Adult Studies

    Full Six-Month Safety and Tolerability Data from Both VAX-24 Adult Studies April 2023

  31. Slide 31: Six-Month Safety Data from VAX-24 Phase 2 Study in Adults Aged 65+

    Six-Month Safety Data from VAX-24 Phase 2 Study in Adults Aged 65+ Safety Results Similar to PCV20 and Across Cohorts April 2023 VAX-24 – Low Dose (1.1mcg) VAX-24 – Middle Dose (2.2mcg) VAX-24 – Mixed Dose (2.2mcg/4.4mcg) PCV20 Number of Subjects with 52 51 53 50 Unsolicited TEAE, n (%) 6 (11.5) 4 (

  32. Slide 32: Six-Month Safety Data from VAX-24 Phase 1/2 Study in Adults Aged 18-64

    Six-Month Safety Data from VAX-24 Phase 1/2 Study in Adults Aged 18-64 Safety Results Similar to PCV20 and Across Cohorts April 2023 VAX-24 – Low Dose (1.1mcg) VAX-24 – Middle Dose (2.2mcg) VAX-24 – Mixed Dose (2.2mcg/4.4mcg) PCV20 Number of Subjects with 209 207 207 212 Unsolicited TEAE, n (%) 32 (

  33. Slide 33: Combined Six-Month Safety Data from Both Adult VAX-24 Studies

    Combined Six-Month Safety Data from Both Adult VAX-24 Studies Safety Results Similar to PCV20 and Across Cohorts April 2023 VAX-24 – Low Dose (1.1mcg) VAX-24 – Middle Dose (2.2mcg) VAX-24 – Mixed Dose (2.2mcg/4.4mcg) PCV20 Number of Subjects with 261 258 260 262 Unsolicited TEAE, n (%) 38 (14.6) 28

  34. Slide 34: Phase 2 Program Conclusions, Status & Next Steps

    Phase 2 Program Conclusions, Status & Next Steps April 2023

  35. Slide 35: Phase 2 Program Conclusions

    Full six-month VAX-24 data (n=779) showed safety and tolerability results similar to PCV20 Improved immunogenicity vs. PCV20 with no evidence of dose-dependent safety and tolerability issues Confirmed 2.2mcg as optimal dose to advance to Phase 3 pivotal study Achieved target immune responses for all

  36. Slide 36: Anticipated PCV Franchise Milestones for 2023-2025

    Anticipated PCV Franchise Milestones for 2023-20251 Vaxcyte is Advancing Clinical Development of VAX-24 and VAX-31 with Several Key Upcoming Milestones April 2023 Conduct FDA End-of-Phase 2 meeting to finalize adult Phase 3 program in 2H:23 Announce topline safety, tolerability and immunogenicity da

  37. Slide 37: Vaxcyte Mission Statement

    April 2023 VAXCYTE MISSION STATEMENT We are on a global mission to engineer high-fidelity vaccines that protect humankind from the consequences of bacterial diseases.

  38. Slide 38: Q&A with Management

    April 2023 Q&A with Management Grant Pickering Chief Executive Officer, Director and Founder Jim Wassil Executive Vice President and Chief Operating Officer Andrew Guggenhime President and Chief Financial Officer

  39. Slide 39: Vaxcyte

    VAXCYTE

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