Vaxcyte, Inc. · NASDAQ:PCVX

Vaxcyte — Technical Presentation (October 2022)

35 slides from Vaxcyte's technical presentation, Oct 24, 2022

  1. Slide 1: VAX-24 Phase 1/2 Proof-of-Concept Study Topline Results

    VAX-24 Phase 1/2 Proof-of-Concept Study Topline Results October 24, 2022 Exhibit 99.2

  2. Slide 2: Forward-Looking Statements

    October 2022 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, in

  3. Slide 3: Unprecedented Results Support Best-in-Class Potential for VAX-24

    Unprecedented Results Support Best-in-Class Potential for VAX-24 and Identify Optimal Dose for Advancement Summary of VAX-24 Phase 1/2 Topline Data Findings October 2022 SAFETY: VAX-24 demonstrated a safety and tolerability profile similar to Prevnar 20™ (PCV20) for all doses IMMUNOGENICITY: Met or

  4. Slide 4: Global Impact of Pneumococcal Disease Remains Significant

    October 2022 Streptococcus pneumoniae is the most common pathogen causing pneumococcal disease (PD). In the U.S. alone, there are ~900K pneumococcal pneumonia cases per year resulting in ~150K hospitalizations. Among children < age 5, PD is a leading cause of death globally. Circulating strains of P

  5. Slide 5: Significant Unmet Needs Remain Despite Available Vaccines

    5 October 2022 Significant Unmet Needs Remain Despite Available Vaccines Spectrum of Coverage Drives Adoption in PCV Segment 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 broade

  6. Slide 6: Site-Specific Conjugation Using Cell-Free Platform

    October 2022 Site-Specific Conjugation Using Cell-Free Platform to Go Beyond Limits of Conventional Chemistry Carrier-Sparing Approach for PCV Franchise Validated By POC Study Random conjugation masks “on-target” T-cell epitopes on the protein carrier Higher ratio of protein carrier to polysaccharid

  7. Slide 7: Global Pneumococcal Vaccine Market Growth

    October 2022 ~$13B ~$7B Market Growth Prevnar 13 Pneumovax 23 Synflorix Billions Other Sources: Company websites; Prevnar 20 and Vaxneuvance have since been approved in 2021. Global Pneumococcal Vaccine Market (2022-2027), Infogence Global Research. Shea KM, Edelsberg J, Weycker D et al. (2014), Ope

  8. Slide 8: VAX-24 Phase 1/2 Study Design

    VAX-24 Phase 1/2 Study Design October 2022

  9. Slide 9: VAX-24 Phase 1/2 Clinical Proof-of-Concept Study Design

    October 2022 VAX-24 Phase 1/2 Clinical Proof-of-Concept Study Design Design: Randomized, Observer-Blind, Dose-Finding, Controlled Study to Evaluate Safety, Tolerability & Immunogenicity of VAX-24 vs SOC in Adults Aged 18-64 Safety Follow-Up Pilot Phase 1 Safety Healthy Adults 18 to 49 (n=64) Immunog

  10. Slide 10: Study Evaluated Three VAX-24 Doses

    Study Evaluated Three VAX-24 Doses October 2022 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-24 (2.2mcg) Mixed Dose includes se

  11. Slide 11: Study Safety, Tolerability and Immunogenicity Outcome Measures

    Study Safety, Tolerability and Immunogenicity Outcome Measures October 2022 Safety and Tolerability Outcome Measures (Phase 1 and 2 portions of the study) Immunogenicity Outcome Measures (Phase 2 portion of the study ONLY) DAY 7 DAY 29 DAY 180 Solicited local reactions Solicited systemic events Unso

  12. Slide 12: VAX-24 Phase 1/2 Study Disposition and Demographics

    VAX-24 Phase 1/2 Study Disposition and Demographics October 2022

  13. Slide 13: Overall High Proportion of Subjects with Safety and Immunogenicity Follow-Up

    Overall High Proportion of Subjects with Safety and Immunogenicity Follow-Up Phase 1/2 Study Disposition October 2022 Phase 1 Safety Healthy Adults 18 to 49 (n=64) Phase 2 POC Study Healthy Adults 50 to 64 (n=771) 9 subjects were lost to follow-up in Phase 2 Enrolled N = 64 Included in Safety Popula

  14. Slide 14: Generally Balanced Across Cohorts and Similar for Safety and Immunogenicity Populations

    Generally Balanced Across Cohorts and Similar for the Safety and Immunogenicity Populations Phase 2 Demographic Population October 2022 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

  15. Slide 15: VAX-24 Phase 2 Study Topline Safety and Tolerability Results

    VAX-24 Phase 2 Study Topline Safety and Tolerability Results October 2022

  16. Slide 16: Local Solicited AEs Similar to PCV20 and Across Cohorts Through Day 7

    Local Solicited AEs Similar to PCV20 and Across Cohorts Through Day 7 October 2022 Represents data for the 50 – 64 year age group; as of August 31, 2022.

  17. Slide 17: Systemic Solicited AEs Similar to PCV20 and Across Cohorts Through Day 7

    Systemic Solicited AEs Similar to PCV20 and Across Cohorts Through Day 7 October 2022 Represents data for the 50 – 64 year age group; as of August 31, 2022.

  18. Slide 18: VAX-24 Safety Profile Similar to PCV20 and Across Cohorts

    VAX-24 Safety Profile Similar to PCV20 and Across Cohorts October 2022 VAX-24 – Low Dose (1.1mcg) VAX-24 – Middle Dose (2.2mcg) VAX-24 – Mixed Dose (2.2mcg/4.4mcg) PCV20 Number of Subjects 193 191 191 196 Subjects with TEAE, n (%) 29 (15.0) 21 (11.0) 22 (11.5) 31 (15.8) Subjects with SAE or NOCI, n

  19. Slide 19: VAX-24 Phase 2 Study Topline Immunogenicity Results

    VAX-24 Phase 2 Study Topline Immunogenicity Results October 2022

  20. Slide 20: Standard Regulatory Criteria for Evaluating PCV Immunogenicity Results

    Criteria for 4 Incremental Serotypes in VAX-24: Superiority Standard: 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 GMT ratio is greater than 2.0 Cri

  21. Slide 21: VAX-24 2.2mcg Dose Met Regulatory Criteria for All Serotypes

    VAX-24 2.2mcg Dose Met Regulatory Criteria for All 24 Serotypes October 2022 Met non-inferiority standard for all 20 common serotypes for the OPA GMR of VAX-24 : PCV20 Met superiority standard for all 4 incremental serotypes in VAX-24 based on 4-fold rise Non-inferiority Criteria (LL 95% CI ≥ 0.5 of

  22. Slide 22: 2.2mcg Dose Demonstrated Higher OPA GMRs and Will Be Advanced

    2.2mcg Dose Demonstrated Higher OPA GMRs for 16 of the 20 Shared Serotypes and Will be Advanced All 3 Doses Induced Immune Responses Sufficient to Move to Phase 3 October 2022 X = 7 VAX-24 serotypes at the 4.4mcg dose; GMR = Geometric Mean Titers; LL= Lower Limit; CI = Confidence Interval

  23. Slide 23: Strong Evidence of a Dose-Dependent Response for the 7 VAX-24 Serotypes

    October 2022 Strong Evidence of a Dose-Dependent Response for the 7 VAX-24 Serotypes Tested at 1.1mcg, 2.2mcg and 4.4mcg 4.4mcg dose deemed not necessary as 2.2mcg dose demonstrated higher OPA GMRs for all 7 serotypes tested versus PCV20.

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

    All 24 Serotypes in VAX-24 Demonstrated Robust OPA Immune Responses Serotypes Contained in PCV20 October 2022 OPA GMTs by Serotype Non-PCV20 Serotypes

  25. Slide 25: All Serotypes in VAX-24 Demonstrated Robust IgG Responses

    All 24 Serotypes in VAX-24 Demonstrated Robust IgG Responses Non-PCV20 Serotypes Serotypes Contained in PCV20 October 2022 IgG GMCs by Serotype 0.1 1 10 IgG GMCs mcg/mLs (95% CI) GMC = Geometric Mean Concentration

  26. Slide 26: Study Conclusions & Program Status

    Study Conclusions & Program Status October 2022

  27. Slide 27: Supports Best-in-Class Potential for VAX-24 and Carrier-Sparing PCV Franchise

    Supports Best-in-Class Potential for VAX-24 and Carrier-Sparing PCV Franchise Study Conclusions October 2022 VAX-24 demonstrated a safety and tolerability profile similar to PCV20 at all doses among 50-64 year olds Met or exceeded regulatory standard for all 24 serotypes (STs) for VAX-24 conventiona

  28. Slide 28: Well-Trodden Clinical Plan Aligned with FDA, EMA and WHO Guidance

    October 2022 Well-Trodden Clinical Plan Aligned with Current FDA, EMA and WHO Guidance and Precedent PCVs Vaxcyte PCV Franchise Leverages Established Regulatory Pathway For adults: Lower limit of the 95% CI for the OPA GMR ≥0.5 for each serotype comparison. For infants: Lower limit of the 95% CI for

  29. Slide 29: VAX-24 Program Anticipated Key Milestones

    Adult Program Topline safety, tolerability and immunogenicity data from Phase 2 study in adults 65 and older anticipated in 1H:23 Final results with 6-month safety data for both Phase 2 adult studies anticipated in 1H:23 Regulatory interactions to inform Phase 3 program anticipated in 2H:23 Topline

  30. Slide 30: Platform and Pipeline Update

    Platform and Pipeline Update October 2022

  31. Slide 31: Carrier-Sparing PCV Franchise Positioned to Deliver Broadest Coverage

    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 Vaxcyte Carrier-Sparing PCV Franchise Positioned to Deliver Broadest Coverage October 2022 Designed to provide coverage for ~95% of the pneumococcal di

  32. Slide 32: Vaxcyte PCV Franchise Potential for Sustained Leadership in Growing Pneumococcal Vaccine Market

    Vaxcyte PCV Franchise has Potential for Sustained Leadership in Growing >$7B Pneumococcal Vaccine Market 4 6B 9V 14 18C 19F 23F 1 5 7F 3 6A 19A 33F 22F 8 10A 11A 12F 15B 2 9N 17F 20 15A 16F 23A 23B 7C 31 35B Source: Prescribing information for Prevnar, Prevnar 13, Prevnar20, Synflorix, Vaxneuvance,

  33. Slide 33: Vaxcyte Mission Statement

    October 2022 VAXCYTE MISSION STATEMENT We are on a global mission to engineer high-fidelity vaccines that protect humankind from the consequences of bacterial diseases.

  34. Slide 34: Q&A with Management

    October 2022 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

  35. Slide 35: Vaxcyte

    VAXCYTE

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