Novavax, Inc. · NASDAQ:NVAX

Novavax — Investor Presentation (September 2021)

71 slides from Novavax's investor presentation, Sep 9, 2021

  1. Slide 1: Corporate Overview and Investor Deck

    Nasdaq: NVAX | September 2021 CORPORATE OVERVIEW AND INVESTOR DECK

  2. Slide 2: Safe Harbor Statement

    2 novavax.com Safe Harbor Statement Certain information, particularly information relating to the future of Novavax, its operating plans and prospects, the ongoing development of NVX - CoV2373 and other Novavax vaccine product candidates, timing of future regulatory filings and actions, anticipated

  3. Slide 3: Novavax at-a-Glance

    3 novavax.com Novavax at - a - Glance 90% Overall Efficacy in PREVENT - 19 Phase 3 Trial 10+ years of Nanoparticle Vaccine Development 150 million Doses per Month Manufacturing Capacity by end of 4Q 2021* 100% Efficacy Against Moderate and Severe Disease $2+ billion in Funding Secured to Date 93% Ef

  4. Slide 4: Significant Progress in 2021

    4 novavax.com Significant Progress in 2021 Filed regulatory submissions for EUA of NVX - CoV2373, in partnership with Serum Institute of India (Serum Institute) Confirmed high levels of efficacy in PREVENT - 19 Phase 3 trial Announced positive data from 6 - month booster study for NVX - CoV2373 Ente

  5. Slide 5: Table of Contents

    5 novavax.com Table of Contents Introduction COVID - 19 Clinical Trial Information Booster Study 6 37 9 51 NVX - CoV2373 Regulatory Pathway 53 NanoFlu Πand Combination Vaccine Programs 56 Strategic Development of COVID - 19 Vaccines NVX - CoV2373 Manufacturing & Distribution 60 Clinical Development

  6. Slide 6: Introduction

    6 novavax.com Introduction

  7. Slide 7: NVX-CoV2373 Vaccine Design

    NVX-CoV2373 Vaccine Design SARS-CoV.2 Spike gone: insect virus ale © | + ate Protea gene r] Final vaccine 19 cells infected S19 Cell ‘Spike gene enters 'Sf9 cell nucleus:

  8. Slide 8: Highlighted in Recent Peer-Reviewed Publications

    8 novavax.com The picture can't be displayed. NVX - CoV2373 Highlighted in Recent Peer - Reviewed Publications

  9. Slide 9: COVID-19 Clinical Trial Information

    9 novavax.com COVID - 19 Clinical Trial Information

  10. Slide 10: Clinical Development Program

    10 novavax.com NVX - CoV2373 Clinical Development Program ▪ Established dose level in younger and older adults ▪ Confirmed need for adjuvant and 2 dose schedule ▪ Defined immunologic phenotype ▪ Described preliminary safety profile Phase 1/2 US & Australia N=131 Phase 1 N=1,288 Phase 2 Keech et al.

  11. Slide 11: Key Takeaways from Clinical Trials Publications in NEJM

    11 novavax.com Key Takeaways from NVX - CoV2373 Clinical Trials 3 Publications in The New England Journal of Medicine Immunogenicity Safety Efficacy x Favorable safety and reactogenicity profile x Efficacy confirmed against original COVID - 19 and variant strains x 100% efficacy against moderate and

  12. Slide 12: PREVENT-19 Phase 3 United States and Mexico

    12 novavax.com PREVENT - 19 Phase 3 United States and Mexico

  13. Slide 13: PREVENT-19 Phase 3 Trial Design

    13 novavax.com PREVENT - 19 Phase 3 Trial Design 5µg + 50µg Matrix - M adjuvant 2 injections, 21 days apart n = ~20,000 Placebo 2 injections, 21 days apart n = ~10,000 29,960 Adults > 18 years R 2:1 • Primary endpoint : PCR - positive symptomatic mild, moderate or severe COVID - 19 illness diagnosed

  14. Slide 14: 90% Overall Vaccine Efficacy

    14 novavax.com 90% Overall Vaccine Efficacy Placebo NVX - CoV2373 0.0% 0.2% 0.4% 0.6% 0.8% 1.0% 1.2% 1.4% 1.6% 1.8% 0 7 14 21 28 35 42 49 56 63 70 77 84 91 98 105 112 119 126 133 140 147 154 Event Rate Days from first vaccination Vaccine and placebo rates separate prior to dose 2 (day 21). No eviden

  15. Slide 15: 93% Efficacy Against Predominantly Circulating Variants

    15 novavax.com 93% Efficacy Against Predominantly Circulating Variants of Interest and Variants of Concern VoI / VoC represented 82% of cases 6 (13.6%) 1 (2.3%) 1 (2.3%) 1 (2.3%) 0 10 20 30 B.1.526 B.1.526-1 B.1.617 P.2 28 (63.6%) 3 (6.8%) 2 (4.5%) 2 (4.5%) 0 10 20 30 B.1.1.7 B.1.429 B.1.351 P.1 Var

  16. Slide 16: Serious and Severe Events: Infrequent and Balanced

    16 novavax.com Serious and Severe Events: Infrequent and Balanced Safety summary through crossover (n=25,981) NVX - CoV2373 Placebo 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Any Adverse Event (AE) Any Medically Attended AE Serious AE Any Severe AE AESIs Deaths An AE is any event reported, whether

  17. Slide 17: Favorable Reactogenicity Profile

    17 novavax.com 0% 20% 40% 60% 80% 100% Tenderness Pain Erythema Swelling 0% 20% 40% 60% 80% 100% Tenderness Pain Erythema Swelling Mild Favorable Reactogenicity Profile Local: Pain and Tenderness most common, 3 days duration Systemic: Fatigue, Headache and Muscle Pain, 2 days duration Dose 1 Dose 2

  18. Slide 18: Final Analysis: High Overall Efficacy

    18 novavax.com Final Analysis: High Overall Efficacy NVX - CoV2373 (n=17,312)* Placebo (n=8,125)* Total 14 63 Mild 14 49 Moderate 0 10 Severe 0 4 Vaccine Efficacy 90.4% (95% CI: 82.9, 94.6) • Primary efficacy statistical criteria achieved with lower bound of 95% CI >30 • 82% of cases caused by Varia

  19. Slide 19: 100% Efficacy Against Variants Not of Interest/Concern

    19 novavax.com 100% Efficacy Against Variants Not Considered Variants of Interest/Concern Protection against variants more closely matched to prototype NVX - CoV2373 (n=17,312)* Placebo (n=8,125)* Total 0 10 Mild 0 7 Moderate 0 2 Severe 0 1 Vaccine Efficacy 100% (95% CI: 80.8, 100) Pre - specified k

  20. Slide 20: High Efficacy Against Variants of Interest & Concern

    20 novavax.com High Efficacy Against Variants of Interest & Variants of Concern NVX - CoV2373 (n=17,312)* Placebo (n=8,125)* Total 6 38 Mild 6 29 Moderate 0 7 Severe 0 2 Vaccine Efficacy 92.6% (95% CI: 83.6, 96.7) Variant definition source: cdc.gov Efficacy updated in post - hoc analyses. Sequence n

  21. Slide 21: 100% Efficacy Against Moderate or Severe Disease

    21 novavax.com 100% Efficacy Against Moderate or Severe Disease NVX - CoV2373 (n=17,312)* Placebo (n=8,125)* Total 0 14 Moderate 0 10 Severe 0 4 Vaccine Efficacy 100% (95% CI: 87.0, 100) • Pre - specified secondary endpoint • Post - hoc analysis for Severe disease only: VE = 100% (95% CI: 35, 100) •

  22. Slide 22: High Efficacy in High-Risk Population

    22 novavax.com High Efficacy in High - Risk Population High Risk defined as: • ≥65 years of age • <65 years of age with obesity, chronic kidney disease, chronic lung disease, cardiovascular disease, Type 2 diabetes • Life circumstances with frequent COVID exposure (e.g., meat packing plants) or dens

  23. Slide 23: PREVENT-19 Pediatric Expansion

    23 novavax.com PREVENT - 19 Phase 3 Pediatric Expansion 5 µg + 50 µg Matrix - M adjuvant (2 injections: Day 0 and Day 21) n = ~1,500 Placebo (2 injections: Day 0 and Day 21) n = ~750 2,248 Adolescents 12 - 17 years R 2:1 Randomized, observer - blinded, placebo - controlled trial evaluating safety, e

  24. Slide 24: PREVENT-19 Pivotal Phase 3 Trial Summary

    24 novavax.com PREVENT - 19 Pivotal Phase 3 Trial Summary Consistent, High Efficacy Among Circulating Variants Reasserted Favorable Safety Profile x Vaccine generally well - tolerated with favorable reactogenicity profile x Serious and severe adverse events were low in number and balanced between va

  25. Slide 25: Phase 3 United Kingdom

    25 novavax.com Phase 3 United Kingdom

  26. Slide 26: 89% Overall Vaccine Efficacy

    26 novavax.com 89% Overall Vaccine Efficacy Placebo NVX - CoV2373 0.0% 0.5% 1.0% 1.5% 2.0% 2.5% 0 4 8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 68 72 76 80 84 88 92 96 100 104 108 112 116 120 124 Event Rate Days from first vaccination = case Heath et al. 2021; DOI: 10.1056/NEJMoa2107659 Phase 3 UK

  27. Slide 27: Safety Events Were Infrequent and Balanced

    27 novavax.com Safety Events Were Infrequent and Balanced Summary of events 1 through Day 7 after Dose 1 & 2 (n=15,139) 1. Events occurring after receipt of deployed vaccines and reactogenicity events (according to preferred terms) are excluded. 2. Missing information not imputed. 3. According to po

  28. Slide 28: Local Symptoms: Majority None or Mild

    28 novavax.com 0% 20% 40% 60% 80% 100% Any local symptom Tenderness Pain Erythema Swelling 0% 20% 40% 60% 80% 100% Any local symptom Tenderness Pain Erythema Swelling Life Threatening 0% 20% 40% 60% 80% 100% Any local symptom Tenderness Pain Erythema Swelling 0% 20% 40% 60% 80% 100% Any local sympto

  29. Slide 29: Systemic Symptoms: Majority None or Mild

    29 novavax.com 0% 20% 40% 60% 80% 100% 0% 20% 40% 60% 80% 100% Life Threatening 0% 20% 40% 60% 80% 100% Any systemic symptom Headache Muscle pain Fatigue Malaise Nausea or vomiting Joint pain Elevated temperature 0% 20% 40% 60% 80% 100% Any systemic symptom Headache Muscle pain Fatigue Malaise Nause

  30. Slide 30: Well-Tolerated when Administered with Influenza Vaccine

    30 novavax.com NVX - CoV2373 Well - Tolerated when Administered with Influenza Vaccine Participants received influenza vaccine or placebo with first dose of NVX - CoV2373 (n=431) Placebo 0% 20% 40% 60% 80% 100% Any local Any systemic Mild 0% 20% 40% 60% 80% 100% Any local Any systemic Moderate 0% 20

  31. Slide 31: UK Phase 3 Trial Summary

    31 novavax.com UK Phase 3 Trial Summary Primary Efficacy Endpoint Achieved Demonstrated Favorable Safety Profile x Safety events were infrequent and balanced between vaccine and placebo groups x When co - administered with influenza: - Generally well - tolerated - Immune responses and vaccine effica

  32. Slide 32: Consistent Efficacy Across Phase 3 Studies

    32 novavax.com Consistent Efficacy Across Phase 3 Studies UK Phase 3 PREVENT - 19 Overall Efficacy 89.7% 90.4% “Matched” Strain Efficacy 96.4% Prototype 100% (Non - VoI / VoC ) Efficacy Against Variants 86.3% Alpha (B.1.1.7) 93.6% Alpha (B.1.1.7) 92.6% VoI / VoC Efficacy Against Severe Disease NS (a

  33. Slide 33: Phase 2b Trial South Africa

    33 novavax.com Phase 2b Trial South Africa

  34. Slide 34: South Africa Phase 2b Trial Summary

    34 novavax.com South Africa Phase 2b Trial Summary Conducted in a context of greater than 90% variant virus Primary Efficacy Endpoint Achieved Demonstrated Favorable Safety Profile x Generally well - tolerated, with preliminary local and systemic reactogenicity events more common in the vaccine grou

  35. Slide 35: Phase 1/2 Trial United States & Australia

    35 novavax.com Phase 1/2 Trial United States & Australia

  36. Slide 36: Robust Immune Response

    36 novavax.com Robust Immune Response 2 doses + Matrix - M adjuvant Convalescent Sera 2 doses: 25µg + Matrix - M adjuvant 2 doses: 5µg + Matrix - M adjuvant 1 dose: 25µg + Matrix - M adjuvant Placebo 100 1,000 10,000 100,000 Day 0 Day 7 Day 21 Day 28 Day 35 Day 49 Day 105 Day 189 Antibody levels at

  37. Slide 37: Booster Study United States & Australia

    37 novavax.com Booster Study United States & Australia

  38. Slide 38: Phase 2 Study Ongoing: Examining Third Dose

    38 novavax.com Phase 2 Study Ongoing: Examining Third Dose Day 189 boost complete, immune responses evaluated on Day 217 USA & Australia — N=1,288 | Adults aged 18 - 84 years (n=583; 60 - 84 years) Placebo n=255 5 µg + Matrix - M n=258 25 µg + Matrix - M n=259 5 µg + Matrix - M n=256 25 µg + Matrix

  39. Slide 39: Adverse Event Rates Comparable with Low Severe and Serious Events

    39 novavax.com Adverse Event Rates Comparable with Low Rates of Severe and Serious Adverse Events Day 217 Safety Summary (5µg/5µg/5µg arm, all ages) 0% 20% 40% 60% 80% 100% AEs Severe AEs MAAEs SAEs Discontinued PIMMCs After Dose 1 0% 20% 40% 60% 80% 100% AEs Severe AEs MAAEs SAEs Discontinued PIMMC

  40. Slide 40: Local Symptoms: Favorable Profile is Consistent

    40 novavax.com Local Symptoms: Favorable Profile is Consistent; Severe Events are Relatively Infrequent Median duration 2 days, except erythema (2.5 days)

  41. Slide 41: Systemic Symptoms: Favorable Profile is Consistent

    41 novavax.com Systemic Symptoms: Favorable Profile is Consistent; Severe Events are Relatively Infrequent Median duration 1 day, except muscle pain (2 days)

  42. Slide 42: Robust Anti-Spike IgG Responses

    42 novavax.com Robust Anti - Spike IgG Responses Vaccination on Day 0 & 21 with boost on Day 189 106 745 41,621 11,514 5,943 202,406 Placebo 100 1,000 10,000 100,000 1,000,000 Day 0 7 21 28 35 49 105 189 Day 217 Anti - Spike IgG (Log 10 EU/mL) Titers increased ~4.6 - fold compared to peak response s

  43. Slide 43: Consistent Anti-Spike IgG Responses

    43 novavax.com Consistent Anti - Spike IgG Responses Vaccination on Day 0 & 21 with boost on Day 189 Overall Ages 18 - 59 Ages 60 - 84 Placebo 100 1,000 10,000 100,000 1,000,000 Day 0 7 21 28 35 49 105 189 Day 217 Anti - Spike IgG (Log 10 EU/mL) Anti - spike IgG titers increased ~3.9 - fold in adult

  44. Slide 44: Robust Beta Anti-Spike IgG Responses

    44 novavax.com Robust Beta Anti - Spike IgG Responses Vaccination on Day 0 & 21 with boost on Day 189 Placebo 4,413 169,770 100 1,000 10,000 100,000 1,000,000 Day 0 7 21 28 35 49 105 189 Day 217 Anti - Spike IgG (Log 10 EU/mL) Beta IgG

  45. Slide 45: Increased Wild Type Neutralization Responses

    45 novavax.com Increased Wild Type Neutralization R esponses Vaccination on Day 0 & 21 and boost on Day 189 10 33 1,581 65 6,039 10 100 1,000 10,000 Day 0 7 21 28 35 49 105 189 Day 217 IC<50% Wild Type Virus Neutralization (Log 10 ) WT neutralization titers increased ~4.3 - fold compared to peak res

  46. Slide 46: Boosted Anti-spike IgG Responses Greater Than Phase 3 Studies

    46 novavax.com 1,000 10,000 100,000 1,000,000 UK Ph3 Day 35 PREVENT-19 Day 35 US/AU Ph2 Day 217 Boosted Anti - spike IgG Responses Greater Than Observed in Phase 3 Studies Anti - Spike IgG (EU/mL, Log 10 ) IgG Responses with 95% CI PREVENT - 19 Efficacy Non - VoI / VoC : 100% VoI / VoC : 93% B.1.1.7

  47. Slide 47: Boosted Microneutralization Responses Greater Than Phase 3 Studies

    47 novavax.com 100 1,000 10,000 100,000 UK Ph3 Day 35 PREVENT-19 Day 35 US/AU Ph2 Day 217 Boosted Microneutralization Responses Greater Than Observed in Phase 3 Studies Wild Type Virus Neutralization (Log 10 ) Microneutralization Responses with 95% CI 4.6 - 5.5x PREVENT - 19 Efficacy Non - VoI / VoC

  48. Slide 48: High Levels of Functional hACE2 Responses Against All Variants

    48 novavax.com After Boosting, All Participants Developed High Levels of Functional hACE2 Responses Against All Variants Post - boost consistency suggests maturation of immune response (n=29) Assays performed by Novavax Discovery 1 10 100 1,000 10,000 Day 35 Day 217 Delta 8.1x increase 50% Receptor

  49. Slide 49: Use of NVX-CoV2373 in a Boosting Campaign

    49 novavax.com Use of NVX - CoV2373 in a Boosting Campaign A single dose of NVX - CoV2373 at 6 months significantly increases immune responses: • Wild - type Neutralization and Anti - Spike IgG levels up >4x over peak primary vaccination response • Increased functional hACE - 2 immune response again

  50. Slide 50: Emerging Shift Toward Booster Doses

    50 novavax.com Emerging Shift Toward Booster Doses NVX - CoV2373 Positioned to be Booster of Choice Emerging Booster Policy Recommendations • Waning immunity reinforces need for booster doses • Emerging policy recommendations reflect shift towards booster programs Ongoing and Upcoming Heterologous B

  51. Slide 51: Regulatory Pathway

    51 novavax.com NVX - CoV2373 Regulatory Pathway

  52. Slide 52: Filings for Authorization Underway

    52 novavax.com a The Philippines Indonesi a Drugs Controller General of India European Medicines Agency (EMA) UK Medicines and Healthcare products Regulatory Agency (MHRA) Australian Therapeutic Goods Administration New Zealand Medsafe Health Canada US Food and Drug Administration (FDA) * Regulatory

  53. Slide 53: NanoFlu and Combination Vaccine Programs

    53 novavax.com NanoFlu and Combination Vaccine Programs

  54. Slide 54: NanoFlu Addresses the Need for Greater and Broader Immune Responses

    54 novavax.com NanoFlu Addresses the Need for Greater and Broader Immune Responses Enhances immune response to generate potent, robust, and long - lasting protective immune responses Eliminates egg - adaptive strain changes that result in mismatch between vaccine and circulating viruses Provides bro

  55. Slide 55: COVID-NanoFlu Combination Vaccine Development

    55 novavax.com COVID - NanoFlu Combination Vaccine Development A transformative innovation to fight both illnesses June 2021 Announced data from co - administration sub - study** May 2021 Announced positive preclinical data* September 2021 Initiated phase 1/2 clinical trial of COVID - NanoFlu Combin

  56. Slide 56: Strategic Development of COVID-19 Vaccines

    56 novavax.com Strategic Development of COVID - 19 Vaccines

  57. Slide 57: Variant Strain Vaccine Development

    57 novavax.com Variant Strain Vaccine Development Logue et al. 2021; DOI : 10.1101/2021.06.08.447631 Study 1 Preclinical Study 2 Preclinical Study 3 • Compared immunization with NVX - CoV2373 or rS - B.1.351 alone, in combination or as heterologous prime boost • rS - B.1.351 was highly immunogenic a

  58. Slide 58: Response in Baboons Immunized a Year Ago

    58 novavax.com Response in Baboons Immunized 1 Year Ago Boost: 3µg rS - B.1.351 + 50µg Matrix - M adjuvant 10 100 1000 10000 100000 1000000 10000000 0 3 4 5 7 17 26 43 46 48 50 Anti - rS IgG Titer EC 50 (log10) weeks after immunization Geometric mean of 1, 5 or 25µg NVX - CoV2373 + 50µg Matrix - M a

  59. Slide 59: ACE2 Receptor Inhibition Increases After Boost at 1 Year

    59 novavax.com 1 10 100 1000 10000 Pre- boost 7 days Post-boost 21 days 35 days 50% Receptor Inhibition Titer Ace2 Receptor Inhibition Increases After Boost at 1 Year Boost: 3µg rS - B.1.351 + 50µg Matrix - M adjuvant LOD 1 10 100 1000 10000 Pre- boost 7 days Post-boost 21 days 35 days 50% Receptor

  60. Slide 60: Manufacturing & Distribution

    60 novavax.com NVX - CoV2373 Manufacturing & Distribution

  61. Slide 61: Practical Benefits Enabling Efficient Distribution

    61 novavax.com Practical Benefits Enabling Efficient Distribution Presentation • 10 - dose vials Transportation & Storage • Stable at 2 to 8 ° C Administration • Ready to use Large Global Capacity • Well - characterized technology platform; Dose - sparing

  62. Slide 62: Global Supply Chain Established

    62 novavax.com AGC Biologics Global Supply Chain Established Capacity of approx. 150 million* doses per month starting by end of 4Q 2021 Par Sterile Products PolyPeptide Group FujiFilm TX FujiFilm NC Novavax HQ MD Biofabri FujiFilm UK AGC Biologics PolyPeptide Group Novavax AB Serum Institute SK Bio

  63. Slide 63: Agreements Executed for NVX-CoV2373

    63 novavax.com Agreements Executed for NVX - CoV2373 Ensuring fair and equitable global access • Finalized APA with Gavi • NVAX to provide 350 million doses • Serum Institute to provide balance of the 1.1 billion doses • Ensuring fair and equitable access of NVX - CoV2373 • Doses committed to US gov

  64. Slide 64: Clinical Development Conducted by Partners

    64 novavax.com Clinical Development Conducted by Partners

  65. Slide 65: Clinical Development Conducted by Partners

    65 novavax.com NVX - CoV2373 Clinical Development Conducted by Partners Phase 1/2 Japan • Evaluating immunogenicity and safety of NVX - CoV2373 Sponsored by Takeda Enrollment Complete n = 200 ≥ 20 years Phase 2/3 India • Evaluating immunogenicity and safety of NVX - CoV2373 Sponsored by Serum Instit

  66. Slide 66: Malaria Vaccine Candidates / Matrix-M Adjuvant Collaborations

    66 novavax.com Malaria Vaccine Candidates / Matrix - M Adjuvant Collaborations R21 with Matrix - M Adjuvant R0.6C with Matrix - M Adjuvant Vaccine created and trial sponsored by University of Oxford in collaboration with Serum Institute, with Matrix - M adjuvant Vaccine created by Statens Serum Inst

  67. Slide 67: Upcoming Milestones

    67 novavax.com Upcoming Milestones

  68. Slide 68: Key Upcoming Milestones

    68 novavax.com Key Upcoming Milestones By end of 2021 Protection against variants Highly adaptable platform Strong stability profile Favorable safety profile • Expect to c omplete regulatory filings for emergency authorization with the MHRA, WHO, EMA, FDA, New Zealand Medsafe , Health Canada and Aus

  69. Slide 69: Pipeline Overview

    69 novavax.com Pipeline Overview

  70. Slide 70: Near-Term Vaccine Pipeline

    70 novavax.com Near - Term Vaccine Pipeline Significant Opportunities for Future Development Clinical Development Conducted by Novavax Therapeutic Area Name Preclinical Phase 1 Phase 2 Phase 3 Marketed Coronavirus NVX - CoV2373 (Booster) Variant Strain (Monovalent and / or Bivalent) Seasonal Influen

  71. Slide 71: Novavax contact details

    71 novavax.com 21 Firstfield Road Gaithersburg, MD 20878 United States novavax.com ir@novavax.com

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