Novavax, Inc. · NASDAQ:NVAX
Novavax — Investor Presentation (May 2021)
42 slides from Novavax's investor presentation, May 2021
Slide 1: Corporate Overview and Investor Deck
CORPORATE OVERVIEW AND INVESTOR DECK Nasdaq: NVAX | May 2021
Slide 2: Safe Harbor Statement
Certain information, particularly information relating to future performance and other business matters, including expectations regarding clinical development, market opportunities and anticipated milestones constitute forward-looking statements within the meaning of the Private Securities Litigatio
Slide 3: Novavax at-a-Glance
Novavax at-a-Glance 10+ years $2+ billion of Nanoparticle Vaccine Development in Funding Secured to Date 150 million 50,000+ Doses per Month Participants Enrolled in Manufacturing Capacity by 4Q 2021* COVID-19 Clinical Trials 96% ~800 Efficacy Demonstrated Employees Globally Against Original COVID-1
Slide 4: Strong Momentum Continues
Strong Momentum Continues Confirmed high efficacy of NVX-CoV2373 against original COVID-19, as well as widely circulating variant strains Advanced key areas of product development, including PREVENT-19 study, variant strain vaccine candidates and combination vaccines Expanded manufacturing capacity
Slide 5: NVX-CoV2373 Progress Built Upon Years of Vaccine Research
NVX-CoV2373 Progress Built Upon Years of Vaccine Research novavax.com 5
Slide 6: Recombinant Nanoparticle Technology Platform and Matrix-M Adjuvant
Recombinant Nanoparticle Technology Platform and Matrix-M™ Adjuvant Combined to Create Vaccines That Address Global Public Health Threats Coronavirus uses Spike Recombinant Spike Matrix-M adjuvant helps Recombinant nanoparticle protein to attach and protein nanoparticles stimulate a robust, protecti
Slide 7: NVX-CoV2373: Full-length Stabilized Prefusion Spike Glycoprotein + Matrix-M
NVX-CoV2373: A Full-length, Stabilized Prefusion SARS-CoV-2 Spike (S) Glycoprotein + Matrix-M™ Adjuvant • Full-length, native conformation Spike protein trimer configured in a nanoparticle • Formulated with Matrix-M adjuvant • Highly immunogenic • Spike protein is a validated Transmission Electron M
Slide 8: Novavax Technology Highlighted in Recent Peer-Reviewed Publications
Novavax Technology Highlighted in Recent Peer-Reviewed Publications novavax.com 8
Slide 9: NVX-CoV2373 Clinical Development Overview
NVX-CoV2373 Clinical Development Overview novavax.com 9
Slide 10: NVX-CoV2373 Clinical Development Overview
NVX-CoV2373 Clinical Development Overview PHASE PHASE PHASE PHASE 1/2 2b 3 3 US & AUSTRALIA SOUTH AFRICA UNITED KINGDOM US & MEXICO (PREVENT-19) n = 131 n = 4,404 n = 15,203 n ~ 30,000 18-59 years 18-65 years 18-84 years Phase 1 ≥18 years (n=245 HIV+) (n=400 co-admin with flu Enrollment Complete vac
Slide 11: Robust Antibody Response Demonstrated at Day 35
Robust Antibody Response Demonstrated at Day 35 2 doses + Matrix-M™ adjuvant* 100,000 Phase 1/2 US & Australia 10,000 Convalescent Sera Anti-Spike IgG (Log10EU/mL) 1,000 100 Placebo 25µg 25µg + Matrix-M 5µg + Matrix-M 25µg + Matrix-M Placebo 25µg Placebo 5µg + Matrix-M 25µg + Matrix-M *Matrix-MTM re
Slide 12: Robust Immune Response
Robust Immune Response 2 doses + Matrix-M™ adjuvant Phase 1/2 US & Australia 100,000 2 doses: 5µg + Matrix-M adjuvant Antibody levels at 6 months are within the 2 doses: 25µg + Matrix-M adjuvant range of recently recovered patients 10,000 Convalescent Sera Anti-Spike IgG (Log10EU/mL) 1 dose: 25µg +
Slide 13: 6-Month Boost
6-Month Boost Phase 2 US & Australia • Select participants in the 5µg dose cohorts received booster doses • Two treatment groups were boosted at 6 months: § Group 1: received 5µg on day 0 • Randomized received 5µg vs placebo at day 186 § Group 2: received 5µg on day 0 and day 21 • Randomized receive
Slide 14: Key Takeaways from Phase 2b Study in South Africa
Key Takeaways from Phase 2b Study in South Africa Conducted in a context of greater than 90% variant virus Primary Efficacy • 55% efficacy in HIV-negative population Endpoint Achieved: (95% of study participants) 49% in Overall Trial • 51% efficacy against B.1.351 escape Population variant* (first d
Slide 15: Key Takeaways from Phase 3 Study in the UK
Key Takeaways from Phase 3 Study in the UK • 96% efficacy against original COVID-19 • 86% efficacy against B.1.1.7 variant Primary Efficacy (first described in UK) Endpoint Achieved: • 89% efficacy in participants ≥ 65 years of 90% Overall Efficacy age • 91% efficacy in participants with high- risk
Slide 16: Events Were Infrequent and Balanced
Events Were Infrequent and Balanced Summary of events1 through Day 7 after Dose 1 & 2 (n=15,139) Phase 3 UK NVX-CoV2373 Treatment Emergent MAAEs Placebo 2 Any Severe TEAEs Any Serious TEAEs Events were infrequent and balanced between vaccine Vaccination Discontinuations and placebo groups. Study Dis
Slide 17: Local Symptoms: Majority None or Mild
Local Symptoms: Majority “None” or “Mild” Phase 3 UK Mild Moderate Severe Life Threatening Dose 1 0% 20% 40% 60% 80% 100% 0% 20% 40% 60% 80% 100% 0% 20% 40% 60% 80% 100% 0% 20% 40% 60% 80% 100% Any local symptom Any localPlacebo symptom NVX-CoV2373 Any local symptom Any local symptom Tenderness Tend
Slide 18: Systemic Symptoms: Majority None or Mild
Systemic Symptoms: Majority “None” or “Mild” Phase 3 UK Mild Moderate Severe Life Threatening Dose 1 0% 20% 40% 60% 80% 100% 0% 20% 40% 60% 80% 100% 0% 20% 40% 60% 80% 100% 0% 20% 40% 60% 80% 100% Any systemic symptom Placebo Any systemic symptom NVX-CoV2373 Any systemic symptom Any systemic symptom
Slide 19: Key Takeaways from Phase 3 UK and Phase 2b South Africa Trials
Key Takeaways from Phase 3 UK and Phase 2b South Africa Clinical Trials Efficacy ü Achieved statistical success criteria in both trials ü High efficacy confirmed against multiple strains of COVID-19 ü 100% protection against severe disease Safety ü Favorable safety profile Ongoing Development ü Cros
Slide 20: PREVENT-19 Phase 3 Update
PREVENT-19 Phase 3 Update 20% Latin American ~30K participants enrolled (13% Older Adults) Blinded crossover underway 12% African American Pediatric extension underway 1-5 sites 6% Native American 6-10 sites 11-15 sites 5% Asian American novavax.com 20
Slide 21: PREVENT-19 Phase 3 Trial Crossover Ongoing
PREVENT-19 Phase 3 Trial Crossover Ongoing Randomized, observer-blinded, placebo-controlled trial evaluating efficacy, immunogenicity and safety 5 µg + 50 µg Matrix-M™ adjuvant Placebo (2 injections: Day 0 and Day 21) 30,000 2 injections 21 days apart R n = ~20,000 Adults 2:1 >18 years Placebo 5 µg
Slide 22: PREVENT-19 Phase 3 Pediatric Extension
PREVENT-19 Phase 3 Pediatric Extension Randomized, observer-blinded, placebo-controlled trial evaluating safety, efficacy and effectiveness 5 µg + 50 µg Matrix-M™ adjuvant (2 injections: Day 0 and Day 21) ~3,000 n = ~2,000 Adolescents R 2:1 12-17 years Placebo (2 injections: Day 0 and Day 21) n = ~1
Slide 23: Pathway to Regulatory Approvals
Pathway to Regulatory Approvals UK Medicines and Healthcare products Regulatory Agency US Food and Drug Administration • Rolling reviews in various markets Australian Therapeutic Goods Administration • Ongoing discussions with FDA through submissions to open IND European Medicines Agency • Anticipat
Slide 24: Clinical Development Conducted by Partners
Clinical Development Conducted by Partners NVX-CoV2373 Phase 1/2 Japan Phase 2 Com-COV2 Phase 2/3 India n = 1,050 n = 200 n = 1,600 ≥ 50 years ≥ 20 years (n=350 NVX-CoV2373 admin) 18-65 years Enrollment Complete Conducted by University of Oxford Enrollment Complete in Phase 2 Cohort Sponsored by Tak
Slide 25: Variant Strain Vaccine Clinical Development
Variant Strain Vaccine Clinical Development novavax.com 25
Slide 26: Variant Vaccines Under Development Against Emerging COVID-19 Variants
Variant Vaccines Under Development Against Emerging COVID-19 Variants Development underway for new constructs against emerging strains, using both variant and bivalent approaches Evaluated B.1.351 variant strain vaccine candidate as one year booster in preclinical study • Demonstrated strong functio
Slide 27: Response in Baboons Immunized 1 Year Ago
Response in Baboons Immunized 1 Year Ago Boost: 3µg B.1.351 rS + 50µg Matrix-M™ adjuvant Prime/Boost Boost Original strain Variant strain Dose 1 Dose 2 Dose 1 Dose 2 10000000 1000000 Geometric mean of 1, 5 or 25µg NVX-CoV2373 7 days after dose + 50µg Matrix-M™ adjuvant 100000 Anti-rS IgG Titer EC50
Slide 28: ACE2 Receptor Inhibition Increases After Boost at 1 Year
Ace2 Receptor Inhibition Increases After Boost at 1 Year Boost: 3µg B.1.351 rS + 50µg Matrix-M™ adjuvant US-WU1 (Original) B.1.351 Spike Spike Inhibition Inhibition 10000 10000 Priming Regimen 50% Receptor Inhibition Titer 50% Receptor Inhibition Titer 1000 1000 Geometric mean of 1, 5 or 25µg NVX-Co
Slide 29: NVX-CoV2373 Manufacturing & Distribution
NVX-CoV2373 Manufacturing & Distribution novavax.com 29
Slide 30: Practical Benefits Enabling Efficient Distribution
Practical Benefits Enabling Efficient Distribution Presentation • 10-dose vials Transportation & Storage • Stable at 2 to 8°C Administration • Ready to use • Well-characterized technology Large Global Capacity platform; Dose-sparing novavax.com 30
Slide 31: Global Supply Chain Established
Global Supply Chain Established Annual capacity of approx. 150 million* doses per month starting in 4Q 2021 PolyPeptide Group AGC Biologics Biologics Jubilant Manufacturing Novavax AB HollisterStier Centre GSK Par Sterile FujiFilm SK AGC Products UK Novavax Novavax CZ Bioscience Biologics Biofabri H
Slide 32: Agreements Executed for NVX-CoV2373
Agreements Executed for NVX-CoV2373 Ensuring fair and equitable global access Gavi / COVAX Facility* Commitment to US Government • Finalized APA with Gavi • NVAX to provide 350 million doses • Doses committed to US ~1.1 billion • Serum Institute to provide 110 million government in relation to doses
Slide 33: NanoFlu and Combination Vaccine Programs
NanoFlu™ and Combination Vaccine Programs novavax.com 33
Slide 34: NanoFlu Addresses the Need for Greater and Broader Immune Responses
NanoFlu™ Addresses the Need for Greater and Broader Immune Responses Recombinant nanoparticle technology and Matrix-M™ adjuvant Next-generation flu vaccine for improved protection Provides broader Eliminates egg-adaptive Enhances immune protection against strain changes that response to generate ant
Slide 35: Ongoing Development of Combination Vaccine Candidates
Ongoing Development of Combination Vaccine Candidates Advanced NanoFlu™ / NVX-CoV2373 combination vaccine candidate into preclinical studies Vaccine candidate induced strong functional antibodies in animal models comparable to vaccination with standalone vaccines Expect to initiate clinical evaluati
Slide 36: NanoFlu/NVX-CoV2373 Combination Vaccine: Robust Immune Responses
NanoFlu™/NVX-CoV2373 Combination Vaccine: Robust Immune Responses, Protection Against COVID-19 • Hemagglutination inhibition (HAI) and ACE2 receptor-inhibiting titers were comparable between immunization with the combination vaccine and with component vaccines • Maintained clinical and virologic pro
Slide 37: Summary
Summary novavax.com 37
Slide 38: Leveraging Our Differentiated Platform to Build for the Future
Leveraging Our Differentiated Platform to Build for the Future Short-Term Protection against variants • Emergency authorization of NVX-CoV2373 in multiple markets • Expansive distribution of NVX-CoV2373 Highly adaptable platform Near-Term • Leveraging NVX-CoV2373 as a booster and for seasonal revacc
Slide 39: Key Upcoming Milestones
Key Upcoming Milestones Execute ongoing product development for NVX-CoV2373, including PREVENT-19, pediatric studies and ongoing booster/crossover studies Finalize preparations across our global supply chain to ensure successful commercial roll-out of NVX-CoV2373 Gain authorization of NVX-CoV2373 fr
Slide 40: Pipeline Overview
Pipeline Overview novavax.com 40
Slide 41: Near-Term Vaccine Pipeline
Near-Term Vaccine Pipeline Significant opportunities for future development Therapeutic Area Name Preclinical Phase 1 Phase 2 Phase 3 Marketed NVX-CoV2373 (Booster) Coronavirus Variant Strain (Monovalent and / or Bivalent) NanoFlu Seasonal Influenza (Older Adults) (Pre-BLA) NanoFlu / NVX-CoV2373 Com
Slide 42: novavax.com ir@novavax.com
21 Firstfield Road Gaithersburg, MD 20878 United States novavax.com ir@novavax.com novavax.com 42