Novavax, Inc. · NASDAQ:NVAX
Novavax — Investor Presentation (October 2020)
30 slides from Novavax's investor presentation, Oct 27, 2020
Slide 1: Corporate Overview and Investor Deck
Corporate Overview and Investor Deck Nasdaq: NVAX | October 27, 2020
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: Recent progress leading to significant opportunity
Recent progress leading to significant opportunity Recent positive Phase 1 results for coronavirus vaccine candidate, NVX-CoV2373; Phase 2 clinical trial ongoing in US and Australia; UK Phase 3 efficacy trial ongoing and others initiating globally Over $2 billion in funding for global coronavirus va
Slide 4: Novavax vaccine pipeline
. Novavax vaccine pipeline PROGRAM DESCRIPTION PRECLINICAL CLINICAL PHASE 1 PHASE 2 PHASE 3 Matrix-M NVX-CoV2373 – Coronavirus Vaccine Candidate Matrix-M NanoFlu™ – Nanoparticle Seasonal Influenza Vaccine - Older Adults (65+ yrs) ResVax™ - RSV F Vaccine - Infants via Maternal Immunization Matrix-M R
Slide 5: NVX-CoV2373 vaccine program
NVX-CoV2373 vaccine program novavax.com 5
Slide 6: Recombinant nanoparticle technology platform and Matrix-M combined to create NVX-CoV2373
Recombinant nanoparticle technology platform and Matrix-M™ combined to create NVX-CoV2373 and address global public health threat Novavax TECHNOLOGY PLATFORMS Enhance immune responses and stimulate high levels of neutralizing antibodies Platform combines the Matrix-M, a potent and power and speed of
Slide 7: NVX-CoV2373: full-length, prefusion stabilized spike glycoprotein + Matrix-M
NVX-CoV2373: A full-length, prefusion stabilized SARS-CoV-2 spike (S) glycoprotein + Matrix-M™ • Full-length native confirmation trimer nanoparticle formulated with Matrix-M • Liquid formulation in vials, stable at SARS-CoV-2 2°C to 8°C Protein Spike Bangaru S. et al, bioRxiv, 2020.08.06.234674; doi
Slide 8: NVX-CoV2373 in cynomolgus macaques
NVX-CoV2373 in cynomolgus macaques Induced sterile immunity that prevented viral replication in the upper and lower respiratory tracts in experimentally challenged macaques 100% wild-type neutralization Lower airway protection Upper airway protection B A L s g R N A c o p ie s /m L N a s a l S w a b
Slide 9: NVX-CoV2373 binding to hACE2 under stress conditions
NVX-CoV2373 binding to hACE2 under stress conditions NVX-CoV2373 is stable and will utilize the standard cold chain Tian et al., bioRxiv, July 2020, bioRxiv 2020.06.29.178509; doi: https://doi.org/10.1101/2020.06.29.178509 novavax.com 9
Slide 10: Phase 1/2 published in NEJM
Phase 1/2 published in NEJM New England Journal of Medicine CONCLUSION: “At 35 days, NVX-CoV2373 appeared to be safe, and it elicited immune responses that exceeded levels in Covid-19 convalescent serum. The Matrix-M1 adjuvant induced CD4+ T-cell responses that were biased toward a Th1 phenotype.” n
Slide 11: NVX-CoV2373 Phase 1 clinical trial conclusions
NVX-CoV2373 Phase 1 clinical trial conclusions Data demonstrates a dose Wild-type neutralization Strong T cells Phase 1 demonstrated independent response levels numerically superior to response with reassuring safety and • Both dosage levels induce convalescent serum adjuvanted vaccine reactogenicit
Slide 12: Anti-S IgG ELISA units/ml
Anti-S IgG ELISA units/ml 2 doses of vaccine induces high levels of IgG Covid-19 Convalescent Sera (Baylor) GMEU 8,344 (95% CI 4,420; 15,747) A: Placebo Day 35 GMEU 113 (95% CI: 94; 138) B: 2 dose 25 ug (no adjuvant) Day 35 GMEU 575 (95% CI: 332; 999) C: 2 doses 5 ug + Matrix-M Day 35 GMEU 63,160 (9
Slide 13: Wild-type neutralization titers
Wild-type neutralization titers Vaccine responses compared favorably with HCS in patients with clinically significant disease 7,457 3,906 3,305 Covid-19 Convalescent Sera (Baylor) 837 GMT 983 (95% CI 579; 1,670) A: Placebo 254 Day 35 GMT 20 (95% CI: 20; 20) B: 2 dose 25 ug (no adjuvant) Day 35 GMT 4
Slide 14: Adjuvant and Two Dose Effects
Adjuvant and Twovaccinated The majority Dose Effects:develop MN at Day 35neutralizing antibodies high 25 µg Adjuvanted Two Doses 25 µg Adjuvanted One Dose Unadjuvanted Adjuvanted Adjuvanted 5 µg Adjuvanted Two Dose One Dose TwoTwo Dose Doses 25 µg Unadjuvanted Two Doses Placebo novavax.com 14
Slide 15: 100% wild-type neutralizing titer kinetics to day 49
100% wild-type neutralizing titer kinetics to day 49: persistence of immunity 5ug + 50ug Matrix-M x 2 dose 25ug + 50ug Matrix-M x 2 dose 25ug + 50ug Matrix-M x 1 dose 25ug x 2 doses (no Matrix-M) Placebo novavax.com 15
Slide 16: Intracellular cytokine staining Ag-Specific CD4+ T cells analysis
Intracellular cytokine staining Ag-Specific CD4+ T cells analysis Th1 response detected as predicted by non-clinical data Th1 Response Th 2 Response Th1 Response Th 2 Response Group D Th1 Response Th 2 Response Th1 Response Th 2 Response Group D novavax.com 16
Slide 17: High level safety summary
High level safety summary • No serious adverse events • Adverse events of Special Interest • No PIMMC AESI • No confirmed COVID-19 AESIs • Treatment emergent adverse events • All mild and moderate and balanced in active arms • Solicited reactogenicity symptoms • Overall, reactogenicity was mild, and
Slide 18: Localized symptoms
Solicited Localized Symptoms Overall, reactogenicity was mild, and vaccinations were well-tolerated There were no vaccine refusals or dropouts due to systemic reactions Localized symptoms • The majority of localized reactogenicity symptoms were mild novavax.com 18
Slide 19: Systemic symptoms
Solicited Systemic Symptoms Systemic symptoms • Reactogenicity increased after Dose 2 • Average duration of reactions <2 days • Majority of reported symptoms remained at ≤ 1 grade (mild or none) novavax.com 19
Slide 20: NVX-CoV2373 clinical development plan
NVX-CoV2373 clinical development plan STUDY 1 CEPI Part 1 (2019nCoV-101) Phase 1 AU Adults N=131 , 18-59 years Safety STUDY 1 Phase 2 AU/US Adults N=1,500 (n=750 >60 years) Immunogenicity CEPI Part 2 (2019nCoV-101) Includes Efficacy 1 2 Assessment Partner/Funder BMGF STUDY 2 2019nCoV-501 Phase 2b So
Slide 21: UK Phase 3 trial design
UK Phase 3, randomized, observer-blinded, placebo-controlled designed to evaluate the efficacy, immunogenicity and safety of NVX-CoV2373 Trial regimen assesses 5 µg dose level with 50 µg Matrix M vaccine adjuvant UK P3 clinical trial: N= up to 15,000 | Adults ages 18-84 years (25% > age 65) Placebo
Slide 22: Study objectives
Study objectives Primary endpoints: PCR-confirmed symptomatic COVID-19 with onset at least 7 days after the second study UK Phase 3 clinical vaccination in volunteers who have not trial evaluating the been previously infected with SARS-CoV-2 efficacy, safety and Or immunogenicity of PCR-confirmed sy
Slide 23: Rapid vaccine development endorsed by funding awards
Novavax’ rapid vaccine development demonstrates clinical expertise, endorsed by funding awards to deliver product by the end of 2020 Phase 2 preliminary data ‘Q4 2020 Phase 3 UK clinical trial initiated September Positive Phase 1 data announced August Novavax and FujiFilm Diosynth initiated large sc
Slide 24: Global supply chain with annual capacity over 2 billion doses starting in 2021
Global supply chain established with annual capacity of over 2 billion* doses starting in 2021 AGC Biologics Novavax AB FujiFilm UK PolyPeptide Group AGC Par Pharma Biologics Novavax HQ MD Novavax CZ Takeda Biofabri SK biosciences FujiFilm NC PolyPeptide Group FujiFilm TX Serum Institute Vaccine dis
Slide 25: Early agreements for NVX-CoV2373
Early agreements for NVX-CoV2373: Ongoing discussions focused on ensuring global access Government Republic of of Canada South Korea Government HMG, of India Government of UK U.S. Government Government of (OWS, DoD) Japan LMIC (CEPI and BMGF) novavax.com 25
Slide 26: Upcoming milestones to deliver NVX-CoV2373 to the global market
Upcoming milestones to deliver NVX-CoV2373 to the global market Interim data from Phase 2 clinical trial in Australia and US in 4Q 2020 to advance regulatory strategy Global pivotal Phase 3 efficacy trial: initiating end of November to support BLA filing UK Phase 3 efficacy trial: initiated Septembe
Slide 27: NanoFlu vaccine program
w w w . w e b s i t e . c o m NanoFlu™ vaccine program novavax.com 27
Slide 28: NanoFlu addresses the need for greater and broader immune responses
NanoFlu™ addresses the need for greater and broader immune responses via recombinant nanoparticle technology and Matrix-M adjuvant Novavax NanoFlu™ Next generation flu vaccine for improved protection Provides broader Eliminates egg adaptive Enhances biologic protection against changes to strains and
Slide 29: NanoFlu progress continues
NanoFlu progress continues Phase 3 immunogenicity data demonstrated the development of robust T cell-mediated responses, differentiating NanoFlu from leading licensed vaccines • Demonstrated immunologic HAI antibody responses against all four vaccine strains The combination of these results will for
Slide 30: Financial overview
Financial overview Financial position • Strong financial position Cash and > $600 million • Significant funding equivalents* expected to support Market activities through $6.8 billion capitalization** Phase 3 clinical trial results for COVID-19 vaccine development * As of June 30, 2020, ** As of the