Novavax, Inc. · NASDAQ:NVAX
Novavax — Investor Presentation (September 2020)
27 slides from Novavax's investor presentation, Sep 16, 2020
Slide 1: Corporate Overview and Investor Deck
Corporate Overview and Investor Deck Nasdaq: NVAX | September 16, 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, Australia and others initiating globally Over $2 billion in funding for global coronavirus vaccine program; Multiple collaboration
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: NVX-CoV2373 clinical development plan
NVX-CoV2373 clinical development plan Study 1 CEPI Phase 1 AU Adults N=131, 18-59 years Part 1 (2019nCoV-101) Safety Study 1 Immunogenicity CEPI Phase 2 AU/US Adults N=1,500 (n=750 >60 years) Part 2 (2019nCoV-101) Includes Efficacy 1 2 Assessment Study 2 BMGF (2019nCoV-501) Phase 2b South Africa N=2
Slide 13: 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 14: 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 15: Adjuvant and 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 15
Slide 16: 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 16
Slide 17: 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 17
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: 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 3 initiating Phase 2 preliminary data ‘Q4 2020 Positive Phase 1 data announced August Novavax and FujiFilm Diosynth initiated large scale manufacturing July $1.6
Slide 21: Global supply chain with annual capacity of over 2 billion doses
Global supply chain established with annual capacity of over 2 billion* doses starting in 2021 AGC Biologics Novavax AB PolyPeptide Group FujiFilm UK AGC Novavax CZ Biologics Novavax HQ MD Takeda Biofabri SK biosciences FujiFilm NC PolyPeptide Group FujiFilm TX Serum Institute Vaccine distribution &
Slide 22: 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 22
Slide 23: Upcoming milestones to deliver NVX-CoV2373 to the global market
Upcoming milestones to deliver NVX-CoV 2373 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 October to support BLA filing UK Phase 3 efficacy trial: initiating September Expa
Slide 24: NanoFlu vaccine program
w w w . w e b s i t e . c o m NanoFlu™ vaccine program novavax.com 24
Slide 25: 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 26: 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 27: 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