Novavax, Inc. · NASDAQ:NVAX
Novavax — Investor Presentation (September 2020)
26 slides from Novavax's investor presentation, Sep 10, 2020
Slide 1: Corporate Overview and Investor Deck
Nasdaq: NVAX | September 10, 2020 Corporate Overview and Investor Deck
Slide 2: Safe Harbor Statement
2 novavax.com 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 meani
Slide 3: Recent progress leading to significant opportunity
3 novavax.com 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 Balance sheet strengthened significantly with ~ $610M in cash at June 30;
Slide 4: Novavax vaccine pipeline
4 novavax.com Novavax vaccine pipeline PHASE 1 PHASE 2 PHASE 3 CLINICAL PRECLINICAL PROGRAM DESCRIPTION ResVax™ - RSV F Vaccine - Infants via Maternal Immunization RSV F Vaccine - Older Adults (60+ yrs) RSV F Vaccine - Pediatrics (6 mos – 5 yrs) Combination Influenza/RSV F Vaccine - Older Adults (60
Slide 5: NVX-CoV2373 vaccine program
5 novavax.com NVX - CoV2373 vaccine program
Slide 6: Recombinant nanoparticle technology platform and Matrix-M combined to create NVX-CoV2373
6 novavax.com Recombinant nanoparticle technology platform and Matrix - M™ combined to create NVX - CoV2373 and address global public health threat Matrix - M, a potent and well - tolerated adjuvant broadens immune responses and offers potential dose - sparing Platform combines the power and speed o
Slide 7: NVX-CoV2373: full-length, prefusion stabilized SARS-CoV-2 spike glycoprotein + Matrix-M
7 novavax.com Bangaru S. et al, bioRxiv , 2020.08.06.234674; doi : https:// doi.org /10.1101/2020.08.06.234674 Tian et al., bioRxiv , July 2020 SARS - CoV - 2 Protein Spike • Full - length native confirmation trimer nanoparticle formulated with Matrix - M • Liquid formulation in vials, stable at 2 °
Slide 8: NVX-CoV2373 in cynomolgus macaques
8 novavax.com NVX - CoV2373 in cynomolgus macaques 100% wild - type neutralization Lower airway protection Upper airway protection 2.5 g 25 g 5 g 50 g 25 g 50 g Conv n=33 10 1 10 2 10 3 10 4 10 5 1 0 0 % S A R S - C o V - 2 N e u t r a l i z i n g ( C P E A s s a y ) LOD NVX CoV2373 Matr
Slide 9: NVX-CoV2373 is stable and will utilize the standard cold chain
9 novavax.com NVX - CoV2373 is stable and will utilize the standard cold chain NVX - CoV2373 binding to hACE2 under stress conditions Tian et al., bioRxiv , July 2020, bioRxiv 2020.06.29.178509; doi : https:// doi.org /10.1101/2020.06.29.178509
Slide 10: Phase 1/2 published in NEJM
10 novavax.com Phase 1/2 published in NEJM “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.” New England Journal of
Slide 11: NVX-CoV2373 Phase 1 clinical trial conclusions
11 novavax.com NVX - CoV2373 Phase 1 clinical trial conclusions Data demonstrates a dose independent response • Both dosage levels induce high and comparable levels of IgG – dose - sparing • IgG levels compared favorably to those seen in convalescent serum • 100% IgG seroconversion rate • Adjuvant r
Slide 12: Two doses of vaccine induce high levels of IgG
12 novavax.com 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 (95% CI:
Slide 13: Wild-type neutralization titers
13 novavax.com Covid - 19 Convalescent Sera (Baylor) GMT 983 (95% CI 579; 1,670) A: Placebo Day 35 GMT 20 (95% CI: 20; 20) B: 2 dose 25 ug (no adjuvant) Day 35 GMT 41 (95% CI: 28; 62) C: 2 doses 5 ug + Matrix - M Day 35 GMT 3,906 (95% CI: 2,556; 5,970) D: 2 doses 25 ug + Matrix - M Day 35 GMT 3,305
Slide 14: Adjuvant and two dose effects: MN at Day 35
14 novavax.com Adjuvant and Two Dose Effects: MN at Day 35 Unadjuvanted Two Dose Adjuvanted One Dose Adjuvanted Two Dose The majority vaccinated develop high neutralizing antibodies 25 µg Unadjuvanted Two Doses 5 µg Adjuvanted Two Doses Placebo 25 µg Adjuvanted One Dose 25 µg Adjuvanted Two Doses
Slide 15: Wild-type neutralizing titer kinetics to day 49: persistence of immunity
15 novavax.com Placebo 25ug x 2 doses (no Matrix - M) 25ug + 50ug Matrix - M x 1 dose 25ug + 50ug Matrix - M x 2 dose 5ug + 50ug Matrix - M x 2 dose 100% wild - type neutralizing titer kinetics to day 49: persistence of immunity
Slide 16: Intracellular cytokine staining: antigen-specific CD4+ T cells analysis
16 novavax.com Intracellular cytokine staining Ag - Specific CD4 + T cells analysis Th1 response detected as predicted by non - clinical data Group D Th1 Response Th 2 Response Group D Th1 Response Th 2 Response Th1 Response Th 2 Response Th1 Response Th 2 Response
Slide 17: Localized symptoms
17 novavax.com Localized symptoms • The majority of localized reactogenicity symptoms were mild Solicited Localized Symptoms Overall, reactogenicity was mild, and vaccinations were well - tolerated There were no vaccine refusals or dropouts due to systemic reactions
Slide 18: Systemic symptoms
18 novavax.com Systemic symptoms • Reactogenicity increased after Dose 2 • Average duration of reactions <2 days • Majority of reported symptoms remained at ≤ 1 grade (mild or none) Solicited Systemic Symptoms
Slide 19: Rapid vaccine development endorsed by funding awards
19 novavax.com Novavax ’ rapid vaccine development demonstrates clinical expertise, endorsed by funding awards to deliver product by the end of 2020 CEPI funding up to $388M received NVX - CoV2373 vaccine candidate identified SARS - CoV - 2 sequence published April May Jan Phase 1 clinical trial ini
Slide 20: Network of established supply chain partners to target significant capacity in 2021
20 novavax.com Network of established supply chain partners to target significant capacity in 2021 Antigen production Matrix M™ production Novavax AB FujiFilm NC FujiFilm TX PolyPeptide Group AGC Biologics Novavax CZ PolyPeptide Group AGC Biologics Vaccine distribution & license agreement Serum Inst
Slide 21: Early agreements for NVX-CoV2373
21 novavax.com Early agreements for NVX - CoV2373: Ongoing discussions focused on ensuring global access U.S. Government (OWS, DoD) HMG, Government of UK Government of India Government of Japan Government of Canada Republic of South Korea LMIC (CEPI and BMGF)
Slide 22: Upcoming milestones to deliver NVX-CoV2373 to the global market
22 novavax.com 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 Expansion of manufacturing capabilities and global sup
Slide 23: NanoFlu vaccine program
23 novavax.com www.website.com NanoFlu ™ vaccine program
Slide 24: NanoFlu addresses the need for greater and broader immune responses
24 novavax.com NanoFlu ™ addresses the need for greater and broader immune responses Enhances biologic functions to generate potent, robust, and long - lasting protective immune responses Eliminates egg adaptive changes to strains and resulting mismatch between vaccine and circulating viruses Provid
Slide 25: NanoFlu progress continues
25 novavax.com • Demonstrated immunologic HAI antibody responses against all four vaccine strains 2020 U.S. policy objectives encouraging innovative technologies support the need for a new market offering Opportunity for a differentiated flu vaccine brand in a commoditized market with increasing dem
Slide 26: Financial overview
26 novavax.com Financial overview • Strong financial position • Significant funding expected to support activities through Phase 3 clinical trial results for COVID - 19 vaccine development * As of June 30, 2020, ** As of the close on August 31, 2020. Cash and equivalents* > $600 million Market capit