Novavax, Inc. · NASDAQ:NVAX
Novavax — Investor Presentation (December 2020)
35 slides from Novavax's investor presentation, Dec 1, 2020
Slide 1: Corporate Overview and Investor Deck
Corporate Overview and Investor Deck Nasdaq: NVAX | December 1, 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 NVX-CoV2373 coronavirus vaccine candidate: Phase 3 efficacy study in U.K. fully enrolled; Phase 2b efficacy study in South Africa fully enrolled Over $2 billion in funding for global coronavirus vaccine program; Multiple collaboration and supply agr
Slide 4: Novavax vaccine pipeline
Novavax vaccine pipeline PROGRAM DESCRIPTION PRECLINICAL CLINICAL COMMERCIAL PHASE 1 PHASE 2 PHASE 3 PRE BLA Matrix-M NVX-CoV2373 – Coronavirus Matrix-M NanoFlu™ – Nanoparticle Seasonal Influenza - Older Adults (65+ yrs) Matrix-M Combination NVX-CoV2373/NanoFlu Matrix-M Combination NanoFlu/RSV F (60
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 high35neutralizing antibodies 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: Solicited 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: Solicited 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 Phase 1 AU Adults N=131 , 18-59 years CEPI Part 1 (2019nCoV-101) Enrollment complete Safety Immunogenicity 1 Includes Efficacy STUDY 1 Phase 2 AU/US Adults N=1,288 (n=600 >60 years) CEPI Part 2 (2019nCoV-101) Assessment Enrollment complete STUDY 2 BMGF 2
Slide 21: Phase 2 design and status
Phase 2 design and status Partner: CEPI Expanded safety and dose confirmation Sponsor: Novavax USA & Australia — N=1,288 | Adults ages 18-84 years (~50% 60-84 years) Placebo 5 µg + Matrix-M1 5 µg + Matrix-M1 25 µg + Matrix-M1 25 µg + Matrix-M1 n=255 n=258 n=256 n=259 n=255 Day 0 5 µg + 5 µg + 25 µg
Slide 22: Phase 2 Local Reactogenicity Events
Phase 2 Local Reactogenicity Events in 2 Dose adjuvanted groups Partner: CEPI 2 Dose adjuvanted groups compared to placebo Worst grade reported for 7 days after each dose: raw blinded data Oct 5 cut-off Sponsor: Novavax Grade 0 Grade 1 Grade 2 Grade 3 100% • Pain and Vaccination 1 75% Tenderness rep
Slide 23: Phase 2 Systemic Reactogenicity Events
Phase 2 Systemic Reactogenicity Events in 2 Dose adjuvanted groups 2 Dose adjuvanted groups compared to placebo Partner: CEPI Worst grade reported for 7 days after each dose: raw blinded data Oct 5 cut-off Sponsor: Novavax Grade 0 Grade 1 Grade 2 Grade 3 Grade 4 100% • Fatigue, Headache and Myalgia
Slide 24: UK Phase 3 randomized, observer-blinded, placebo-controlled trial
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 25: Study objectives
Study objectives Primary endpoint: First occurrence of virologically confirmed UK Phase 3 clinical (by PCR to SARS-CoV-2), symptomatic mild, trial evaluating the moderate, or severe COVID-19 with onset at least 7 days after second study vaccination efficacy, safety and (e.g., Day 28) in serologicall
Slide 26: U.S. / Mexico Phase 3 Design and Status
U.S. / Mexico Phase 3 Design and Status Partner: OWS/CoVPN Pivotal Safety and Efficacy Sponsor: Novavax • Study design and execution consistent with OWS Tenets • Study design harmonized with other Phase 3 COVID studies • Common immunologic and diagnostic assays, DSMB, secondary/exploratory endpoints
Slide 27: NVX-CoV2373 Summary
NVX-CoV2373 Summary • Vaccine based on the baculovirus/nanoparticle platform technology • Safety database includes >12,100 nanoparticle vaccinees • Safety database includes >2,500 nanoparticle vaccinees adjuvanted with Matrix-M1 • Ten-dose vial with transportation and storage at 2-8o C • Preservativ
Slide 28: Vaccine development expertise, funding awards and manufacturing scale-up have resulted in progress
Novavax’ vaccine development expertise, funding awards and manufacturing scale-up have resulted in significant progress to date Granted Fast Track Status November Phase 2 preliminary data September Phase 3 UK clinical trial initiated August Positive Phase 1 data announced Novavax and FujiFilm Diosyn
Slide 29: Global supply chain established 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 FujiFilm UK PolyPeptide Group AGC Par Pharma Biologics Novavax HQ MD Novavax CZ Takeda Biofabri SK bioscience FujiFilm NC PolyPeptide Group FujiFilm TX Serum Institute Novavax faci
Slide 30: Agreements for NVX-CoV2373: ensuring global access
Agreements for NVX-CoV2373: Ongoing discussions focused on ensuring global access Government Republic of of Canada South Korea Government Government of India of UK U.S. Government Government of (OWS, DoD) Japan LMIC (CEPI and BMGF) Government of Australia novavax.com 30
Slide 31: Upcoming milestones to deliver NVX-CoV2373 to the global market
Upcoming milestones to deliver NVX-CoV2373 to the global market U.K. Phase 3 efficacy trial: fully enrolled and interim data expected as early 1Q 2021; U.S./Mexico Phase 3 efficacy trial initiation in coming weeks Phase 2 data from clinical trial in Australia and US in 1Q 2021 to advance regulatory
Slide 32: NanoFlu vaccine program
w w w . w e b s i t e . c o m NanoFlu™ vaccine program novavax.com 32
Slide 33: 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 34: 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 35: Financial overview
Financial overview Financial position • Strong financial position Cash and > $572 million • Significant funding equivalents* expected to support Market activities through $8.8 billion capitalization** Phase 3 clinical trial results for COVID-19 vaccine development * As of September 30, 2020 ** As of