Nasdaq: NVAX | June 2020 - Novavax
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
Safe harbor statement
Certain information, particularly information relating to future performance and other business matters, including expectations regarding clinical
development, our planned use of the proceeds from the offering, market opportunities and anticipated milestones constitute forward-looking
statements within the meaning of the Private Securities Litigation Reform Act.
Forward-looking statements may generally contain words such as “believe,” “may,” “could,” “will,” “possible,” “can,” “estimate,” “continue,”
“ongoing,” “consider,” “intend,” “indicate,” “plan,” “project,” “expect,” “should,” “would,” or “assume” or variations of such words or other words
with similar meanings. Novavax cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties that
change over time and may cause actual results to differ materially from the results discussed in the forward-looking statements.
Uncertainties include but are not limited to clinical trial results, dependence on third party contractors, competition for clinical resources and
patient enrollment and risks that we may lack the financial resources to fund ongoing operations.
Additional information on Risk Factors are contained in Novavax’ filings with the U.S. Securities and Exchange Commission, including our Annual
Report on Form 10-K for the year ended December 31, 2018, our Quarterly Reports on Form 10-Q, and our Current Reports on Form 8-K, which are
all available at http://www.sec.gov.
Forward-looking statements are based on current expectations and assumptions and currently available data and are neither predictions nor
guarantees of future events or performance.
Current results may not be predictive of future results.
You should not place undue reliance on forward-looking statements which speak only as of the date hereof.
The Company does not undertake to update or revise any forward-looking statements after they are made, whether as a result of new
information, future events, or otherwise, except as required by applicable law.
Prepare, ResVax, Matrix-M, and NanoFlu are trademarks of Novavax, Inc.
novavax.com 2Significant opportunities for value creation
NanoFlu™ Phase 3 clinical trial achieves all primary endpoints
• US BLA to be submitted under FDA’s accelerated approval pathway
Coronavirus vaccine candidate; Initiated Phase 1 clinical trial in May
• Preliminary results expected in July
Recombinant protein nanoparticle technology
• Novel Matrix-M™ adjuvant technology
Pharmaceutical partnership discussions ongoing
novavax.com 34
Novavax vaccine pipeline
PROGRAM DESCRIPTION PRECLINICAL CLINICAL
PHASE 1 PHASE 2 PHASE 3
Matrix-M
NanoFlu™ – Nanoparticle Seasonal Influenza Vaccine - Older Adults (65+ yrs)
Matrix-M
NVX-CoV2373 – Coronavirus vaccine candidate
ResVax™ - RSV F Vaccine - Infants via Maternal Immunization*
Matrix-M
RSV F Vaccine - Older Adults (60+ yrs)
RSV F Vaccine - Pediatrics (6 mos – 5 yrs)
Matrix-M
Combination Influenza/RSV F Vaccine - Older Adults (60+ yrs)
Matrix-M
Ebola GP Vaccine
Completed Phase 3– March 2020 Successfully achieved all primary endpoints and achieved
*Supported by the $89.1 million grant from the Bill and Melinda Gates Foundation.
statistical significance in key secondary endpoints
novavax.com 4Coronavirus disease 2019
COVID 19 Pandemic - A global public health threat
• Global protection for 2nd and 3rd waves may be required
• Demand of 6-8 billion doses globally– estimated by BMGF, CEPI, WHO and
BARDA
• Potential need for a seasonal vaccine, similar to influenza
*Coronavirus image CDC Library
novavax.com 6Accelerating NVX-CoV2373 advances worldwide efforts
to address COVID pandemic
• In preclinical studies, NVX-CoV2373 demonstrated high immunogenicity and
stimulated high levels of neutralizing antibodies
• Initiated first-in-human trial in May; preliminary results are expected in July 2020
• GMP clinical production initiated at Emergent BioSolutions
• Acquired Praha Vaccines for large scale global manufacturing; capacity over 1 billion
doses
• Secured up to $388M external funding from CEPI to fund and advance NVX-CoV2373
to clinical research and manufacturing
novavax.com 7Novavax proven expertise in developing emerging
infectious disease vaccines
Novavax’ prior experience with emerging Safe and effective recombinant
infectious disease vaccines positions us expression system and Matrix-M
well for current COVID-19 crisis vaccine adjuvant
• Developed 2 prior coronavirus vaccines; SARS, • Matrix-M likely to induce higher titers, high
MERS affinity neutralizing antibodies and optimal
antigen dose-sparing
• Both 100% protective in challenge models
Recently announced positive Phase 3 GMP manufacturing initiated
results for its NanoFlu vaccine
candidate • GMP clinical production initiated at
Emergent BioSolutions
• NVX-CoV2373 based on same recombinant
protein nanoparticle platform and Matrix-M • Matrix-M production readily scalable to
adjuvant as NanoFlu program meet pandemic needs
novavax.com 8
CONFIDENTIALNVX-CoV2373 candidate entering Phase 1 clinical trial
Preclinical results
• Created several candidates; evaluated in animal models with collaborators (University of Maryland)
• Identified NVX-CoV2373, SARS-CoV-2 candidate, for Phase 1 clinical trials
• NVX-CoV2373 demonstrated high immunogenicity and stimulated high levels of neutralizing antibodies
• Provided strong evidence that the vaccine candidate will be highly immunogenic in humans with the
potential to protect from COVID-19, thus helping to control the spread of this disease
Clinical plans initiated
• Initiated first-in-human trial in May
• Preliminary human results for NVX-CoV2373 are anticipated in July
novavax.com 9CONFIDENTIAL
10
NVX-CoV2373 generated a strong immune response and
stimulated high levels of neutralizing antibodies
Anti-SARS-CoV-2 rS IgG vs receptor inhibition antibodies
(A) very immunogenic; (B) antibodies block spike protein binding
A A n ti-S A R S -C o V -2 rS Ig G T ite r: + M a trix M 1 G ro u p s B 7 0 2 - 0 9 0 S t u d y : h A C E 2 In h ib it io n T it e r
10 7 1 g 3 Q -2 P
CoV2373 10 g 3 Q -2 P 10000
CoV2373 D13
D21
1 g 3Q
A n t i- S A R S C o V - 2 r S Ig G T it e r
6
10
10 g 3 Q
5 0 % h A C E 2 In h ib itio n T ite r
1000
10 5
100
10 4
10 3 10
10 2
1
3Q 3Q 3 Q -2 P 3 Q -2 P
1g 10g 1g 10g
10 1
Da y 0 Da y 13 Da y 21
P o o l S e r u m ( + M a t r ix G r o u p )
Immunization at day 0, 14, serology at day 13, 21
novavax.com 10NVX-CoV2373: Neutralizing antibodies
NVX-CoV2373 induced antibodies neutralize wild-type
SARs-CoV-2 virus after 1st dose; 8-fold increase after 2nd dose
SARs-CoV-2 virus Neutralization Titers
Key early development milestones: RBD D13
BV2373
• stable and immunogenic RBD D28
• key role of Matrix-M confirmed
BV2365 D13
BV2365 D28
• induction of neutralizing antibodies BV2373 D13
BV2373 D28
Prebleed
10 40 160 640 2560 10240
Source: Matt Frieman (University of Maryland School of Medicine)
novavax.com 11Novavax at the forefront of fighting a COVID pandemic
Novavax has a viable immunogenic vaccine candidate (NVX-CoV2373) against
SARS-CoV-2
Novavax is experienced at rapid vaccine development under pandemic
circumstances
NVX-CoV2373 leverages the same technology platform and uses the same adjuvant
as vaccines with proven efficacy for influenza, ebola and previous corona viruses
Novavax research and manufacturing capacity made possible through partnerships
with CEPI, Emergent and need emphasized by BMGF, CEPI, WHO and BARDA
novavax.com 12NanoFlu
w w w . w e b s i t e . c o m
program
update
novavax.com 13Influenza older adult U.S. market >$2B
Total U.S. and
U.S. Market 5 EU Major Markets
Population >65 Medicare Reimbursement Vaccination Rate
~62M $55
estimated Medicare
60-90% $2B >$4B
# of U.S. older adults vaccination assumes 60% vaccination
in 2023 allowable pricing for rate current & CDC goal rate and all dosing is with
older adults flu vaccine premium-priced older adults
in 2023 flu vaccines
Major markets include: U.S., U.K., Italy, France, Spain, Germany
novavax.com 142019 Presidential Executive Order encourages
influenza vaccine innovation
Critical policy objectives include:
• Reducing the reliance on egg-based influenza vaccine production
• Expanding alternative methods
• Advancing the development of new, broadly protective vaccine candidates
Recombinant influenza vaccines specifically cited as a necessary innovation with the
potential to cut production time and improve efficacy
Novavax supports this order and is advocating for appropriate funding and government
resources to deliver on the Administration’s commitment
novavax.com 15Flu is not just another cold
Number of deaths
40,231
Motor vehicle accidents
2017
47,600
Opioid overdose
2017
79,400
Influenza
2017-2018 season
0 10K 20K 30K 40K 50K 60K 70K 80K 90K
Based on data from the Centers for Disease Control and Prevention (2018a), National Safety Council (2018), and Scholl, et al. (2019)
novavax.com 162018-2019 U.S. flu season demonstrates need for
improved vaccine effectiveness in older adults
Vaccine effectiveness by strain in older adults
Circulating Virus 40%
% of vaccine effectiveness (VE)
35%
34%
30%
25%
20%
15% 16%
13%
10% 12%
5%
A/H3N2 A/H1N1 B/Yamagata B/Victoria Lineage not subtyped 0%
Overall A/H1N1 A/H3N2 B Viruses*
Centers for Disease Control and Prevention, National Center for Immunization and Respiratory Diseases (NCIRD), * B Virus VE is across all ages
November, 2019. Flannery et al, 2019
novavax.com 17Two issues contribute to poor flu vaccine
effectiveness1
Antigenic Egg adaptation
evolution and drift Viruses are modified to grow
better in chicken eggs
Vaccines are derived from
recommended strains, but when Over multiple egg-growth
viruses “drift” – natural genetic passages, these changes can
evolution – vaccines may not result in mismatch between
protect as well vaccine and circulating viruses
Image Source: https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm336267.htm
Adapted from CDC Grand Rounds. January 16, 2018. https://www.cdc.gov/cdcgrandrounds/pdf/archives/2018/january2018.pdf
1MMWR / June 21, 2019 / Vol. 68 / No. 24
novavax.com 18NanoFlu: A novel flu vaccine
• Recombinant nanoparticle
• Non-egg based
• Adjuvanted with Matrix-M
• Exact genetic match to
recommended vaccine strains
PROVIDES GREATER
~87% of flu Novavax is advancing NanoFlu is AND BROADER
vaccine doses are an improved flu vaccine differentiated… IMMUNE RESPONSES
egg-based1
1. CDC Grand Rounds. January 16, 2018. https://www.cdc.gov/cdcgrandrounds/pdf/archives/2018/January2018
novavax.com 19NanoFlu program: Rapid evolution and diversity
of H3N2 requires a better vaccine
Phylogeny
Epitope mutations ^
A/Cardiff/508/19
A/CA/94/19
A/Singapore/2016
A/Tokyo/EH1801/18
A/Swiz/8060/17
A/Neth/1268/19
A/HK/4801/14
A/Kansas/14/17 x A/ID/13/18
2013 2014 2015 2016 2017 2018 2019
novavax.com 20NanoFlu
w w w . w e b s i t e . c o m
Phase 3
results
novavax.com 21NanoFlu Phase 3 clinical trial goals and design
• To demonstrate the non-inferior immunogenicity of NanoFlu, relative to Fluzone® Quadrivalent, in terms of hemagglutination
Primary inhibition (HAI) antibody responses to all vaccine homologous influenza strains at Day 28.
objectives
• To describe the safety profile of NanoFlu and Fluzone
• To describe the immunogenicity with both egg-propagated virus and wild-type VLP reagents to all four vaccine-homologous
influenza strains and to select drifted strains at Day 28.
Secondary
• To describe the immunogenicity in terms of microneutralization (MN) responses to vaccine-homologous and/or antigenically
objectives drifted influenza strains at Day 0 and 28
• To describe the quality and amplitude of cell-mediated immune (CMI) responses in a subset of participants
Randomized, observer-blinded, active-comparator controlled trial
Design
• WHO-recommended 2019-2020 Northern Hemisphere influenza vaccine strains.
Vaccine strains
A/Brisbane (H1N1); A/Kansas (H3N2); B/Maryland (Victoria); B/Phuket (Yamagata)
Investigational and comparator • Hemagglutinin nanoparticle influenza vaccine, quadrivalent with Matrix-M ™ adjuvant
vaccines (quad-NIV) [NanoFlu]
• Quadrivalent inactivated influenza vaccine (IIV4) [Fluzone]
Stratification • History of receipt of 2018-2019 influenza vaccine
• 2,650 clinically stable adults >65 years of age
Participants
• Randomized 1:1 (NanoFlu : Fluzone), Single vaccination at Day 0
Study sites • 19 U.S. sites
Length of study participation • 1 year (safety assessment through 1 year)
novavax.com 22NanoFlu Phase 3 clinical trial conclusions
Primary endpoint met: demonstrated immunologic non-inferiority to Fluzone in terms
of hemagglutination inhibition (HAI) antibody responses (assayed with egg-derived
virus reagents) against all four vaccine homologous strains (per CBER criteria).
Statistically significant higher HAI antibody responses (assayed with wild-type VLP
reagents) compared to Fluzone:
• 24—66% improved Day 28 GMTs against homologous strains
• 34—41% improved Day 28 GMTs against drifted H3N2 strains
• 11.4—20.4% increased Day 28 seroconversion rate against homologous strains
• 14.1—16.8% increased Day 28 seroconversion rate against drifted H3N2 strains
NanoFlu was well-tolerated
novavax.com 23Immunogenicity: Primary endpoint GMT
Egg - based Day 28 HAI GMTs and GMT ratios (NanoFlu / Fluzone)
NanoFlu Fluzone Quad D28 GMT Ratio
Assay Strain D28 GMT D28 GMT (NanoFlu / Fluzone) 95% CI
HAI: EGG A/Brisbane/02/2018 (H1N1) pdm09 (Homologous) 49.3 45.0 1.09 ( 1.03, 1.15) Success:
All 95% CI
A/Kansas/14/2017 (H3N2) (Homologous) 151.5 126.8 1.19 ( 1.11, 1.27) lower
bounds are
B/Maryland/15/2016 (Vic) (Homologous) 110.7 106.3 1.03 ( 0.99, 1.07) ≥ 0.67
B/Phuket/3073/2013 (Yam) (Homologous) 168.5 133.9 1.23 ( 1.16, 1.29)
✓ GMT ratio success criteria met
✓ NanoFlu: 3—23% improved responses using egg-based HAI
novavax.com 24Immunogenicity: Primary and secondary GMT endpoints
Egg- or wild-type VLP- based Day 28 HAI GMTs and GMT ratios (NanoFlu / Fluzone)
NanoFlu Fluzone Quad D28 GMT Ratio
Assay Strain D28 GMT D28 GMT (NanoFlu / Fluzone) 95% CI
HAI: EGG A/Brisbane/02/2018 (H1N1) pdm09 (Homologous) 49.3 45.0 1.09 ( 1.03, 1.15)
A/Kansas/14/2017 (H3N2) (Homologous) 151.5 126.8 1.19 ( 1.11, 1.27)
B/Maryland/15/2016 (Vic) (Homologous) 110.7 106.3 1.03 ( 0.99, 1.07)
B/Phuket/3073/2013 (Yam) (Homologous) 168.5 133.9 1.23 ( 1.16, 1.29)
HAI: VLP A/Brisbane/02/2018 (H1N1) pdm09 (Homologous) 76.6 62.7 1.24 ( 1.17, 1.32)
A/Kansas/14/2017 (H3N2) (Homologous) 153.6 90.7 1.66 ( 1.53, 1.79)
B/Maryland/15/2016 (Vic) (Homologous) 62.8 47.2 1.32 ( 1.26, 1.39)
B/Phuket/3073/2013 (Yam) (Homologous) 118.3 78.4 1.47 ( 1.40, 1.55)
✓ NanoFlu: 24—66% improved responses using VLP-based HAI
✓ “Superiority” criteria met for homologous H3N2 (66% better)
novavax.com 25Immunogenicity: Effect on drifted strains (GMT)
Egg- or wild-type VLP- based Day 28 HAI GMTs and GMT ratios (NanoFlu / Fluzone)
NanoFlu Fluzone Quad D28 GMT Ratio
Assay Strain D28 GMT D28 GMT (NanoFlu / Fluzone) 95% CI
HAI: EGG A/Brisbane/02/2018 (H1N1) pdm09 (Homologous) 49.3 45.0 1.09 ( 1.03, 1.15)
A/Kansas/14/2017 (H3N2) (Homologous) 151.5 126.8 1.19 ( 1.11, 1.27)
B/Maryland/15/2016 (Homologous) 110.7 106.3 1.03 ( 0.99, 1.07)
B/Phuket/3073/2013 (Homologous) 168.5 133.9 1.23 ( 1.16, 1.29)
HAI: VLP A/Brisbane/02/2018 (H1N1) pdm09 (Homologous) 76.6 62.7 1.24 ( 1.17, 1.32)
A/Kansas/14/2017 (H3N2) (Homologous) 153.6 90.7 1.66 ( 1.53, 1.79)
B/Maryland/15/2016 (Homologous) 62.8 47.2 1.32 ( 1.26, 1.39)
B/Phuket/3073/2013 (Homologous) 118.3 78.4 1.47 ( 1.40, 1.55)
A/California (“Drifted” H3N2) 115.0 80.6 1.41 ( 1.33, 1.50)
A/Cardiff (“Drifted” H3N2) 63.9 45.4 1.34 ( 1.27, 1.43)
A/Netherlands (“Drifted” H3N2) 102.3 74.7 1.38 ( 1.30, 1.46)
A/South Australia (“Drifted” H3N2) 98.1 70.4 1.36 ( 1.28, 1.44)
✓ NanoFlu: 34—41% improved responses on drifted H3N2s using VLP-based HAI
novavax.com 26Immunogenicity: Primary endpoint seroconversion
Egg- based Day 28 HAI GMTs and GMT ratios (NanoFlu / Fluzone)
NanoFlu Fluzone Quad Absolute SCR Difference
NanoFlu -
Assay Strain SCR SCR Fluzone Quad 95% CI
HAI:EGG A/Brisbane/02/2018 (H1N1) pdm09 (Homologous) 22.0% (282/1280) 17.0% (219/1286) 5.0 ( 1.9, 8.1)
Success:
A/Kansas/14/2017 (H3N2) (Homologous) 41.8% (535/1280) 34.4% (443/1286) 7.3 ( 3.6, 11.1) All 95% CI
lower
bounds are
B/Maryland/15/2016 (Vic) (Homologous) 11.2% (143/1280) 10.7% (137/1286) 0.5 ( -1.9, 2.9)
≥ -10
B/Phuket/3073/2013 (Yam) (Homologous) 31.3% (401/1280) 22.9% (294/1286) 8.5 ( 5.0, 11.9)
✓ Seroconversion (SCR) difference success criteria met
✓ NanoFlu: 0.5—8.5% increased SCR using egg-based HAI
novavax.com 27Immunogenicity: Seroconversion
Egg- or wild-type VLP- based Day 28 HAI GMT ratios (NanoFlu / Fluzone)
NanoFlu Fluzone Quad Absolute SCR Difference
NanoFlu - Fluzone
Assay Strain SCR SCR Quad 95% CI
HAI:EGG A/Brisbane/02/2018 (H1N1) pdm09 (Homologous) 22.0% (282/1280) 17.0% (219/1286) 5.0 ( 1.9, 8.1)
A/Kansas/14/2017 (H3N2) (Homologous) 41.8% (535/1280) 34.4% (443/1286) 7.3 ( 3.6, 11.1)
B/Maryland/15/2016 (Vic) (Homologous) 11.2% (143/1280) 10.7% (137/1286) 0.5 ( -1.9, 2.9)
B/Phuket/3073/2013 (Yam) (Homologous) 31.3% (401/1280) 22.9% (294/1286) 8.5 ( 5.0, 11.9)
HAI:VLP A/Brisbane/02/2018 (H1N1) pdm09 (Homologous) 32.7% (419/1280) 21.4% (275/1286) 11.4 ( 7.9, 14.7)
A/Kansas/14/2017 (H3N2) (Homologous) 69.8% (894/1280) 49.5% (636/1286) 20.4 ( 16.6, 24.1)
B/Maryland/15/2016 (Vic) (Homologous) 25.1% (321/1280) 13.5% (173/1286) 11.6 ( 8.6, 14.6)
B/Phuket/3073/2013 (Yam) (Homologous) 35.4% (453/1280) 17.7% (228/1286) 17.7 ( 14.3, 21.0)
✓ NanoFlu: 11.4—20.4% increased SCR using VLP-based HAI
novavax.com 28Immunogenicity: Seroconversion including drifted strains
Egg- or wild-type VLP- based Day 28 HAI GMTs and GMT ratios (NanoFlu / Fluzone)
NanoFlu Fluzone Quad Absolute SCR Difference
NanoFlu - Fluzone
Assay Strain SCR SCR Quad 95% CI
HAI:EGG A/Brisbane/02/2018 (H1N1) pdm09 (Homologous) 22.0% (282/1280) 17.0% (219/1286) 5.0 ( 1.9, 8.1)
A/Kansas/14/2017 (H3N2) (Homologous) 41.8% (535/1280) 34.4% (443/1286) 7.3 ( 3.6, 11.1)
B/Maryland/15/2016 (Vic) (Homologous) 11.2% (143/1280) 10.7% (137/1286) 0.5 ( -1.9, 2.9)
B/Phuket/3073/2013 (Yam) (Homologous) 31.3% (401/1280) 22.9% (294/1286) 8.5 ( 5.0, 11.9)
HAI:VLP A/Brisbane/02/2018 (H1N1) pdm09 (Homologous) 32.7% (419/1280) 21.4% (275/1286) 11.4 ( 7.9, 14.7)
A/Kansas/14/2017 (H3N2) (Homologous) 69.8% (894/1280) 49.5% (636/1286) 20.4 ( 16.6, 24.1)
B/Maryland/15/2016 (Vic) (Homologous) 25.1% (321/1280) 13.5% (173/1286) 11.6 ( 8.6, 14.6)
B/Phuket/3073/2013 (Yam) (Homologous) 35.4% (453/1280) 17.7% (228/1286) 17.7 ( 14.3, 21.0)
A/California (“Drifted” H3N2) 37.1% (475/1280) 20.5% (264/1286) 16.6 ( 13.1, 20.0)
A/Cardiff (“Drifted” H3N2) 32.7% (419/1280) 18.6% (239/1286) 14.1 ( 10.8, 17.5)
A/Netherlands (“Drifted” H3N2) 38.4% (492/1280) 21.7% (278/1284) 16.8 ( 13.3, 20.2)
A/South Australia (“Drifted” H3N2) 34.4% (440/1280) 19.6% (252/1284) 14.7 ( 11.3, 18.1)
✓ NanoFlu: 14.1—16.8% increased SCR using VLP-based HAI
novavax.com 29Topline safety
Safety events (through Day 28) NanoFlu Fluzone Quad (SD)
N 1333 1319
Counts (%) of Subjects with Events
Any treatment emergent adverse event 659 (49.4) 551 (41.8)
(TEAE)
Any Solicited TEAE 551 (41.3) 420 (31.8)
Local solicited 372 (27.9) 243 (18.4)
Severe local solicited 8 (0.6) 2 (0.2)
Systemic Solicited 369 (27.7) 292 (22.1)
Severe systemic solicited 15 (1.1) 11 (0.8)
Unsolicited TEAE 248 (18.6) 241 (18.3)
Severe unsolicited 23 (1.7) 12 (0.9)
Severe & related unsolicited 10 (0.8) 2 (0.2)
Medically-attended unsolicited 99 (7.4) 104 (7.9)
Serious adverse events (SAEs) 11 (0.8) 5 (0.4)
novavax.com 30NanoFlu Phase 3 clinical trial conclusions
Primary endpoint met: demonstrated immunologic non-inferiority to Fluzone in terms
of hemagglutination inhibition (HAI) antibody responses (assayed with egg-derived
virus reagents) against all four vaccine homologous strains (per CBER criteria).
Statistically significant higher HAI antibody responses (assayed with wild-type VLP
reagents) compared to Fluzone:
• 24—66% improved Day 28 GMTs against homologous strains
• 34—41% improved Day 28 GMTs against drifted H3N2 strains
• 11.4—20.4% increased Day 28 seroconversion rate against homologous strains
• 14.1—16.8% increased Day 28 seroconversion rate against drifted H3N2 strains
NanoFlu was well-tolerated
novavax.com 31Significant opportunities for value creation
NanoFlu™ Phase 3 clinical trial achieves all primary endpoints
• US BLA to be submitted under FDA’s accelerated approval pathway
Coronavirus vaccine candidate; Initiated Phase 1 clinical trial in May
• Preliminary results expected in July
Recombinant protein nanoparticle technology
• Novel Matrix-M™ adjuvant technology
Pharmaceutical partnership discussions ongoing
novavax.com 32novavax.com 33
You can also read