nasdaq: nvax | june 2020 · 6/2/2020 · n o v a v a x . c o m 4 4 *supported by the $89.1 million...

Nasdaq: NVAX | June 2020

2n o v a v a x . c o m

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.


Significant opportunities for value creation

NanoFlu™ Phase 3 clinical trial achieves all primary endpoints

• US BLA to be submitted under FDA’s accelerated approval pathway

Pharmaceutical partnership discussions ongoing

Recombinant protein nanoparticle technology

Coronavirus vaccine candidate; Initiated Phase 1 clinical trial in May

• Novel Matrix-M™ adjuvant technology

• Preliminary results expected in July


4

*Supported by the $89.1 million grant from the Bill and Melinda Gates Foundation.

Novavax vaccine pipeline

PHASE 1 PHASE 2 PHASE 3

CLINICALPRECLINICALPROGRAM DESCRIPTION

NanoFlu™ – Nanoparticle Seasonal Influenza Vaccine - Older Adults (65+ yrs) Matrix-M

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+ yrs)

Ebola GP Vaccine

Matrix-M

Matrix-M

Matrix-M

NVX-CoV2373 – Coronavirus vaccine candidateMatrix-M

Completed Phase 3– March 2020 Successfully achieved all primary endpoints and achieved statistical significance in key secondary endpoints


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mNVX-CoV2373 program update


Coronavirus disease 2019COVID 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


• 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

Accelerating NVX-CoV2373 advances worldwide efforts to address COVID pandemic


Novavax’ prior experience with emerging infectious disease vaccines positions us well for current COVID-19 crisis

• Developed 2 prior coronavirus vaccines; SARS, MERS

• Both 100% protective in challenge models

CONFIDENTIAL

Novavax proven expertise in developing emerging infectious disease vaccines

GMP manufacturing initiated

• GMP clinical production initiated at Emergent BioSolutions

• Matrix-M production readily scalable to meet pandemic needs

Recently announced positive Phase 3 results for its NanoFlu vaccine candidate

• NVX-CoV2373 based on same recombinant protein nanoparticle platform and Matrix-M adjuvant as NanoFlu program

Safe and effective recombinant expression system and Matrix-M vaccine adjuvant

• Matrix-M likely to induce higher titers, high affinity neutralizing antibodies and optimal antigen dose-sparing


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

NVX-CoV2373 candidate entering Phase 1 clinical trial


10CONFIDENTIAL

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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 B

Immunization at day 0, 14, serology at day 13, 21

CoV2373CoV2373


NVX-CoV2373: Neutralizing antibodies

NVX-CoV2373 induced antibodies neutralize wild-type SARs-CoV-2 virus after 1st dose; 8-fold increase after 2nd dose

Key early development milestones:

• stable and immunogenic

• key role of Matrix-M confirmed

• induction of neutralizing antibodies

BV2373

Source: Matt Frieman (University of Maryland School of Medicine)

10 40 160 640 2560 10240

Prebleed

BV2373 D28

BV2373 D13

BV2365 D28

BV2365 D13

RBD D28

RBD D13

SARs-CoV-2 virus Neutralization Titers


Novavax at the forefront of fighting a COVID pandemic

Novavax has a viable immunogenic vaccine candidate (NVX-CoV2373) against SARS-CoV-2

Novavax research and manufacturing capacity made possible through partnerships with CEPI, Emergent and need emphasized by BMGF, CEPI, WHO and BARDA

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 is experienced at rapid vaccine development under pandemic circumstances


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mNanoFlu program update


Influenza older adult U.S. market >$2B

Major markets include: U.S., U.K., Italy, France, Spain, Germany

Population >65 Vaccination RateMedicare Reimbursement

U.S. Market

# of U.S. older adults in 2023

estimated Medicare allowable pricing for

older adults flu vaccine in 2023

$55 ~62M 60-90%vaccination

rate current & CDC goal

Total U.S. and 5 EU Major Markets

>$4B assumes 60% vaccination rate and all dosing is with

premium-priced older adults flu vaccines

$2B


2019 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


Flu is not just another coldNumber of deaths

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)

40,231

47,600

79,400

Motor vehicle accidents 2017

Opioid overdose2017

Influenza2017-2018 season


Circulating Virus

A/H3N2 A/H1N1 B/Yamagata B/Victoria Lineage not subtyped

12%

16%

13%

34%

0%

5%

10%

15%

20%

25%

30%

35%

40%

Overall A/H1N1 A/H3N2 B Viruses

Vaccine effectiveness by strain in older adults

*

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* B Virus VE is across all agesCenters for Disease Control and Prevention, National Center for Immunization and Respiratory Diseases (NCIRD),

November, 2019. Flannery et al, 2019

2018-2019 U.S. flu season demonstrates need for

improved vaccine effectiveness in older adults


Two issues contribute to poor flu vaccine

effectiveness1

Antigenic

evolution and driftVaccines are derived from recommended strains, but when viruses “drift” – natural genetic evolution – vaccines may not protect as well

Egg adaptationViruses are modified to grow better in chicken eggs

Over multiple egg-growth passages, these changes can result in mismatch between vaccine and circulating viruses

Image Source: https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm336267.htmAdapted from CDC Grand Rounds. January 16, 2018. https://www.cdc.gov/cdcgrandrounds/pdf/archives/2018/january2018.pdf1MMWR / June 21, 2019 / Vol. 68 / No. 24

https://www.cdc.gov/cdcgrandrounds/pdf/archives/2018/january2018.pdf


NanoFlu: A novel flu vaccine

1. CDC Grand Rounds. January 16, 2018. https://www.cdc.gov/cdcgrandrounds/pdf/archives/2018/January2018

~87% of flu vaccine doses are

egg-based1

NanoFlu is differentiated…

Novavax is advancing an improved flu vaccine

• Recombinant nanoparticle

• Non-egg based

• Adjuvanted with Matrix-M

• Exact genetic match to recommended vaccine strains

PROVIDES GREATER

AND BROADER

IMMUNE RESPONSES


x

A/Tokyo/EH1801/18

A/Neth/1268/19

2013 2014 2015 2016 2017 2018 2019

A/Kansas/14/17

A/Swiz/8060/17

A/Singapore/2016

A/HK/4801/14

A/ID/13/18

A/CA/94/19

A/Cardiff/508/19

PhylogenyEpitope mutations ^

NanoFlu program: Rapid evolution and diversity of H3N2 requires a better vaccine


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mNanoFlu Phase 3 results


NanoFlu Phase 3 clinical trial goals and design

Primary

objectives

• To demonstrate the non-inferior immunogenicity of NanoFlu, relative to Fluzone® Quadrivalent, in terms of hemagglutination inhibition (HAI) antibody responses to all vaccine homologous influenza strains at Day 28.

• To describe the safety profile of NanoFlu and Fluzone

Secondary

objectives

• 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.

• To describe the immunogenicity in terms of microneutralization (MN) responses to vaccine-homologous and/or antigenically 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

DesignRandomized, observer-blinded, active-comparator controlled trial

Vaccine strains• WHO-recommended 2019-2020 Northern Hemisphere influenza vaccine strains.

A/Brisbane (H1N1); A/Kansas (H3N2); B/Maryland (Victoria); B/Phuket (Yamagata)

Investigational and comparator vaccines

• Hemagglutinin nanoparticle influenza vaccine, quadrivalent with Matrix-M ™ adjuvant (quad-NIV) [NanoFlu]

• Quadrivalent inactivated influenza vaccine (IIV4) [Fluzone]

Stratification • History of receipt of 2018-2019 influenza vaccine

Participants • 2,650 clinically stable adults >65 years of age• 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)


NanoFlu 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


Immunogenicity: Primary endpoint GMT

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)

Egg - based Day 28 HAI GMTs and GMT ratios (NanoFlu / Fluzone)

Success:All 95% CI lower bounds are≥ 0.67

✓ GMT ratio success criteria met ✓ NanoFlu: 3—23% improved responses using egg-based HAI


Immunogenicity: Primary and secondary GMT endpoints


Assay Strain D28 GMT D28 GMT (NanoFlu / Fluzone) 95% CIHAI: EGG A/Brisbane/02/2018 (H1N1) pdm09 (Homologous) 49.3 45.0 1.09 ( 1.03, 1.15)




HAI: VLP A/Brisbane/02/2018 (H1N1) pdm09 (Homologous) 76.6 62.7 1.24 ( 1.17, 1.32)




Egg- or wild-type VLP- based Day 28 HAI GMTs and GMT ratios (NanoFlu / Fluzone)

✓ NanoFlu: 24—66% improved responses using VLP-based HAI✓ “Superiority” criteria met for homologous H3N2 (66% better)



Assay Strain D28 GMT D28 GMT (NanoFlu / Fluzone) 95% CIHAI: EGG A/Brisbane/02/2018 (H1N1) pdm09 (Homologous) 49.3 45.0 1.09 ( 1.03, 1.15)


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)


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

Immunogenicity: Effect on drifted strains (GMT)


NanoFlu Fluzone Quad Absolute SCR Difference

Assay Strain SCR SCR

NanoFlu -

Fluzone Quad 95% CIHAI: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)

Egg- based Day 28 HAI GMTs and GMT ratios (NanoFlu / Fluzone)

Success:All 95% CI lower bounds are ≥ -10

✓ Seroconversion (SCR) difference success criteria met ✓ NanoFlu: 0.5—8.5% increased SCR using egg-based HAI

Immunogenicity: Primary endpoint seroconversion




NanoFlu - Fluzone

Quad 95% CIHAI:EGG A/Brisbane/02/2018 (H1N1) pdm09 (Homologous) 22.0% (282/1280) 17.0% (219/1286) 5.0 ( 1.9, 8.1)




HAI:VLP A/Brisbane/02/2018 (H1N1) pdm09 (Homologous) 32.7% (419/1280) 21.4% (275/1286) 11.4 ( 7.9, 14.7)


B/Maryland/15/2016 (Vic) (Homologous) 25.1% (321/1280) 13.5% (173/1286) 11.6 ( 8.6, 14.6)


Egg- or wild-type VLP- based Day 28 HAI GMT ratios (NanoFlu / Fluzone)

✓ NanoFlu: 11.4—20.4% increased SCR using VLP-based HAI

Immunogenicity: Seroconversion




NanoFlu - Fluzone

Quad 95% CIHAI:EGG A/Brisbane/02/2018 (H1N1) pdm09 (Homologous) 22.0% (282/1280) 17.0% (219/1286) 5.0 ( 1.9, 8.1)




HAI:VLP A/Brisbane/02/2018 (H1N1) pdm09 (Homologous) 32.7% (419/1280) 21.4% (275/1286) 11.4 ( 7.9, 14.7)


B/Maryland/15/2016 (Vic) (Homologous) 25.1% (321/1280) 13.5% (173/1286) 11.6 ( 8.6, 14.6)


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

Immunogenicity: Seroconversion including drifted strains


Topline safety

N 1333 1319

Counts (%) of Subjects with Events

Any treatment emergent adverse event (TEAE)

659 (49.4) 551 (41.8)

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)

NanoFlu Fluzone Quad (SD)Safety events (through Day 28)


NanoFlu 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


Significant opportunities for value creation

NanoFlu™ Phase 3 clinical trial achieves all primary endpoints

• US BLA to be submitted under FDA’s accelerated approval pathway

Pharmaceutical partnership discussions ongoing

Recombinant protein nanoparticle technology

Coronavirus vaccine candidate; Initiated Phase 1 clinical trial in May

• Novel Matrix-M™ adjuvant technology

• Preliminary results expected in July

nasdaq: nvax | june 2020 · 6/2/2020 · n o v a v a x . c o m 4 4 *supported by the $89.1 million...

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