Novavax, Inc. · NASDAQ:NVAX
Novavax — J.P. Morgan 39th Annual Healthcare Conference - Virtual (January 2021)
35 slides from Novavax's conference presentation, Jan 11, 2021
Slide 1: J.P. Morgan 39th Annual Healthcare Conference - Virtual
Nasdaq: NVAX | January 2021 J.P. MORGAN 39 TH ANNUAL HEALTHCARE CONFERENCE - VIRTUAL
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: Agenda
3 novavax.com Agenda • Review of NVX - CoV2373 development • Unique and differentiated vaccine platform • Clinical development program update • Manufacturing and commercial plans • Financial summary
Slide 4: NVX-CoV2373 Overview
4 novavax.com NVX - CoV2373 Overview
Slide 5: 2020 NVX-CoV2373 Key Accomplishments
5 novavax.com 2020 NVX - CoV2373 Key Accomplishments DISCOVERY CLINICAL MANUFACTURING FUNDING SARS - CoV - 2 Sequence Published US DoD Funding Praha Vaccines Acquired to Expand Global Supply Chain Large - Scale Manufacturing Initiated Phase 1 - 2 Clinical Trial Initiated Positive Phase 1 Data Announ
Slide 6: 2021: A Pivotal Year for Novavax
6 novavax.com 2021: A Pivotal Year for Novavax • Phase 2b South Africa data readout • Phase 3 UK data readout • PREVENT - 19 trial (Phase 3 US/Mexico trial); complete enrollment and data readout • Finalize multiple Advance Purchase Agreements • Gain authorization for use in UK, US, EU and other coun
Slide 7: NVX-CoV2373 Progress Built Upon Years of Vaccine Research
7 novavax.com NVX - CoV2373 Progress Built Upon Years of Vaccine Research
Slide 8: Recombinant Nanoparticle Technology Platform and Matrix-M
8 novavax.com Recombinant Nanoparticle Technology Platform and Matrix - M™ Combined to Create Vaccines That Address Global Public Health Threats Matrix - M adjuvant provides the danger signal to the immune cells, leading to higher quantity and quality immunity Recombinant protein nanoparticles mimic
Slide 9: SARS-CoV-2 Full Length Spike Protein
9 novavax.com SARS - CoV - 2 Full Length Spike Protein • Full - length, natively configured spike protein trimer in a detergent nanoparticle • Formulated with Matrix - M • Highly immunogenic • Spike protein is a validated target NVX - CoV2373: A full - length, prefusion stabilized SARS - CoV - 2 spi
Slide 10: Technology and Programs Validated Through Peer-Reviewed Publications in 2020
10 novavax.com Novavax Technology and Programs Validated Through Peer - Reviewed Publications in 2020
Slide 11: NVX-CoV2373 Protected Lower & Upper Airways in Rhesus Macaques
11 novavax.com NVX - CoV2373 Protected Lower & Upper Airways in Rhesus Macaques No viral replication observed following Day 38 challenge with WT SARS - CoV - 2 2 4 2 4 2 4 1 2 3 4 5 6 s g R N A G e n e E c o p i e s / m L w a s h f l u i d ( l o g 1 0 ) Placebo Days Post Challenge 25g vaccine+50g Ma
Slide 12: NVX-CoV2373 Clinical Development Plan Overview
12 novavax.com NVX - CoV2373 Clinical Development Plan Overview
Slide 13: NVX-CoV2373 Clinical Development Plan
13 novavax.com NVX - CoV2373 Clinical Development Plan US & AUSTRALIA PHASE 1 - 2 PHASE 2b PHASE 3 PHASE 3 SOUTH AFRICA UNITED KINGDOM US & MEXICO (PREVENT - 19) n = 4,404 18 - 65 years (n=245 HIV+) Enrollment Complete Data Expected Q1 ’21 n = 15,203 18 - 84 years (n=400 co - admin with flu vaccine)
Slide 14: NVX-CoV2373 Phase 1-2 Study (US & Australia)
14 novavax.com NVX - CoV2373 Phase 1 - 2 Study (US & Australia)
Slide 15: US and Australia Phase 1 Study Design
15 novavax.com US and Australia Phase 1 Study Design 5 µg + 50 µg Matrix - M™ (2 injections: Day 0 and Day 21) n = 131 Adults 18 - 59 years R 25 µg + 50 µg Matrix - M (2 injections: Day 0 and Day 21) Placebo (2 injections: Day 0 and Day 21) N= 258 Placebo (Day 21) 25 µg + 50 µg Matrix - M (Day 0) N=
Slide 16: Phase 1: Robust Anti-S IgG and Neutralization Responses at Day 35
16 novavax.com Phase 1: Induction of Robust Levels of Anti - S IgG and 100% Neutralization Responses at Day 35 GMEU 63,160 47,521 8,344 95% CI (47,117; 84,666) (33,803; 66,804) (4, 420 ; 15,747) GMT 3,906 3,305 983 95% CI (2,556; 5,970) (2,205; 4,953) (579 ; 1 ,670) *Convalescent Sera donated by Dr
Slide 17: Phase 1: Robust Immune Response Through Six Months
17 novavax.com Phase 1: Robust Immune Response Through Six Months Matrix - M TM required for optimal immune response; 2 adjuvanted doses superior to 1 dose Matrix - M is dose - sparing Phase 1: n = 131; 18 - 59 years of age; Vaccination on Day 0 and D21 (pre - publication) Placebo 2 Doses: 25 µg (no
Slide 18: US and Australia Phase 2 Study Design
18 novavax.com US and Australia Phase 2 Study Design Includes ~50% of adults age 60 - 84 years 5 µg + 50 µg Matrix - M™ (2 injections: Day 0 and Day 21) n = 1,288 Adults > 18 years 25 µg + 50 µg Matrix - M (2 injections: Day 0 and Day 21) Placebo (2 injections: Day 0 and Day 21) 5 µg + 50 µg Matrix
Slide 19: Phase 2: Strong Immune Response in All Age Groups
19 novavax.com Phase 2: Strong Immune Response in All Age Groups 2 Matrix - M™ - adjuvanted doses of 5 µg and 25 µ g induced comparable, robust immune responses Consistent with Phase 1 data 5 µg Phase 2: n =1288; ≥ 18 years of age (n = 583 >60 years of age) ( pre - publication) 2 Doses: 25 µg + Matr
Slide 20: Phase 2 Local Reactogenicity: Well-tolerated
20 novavax.com • Pain and Tenderness reported most frequently • Rates after Dose 2 were higher in adjuvanted groups Percent of Participants Reporting Reactogenicity • Reactogenicity attenuated in adults >60 years of age Phase 2 Local Reactogenicity: Well - tolerated Many participants experienced no
Slide 21: Phase 2 Systemic Reactogenicity: Well-tolerated
21 novavax.com 0% 25% 50% 75% 100% 0% 25% 50% 75% 100% Phase 2 Systemic Reactogenicity: Well - tolerated Many participants experienced no reactions, and when they did occur, all were mild - to - moderate in severity with a mean duration ~2 Days • Fatigue, Headache and Myalgia reported most frequentl
Slide 22: Phase 1-2 Summary: 5 µg Dose Well-tolerated, Strong Responses
22 novavax.com Phase 1 - 2 Summary: Confirms 5 µg Dose is Well - tolerated, with Strong and Consistent Responses • Consistent results from Phase 1 and Phase 2 • Confirms 5 µg dose for late - stage development • Immunogenicity ▪ High levels of antibody maintained through six months (Phase 1) ▪ Antibo
Slide 23: NVX-CoV2373 Phase 2b Study (South Africa)
23 novavax.com NVX - CoV2373 Phase 2b Study (South Africa)
Slide 24: South Africa Phase 2b Fully Enrolled
24 novavax.com South Africa Phase 2b Fully Enrolled Preliminary Data Expected Early Q1 5 µg + 50 µg Matrix - M™ (2 injections: Day 0 and Day 21) n = ~2,200 Placebo (2 injections: Day 0 and Day 21) n = ~2,200 4,400 Adults 18 - 65 years (n=245 HIV+) R 1:1 • Enrollment population includes a cohort of 2
Slide 25: NVX-CoV2373 UK Phase 3 Study
25 novavax.com NVX - CoV2373 UK Phase 3 Study
Slide 26: UK Phase 3 Fully Enrolled
26 novavax.com UK Phase 3 Fully Enrolled Preliminary Data Expected Early Q1 5 µg + 50 µg Matrix - M™ (2 injections: Day 0 and Day 21) n = ~7,500 Placebo (2 injections: Day 0 and Day 21) n = ~7,500 15,000 Adults > 18 years 25% > age 65 R 1:1 Randomized, observer - blinded, placebo - controlled trial
Slide 27: NVX-CoV2373 PREVENT-19 US & Mexico Phase 3 Study
27 novavax.com NVX - CoV2373 PREVENT - 19 US & Mexico Phase 3 Study
Slide 28: PREVENT-19 Phase 3 Trial Currently Enrolling
28 novavax.com PREVENT - 19 Phase 3 Trial Currently Enrolling Enrollment goals : 25% > age 65 years 15% Black/African American 10 - 20% LatinX 1 - 2% American Indian 5 µg + 50 µg Matrix - M™ (2 injections: Day 0 and Day 21) n = ~20,000 Placebo (2 injections: Day 0 and Day 21) n = ~10,000 n = 30,000
Slide 29: PREVENT-19 Phase 3 Enrollment
29 novavax.com PREVENT - 19 Phase 3 Enrollment OK GA VA NY FL NM TX KS NE SD ND MT WY CO UT ID AZ NV WA CA OR KY ME PA MI MA CT WV OH IN IL NC TN SC AL MS AR LA MO IA MN WI NJ VT NH DC Mexico City Merida Monterrey Guadalajara 5,709 randomized through 1/10/2021 1 - 5 sites 6 - 10 sites 11 - 15 sites
Slide 30: NVX-CoV2373 Manufacturing & Distribution
30 novavax.com NVX - CoV2373 Manufacturing & Distribution
Slide 31: Practical Benefits Enabling Efficient Distribution
31 novavax.com Practical Benefits Enabling Efficient Distribution Presentation • 10 - dose vials Transportation & Storage • Stable at 2 to 8 ° C Administration • Ready to use Large Global Capacity • Well - characterized technology platform; Dose - sparing
Slide 32: Global Supply Chain Established
32 novavax.com Global Supply Chain Established Annual capacity of over 2 billion* doses starting in 2021 Par Pharma AGC Biologics PolyPeptide Group FujiFilm TX FujiFilm NC Novavax HQ MD Biofabri FujiFilm UK AGC Biologics PolyPeptide Group Novavax AB Serum Institute SK Bioscience Takeda Novavax facil
Slide 33: Summary
33 novavax.com Summary
Slide 34: Novavax Summary
34 novavax.com Novavax Summary • Strong financial position and revenue realization ▪ >$2 billion non - dilutive financing through CEPI and OWS ▪ Finalize multiple Advance Purchase Agreements • Phase 3 trials on schedule – with efficacy readouts in early Q1 • Commercial scale manufacturing on track w
Slide 35: Novavax - Creating Tomorrow's Vaccines Today
NOVAVAX Creating Tomorrow's Vaccines Today NOVAVAX novavex.com
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