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 2
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 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 3
4 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 4
Coronavirus 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 6
Accelerating 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 7
Novavax 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 CONFIDENTIAL
NVX-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 9
CONFIDENTIAL 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 10
NVX-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 11
Novavax 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 12
NanoFlu w w w . w e b s i t e . c o m program update novavax.com 13
Influenza 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 14
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 novavax.com 15
Flu 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 16
2018-2019 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 17
Two 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 18
NanoFlu: 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 19
NanoFlu 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 20
NanoFlu w w w . w e b s i t e . c o m Phase 3 results novavax.com 21
NanoFlu 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 22
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 novavax.com 23
Immunogenicity: 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 24
Immunogenicity: 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 25
Immunogenicity: 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 26
Immunogenicity: 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 27
Immunogenicity: 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 28
Immunogenicity: 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 29
Topline 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 30
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 novavax.com 31
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 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 32
novavax.com 33
You can also read