Novavax, Inc. · NASDAQ:NVAX
Novavax — Technical Presentation (February 2019)
27 slides from Novavax's technical presentation, Feb 28, 2019
Slide 1: Prepare Trial Topline Results
Prepare™ Trial Topline Results February 28, 2019
Slide 2: Safe harbor statement
Safe harbor statement Certain information, particularly information relating to future performance and other business matters, including expectatio ns regarding clinical development, our planned use of the proceeds from the offering, market opportunities and anticipated milestones constitute fo rwa
Slide 3: RSV is among the great threats to child health (quote)
“RSV is among the great threats to child health, causing illness and death by inflammatory disease of the lower respiratory tract.” Principals and Practice of Pediatric Infections Diseases, 4 th Edition, 2012, Etiologic Agents of Infectious Diseases H. Cody Meissner, M.D, Chief of the division of pe
Slide 4: Respiratory syncytial virus: largest unmet need for a vaccine-preventable disease
Respiratory syncytial virus Largest unmet need for a vaccine - preventable disease 4 Leading cause of hospitalizations in infants in the U.S., especially in the first 6 months of life 1 Leading cause of death in children under one year of age worldwide 2 # 2 # 1 1. Leader S. J Pediatr . 2003;143:S12
Slide 5: Timing of RSV hospitalizations in infants
5 Timing of RSV hospitalizations in infants 1. Ting S/Nair H. Lancet. 2017/Sep2;390:946 69% of infants <1 year contract RSV 77% of these RSV infections occur before 6 months of age medical interventions 400,000 of infants < 6 months are admitted to the hospital 2 - 4% 1 Adapted from Hall Average Age
Slide 6: Prevention of severe RSV disease
6 Prevention of severe RSV disease Protect infants as early as birth and during the first months of life when they are most at risk for hospitalization Ease of administration during routine OBGyn visit Maternal immunization a proven strategy to protect infants Importance of its safety profile – admi
Slide 7: Maternal vaccination has become a priority
Maternal vaccination has become a priority for expectant mothers, healthcare providers, and policy makers 1. U.S. FDA. Vaccines for Use During Pregnancy to Protect Young Infants from Disease – FDA Update. Available at https://www.fda.gov /aboutfda/transparency/basics/ucm508553.htm. 2. CDC Guidelines
Slide 8: Global footprint
Global footprint Multi - year global trial Enrollment occurred at 87 sites in 11 countries Supported by Bill & Melinda Gates Foundation ($89 million grant) 8
Slide 9: Goals and design
Determine the efficacy of maternal immunization with the RSV F vaccine against medically significant symptomatic RSV lower respiratory tract infection (LRTI) through 90, 120, 150 and 180 days of life in infants. 9 Goals and design Design Randomized, Observer - Blind, Placebo - Controlled Number of P
Slide 10: Trial execution and immunogenicity data as expected
Trial execution and immunogenicity data as expected Safety appears benign in mothers and infants Efficacy endpoints • Primary endpoint (Day 90 site data) did not succeed (39.4%, 97.5%CI, - 1.0% to 63.7%) • ResVax demonstrated efficacy in preventing RSV - hospitalization (44.4%, 95%CI, 19.6% to 61.5%
Slide 11: Expected hierarchy of attack rates by severity
11 15.5% 13.6% 6.1% 3.9% 3.8% 2.2% Infections LRTI LRTI w/ hypoxemia or tachypnea Primary endpoint Hospitalization Severe hypoxemia RSV attack rates 1 1. Expanded data from sites and hospitalizations, through 90 days, * LB 95%CI >0 We observed the expected hierarchy of attack rates by severity
Slide 12: Expectation for relative efficacy against RSV endpoints
12 What was our expectation for relative efficacy against the RSV infections/endpoints? 15.5% 13.6% 6.1% 2.2% HIGH LOW Infections LRTI Primary endpoint Hospitalization Severe hypoxemia 3.9% 3.8% RSV attack rates 1 Expected vaccine efficacy rates 1. Expanded data from sites and hospitalizations, thro
Slide 13: A hierarchy of efficacy by severity of disease
13 A hierarchy of efficacy by severity of disease 15.5% 13.6% 6.1% 3.9% 3.8% 2.2% 60%* 11% Observed vaccine efficacy rates Infections LRTI Primary endpoint Hospitalization Severe hypoxemia 15% 19% 41%* 42%* RSV attack rates 1 1. Expanded data from sites and hospitalizations, through 90 days, * LB 95
Slide 14: Vaccine impact on all-cause respiratory disease
14 Vaccine impact on all - cause respiratory disease 15.5% 13.6% 6.1% 3.9% 3.8% 2.2% 60%* 11% Observed vaccine efficacy rates Infections LRTI Primary endpoint Hospitalization Severe hypoxemia 15% 19% 41%* 42%* 25% 39% Vaccine efficacy for all - cause respiratory event over 180 days RSV attack rates
Slide 15: Primary, secondary, and exploratory efficacy endpoints
Primary endpoint: medically - significant RSV LRTI • RSV detected by RT - PCR and • At least one manifestation of LRTI , and • At least one of the following: • SpO2 <95% at sea level or <92% at >1800m • Respiratory rate ≥70 bpm in infants 0 to 59 days of age or ≥60 bpm in infants ≥60 days of age Sec
Slide 16: Evaluation of Day 90 efficacy endpoints
Evaluation of Day 90 e fficacy endpoints All countries, per - protocol population 16 Day 90 Vac. Efficacy (%) (97.52%CI and 95%CI for MS RSV LRTI primary endpoint, all others 95%CI) Placebo, Vaccine cases RSV MS LRTI RSV hospitalizations RSV LRTI w/ severe hypoxemia Primary and secondary: Site data
Slide 17: Evaluation of Day 90 efficacy endpoints
Evaluation of Day 90 e fficacy endpoints All countries, per - protocol population 17 Day 90 Vac. Efficacy (%) (97.52%CI and 95%CI for MS RSV LRTI primary endpoint, all others 95%CI) Placebo, Vaccine cases RSV MS LRTI RSV hospitalizations RSV LRTI w/ severe hypoxemia Primary and secondary: Site data
Slide 18: Evaluation of Day 90 efficacy endpoints
Evaluation of Day 90 e fficacy endpoints All countries, per - protocol population 18 Day 90 Vac. Efficacy (%) (97.52%CI and 95%CI for MS RSV LRTI primary endpoint, all others 95%CI) Placebo, Vaccine cases RSV MS LRTI RSV hospitalizations RSV LRTI w/ severe hypoxemia Primary and secondary: Site data
Slide 19: Geographic imbalance in efficacy
Geographic imbalance in efficacy Pre - specified exploratory: expanded data, per protocol population Day 90 Vac. Efficacy (%) (95%CI) Placebo, Vaccine cases All U.S. S. Africa ROW* MS RSV LRTI 40.9 (15.9, 58.5) 56/1430, 64/2765 - 32.7 ( - 238.9, 48.1) 6/346, 15/652 57.0 (32.7, 72.5) 40/732, 34/1447
Slide 20: Effect of gestational age at immunization <33 weeks
Effect of gestational age at immunization <33 weeks Day 90 Vac. Efficacy (%) (95%CI) Placebo, Vaccine cases All U.S . S. Africa < 33 weeks > 33 weeks < 33 weeks > 33 weeks < 33 weeks > 33 weeks RSV MS - LRTI 41.4 ( 4.1, 64.2) 29/848 33/1646 40.3 ( 0.9, 64.0) 27/582 31/1119 - 9.7 ( - 259.2, 66.5) 4/1
Slide 21: Discuss data and licensure path forward with regulators
Discuss data and licensure path forward with the FDA and European regulatory authorities Basis for discussion: • Vaccine is safe • Immune responses, transfer, and antibody half - lives are similar across countries • Immunization can be focused on 26 to <33 weeks gestational age to optimize efficacy
Slide 22: Critical efficacy findings
22 Critical efficacy findings Day 90 Vac. Efficacy (%) (95%CI) Placebo, Vaccine cases RSV MS LRTI RSV hospitalizations RSV LRTI w/ severe hypoxemia Primary and secondary: Site data through 90 days 39.4 (5.3, 61.2) 35/1430, 41/2765 44.4 ( 19.6, 61.5) 53/1430, 57/2765 48.3 ( - 8.2, 75.3) 14/1430, 14/2
Slide 23: All-cause findings
All hospitalizations with LRTI signs or symptoms that includes but doesn’t require RSV detection The effect of the pneumococcal vaccine against all - cause LRTI hospitalization was 7 - 9% 1 , or against all - cause ‘clinical pneumonia’ was 4 - 7% 2,3 25% reduction in all hospitalizations with LRTI s
Slide 24: Conclusions
Conclusions 24 Vaccine appears to be safe in mothers and infants. First RSV vaccine to demonstrate efficacy against RSV - hospitalization in a Phase 3 trial . Reduction in all - cause hospitalization and respiratory illness with severe hypoxemia has major public health implications globally. Prevent
Slide 25: Quote from Gates Foundation Pneumonia Program director
“ We are very encouraged that the Novavax maternal RSV vaccine reduced severe RSV hypoxemia by 60% in the first months of life and believe this vaccine has great potential for reducing RSV - associated deaths in young babies.” Keith Klugman, M.D., Ph.D. Director of the Bill & Melinda Gates Foundatio
Slide 26: The power of collaboration through our partners
26 The power of collaboration through our partners $89 Million in grants $7 Million in grants
Slide 27: a mH.
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