Novavax, Inc. · NASDAQ:NVAX
Novavax — Wedbush PacGrow Healthcare Conference 2015
26 slides from Novavax's conference presentation, August 2015
Slide 1: Wedbush PacGrow Healthcare Conference
Wedbush PacGrow Healthcare Conference August 2015
Slide 2: Safe Harbor Statement
Safe Harbor Statement Certain information contained herein, particularly information relating to future financial or business performance, conditions or strategies and other financial and business matters, including expectations regarding clinical development, product sales, operating expenses, our
Slide 3: Investment Highlights
Investment Highlights Announced data from 3 of 4 clinical trials expected in the 3rd quarter • Ebola GP Vaccine • Quadrivalent Seasonal Influenza • RSV F Vaccine in older adults • RSV F Vaccine to protect infants via maternal immunization Novavax Vaccine Platform • Recombinant nanoparticles that ind
Slide 4: Product Pipeline
Product Pipeline Funding Program Preclinical Phase 1 Phase 2 Phase 3 Support RSV Older Adults * Infants (Maternal Immunization) Pediatrics (6 mos – 6 yrs) Influenza Quadrivalent Seasonal Combination Respiratory New Vaccines Pandemic (H7N9 + Matrix‐M) Ebola + Matrix‐M 4 *Our funding and development a
Slide 5: Phase 1 Ebola GP Vaccine Clinical Trial in Healthy Adults
Phase 1 Ebola GP Vaccine Clinical Trial in Healthy Adults Trial Overview Goal: evaluate the safety and immunogenicity GP dose‐escalation trial, with and without Matrix‐M™ adjuvant 230 healthy adults 18 ‐ 49 years of age Participants received either one or two intramuscular injections of 6.5µg ‐ 50µg
Slide 6: Phase 2 Quadrivalent Seasonal Influenza VLP Clinical Trial in Healthy Adults
Phase 2 Quadrivalent Seasonal Influenza VLP Clinical Trial in Healthy Adults Trial Overview Conducted under HHS BARDA contract 400 healthy adults 18 ‐ 49 years of age Primary outcomes assessed safety and tolerability and quantified immune responses to each of the four influenza strains based on hema
Slide 7: Novavax Platform Technology
Novavax Platform Technology Click here to view video 7
Slide 8: Novavax Novel RSV F Vaccine
Novavax Novel RSV F Vaccine Novavax has developed a novel RSV Fusion‐protein vaccine (RSV F Vaccine) using recombinant nanoparticle technology Novavax has completed extensive studies in relevant preclinical models that demonstrated the vaccine is safe, immunogenic and highly efficacious in animals I
Slide 9: Phase 2 RSV F Vaccine Clinical Trial in Older Adults
Phase 2 RSV F Vaccine Clinical Trial in Older Adults In October 2014, we initiated a Phase 2 clinical trial in older adults (clinically stable adults 60 years of age or older) The goals were to evaluate the incidence of symptomatic RSV illness in this population and describe the vaccine effect upon
Slide 10: Study Objectives
Study Objectives Primary Evaluate the incidence of all symptomatic respiratory illnesses due to RSV, medically attended illness and hospitalization, in community‐living older adults who have been treated with placebo Examine the amplitude and duration of anti‐F IgG antibody responses Evaluate safety
Slide 11: Exploratory Objectives and Ad Hoc Evaluation
Exploratory Objectives and Ad Hoc Evaluation Estimate the efficacy of RSV F vaccine on all symptomatic RSV respiratory illnesses and all RSV lower respiratory tract infections (LRTI) Explore the potential correlation of the above‐listed immune responses with risk of RSV illness Describe the spectrum
Slide 12: Study Population and Demographics
Study Population and Demographics RSV F Vaccine Placebo Study Populations Safety 798 801 Intent‐to‐Treat 798 798 Per‐Protocol 759 771 Percent Male 42.0 41.7 Mean Age, yrs (SD) 69.4 (6.5) 69.5 (6.4) Percent 60‐75 yrs 82.7 82.1 Percent >75 yrs 17 17.9 Race (%) White 90.4 90.9 Black 7.8 7.5 Other 1.8 1
Slide 13: Results: Epidemiology of RSV in Older Adults
Results: Epidemiology of RSV in Older Adults 4.9% with symptomatic RSV infections • Pharyngitis, nasal congestion, cough, wheezing, shortness of breath or increased sputum production 95% of RSV infected subjects with LRTI symptoms • Cough, wheezing, shortness of breath or increased sputum production
Slide 14: Relative Risk and Efficacy Estimates
Relative Risk and Efficacy Estimates Population Endpoint Placebo Active RR (95% CI) Efficacy ITT Total N 798 798 All symptomatic RSV 39 23 0.590 (0.356‐0.978) 41.3% RSV LRTI 37 21 0.568 (0.335‐0.961) 43.2% Per protocol Total N 771 759 All symptomatic RSV 38 21 0.561 (0.333‐0.947) 43.9% RSV LRTI 36 1
Slide 15: Ad Hoc Analysis of LRTI and Difficulty Breathing
Ad Hoc Analysis of LRTI and Difficulty Breathing Measures of more severe illness: Number of Symptoms Number of vaccine vs and Signs Reported* placebo subjects 95% CI Relative At least 3 5 vs 14 Rate 0.36 0.129 – 0.987 Vaccine efficacy 64% Relative At least 4 2 vs 8 Rate 0.25 0.053 – 1.174 Vaccine ef
Slide 16: Results: Early and Durable Protection from RSV Infection
Results: Early and Durable Protection from RSV Infection 1.00 Proportion of Group With No RSV Infection 0.98 135 g RSV F Vaccine 0.96 Placebo 0.94 0.92 October 31, 2014 April, 15, 2015 0.90 0 50 100 150 200 Time to RSV Onset (days) RT‐PCR confirmed RSV Events Product‐Limit Survival Estimate Log‐Ran
Slide 17: Results: Anti-F Antibody Response
Results: Anti‐F Antibody Response • Durable, 4.8‐fold increase in anti‐F IgG response • Seroresponse in >93% of subjects2 6000 Anti‐F IgG GMEU1 (95% CI) 5000 135 g RSV F Vaccine 4000 3000 2000 Placebo 1000 0 0 10 20 30 40 50 60 Days 1geometric mean rise relative to Day 0 2% of group with EU >95th p
Slide 18: Results: Palivizumab-competing Antibody Response
Results: Palivizumab‐competing Antibody Response • Durable, 5.2‐fold increase in PCA response • Seroresponse in >96% of subjects2 120 100 135 g RSV F Vaccine PCA GMC 1 (µg/mL) 80 60 40 Placebo 20 0 0 10 20 30 40 50 60 Days 1geometric mean rise relative to Day 0 2% of group with EU >95th percentile
Slide 19: RSV A and B Microneutralizing Antibodies
RSV A and B Microneutralizing Antibodies 2.1 Geometric Mean Rise in Neutralizing Titers RSV A RSV B 1.9 (baseline adjusted) 1.7 1.5 1.3 1.1 0.9 RSV F Placebo RSV F Placebo RSV F Placebo RSV F Placebo Vaccine RSV/A Vaccine RSV/A Vaccine RSV/B Vaccine RSV/B RSV/A RSV/A RSV/B RSV/B Day 28 Day 56 Day 28
Slide 20: Efficacy of Licensed Respiratory Vaccines
Efficacy of Licensed Respiratory Vaccines • Novavax RSV F Vaccine efficacy is similar to or better than a number of respiratory vaccines1,2,3 • Influenza vaccine recommended for US population by gov’t health agencies (ACIP, CDC, other) • Pneumococcal conjugate vaccine efficacy in older adults is 46%
Slide 21: Summary
Summary Significant disease burden due to RSV in older adults • 4.9% of older adults had symptomatic RSV disease • 95% of these illnesses were associated with LRTI 46% reduction in symptomatic RSV related LRTI using the vaccine • 64% reduction in more severe illnesses Durable protection for the enti
Slide 22: Annual Burden of RSV Disease in Adults 65 and Older
Annual Burden of RSV Disease in Adults 65 and Older ~14,000 ~4,500,000 Deaths7 Lost Productivity Days2,3 ~152,000 2.4M ~497,000 ER Visits2, 5 Infections1 Physician Visits4 ~204,000 Hospital Admissions2, 5, 6 Values represent estimated annual rates 1Falsey et al NEJM, 2005; 2Falsey et al JID 2013; 3L
Slide 23: Burden of Disease for RSV, Influenza, and Pneumococcal Pneumonia
Burden of Disease for RSV, Influenza, and Pneumococcal Pneumonia in Adults 65 and Older RSV Influenza* Pneumonia Number of 2,400,000 2,883,052 1,286,556 Infections Hospitalization 203,600 262,095 339,853 Deaths 14,000 14,607 22,449 Deaths Hospitalizations # of infections *Average of 3 past seasons,
Slide 24: Financial and Corporate Highlights
Financial and Corporate Highlights Novavax by the Numbers*: Cash and Investments: $314.9 M Debt: None BARDA contract for seasonal and pandemic flu: $179 M Shares Outstanding: 268.0 M Employees (approx): 356 * Novavax, Inc. August 10, 2015 10Q 24
Slide 25: Upcoming Development Milestones
Upcoming Development Milestones Q3‐14 Q4‐14 Q1‐15 Q2‐15 Q3‐15 Q4‐15 Ongoing Trials RSV Maternal Ph 2 RSV Older Adults Ph 2 RSV Pediatric Ph 1 Seasonal Flu Ph 2 Ebola Ph 1 Planned Trials RSV/Flu Combo Ph 1 H7N9 + Matrix Ph 2 Trial Initiated Data announced 25
Slide 26: Investment Highlights
Investment Highlights Announced data from 3 of 4 clinical trials expected in the 3rd quarter • Ebola GP Vaccine • Quadrivalent Seasonal Influenza • RSV F Vaccine in older adults • RSV F Vaccine to protect infants via maternal immunization Novavax Vaccine Platform • Recombinant nanoparticles that ind