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www.novavax.com
Jefferies Global Healthcare Conference, Nov. 20, 2014 1 - - PowerPoint PPT Presentation
Jefferies Global Healthcare Conference, Nov. 20, 2014 1 www.novavax.com Safe Harbor Statement Certain information contained herein, particularly information relating to future financial or business performance, conditions or strategies and
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www.novavax.com
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Certain information contained herein, particularly information relating to future financial or business performance, conditions
Securities Litigation Reform Act. Forward-looking statements can be identified by the fact that they do not relate strictly to historical or current facts and generally contains words such as “believe,” “may,” “could,” “will,” “possible,” “can,” “estimate,” “continue,” “ongoing,” “consider,” “anticipate,” “intend,” “seek,” “plan,” “project,” “expect,” “should,” “would,” or “assume” or any variations of such words or other words with similar meanings, although all forward-looking statements do not contain these identifying words. These Novavax cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time and could cause actual results to differ materially from the results discussed in the forward-looking statements. These risks and uncertainties include, but are not limited to, risks relating to the early stage of Novavax’s product candidates under development; current results may not be predictive of future pandemic results, results of
approval can be applied for and the FDA may not approve a vaccine even if further trial results are similar to those disclosed previously by the company; uncertainties relating to clinical trials, including possible delays in initiating or completing the trials and safety and efficacy results; dependence on the efforts of third parties; competition for clinical resources and patient enrollment from drug candidates in development by other companies with greater resources and visibility; and risks that we may lack the financial resources and access to capital to fund our operations including further clinical trials. Further information on the factors and risks that could affect Novavax’s business, financial conditions and results of operations, is contained in Novavax’s filings with the U.S. Securities and Exchange Commission, including our Annual Report on Form 10- K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, which are 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. 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.
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‒ Virus-Like Particles and Nanoparticles induce robust and functional immunity
‒ RSV Vaccine - Only late-stage RSV vaccine candidate
‒ Seasonal & Pandemic Flu – Novel recombinant vaccine
‒ RSV Vaccine: induces immune response activity similar to blockbuster mAb ‒ H7N9 flu vaccine: first positive clinical data, published in NEJM
‒ Experienced management team ‒ Strong balance sheet ‒ Commercial and clinical GMP manufacturing capacity
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Preclinical Phase 1 Phase 2 Phase 3
Funding Support
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Clone genes into baculovirus Infect Sf9 insect cells with baculovirus Sf9 cells express protein antigens
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HA, NA Protein M1 Matrix Protein Empty - No genetic material
RSV, Rabies
Hydrophilic head of protein particle Hydrophobic tail of protein particle Protein particles form micelles for efficient antigen presentation:
antigen
unit Configuration and size of the virus without RNA genome
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1. Nair, et al. Lancet 2010, 375:1545 2. MMWR , 2013, 263:141 3. Escobar et al. BMC Pediatrics 2013, 13:97
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Provide protection for infants younger than six months and most at risk
prevent hospitalization, medical care, wheezing Decrease respiratory disease burden in children, prevent medical care, wheezing Mitigate RSV disease burden that results from waning immunity and immunosenescence, prevent hospitalization and death
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immature immune systems
the mother, is ineffective
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Mother’s Blood Baby’s Blood
Antibody
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100 200 300 400 500 Placebo Group B Group C Group D Group E Group F Group G Group A Palivizumab-Competitive ELISA Responses Day 0 Day 14 Day 28
N=77 N=75 N=76 N=79 N=76 N=81 N=85 N=80
~400μg/ml
Near-Absence
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Provide protection for infants younger than six months and most at risk
prevent hospitalization, medical care, wheezing Decrease respiratory disease burden in children, prevent medical care, wheezing Mitigate RSV disease burden that results from waning immunity and immunosenescence, prevent hospitalization and death
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Duration of Needed Immunity
Palivizumab Competing Antibody
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Provide protection for infants younger than six months and most at risk
prevent hospitalization, medical care, wheezing Decrease respiratory disease burden in children, prevent medical care, wheezing Mitigate RSV disease burden that results from waning immunity and immunosenescence, prevent hospitalization and death
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‒ Stimulated robust immune responses ‒ Induced production of palivizumab-competing antibodies
‒ Safety, dose selection
‒ Define attack rate, Vaccine efficacy ‒ Enrolling
‒ Confirmation of safety and immunogenicity in target population
‒ Selection of dose and schedule for pregnant women
‒ Active immunization of mothers, safety, transplacental antibody transfer and half life ‒ Enrolling
‒ Seropositive children 2-5 years of age ‒ Enrolling
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RSV Flu Combo
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A/H5N1 Vietnam
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Clinical Trials Q1 Q2 Q3 Q4 Q1 Q2 Q3
2014 2015
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‒ Iomai, Procept, Integrated Genetics (Genzyme), Baxter
‒ Isconova, Beta-Cell, Active Biotech, Pharmacia
‒ Iomai, Walter Reed Army Institute of Research
‒ MedImmune, Merck
‒ Gene Logic, Celera Genomics, Baxter
‒ MedImmune, Merck, NIH
‒ Micromet, Vector Fund Management, INVESCO Funds Group
‒ Immunovaccine, MedImmune, ID Biomedical, Henry Schein
‒ Supernus, Iomai, North American Vaccines
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‒ Virus-Like Particles and Nanoparticles induce robust and functional immunity
‒ RSV Vaccine - Only late-stage RSV vaccine candidate
‒ Seasonal & Pandemic Flu – Novel recombinant vaccine
‒ RSV Vaccine: induces immune response activity similar to blockbuster mAb ‒ H7N9 flu vaccine: first positive clinical data, published in NEJM
‒ Experienced management team ‒ Strong balance sheet ‒ Commercial and clinical GMP manufacturing capacity