1. GAITHERSBURG, Md., Jan. 22, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it has finalized an agreement with the Government of Canada to supply up to 76 million doses of NVX-CoV2373, the company's recombinant protein-based COVID-19 vaccine. Canada has committed to purchase 52 million doses of the vaccine with the option for up to an additional 24 million doses. NVX-CoV2373 is currently in Phase 3 clinical development for the prevention of COVID-19.

    "We thank the Government of Canada for their confidence in our program and ongoing partnership in the regulatory review and delivery of a safe, effective COVID-19…

    GAITHERSBURG, Md., Jan. 22, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it has finalized an agreement with the Government of Canada to supply up to 76 million doses of NVX-CoV2373, the company's recombinant protein-based COVID-19 vaccine. Canada has committed to purchase 52 million doses of the vaccine with the option for up to an additional 24 million doses. NVX-CoV2373 is currently in Phase 3 clinical development for the prevention of COVID-19.

    "We thank the Government of Canada for their confidence in our program and ongoing partnership in the regulatory review and delivery of a safe, effective COVID-19 vaccine for the citizens of Canada," said John J. Trizzino, Chief Commercial Officer and Chief Business Officer, Novavax. "Novavax is proud to play our part in working tirelessly together with governments, scientists, regulators and others in the global effort to put an end to the pandemic."

    The company expects to supply NVX-CoV2373 to Canada beginning as early as the second quarter of 2021, following authorization by Canada's regulatory agency.

    Novavax is currently conducting three efficacy, safety and immunogenicity studies of NVX-CoV2373 and expects to announce initial efficacy results as early as the first quarter of 2021.

    About NVX-CoV2373

    NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is adjuvanted with Novavax' patented saponin-based Matrix-M™ to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that block binding of spike protein to cellular receptors and provided protection from infection and disease. It was generally well-tolerated and elicited robust antibody response numerically superior to that seen in human convalescent sera in Phase 1/2 clinical testing. NVX-CoV2373 is currently being evaluated in two pivotal Phase 3 trials: a trial in the U.K that completed enrollment in November and the PREVENT-19 trial in the U.S. and Mexico that began in December. It is also being tested in two ongoing Phase 2 studies that began in August: A Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia.

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The Company's proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Novavax Forward Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended September 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.



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    Erika Trahan
    
    240-268-2022
    
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    Edna Kaplan
    
    617-974-8659

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  2. GAITHERSBURG, Md., Jan. 22, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the appointment of Madelyn ‘Lyn' Caltabiano, Ph.D. to the position of Senior Vice President, Global Program Management. In this newly created role, Dr. Caltabiano will lead and expand the Global Program Management organization for the company's pipeline and will develop appropriate strategies to assess the company's operational performance, including areas related to portfolio valuation, milestone decision making and prioritization. She will report directly to Stanley C. Erck, President and Chief Executive Officer.

    "Lyn's deep experience in…

    GAITHERSBURG, Md., Jan. 22, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the appointment of Madelyn ‘Lyn' Caltabiano, Ph.D. to the position of Senior Vice President, Global Program Management. In this newly created role, Dr. Caltabiano will lead and expand the Global Program Management organization for the company's pipeline and will develop appropriate strategies to assess the company's operational performance, including areas related to portfolio valuation, milestone decision making and prioritization. She will report directly to Stanley C. Erck, President and Chief Executive Officer.

    "Lyn's deep experience in managing complex global programs will be critical as we work to simultaneously advance NVX-CoV2373 regulatory activities forward in multiple regions," said Mr. Erck. "We welcome her invaluable project management experience as Novavax works to effectively deliver our vaccine candidate in the fight against the COVID-19 pandemic."

    Dr. Caltabiano joins Novavax from NexEos Diagnostics, Inc., where she was Development Lead and a core member of the management team. Previously, as Senior Vice President, Global Project and Alliance Management at Merck Research Laboratories, she rebuilt the R&D project and Alliance Management organizations and led the development of critical portfolio management and executive decision-making processes. Earlier, Dr. Caltabiano spent more than a decade at GlaxoSmithKline where she built the Alliance Management organization, headed project operations in Oncology R&D, and led the development of several new therapeutics.

    Dr. Caltabiano graduated summa cum laude from Drexel University with a Bachelor of Science in biological sciences and earned a doctorate in pathology from the University of Pennsylvania.

    About NVX-CoV2373

    NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein. It is adjuvanted with Novavax' patented saponin-based Matrix-M™ to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that block binding of spike protein to cellular receptors and provided protection from infection and disease. NVX-CoV2373 was generally well-tolerated and elicited robust antibody response numerically superior to that seen in human convalescent sera in Phase 1/2 clinical testing. NVX-CoV2373 is currently being evaluated in two pivotal Phase 3 trials: a trial in the U.K. that completed enrollment in November and the PREVENT-19 trial in the U.S. and Mexico that began in December. It is also being tested in two ongoing Phase 2 studies that began in August: a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia.

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The Company's proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Novavax Forward Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended September 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.



    Contacts:         
    Investors
    Erika Trahan
    
    240-268-2022
    
    Media
    Edna Kaplan
    
    617-974-8659

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  3. GAITHERSBURG, Md., Jan. 15, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the appointment of Henrietta Ukwu, M.D., FACP, FRAPS, to the position of Senior Vice President, Chief Regulatory and Quality Officer. In this newly created role, Dr. Ukwu will lead global regulatory strategy and execution as well as the quality assurance function for the company's development-stage vaccine candidates, including its recombinant protein-based COVID-19 candidate vaccine, NVX-CoV2373.

    "Dr. Ukwu brings extensive regulatory affairs and quality expertise and leadership experience at precisely the right time for Novavax, as we advance…

    GAITHERSBURG, Md., Jan. 15, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the appointment of Henrietta Ukwu, M.D., FACP, FRAPS, to the position of Senior Vice President, Chief Regulatory and Quality Officer. In this newly created role, Dr. Ukwu will lead global regulatory strategy and execution as well as the quality assurance function for the company's development-stage vaccine candidates, including its recombinant protein-based COVID-19 candidate vaccine, NVX-CoV2373.

    "Dr. Ukwu brings extensive regulatory affairs and quality expertise and leadership experience at precisely the right time for Novavax, as we advance toward data readouts and regulatory submissions in 2021," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "We welcome her medical perspective and intricate knowledge of the regulatory process at this extraordinary time for the company and the race against the global pandemic."

    Dr. Ukwu most recently served as Chief Regulatory Officer and Global Head of Quality and Regulatory at Otsuka Pharmaceuticals. While there, she globalized and led the regulatory and quality organizations with a focus on compliance excellence, inspection readiness, engagement with health authorities and regulatory agencies and successful outcomes. Prior to Otsuka, she held senior leadership roles at PPD as Senior Vice President and Head of Global Regulatory Affairs, where she had responsibilities for regulatory services across all PPD lines of business; Wyeth Pharmaceuticals, Inc. (Pfizer), where she was Vice President, Regulatory Affairs, with responsibility that spanned vaccines, biologics and pharmaceuticals across all regions; and at Merck & Co., Inc., as Head of Vaccine Regulatory Development, Vice President of Global Regulatory Affairs and Global Regulatory Policy. Dr. Ukwu has led approval of many products, including for Varivax®, a chickenpox varicella vaccine, and Crixivan®, (indinavir), an HIV protease inhibitor that significantly impacted the treatment paradigm of HIV/AIDS.

    Dr. Ukwu's significant contributions to medicine, science and the pharmaceutical industry include developing and enriching the regulatory and quality profession, as well as serving as a mentor to others who have progressed into senior leadership positions. These contributions have been recognized with numerous prestigious awards.

    Dr. Ukwu earned her medical and surgical degrees from the University of Jos School of Medicine in Nigeria. She completed her residency in internal medicine at Baptist Hospital, and a fellowship in infectious diseases at Vanderbilt University, both in Nashville, Tennessee. She is a Fellow of both the American College of Physicians (FACP) and the Regulatory Affairs Professional Society (FRAPS) and is a pioneer professor at the Graduate School of Pharmacy at Temple University in Ambler, Pennsylvania.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The company's proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Novavax Forward Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended September 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should consider these risks and uncertainties.



    Contacts:         
    Investors
    Erika Trahan
    
    240-268-2022
    
    Media
    Edna Kaplan
    
    617-974-8659

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    • Advance Purchase Agreement signed for NVX-CoV2373, Novavax' adjuvanted protein vaccine candidate
    • Initial doses expected to be delivered as early as mid-2021

    GAITHERSBURG, Md., Jan. 07, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it has executed an Advance Purchase Agreement with the Commonwealth of Australia for 51 million doses of NVX-CoV2373, Novavax' COVID-19 vaccine candidate. This follows an agreement in principle that was announced in November 2020. NVX-CoV2373 is a recombinant protein vaccine adjuvanted with Novavax' proprietary Matrix-M™ to enhance the immune response.

    Novavax is currently conducting…

    • Advance Purchase Agreement signed for NVX-CoV2373, Novavax' adjuvanted protein vaccine candidate
    • Initial doses expected to be delivered as early as mid-2021

    GAITHERSBURG, Md., Jan. 07, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it has executed an Advance Purchase Agreement with the Commonwealth of Australia for 51 million doses of NVX-CoV2373, Novavax' COVID-19 vaccine candidate. This follows an agreement in principle that was announced in November 2020. NVX-CoV2373 is a recombinant protein vaccine adjuvanted with Novavax' proprietary Matrix-M™ to enhance the immune response.

    Novavax is currently conducting late-stage clinical studies to demonstrate the efficacy, safety and immunogenicity of NVX-CoV2373 for the prevention of COVID-19. This includes two large pivotal Phase 3 clinical trials in the United States/Mexico (the PREVENT-19 trial) and in the United Kingdom, as well as a Phase 2b trial in South Africa.

    "The continued increase in significant COVID-19 transmission in virtually all parts of the world underscores the need for multiple safe, efficacious vaccines in enormous quantities to stop the pandemic," said Stanley C. Erck, Novavax President and Chief Executive Officer. "We appreciate the confidence of the Australian government and the opportunity to play a role in ensuring that its citizens will have access to a protein-based vaccine that can be distributed using existing distribution channels, should it receive regulatory approval."

    Novavax will work with Australia's regulatory agency, the Therapeutics Goods Administration (TGA), to obtain product approvals upon demonstrating efficacy in clinical studies. The company aims to deliver initial doses by mid-2021. As part of the agreement, Australia will have the option to purchase up to an additional 10 million doses.

    Additional terms of the agreement were not disclosed.

    About NVX-CoV2373

    NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein. It is adjuvanted with Novavax' patented saponin-based Matrix-M™ to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that block binding of spike protein to cellular receptors and provided protection from infection and disease. NVX-CoV2373 was generally well-tolerated and elicited robust antibody response numerically superior to that seen in human convalescent sera in Phase 1/2 clinical testing. NVX-CoV2373 is currently being evaluated in two pivotal Phase 3 trials: a trial in the U.K that completed enrollment in November and the PREVENT-19 trial in the U.S. and Mexico that began in December. It is also being tested in two ongoing Phase 2 studies that began in August: a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia.

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The Company's proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Novavax Forward Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended September 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.



    Contacts:         
    
    Investors
    Erika Trahan
    
    240-268-2022
    
    Media
    Edna Kaplan
    
    617-974-8659

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  4. GAITHERSBURG, Md., Jan. 06, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it will participate in two upcoming investor conferences. Novavax' COVID-19 vaccine candidate, NVX-CoV2373, will be the topic of discussion in each presentation.

    J.P. Morgan 39th Annual Healthcare Conference
    Presentation
    Date:Monday, January 11, 2021
    Time:8:20 a.m. Eastern Time (ET)
    Presenters:Stanley C. Erck, President and Chief Executive Officer and
    Gregory M. Glenn, M.D., President, Research and Development
    Webcast:www.novavax.com, "Investors" / "Events"
      
    Conference
    Event:Investor meetings
    Date:Monday, January 11, 2021 – Wednesday, January

    GAITHERSBURG, Md., Jan. 06, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it will participate in two upcoming investor conferences. Novavax' COVID-19 vaccine candidate, NVX-CoV2373, will be the topic of discussion in each presentation.

    J.P. Morgan 39th Annual Healthcare Conference

    Presentation

    Date:Monday, January 11, 2021
    Time:8:20 a.m. Eastern Time (ET)
    Presenters:Stanley C. Erck, President and Chief Executive Officer and

    Gregory M. Glenn, M.D., President, Research and Development
    Webcast:www.novavax.com, "Investors" / "Events"
      
    Conference

    Event:Investor meetings
    Date:Monday, January 11, 2021 – Wednesday, January 13, 2021



    13th Annual Biotech Showcase

    Panel

    Date:Friday, January 8, 2021
    Time:11:00 a.m. Eastern Time (ET)
    Panel title:In Conversation with COVID-19 Leaders: The Novavax COVID-19 Journey
    Moderator:Kimberly Ha, Founder and Chief Executive Officer, KKH Advisors
    Panelist:John J. Trizzino, Executive Vice President, Chief Commercial Officer and Chief Business Officer, Novavax
    Webcast:A replay of the recorded fireside session will be available through the events page of the Company's website at ir.novavax.com for 90 days.
      

    About NVX-CoV2373

    NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein. It is adjuvanted with Novavax' patented saponin-based Matrix-M™ to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that block binding of spike protein to cellular receptors and provided protection from infection and disease. NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera in Phase 1/2 clinical testing. NVX-CoV2373 is currently being evaluated in two pivotal Phase 3 trials: a trial in the U.K that completed enrollment in November and a trial in the U.S. and Mexico that began in December. It is also being tested in two ongoing Phase 2 studies that began in August: a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia.

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The Company's proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Novavax Forward Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended September 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Contacts:         

    Investors

    Erika Trahan



    240-268-2022

    Media

    Brandzone/KOGS Communication

    Edna Kaplan



    617-974-8659



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    • PREVENT-19 will assess the efficacy, safety and immunogenicity of NVX-CoV2373 in the prevention of COVID-19
    • Trial to enroll up to 30,000 volunteers across approximately 115 sites in the U.S. and Mexico
    • Two-thirds of enrollees to receive active vaccine

    GAITHERSBURG, Md., Dec. 28, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced initiation of PREVENT-19, its pivotal Phase 3 study in the United States and Mexico to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373, the Company's COVID-19 vaccine candidate. The trial builds on research from Phase 1/2 studies demonstrating that the vaccine provoked a robust immune…

    • PREVENT-19 will assess the efficacy, safety and immunogenicity of NVX-CoV2373 in the prevention of COVID-19

    • Trial to enroll up to 30,000 volunteers across approximately 115 sites in the U.S. and Mexico
    • Two-thirds of enrollees to receive active vaccine

    GAITHERSBURG, Md., Dec. 28, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced initiation of PREVENT-19, its pivotal Phase 3 study in the United States and Mexico to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373, the Company's COVID-19 vaccine candidate. The trial builds on research from Phase 1/2 studies demonstrating that the vaccine provoked a robust immune response, generated highly neutralizing antibodies against the virus and was generally well-tolerated.

    "With the COVID-19 pandemic raging around the globe, this trial is a critical step in building the global portfolio of safe and effective vaccines to protect the world's population," said Stanley C. Erck, president and chief executive officer, Novavax. "We thank our colleagues and partners who continue to work with us to urgently advance our commercial-scale manufacturing processes, and we are grateful for the hard work and assistance from Operation Warp Speed, the U.S. FDA and the government of Mexico on this program."

    NVX-CoV2373 contains a full-length, prefusion spike protein made using Novavax' recombinant nanoparticle technology and the company's proprietary saponin-based Matrix-M™ adjuvant. The purified protein is encoded by the genetic sequence of the SARS-CoV-2 spike (S) protein and is produced in insect cells. It can neither cause COVID-19 nor can it replicate, is stable at 2°C to 8°C and is shipped in a ready-to-use liquid formulation that permits distribution using standard vaccine supply chain channels.

    PREVENT-19 is being conducted with support from Operation Warp Speed partners, including the Department of Defense and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response. BARDA is also providing up to $1.6 billion under a Department of Defense agreement (identifier MCDC OTA agreement number W15QKN-16-9-1002).

    The company is also currently conducting a large pivotal Phase 3 clinical study in the United Kingdom (U.K.), a Phase 2b safety and efficacy study in South Africa, and an ongoing Phase1/2 trial in the U.S. and Australia. Data from these trials are expected as soon as early first quarter 2021, although timing depends on transmission rates in the regions.

    About the PREVENT-19 Phase 3 Study

    PREVENT-19 (the PRE-fusion protein subunit Vaccine Efficacy Novavax Trial | COVID-19) is a randomized, placebo-controlled, observer-blinded study to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373 with Matrix-M in up to 30,000 subjects 18 years of age and older compared with placebo. The trial design has been harmonized to align with other Phase 3 trials conducted under the auspices of Operation Warp Speed, including the use of a single external independent Data and Safety Monitoring Board to evaluate safety and conduct an unblinded review when predetermined interim analysis events are reached.

    The trial's primary endpoint is the prevention of PCR-confirmed, symptomatic COVID-19. The key secondary endpoint is the prevention of PCR-confirmed, symptomatic moderate or severe COVID-19. Both endpoints will be assessed at least seven days after the second study vaccination in volunteers who have not been previously infected with SARS-CoV-2.

    Two thirds of the participants will be assigned to randomly receive two intramuscular injections of the vaccine, administered 21 days apart, while one third of the trial participants will receive placebo. Trial sites were selected in locations where transmission rates are currently high, to accelerate the accumulation of positive cases that could show efficacy.

    The primary efficacy analysis is event-driven, based on the number of participants with symptomatic mild, moderate or severe COVID-19 disease. Participants will be followed for 24 months following the second injection.

    Enrollment and Study Population

    Information about the trial and how to enroll in PREVENT-19 is available on clinicaltrials.gov under trial identifier NCT04611802 and www.Novavax.com/PREVENT-19.

    Novavax plans to recruit, enroll, and study a diverse population with an emphasis on communities and demographic groups most impacted by the disease as well as to maximize participation of older adults and those living with co-morbid conditions (e.g., obesity, hypertension and diabetes) that place them at higher risk of complications from COVID-19. Enrollment goals are:

    • ≥ 25 percent of the study population is intended to be in the 65 years of age or older group
    • ≥ 15 percent black/African American
    • 10-20 percent LatinX
    • 1-2 percent American Indian

    "We are encouraged by the data generated to-date on NVX-CoV2373 and are optimistic about our ability to positively build on the body of evidence with this trial," said Gregory M. Glenn, M.D, president of research and development, Novavax. "We recognize that volunteers considering our trial may have questions about the potential impact on their ability to receive an authorized vaccine when it becomes available to them. We wish to reassure participants that we are working to ensure that their involvement in our trial does not negatively impact their ability to be vaccinated at the appropriate time."

    Many of the trial sites participating in PREVENT-19 are part of the NIAID-supported COVID-19 Prevention Network (CoVPN), which includes existing NIAID-supported clinical research networks with infectious disease expertise and was designed for rapid and thorough evaluation of vaccine candidates and monoclonal antibodies for preventing COVID-19.

    "This trial underscores the importance of private/public partnerships in solving the need for globally available vaccines to interrupt the ongoing COVID-19 epidemic," said Larry Corey, M.D., virologist at the Fred Hutchinson Cancer Research Center and co-leader of the CoVPN.

    In the interest of transparency and scientific exchange and to demonstrate the rigor with which the study is being executed, Novavax has posted the Phase 3 trial protocol on its website at novavax.com/resources.

    For further information, including media-ready images, b-roll, downloadable resources and more, click here.

    About NVX-CoV2373

    NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein. It is adjuvanted with Novavax' patented saponin-based Matrix-M™ to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that block binding of spike protein to cellular receptors and provided protection from infection and disease. NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera in Phase 1/2 clinical testing.

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The Company's proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Novavax Forward Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended September 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.





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    Erika Trahan
    
    240-268-2022
    
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  5. GAITHERSBURG, Md., Dec. 21, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the appointment of Rick Crowley to the newly created position of Executive Vice President, Chief Operations Officer. In this role, Mr. Crowley will have leadership responsibility for all operations, including Quality, Manufacturing, Supply Chain and Regulatory Affairs. He takes over manufacturing from Ben Machielse, who will continue with the company as an executive advisor to the Chief Executive Officer, supporting the development of the COVID vaccine.

    "Rick's wealth of biopharmaceutical experience and record of on-time FDA approvals comes…

    GAITHERSBURG, Md., Dec. 21, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the appointment of Rick Crowley to the newly created position of Executive Vice President, Chief Operations Officer. In this role, Mr. Crowley will have leadership responsibility for all operations, including Quality, Manufacturing, Supply Chain and Regulatory Affairs. He takes over manufacturing from Ben Machielse, who will continue with the company as an executive advisor to the Chief Executive Officer, supporting the development of the COVID vaccine.

    "Rick's wealth of biopharmaceutical experience and record of on-time FDA approvals comes at the perfect time to help ensure that Novavax delivers on our global manufacturing mission and supply commitments," said Stanley C. Erck, Novavax President and Chief Executive Officer. "We welcome his leadership as we work to advance not only our COVID-19 candidate, but also influenza and RSV vaccines."

    Prior to joining Novavax, Mr. Crowley was Executive Vice President, Technical Operations for TerSera Pharmaceuticals, where he was responsible for technical support as well as development and strategy for the company's products, created the initial quality systems, and managed all CMC activities. He served as Senior Vice President, Operations and Quality Assurance for Crealta Pharmaceuticals 2014-2016, where he led all aspects of the supply chain function, managed suppliers and testing, and held responsibility for the management of Regulatory Affairs. Previously, he held the role of Co-President and Chief Operating Officer at Savient Pharmaceuticals, with responsibility for Commercial Operations, Clinical Affairs, Manufacturing/Technical Operations, Regulatory Affairs, Quality Assurance, Quality Control, Project Management, Logistics and Planning. Earlier in his career he held roles of increasing responsibility at ImClone Systems, Incorporated and BASF Bioresearch Corp.

    "Novavax is well-positioned to execute on a strategic global operations plan that leverages the company's strengths and the expertise of its partners to deliver in the near and long term," said Mr. Crowley. "I am impressed with the astounding progress to-date and look forward to contributing to continue the momentum."

    Mr. Crowley earned a Bachelor of Science degree in chemistry from Denison University and a Master of Science in chemical engineering from the University of Pennsylvania.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The Company's proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Novavax Forward Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended September 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Contacts:

    Investors

    Erika Trahan



    240-268-2022

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    Brandzone/KOGS Communication

    Edna Kaplan



    617-974-8659



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  6. GAITHERSBURG, Md., Dec. 16, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced an Advance Purchase Agreement with the government of New Zealand for the purchase of 10.7 million doses of NVX-CoV2373, Novavax' candidate vaccine against COVID-19.

    Currently in Phase 3 clinical testing in the United Kingdom for the prevention of COVID-19, NVX-CoV2373 is a recombinant protein vaccine adjuvanted with Novavax' proprietary Matrix-M™ to enhance the immune response.

    "The global reach of the pandemic requires that all regions of the world have an adequate supply of vaccine available to protect their entire citizenry," said Stanley…

    GAITHERSBURG, Md., Dec. 16, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced an Advance Purchase Agreement with the government of New Zealand for the purchase of 10.7 million doses of NVX-CoV2373, Novavax' candidate vaccine against COVID-19.

    Currently in Phase 3 clinical testing in the United Kingdom for the prevention of COVID-19, NVX-CoV2373 is a recombinant protein vaccine adjuvanted with Novavax' proprietary Matrix-M™ to enhance the immune response.

    "The global reach of the pandemic requires that all regions of the world have an adequate supply of vaccine available to protect their entire citizenry," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "We appreciate the confidence of the government of New Zealand and are pleased to contribute to ensuring that New Zealanders will have access to a protein-based vaccine through standard distribution channels, should it receive regulatory approval."

    Under the terms of the agreement, Novavax will manufacture NVX-CoV2373 with a target of delivering initial doses by mid-2021. The company will work with Medsafe, New Zealand's regulatory agency, to obtain product approvals as needed. Given the urgency of timely approval and delivery of vaccine during the pandemic, the regulatory review process may leverage review by prioritized regulatory bodies such as the U.S. Food and Drug Administration, European Medicines Agency and/or Medicines and Healthcare products Regulatory Authority in the United Kingdom.

    Additional terms of the agreement were not disclosed.

    About NVX-CoV2373

    NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein adjuvanted with Novavax' patented saponin-based Matrix-M™ to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that block binding of spike protein to cellular receptors and provided protection from infection and disease. NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera in Phase 1/2 clinical testing. NVX-CoV2373 is being evaluated in an ongoing Phase 3 trial in the U.K. and two ongoing Phase 2 studies that began in August: a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia.

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The Company's proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Novavax Forward Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended September 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties. 



    Contacts:         
    
    Investors
    Erika Trahan
    
    240-268-2022
    
    Media
    Edna Kaplan
    
    617-974-8659

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  7. GAITHERSBURG, Md., Dec. 09, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the appointment of Margaret G. McGlynn, R. Ph. to its board as an independent director. Ms. McGlynn brings extensive pharmaceutical industry, vaccine and non-profit experience to her role on the Novavax Board of Directors.

    "Margie's deep experience in vaccine commercialization and understanding of global public health will be invaluable as we move closer to collecting Phase 3 clinical data and submitting NVX-CoV2373, our COVID-19 vaccine candidate, for regulatory authorization and approval," said Stanley C. Erck, Novavax President and Chief…

    GAITHERSBURG, Md., Dec. 09, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the appointment of Margaret G. McGlynn, R. Ph. to its board as an independent director. Ms. McGlynn brings extensive pharmaceutical industry, vaccine and non-profit experience to her role on the Novavax Board of Directors.

    "Margie's deep experience in vaccine commercialization and understanding of global public health will be invaluable as we move closer to collecting Phase 3 clinical data and submitting NVX-CoV2373, our COVID-19 vaccine candidate, for regulatory authorization and approval," said Stanley C. Erck, Novavax President and Chief Executive Officer.

    Ms. McGlynn is currently President and Board Chair for HCU Network America, an advocacy organization she founded in 2016 that is dedicated to supporting the needs of those impacted by the rare genetic condition homocystinuria (HCU) and related disorders. Prior to founding HCU Network America, Ms. McGlynn served as President and Chief Executive Officer of the International AIDS Vaccine Initiative (IAVI), where she led extensive partnership efforts to advance the development, global launch and access to a broadly effective HIV vaccine. She previously spent more than two decades at Merck, where she held roles of increasing responsibility, including President of Merck Vaccines and Infectious Diseases, and President, U.S. Hospital and Specialty Products Division.

    "This is a very exciting time to be joining the Novavax Board, and I look forward to working with my fellow directors to support Novavax' critical priority to advance and deploy NVX-CoV2373 globally to help end this devastating pandemic, as well as progress the broader vaccine portfolio," said Ms. McGlynn.

    She currently serves on the boards of directors of Amicus Therapeutics and Vertex Pharmaceuticals. In addition to her corporate experience, Ms. McGlynn has served as a Board member for several non-profit organizations, including Hilleman Institute for Developing World Vaccine Research, Gavi, the Vaccine Alliance, the Biotechnology Innovation Organization (BIO), and Life Science Cares Philadelphia.

    Ms. McGlynn holds a Bachelor of Science degree in pharmacy, a Master of Business Administration in marketing, and an honorary doctorate from the State University of New York at Buffalo.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The Company's proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Novavax Forward Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended September 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.



    Contacts:         
    Investors
    Erika Trahan
    
    240-268-2022
    
    Media
    Brandzone/KOGS Communication
    Edna Kaplan
    
    617-974-8659

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    • Pivotal Phase 3 trial in United Kingdom completes enrollment
    • Phase 2b efficacy trial in South Africa completes enrollment
    • U.S./Mexico Phase 3 trial expected to begin in the coming weeks

    GAITHERSBURG, Md., Nov. 30, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today provided an update on its COVID-19 vaccine program. NVX‑CoV2373 is a stable, prefusion protein antigen derived from the genetic sequence of the SARS-CoV-2 coronavirus spike (S) protein and adjuvanted with Novavax' proprietary Matrix‑M™.

    "Novavax is in a leading position to significantly contribute to the need for safe and efficacious vaccines that will ultimately…

    • Pivotal Phase 3 trial in United Kingdom completes enrollment

    • Phase 2b efficacy trial in South Africa completes enrollment
    • U.S./Mexico Phase 3 trial expected to begin in the coming weeks

    GAITHERSBURG, Md., Nov. 30, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today provided an update on its COVID-19 vaccine program. NVX‑CoV2373 is a stable, prefusion protein antigen derived from the genetic sequence of the SARS-CoV-2 coronavirus spike (S) protein and adjuvanted with Novavax' proprietary Matrix‑M™.

    "Novavax is in a leading position to significantly contribute to the need for safe and efficacious vaccines that will ultimately end the worldwide COVID-19 pandemic," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "We continue to make meaningful progress as we work to test, manufacture and ultimately deliver NVX-CoV2373 with unprecedented speed, as well as put partnerships in place that would ensure widespread and equitable access worldwide."

    Two of the three planned late-stage efficacy trials for NVX-CoV2373 sponsored by Novavax are fully enrolled, and more than 20,000 participants have been dosed to-date. The primary efficacy endpoints for these trials have been harmonized and reviewed by global regulatory agencies in order to facilitate regulatory approval and ensure that the results are generalizable across global populations. In alignment with Novavax' commitment to transparency, Phase 3 clinical trial protocols are posted to the company's website at Novavax.com/resources upon finalization.

    United Kingdom (U.K.) pivotal Phase 3 trial update

    Novavax completed enrollment of 15,000 participants in a pivotal Phase 3 clinical trial being conducted in the U.K. to determine efficacy and safety of NVX-CoV2373. The U.K. Vaccines Taskforce and National Institute for Health Research played pivotal roles in the rapid recruitment and enrollment of volunteers.

    Interim data in this event-driven trial are expected as soon as early first quarter 2021, although the timing depends on the overall COVID-19 rate in the region. These data are expected to serve as the basis for licensure application in the U.K., European Union and other countries. More than 25 percent of enrollees in the trial are over the age of 65, while a large proportion of volunteers had underlying co-morbid medical conditions generally representative of the population.

    South Africa Phase 2b trial update

    The Phase 2b trial taking place in South Africa to evaluate safety and provide an early indication of efficacy is now fully enrolled. A total of 4,422 volunteers are taking part in the trial, which includes 245 medically stable, HIV-positive participants.

    This trial is expected to increase the body of efficacy data of NVX-CoV2373 in racially and geographically diverse populations as well as in older adults. As in the U.K., availability of efficacy data depends on the illness rate in South Africa and may be available as soon as the first quarter 2021. The trial is being conducted in collaboration with Professor Shabir Mahdi and Wits University and is funded in part by the Bill & Melinda Gates Foundation. The Coalition for Epidemic Preparedness Innovations (CEPI) funded the manufacturing of doses of NVX-CoV2373 for this Phase 2b clinical trial.

    U.S./Mexico pivotal Phase 3 trial update

    Novavax expects its pivotal Phase 3 clinical trial in the United States and Mexico to begin in the coming weeks. More than 100 trial sites have been selected with some alternate sites in place, should they be needed.

    Preliminary blinded data on NVX-CoV2373 in older adults needed to proceed to Phase 3 has previously been positively reviewed by the Food and Drug Administration (FDA). Additional clinical data from the Phase 2 trial conducted in the U.S. and Australia are expected to be unblinded in Q1 and will be targeted for publication.

    Novavax will use vaccine material produced at commercial scale for this trial. Therefore, the Company has been working closely with the FDA to complete trial-initiation gating activities related to its commercial-scale production at FUJIFILM Diosynth Biotechnologies in Research Triangle Park, North Carolina.

    Novavax was awarded $1.6 billion in funding from the U.S. government to meet its Operation Warp Speed goals to expedite the delivery of millions of doses of safe, effective vaccines for COVID-19. The award is funding the U.S. and Mexico pivotal Phase 3 trial and manufacturing scale-up. 

    About NVX-CoV2373

    NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein adjuvanted with Novavax' patented saponin-based Matrix-M™ to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that block binding of spike protein to cellular receptors and provided protection from infection and disease. NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera in Phase 1/2 clinical testing. NVX-CoV2373 is being evaluated in a Phase 3 trial in the U.K. and two ongoing Phase 2 studies that began in August: a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $399 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI) and more than $1.6 billion from the U.S. Government's Operation Warp Speed program.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undertaking clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Novavax Forward Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended September 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.



    Contacts:
    Investors
    Erika Trahan
    
    240-268-2022
    
    Media
    Edna Kaplan
    
    617-974-8659

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  8. GAITHERSBURG, Md., Nov. 25, 2020 (GLOBE NEWSWIRE) -- Novavax Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it will participate in two upcoming investor conferences. Novavax' COVID-19 vaccine candidate, NVX-CoV2373, will be a topic of discussion in each conference.

    Piper Sandler 32nd Annual Virtual Healthcare Conference
    Panel
    Date:

    Tuesday, December 1, 2020
    Time:10:00 a.m. Eastern Time (ET)
    Panel title:The Road Ahead for COVID-19 Vaccines: What We Know and Questions Still to Be Answered into 2021
    Moderators:Edward A. Tenthoff and Yasmeen Rahimi, Ph.D.
    NVAX Panelist:Gregory M. Glenn, M.D., President of Research and Development, Novavax
    Additional panelists:

    GAITHERSBURG, Md., Nov. 25, 2020 (GLOBE NEWSWIRE) -- Novavax Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it will participate in two upcoming investor conferences. Novavax' COVID-19 vaccine candidate, NVX-CoV2373, will be a topic of discussion in each conference.

    Piper Sandler 32nd Annual Virtual Healthcare Conference
    Panel

    Date:


    Tuesday, December 1, 2020
    Time:10:00 a.m. Eastern Time (ET)
    Panel title:The Road Ahead for COVID-19 Vaccines: What We Know and Questions Still to Be Answered into 2021
    Moderators:Edward A. Tenthoff and Yasmeen Rahimi, Ph.D.
    NVAX Panelist:Gregory M. Glenn, M.D., President of Research and Development, Novavax

    Additional panelists: Moderna, Inc., Arcturus Therapeutics Holdings, Inc. and Altimmune, Inc.

    This event is open to Piper Sandler clients
      
    Conference 
    Event:

    Participants:
    Fireside chat

    Stanley C. Erck, President and Chief Executive Officer, and Dr. Glenn
    Webcast:

    A replay of the recorded fireside session is available through the events page of the Company's website at ir.novavax.com for 90 days.
      
    Event:

    Date:



    Investor meetings

    Wednesday, December 2, 2020
    Evercore ISI 3rd Annual HealthCONx Conference
    Date:Thursday, December 3, 2020
    Time:2:15 p.m. Eastern Time (ET)
    Participation:Fireside chat and investor meetings
    Live webcast:www.novavax.com, "Investors"/ "Events"

      

    About NVX-CoV2373

    NVX-CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and cannot replicate, nor can it cause COVID-19. In preclinical trials, NVX-CoV2373 demonstrated induction of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In the Phase 1 portion of its Phase 1/2 clinical trial, NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. NVX-CoV2373 is also being evaluated in a Phase 3 trial in the U.K. and two ongoing Phase 2 studies that began in August; a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $399 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI) and almost $1.7 billion from the U.S. government.        

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases.  Novavax is currently conducting multiple clinical trials for NVX-CoV2373, its vaccine candidate against the virus that causes COVID-19, including a pivotal Phase 3 clinical trial in the United Kingdom to evaluate the efficacy, safety and immunogenicity in individuals aged 18-84 years of age. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both candidate vaccines incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Contacts:

    Investors

    Erika Trahan



    240-268-2022

    Media

    Brandzone/KOGS Communication

    Edna Kaplan



    617-974-8659



    Primary Logo

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  9. GAITHERSBURG, Md., Nov. 10, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, will host a conference call for the investment community to pose questions related to the Company's third quarter 2020 financial and operating results. The call will be held because of technical issues experienced by the Company's external conference call host during the earnings call that took place on November 9 at 4:30 pm. The call will be held following the close of U.S. financial markets on Tuesday, November 10, 2020.

    Conference call details are as follows:

    Date:November 10, 2020
    Time:4:30 p.m. U.S. Eastern Time (ET)
    Dial-in number:(877) 212-6076 (Domestic)

    GAITHERSBURG, Md., Nov. 10, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, will host a conference call for the investment community to pose questions related to the Company's third quarter 2020 financial and operating results. The call will be held because of technical issues experienced by the Company's external conference call host during the earnings call that took place on November 9 at 4:30 pm. The call will be held following the close of U.S. financial markets on Tuesday, November 10, 2020.

    Conference call details are as follows:

    Date:November 10, 2020
    Time:4:30 p.m. U.S. Eastern Time (ET)
    Dial-in number:(877) 212-6076 (Domestic) or (707) 287-9331 (International)
    Conference ID: 1376583
    Webcast:www.novavax.com, "For Investors"/ "Events"
      
    Conference call webcast replay:
      
    Dates: Starting at 7:30 p.m. ET, November 10, 2020 until 7:30 p.m. ET November 17, 2020
    Dial-in number:(855) 859-2056 (Domestic) or (404) 537-3406 (International)
    Conference ID:1376583
    Webcast:www.novavax.com, "For Investors"/ "Events" until 11/17/2020



    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases.  Novavax is currently conducting multiple clinical trials for NVX-CoV2373, its vaccine candidate against the virus that causes COVID-19, including a pivotal Phase 3 clinical trial in the United Kingdom to evaluate the efficacy, safety and immunogenicity in individuals aged 18-84 years of age.  NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both candidate vaccines incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Contacts:         

    Investors

    Erika Trahan



    240-268-2022

    Media

    Brandzone/KOGS Communication

    Edna Kaplan



    617-974-8659

    Primary Logo

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    • Covino brings global biopharmaceutical finance experience to Novavax
    • John Trizzino, Chief Business Officer, takes on additional role as Chief Commercial Officer
    • Filip Dubovsky, M.D. promoted to Executive Vice President, Chief Medical Officer
    • Biegie Lee promoted to Senior Vice President, Chief Information Officer

    GAITHERSBURG, Md., Nov. 09, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced updates to its leadership team, including the appointment of Gregory F. Covino as Executive Vice President and Chief Financial Officer (CFO). Executive Vice President John Trizzino, who previously served as CFO, will now become the Chief…

    • Covino brings global biopharmaceutical finance experience to Novavax
    • John Trizzino, Chief Business Officer, takes on additional role as Chief Commercial Officer
    • Filip Dubovsky, M.D. promoted to Executive Vice President, Chief Medical Officer
    • Biegie Lee promoted to Senior Vice President, Chief Information Officer

    GAITHERSBURG, Md., Nov. 09, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced updates to its leadership team, including the appointment of Gregory F. Covino as Executive Vice President and Chief Financial Officer (CFO). Executive Vice President John Trizzino, who previously served as CFO, will now become the Chief Commercial Officer while continuing in his role as Chief Business Officer.

    "We welcome Greg's multifaceted and extensive global financial experience at a pivotal time as Novavax transforms into a commercial stage company," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "His expertise will be of significant value as we advance both our COVID-19 vaccine candidate, NVXCoV2373, and our NanoFlu influenza vaccine toward commercialization."

    Prior to joining Novavax, Mr. Covino was Group CFO at GlaxoSmithKline's TESARO Oncology Division, where he also served as Senior Vice President and Chief Accounting Officer. He previously served as Chief Accounting Officer at leading biopharmaceutical company Biogen Inc. He held earlier positions as Vice President, Corporate Internal Audit, and Vice President, International Finance for Boston Scientific. Earlier in his career, Mr. Covino spent 10 years at international accounting and consulting firm PricewaterhouseCoopers.

    "I look forward to contributing to Novavax' positive impact on reducing the global burden of serious infectious diseases around the world, including COVID-19 and influenza," said Mr. Covino. "This is a very exciting time to join Novavax and play a role in the company's rapid strategic growth."

    Executive Updates

    Since re-joining Novavax in 2014, John Trizzino has held roles of increasing responsibility across Finance, Commercial and executive management. With his newly created role of Chief Commercial Officer, Mr. Trizzino will focus on advancing NVX-CoV2373, the Company's protein-based vaccine candidate for the prevention of COVID-19, and NanoFlu™ toward commercialization, applying his broad vaccine industry experience in previous roles overseeing commercialization, vaccine policy, strategic development, business development, financing, investor relations and public relations as the company prepares to enter global markets.

    Chief Medical Officer, Filip Dubovsky, M.D. was promoted to Executive Vice President. Since joining Novavax in June 2020, Dr. Dubovsky has played a key role in leading global clinical development planning and trial execution for NVX-CoV2373 in multiple trials in various global locations.

    Biegie Lee was promoted to Senior Vice President and Chief Information Officer. Since joining the Company in 2017, he has led the Information Technology (IT) function's modernization, encompassing technology operations and network operations, enterprise applications and project management. He is also leading the transformation of Novavax' state-of-the-art cybersecurity programs.

    "I congratulate John on his expanded responsibilities, and Filip and Biegie on their promotions, as Novavax grows quickly into a global vaccine leader," continued Mr. Erck. "Their continued leadership will help the Company successfully navigate this crucial time."

    About NVX-CoV2373

    NVX-CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and cannot replicate, nor can it cause COVID-19. In preclinical trials, NVX-CoV2373 demonstrated induction of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In the Phase 1 portion of its Phase 1/2 clinical trial, NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. NVX-CoV2373 is also being evaluated in a Phase 3 trial in the UK and two ongoing Phase 2 studies that began in August: a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $399 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI) and almost $1.7 billion from the U.S. government.

    About NanoFlu

    NanoFlu™ is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced by Novavax in its SF9 insect cell baculovirus system. NanoFlu uses HA amino acid protein sequences that are the same as the recommended wild-type circulating virus HA sequences. NanoFlu contains Novavax' patented saponin-based Matrix-M™ adjuvant.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases.  Novavax is currently conducting multiple clinical trials for NVX-CoV2373, its vaccine candidate against the virus that causes COVID-19, including a pivotal Phase 3 clinical trial in the United Kingdom to evaluate the efficacy, safety and immunogenicity in individuals aged 18-84 years of age. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both candidate vaccines incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Contacts:        
    
    Investors
    Erika Trahan
     
    240-268-2022
    
    Media
    Brandzone/KOGS Communication
    Edna Kaplan
    
    617-974-8659

    Primary Logo

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    • Advanced clinical development of NVXCoV2373 with initiation of first Phase 3 trial to evaluate efficacy, safety and immunogenicity
    • U.K. Phase 3 interim data expected as soon as early first quarter 2021
    • Secured additional large-scale manufacturing for NVX-CoV2373 with expected global capacity over two billion doses by mid-2021
    • Formed leadership team to advance NanoFlu through global licensure
    • Company to host conference call today at 4:30 p.m. ET

    GAITHERSBURG, Md., Nov. 09, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced its financial results and operational highlights for the third quarter ended September 30, 2020.

    • Advanced clinical development of NVXCoV2373 with initiation of first Phase 3 trial to evaluate efficacy, safety and immunogenicity
    • U.K. Phase 3 interim data expected as soon as early first quarter 2021
    • Secured additional large-scale manufacturing for NVX-CoV2373 with expected global capacity over two billion doses by mid-2021
    • Formed leadership team to advance NanoFlu through global licensure
    • Company to host conference call today at 4:30 p.m. ET

    GAITHERSBURG, Md., Nov. 09, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced its financial results and operational highlights for the third quarter ended September 30, 2020.

    "Novavax continued to deliver remarkable progress this quarter, with our most notable achievement being the initiation of a 15,000-person pivotal Phase 3 trial in the U.K. of NVX-CoV2373, our COVID-19 vaccine candidate," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "With multiple clinical trials ongoing worldwide, we expect initial efficacy data potentially by early first quarter 2021. In the U.S., we made significant progress in large-scale manufacturing and expect to launch a pivotal Phase 3 trial by the end of November. We also announced a newly formed team to lead the NanoFlu program to licensure in the U.S. and look forward to providing updates as the team finalizes its strategy."

    Third Quarter 2020 and Recent Highlights

    COVID-19 Program

    • Secured funding for late-stage clinical development of NVX‑CoV2373
      • U.S. Government funding through Operation Warp Speed (OWS) up to $1.6 billion
      • Coalition for Epidemic Preparedness Innovations (CEPI) funding increased up to a total of $399 million
      • Cumulative $2 billion funding to date through OWS, CEPI and Department of Defense (DoD)



    • Advanced ongoing clinical trials for NVX‑CoV2373
      • Phase 3 clinical trial in the United Kingdom (U.K.) initiated
        • Trial expanded to 15,000 participants with full enrollment expected by the end of November
        • Enrollment approximately 9,000 participants, over 60% as of today
        • Event-driven interim data expected as soon as early first quarter 2021
      • Pivotal Phase 3 clinical trial in the U.S. expected to begin by end of November
        • U.S. Food and Drug Administration granted Fast Track designation
        • Conducted with support from the U.S. Government through OWS
        • Enrollment of up to 30,000 participants in the U.S. and Mexico, with proportional representation among diverse populations most vulnerable to COVID-19 distributed across race/ethnicity, age and those living with co-morbidities
      • Phase 2b clinical trial in South Africa initiated
        • Includes two cohorts, one in healthy adults and one in medically stable, HIV-positive adults, to allow for evaluation across a diverse, representative study population
        • Trial expanded to approximately 4,404 participants
        • Enrollment over 50% as of today
        • Supported in part by a $15 million grant from Bill & Melinda Gates Foundation
      • Phase 2 portion of Phase 1/2 clinical trial in the U.S. and Australia initiated
        • Enrollment completed with 1,288 healthy volunteers
        • Presented favorable preliminary reactogenicity data during the CDC Advisory Committee on Immunization Practices meeting

           
    • Published Phase 1 data in The New England Journal of Medicine from the Phase 1/2 clinical trial of NVX‑CoV2373 in healthy adults 18-59 years of age in September 2020

       
    • Completed collaborations for global development, manufacture, supply and commercialization of NVX‑CoV2373 with:
      • Australian Federal Government to be supplied 40 million doses
        • Novavax to supply doses beginning as early as the first half of 2021
      • Government of Canada to be supplied up to 76 million doses
      • U.K. Government for the purchase of 60 million doses and support for the Phase 3 clinical trial to assess the efficacy in the U.K. population
        • Novavax to supply doses beginning as early as the first quarter of 2021
      • SK bioscience for development and supply in global markets including the COVAX Facility
        • Signed letter of intent with Republic of Korea's Ministry of Health and Welfare
        • SK bioscience to manufacture the vaccine antigen component for use in the final drug product
      • AGC Biologics for manufacture of Matrix-M™ adjuvant in Copenhagen, Denmark and Seattle, Washington in the U.S.
      • Takeda Pharmaceutical Company Limited for development, manufacture and commercialization in Japan
        • Novavax to receive payments based on achievement of certain development and commercial milestones
        • Novavax shares in proceeds from vaccine sales
      • Serum Institute of India (SII) for development and commercialization in India and low- and middle-income countries
        • Novavax and SII will split revenue from sale of product, net of agreed costs
        • SII to manufacture the antigen component
      • FUJIFILM Diosynth Biotechnologies (FDB) to manufacture bulk drug substance in North Carolina, Texas and in the U.K.
    • Increased manufacturing capacity of NVX-CoV2373 to over two billion doses annually, when all planned capacity has been brought online anticipated by mid-2021

    NanoFlu™ Program

    • Formed a leadership team to advance NanoFlu to regulatory licensure and accelerate all activities required to file a biologics licensing application (BLA), including exploration of a combined NanoFlu/NVX-CoV2373 vaccine that could be used in a post-pandemic setting.
      • Russell (Rip) Wilson, J.D./M.B.A., to Executive Vice President and NanoFlu General Manager
    • Published Phase 2 data in Clinical Infectious Diseases

    Corporate

    • Strengthened corporate leadership with additional executive management promotions and hiring
      • Gregory F. Covino as Chief Financial Officer
      • John J. Trizzino as Chief Commercial Officer and Chief Business Officer
      • Filip Dubovsky, M.D. to Executive Vice President, Chief Medical Officer
      • Biegie Lee to Senior Vice President, Chief Information Officer

        Click here to read today's leadership announcement
    • Appointed Gregg Alton, J.D. to Novavax' Board of Directors
      • Provides extensive industry experience, including more than 20 years at Gilead Pharmaceuticals in an array of leadership roles across a portfolio of responsibilities
    • Expanded facilities to support global vaccine development
      • 170,000 square feet in Gaithersburg, Maryland for manufacturing, research and development, and general operational purposes
      • 9.7-acre parcel of land in Gaithersburg, Maryland to develop in the future to accommodate growth

    Financial Results for the Three and Nine Months Ended September 30, 2020

    Novavax reported a net loss of $197.3 million, or $3.21 per share, for the third quarter of 2020, compared to a net loss of $18.0 million, or $0.74 per share, for the third quarter of 2019. For the nine months ended September 30, 2020, the net loss was $240.7 million, or $4.39 per share, compared to a net loss of $100.9 million, or $4.43 per share, for the same period in 2019.

    Novavax revenue in the third quarter of 2020 was $157.0 million, compared to $2.5 million in the same period in 2019. This significant increase was due to increased development activities relating to NVX-CoV2373 under the CEPI agreement, participation in OWS and the DOD contract.

    Research and development expenses increased to $294.1 million in the third quarter of 2020, compared to $18.6 million in the same period in 2019. The increase was primarily due to increased development activities relating to NVX-CoV2373, including an expense of $187.2 million associated with its manufacturing supply agreements for NVX-CoV2373. Of the $187.2 million expense, approximately $122 million was non-cash in the period, and is based on Novavax' determination that certain supply agreements contain an embedded lease under U.S. accounting principles. Given that determination, Novavax recognized a financing lease liability and a right-of-use (ROU) asset. As Novavax is in the research and development phase of its vaccine development, the ROU asset was expensed in the third quarter, as it did not have an alternative use. Research and development expenses also increased due to increased employee-related costs, primarily stock-based compensation expense.

    General and administrative expenses increased to $56.9 million in the third quarter of 2020, compared to $7.9 million for the same period in 2019. This increase was primarily due to increased employee-related costs, primarily stock-based compensation expenses, and increased professional fees relating to the integration of Novavax CZ and supporting our NVX-CoV2373 program.

    As of September 30, 2020, Novavax had $571.6 million in cash, cash equivalents, marketable securities and restricted cash, compared to $82.2 million as of December 31, 2019. Net cash provided by operating activities for the first nine months of 2020 was $86.0 million, compared to net cash used in operating activities of $112.9 million for same period in 2019.

    Through utilization of At-the-market (ATM) offerings during the third quarter of 2020, Novavax raised net proceeds of $53.3 million and $445.6 million since the beginning of the year. In addition, in the second quarter of 2020, Novavax entered into an agreement to sell Series A Convertible preferred stock, convertible into 4,388,850 shares of common stock, to an investment fund affiliated with RA Capital Management (RA Capital) in a private placement. Novavax received gross proceeds of $200 million.

    Conference Call

    Novavax will host its quarterly conference call today at 4:30 p.m. ET. The dial-in numbers for the conference call are (877) 212-6076 (Domestic) or (707) 287-9331 (International), passcode 8059421. A replay of the conference call will be available starting at 7:30 p.m. ET on November 9, 2020 until 7:30 p.m. ET on November 16, 2020. To access the replay by telephone, dial (855) 859-2056 (Domestic) or (404) 537-3406 (International) and use passcode 8059421.

    A webcast of the conference call can also be accessed via a link on the home page of the Novavax website (novavax.com) or through the "For Investors"/"Events" tab on the Novavax website. A replay of the webcast will be available on the Novavax website until February 9, 2021.

    About NVX-CoV2373

    NVX-CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and cannot replicate, nor can it cause COVID-19. In preclinical trials, NVX-CoV2373 demonstrated induction of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In the Phase 1 portion of its Phase 1/2 clinical trial, NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. NVX-CoV2373 is also being evaluated in a Phase 3 trial in the U.K. and two ongoing Phase 2 studies that began in August; a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $399 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI) and almost $1.7 billion from the U.S. government.

    About NanoFlu™

    NanoFlu is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced by Novavax in its SF9 insect cell baculovirus system. NanoFlu uses HA amino acid protein sequences that are the same as the recommended wild-type circulating virus HA sequences. NanoFlu contains Novavax' patented saponin-based Matrix-M™ adjuvant.

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is currently conducting multiple clinical trials for NVX-CoV2373, its vaccine candidate against the virus that causes COVID-19, including a pivotal Phase 3 clinical trial in the United Kingdom to evaluate the efficacy, safety and immunogenicity in individuals aged 18-84 years of age. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both candidate vaccines incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Forward-Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended September 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.





     NOVAVAX, INC. 
     CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS 
     (in thousands, except per share information) 
     (unaudited) 
                
        Three Months Ended Nine Months Ended 
        September 30, September 30, 
        2020

     2019  2020  2019 
            

       
    Revenue$157,024   $2,507  $195,939   $9,846  
               
    Expenses:        
     Research and development 294,087    18,611   345,828   84,502  
     Gain on Catalent transaction --   (9,016)  --   (9,016) 
     General and administrative 56,879    7,899   83,977    26,236  
      Total expenses 350,966    17,494   429,805    101,722  
    Loss from operations (193,942)  (14,987)  (233,866)  (91,876) 
    Interest income (expense), net (4,320)  (3,061)  (10,394)  (8,973) 
    Other income (expense) 952    5   3,565    (15) 
    Net loss$(197,310) $(18,043) $(240,695) $(100,864) 
               
    Basic and diluted net loss per share$(3.21) $(0.74) $(4.39) $(4.43) 
    Basic and diluted weighted average        
     number of common shares outstanding 61,554    24,327   54,810    22,761  

    SELECTED CONSOLIDATED BALANCE SHEET DATA

    (in thousands)

     September 30,

    2020
     December 31,

    2019
     (unaudited)  
    Cash and cash equivalents$334,171 $78,823 
    Marketable securities 169,860  -- 
    Total restricted cash 67,565  3,357 
    Total current assets 671,217  97,247 
    Working capital 431,999  71,452 
    Total assets 944,020  172,957 
    Notes payable 321,679  320,611 
    Total stockholders' equity (deficit) 106,440  (186,017)

    Contacts:

    Investors

    Erika Trahan



    240-268-2022

    Media

    Brandzone/KOGS Communication

    Edna Kaplan

     

    617-974-8659

    Primary Logo

    View Full Article Hide Full Article
  10. GAITHERSBURG, Md., Nov. 09, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for NVX-CoV2373, the Company's COVID-19 vaccine candidate. Currently in late-phase clinical development, NVXCoV2373 is a stable, prefusion protein made using Novavax' nanoparticle technology and includes its proprietary MatrixM™ adjuvant.

    "The FDA's decision to grant Fast Track Designation for NVX-CoV2373 reflects the urgent need for a safe and effective vaccine to prevent COVID-19, and we look forward to working closely with the agency to accelerate access…

    GAITHERSBURG, Md., Nov. 09, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for NVX-CoV2373, the Company's COVID-19 vaccine candidate. Currently in late-phase clinical development, NVXCoV2373 is a stable, prefusion protein made using Novavax' nanoparticle technology and includes its proprietary MatrixM™ adjuvant.

    "The FDA's decision to grant Fast Track Designation for NVX-CoV2373 reflects the urgent need for a safe and effective vaccine to prevent COVID-19, and we look forward to working closely with the agency to accelerate access to this vaccine," said Gregory M. Glenn, M.D., President of Research and Development, Novavax. "While the regulatory review of this clinical program will be expedited, Novavax remains committed to a data-driven and scientifically rigorous approach in demonstrating safety and efficacy, which we believe will support confidence in the vaccine in the U.S. and globally."

    Novavax expects to begin its pivotal Phase 3 clinical trial in the United States and Mexico by the end of November. Data from the event-driven trial could support global authorization and approval, including in the U.S. The Company's ongoing Phase 3 clinical trial in the UK to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373 is expected to be fully enrolled by the end of November. Depending on the overall COVID-19 attack rate, interim data in the UK trial, which is also event-driven, are expected as soon as early first quarter 2021.

    About NVX-CoV2373

    NVX-CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and cannot replicate, nor can it cause COVID-19. In preclinical trials, NVX-CoV2373 demonstrated induction of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In the Phase 1 portion of its Phase 1/2 clinical trial, NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. NVX-CoV2373 is also being evaluated in a Phase 3 trial in the UK and two ongoing Phase 2 studies that began in August; a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $399 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI) and almost $1.7 billion from the U.S. government.

    About Fast Track Designation

    Fast Track Designation by the U.S. FDA is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need, with the intent of getting important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions. Specifically, Fast Track Designation facilitates meetings with FDA to discuss all aspects of development to support licensure and provides the opportunity to submit sections of a BLA on a rolling basis as data become available.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undertaking clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Novavax Forward-Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended June 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Contacts:
    Investors
    Erika Trahan 
    240-268-2022
    
    Media
    Brandzone/KOGS Communication
    Edna Kaplan 
    617-974-8659

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  11. GAITHERSBURG, Md., Nov. 04, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the signing of a non-binding Heads of Terms document with the Australian Government to supply 40 million doses of the Company's COVID-19 vaccine candidate, NVX-CoV2373, for the Australian community.

    "This arrangement with the Australian Government reflects the importance of the ongoing clinical development of NVX-CoV2373, and will ensure that the citizens of Australia will have access to its supply," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "We are pleased with the progress of our ongoing Phase 3 clinical trial…

    GAITHERSBURG, Md., Nov. 04, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the signing of a non-binding Heads of Terms document with the Australian Government to supply 40 million doses of the Company's COVID-19 vaccine candidate, NVX-CoV2373, for the Australian community.

    "This arrangement with the Australian Government reflects the importance of the ongoing clinical development of NVX-CoV2373, and will ensure that the citizens of Australia will have access to its supply," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "We are pleased with the progress of our ongoing Phase 3 clinical trial in the UK, and are pressing forward to deliver efficacy data for NVX-CoV2373, with interim data in this event-driven trial expected as soon as early first quarter 2021."

    The Heads of Terms provides for the delivery of NVX-CoV2373 to Australia starting as early as the first half of 2021, subject to the successful completion of Phase 3 clinical development and approval of the vaccine by Australia's Therapeutic Goods Administration (TGA). The vaccine regimen is expected to require two doses per individual, administered 21 days apart.

    To date, Novavax has established various agreements for the supply of NVX-CoV2373 directly to the United States and the United Kingdom, Canada and now Australia, and through partnerships, supply to Japan, South Korea and India.

    Australia's clinical trial contribution

    Australia has played a pivotal role in the clinical development program for NVX-CoV2373. Australian clinical researchers led the global Phase 1 clinical trial in August. This trial involved 131 Australians across two trial sites (Melbourne and Brisbane). In addition, approximately 690 Australians have participated in the Phase 2 arm of the clinical trial, which has been conducted across up to 40 sites in Australia and the U.S.

    The planned global Phase 3 clinical programs evaluating NVX-CoV2373 will assess immunity, safety and COVID-19 disease prevention. The trials seek to recruit members of the community most vulnerable to COVID-19 – the elderly, those with underlying medical conditions as well as diverse racial and ethnic representation.

    About NVX-CoV2373

    NVX-CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and cannot replicate, nor can it cause COVID-19. In preclinical trials, NVX-CoV2373 demonstrated induction of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In the Phase 1 portion of its Phase 1/2 clinical trial, NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. NVX-CoV2373 is also being evaluated in a Phase 3 trial in the UK and two ongoing Phase 2 studies that began in August; a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    About Manufacturing

    Novavax is progressing large-scale manufacturing of NVX-CoV2373 across multiple locations around the world. Delivery of initial doses of the vaccine is expected as early as the end of this year, with the goal to expand the production to enable delivery of over 2 billion doses annually, once all production is online.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases.  Novavax is currently conducting multiple clinical trials for NVX-CoV2373, its vaccine candidate against the virus that causes COVID-19, including a pivotal Phase 3 clinical trial in the United Kingdom to evaluate the efficacy, safety and immunogenicity in individuals aged 18-84 years of age.  NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both candidate vaccines incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Novavax Forward-Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended June 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Additional Contacts:

    Novavax Investors:

    Erika Trahan



    + 1 240-268-2022

    International Media:

    Edna Kaplan

    (for Novavax outside Australia)

    +1 617-974-8659

    In Australia:

    Anne-Marie Sparrow



    +61 417 421 560



    +61 424 785 063

     

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  12. GAITHERSBURG, Md., Nov. 03, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the appointment of Gregg Alton, J.D. to its Board as an independent Director. Mr. Alton brings extensive industry experience to his role on the Novavax Board of Directors, including more than 20 years at Gilead Sciences, where he served in an array of leadership roles across a portfolio of responsibilities.

    Mr. Alton served as Gilead's interim Chief Executive Officer from January 2019 until March 2019, before and after which he was Chief Patient Officer. During his tenure at Gilead, his wide-ranging roles included leadership of commercial operations…

    GAITHERSBURG, Md., Nov. 03, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the appointment of Gregg Alton, J.D. to its Board as an independent Director. Mr. Alton brings extensive industry experience to his role on the Novavax Board of Directors, including more than 20 years at Gilead Sciences, where he served in an array of leadership roles across a portfolio of responsibilities.

    Mr. Alton served as Gilead's interim Chief Executive Officer from January 2019 until March 2019, before and after which he was Chief Patient Officer. During his tenure at Gilead, his wide-ranging roles included leadership of commercial operations in Europe, Asia, Latin America and Africa, as well as government affairs, public affairs and global medical affairs. He also served as General Counsel and Chief Compliance Officer.

    "We welcome Gregg's broad global experience at a pivotal time for Novavax, as we prepare to launch a Phase 3 trial in the U.S. for our COVID-19 vaccine candidate, and to progress NanoFlu toward FDA registration," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "Gregg's broad perspective across multiple areas of the business and deep insight in infectious disease will be invaluable as we build our commercial organization and advance in our mission to promote improved health globally."

    Prior to joining Gilead, Mr. Alton was an attorney at the law firm of Cooley Godward, LLP, where he specialized in corporate finance transactions for healthcare and information technology companies. He currently serves on the Boards of Directors of Corcept Therapeutics, Enochian Biosciences, and was previously on the Boards of Pharmozyme Inc., Celladon Corp. and Oculus Innovative Sciences.

    In addition to his corporate experience, Mr. Alton has served as a trusted advisor to several health-related advisory boards, including the President's Advisory Council on HIV/AIDS at the U.S. Department of Health and Human Services. He also participates as a board member for a number of non-profit organizations, including Black Women's Health Imperative, AIDSVu and the Boys and Girls Clubs of Oakland.

    Mr. Alton received a bachelor's degree in legal studies from the University of California at Berkeley and a law degree from Stanford University.

    "I am delighted to join Novavax' Board of Directors and look forward to working with my fellow Board members and Novavax' management team, who share my passion for helping protect millions of people across the globe from serious infectious diseases," said Mr. Alton.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases.  Novavax is currently conducting multiple clinical trials for NVX-CoV2373, its vaccine candidate against the virus that causes COVID-19, including a pivotal Phase 3 clinical trial in the United Kingdom to evaluate the efficacy, safety and immunogenicity in individuals aged 18-84 years of age.  NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both candidate vaccines incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Novavax Forward-Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended June 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Contacts:
    Investors
    Erika Trahan 
    240-268-2022
    
    Media
    Brandzone/KOGS Communication
    Edna Kaplan 
    617-974-8659

    Primary Logo

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  13. GAITHERSBURG, Md., Nov. 03, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced it will report its third quarter 2020 financial and operating results following the close of U.S. financial markets on Monday, November 9, 2020.

    Conference call details are as follows:

    Date:November 9, 2020
    Time:4:30 p.m. U.S. Eastern Time (ET)
    Dial-in number:(877) 212-6076 (Domestic) or (707) 287-9331 (International)
    Passcode:8059421
    Webcast:www.novavax.com, "For Investors"/ "Events"

    Conference call and webcast replay:

    Dates: Starting at 7:30 p.m. ET, November 9, 2020 until 
     7:30 p.m. ET November 16, 2020
    Dial-in number:(855) 859-2056 (Domestic)

    GAITHERSBURG, Md., Nov. 03, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced it will report its third quarter 2020 financial and operating results following the close of U.S. financial markets on Monday, November 9, 2020.

    Conference call details are as follows:

    Date:November 9, 2020
    Time:4:30 p.m. U.S. Eastern Time (ET)
    Dial-in number:(877) 212-6076 (Domestic) or (707) 287-9331 (International)
    Passcode:8059421
    Webcast:www.novavax.com, "For Investors"/ "Events"

    Conference call and webcast replay:

    Dates: Starting at 7:30 p.m. ET, November 9, 2020 until 
     7:30 p.m. ET November 16, 2020
    Dial-in number:(855) 859-2056 (Domestic) or (404) 537-3406 (International)
    Passcode:8059421
    Webcast:www.novavax.com, "For Investors"/ "Events", until February 9, 2021

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is currently conducting multiple clinical trials for NVX-CoV2373, its vaccine candidate against the virus that causes COVID-19, including a pivotal Phase 3 clinical trial in the United Kingdom to evaluate the efficacy, safety and immunogenicity in individuals aged 18-84 years of age. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both candidate vaccines incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Contacts:

    Investors

    Erika Trahan



    240-268-2022

    Media

    Brandzone/KOGS Communication

    Edna Kaplan



    617-974-8659

    Primary Logo

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    • Expands campus with two properties to support vaccine research and development, manufacturing, business operations

    GAITHERSBURG, Md., Nov. 02, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the expansion of its Maryland campus to accommodate the company's rapid growth as it works to develop its candidate vaccine against COVID-19 and advance its influenza vaccine for global markets. Novavax has secured two additional properties in Gaithersburg, Maryland to support the Company's immediate need for additional laboratory and office space for manufacturing, R&D and business operations.

    The Company currently has a large…

    • Expands campus with two properties to support vaccine research and development, manufacturing, business operations

    GAITHERSBURG, Md., Nov. 02, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the expansion of its Maryland campus to accommodate the company's rapid growth as it works to develop its candidate vaccine against COVID-19 and advance its influenza vaccine for global markets. Novavax has secured two additional properties in Gaithersburg, Maryland to support the Company's immediate need for additional laboratory and office space for manufacturing, R&D and business operations.

    The Company currently has a large pivotal Phase 3 trial underway in the UK with another slated to begin in the United States and Mexico in November, as well as several Phase 2 trials ongoing and in the planning phases around the globe. Novavax has also created a global production network to enable manufacturing and rapid distribution across the U.S., Asia and Europe if and when its COVID-19 vaccine is approved for use. The Company also reported positive Phase 3 data for its influenza vaccine candidate, NanoFlu, earlier this year. Novavax has received $2 billion in funding for its COVID-19 vaccine efforts, including up to $1.6 billion from the U.S. government to help address the global pandemic and up to $388 million from the Coalition for Epidemic Preparedness Innovations (CEPI).

    "The expansion of our physical footprint reflects Novavax' significant growth as we work to both rapidly deliver a COVID-19 vaccine and progress NanoFlu, our influenza vaccine candidate, for regulatory submission and potential commercialization," said Stanley C. Erck, President and CEO, Novavax. "We appreciate the support, partnership and speed of the Maryland Department of Commerce, Montgomery County, and the City of Gaithersburg, which have enabled the expansion of our operations, enhanced our ability to retain and attract highly skilled employees, and reinforced our longstanding commitment to the biotechnology sector in Maryland."

    Real Estate Transactions

    Novavax entered into a 15-year lease for approximately 122,000 square feet located at 700 Quince Orchard Road, Gaithersburg, to be used for manufacturing, research and development, and offices. The Company will immediately invest in the buildout of the site to prepare for use beginning in early 2021

    In addition, the Company's affiliate, 14 Firstfield Holdings, LLC, purchased a 9.7-acre parcel of land at 14 Firstfield Road, Gaithersburg, that the Company plans to develop in the future to accommodate growth of the Company.

    Novavax currently occupies approximately 79,000 square feet of office and laboratory space in Gaithersburg.

    Government Support and Incentives

    The Maryland Department of Commerce, Montgomery County, and the City of Gaithersburg are providing a combination of incentives, including conditional loans, grants and tax credits to enable the expansion. Additional terms were not disclosed.

    About NVX-CoV2373

    NVX-CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and cannot replicate, nor can it cause COVID-19. In preclinical trials, NVX-CoV2373 demonstrated induction of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In the Phase 1 portion of its Phase 1/2 clinical trial, NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. NVX-CoV2373 is also being evaluated in a Phase 3 trial in the UK and two ongoing Phase 2 studies that began in August; a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

    About NanoFlu™

    NanoFlu is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced by Novavax in its SF9 insect cell baculovirus system. NanoFlu uses HA amino acid protein sequences that are the same as the recommended wild-type circulating virus HA sequences. NanoFlu contains Novavax' patented saponin-based MatrixM adjuvant.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undertaking clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Novavax Forward-Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended June 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Contacts:
    Investors
    Erika Trahan
    
    240-268-2022
    
    Media
    Brandzone/KOGS Communication
    Edna Kaplan
    
    617-974-8659

    Primary Logo

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    • 5,500 volunteers enrolled to date in pivotal Phase 3 clinical trial in the U.K.
      • Study expanded to 15,000 participants
      • Full enrollment expected by end of November
      • Event-driven interim data expected as soon as early first quarter 2021
    • U.S. pivotal Phase 3 clinical trial planned to begin by end of November
      • Significant progress in large-scale manufacturing achieved with some delay from original timeline
    • Company to present data from its ongoing Phase 1/2 clinical trial, including new Phase 2 reactogenicity data, during public CDC Advisory Committee on Immunization Practices (ACIP) meeting on October 30

    GAITHERSBURG, Md., Oct. 27, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines…

    • 5,500 volunteers enrolled to date in pivotal Phase 3 clinical trial in the U.K.
      • Study expanded to 15,000 participants
      • Full enrollment expected by end of November
      • Event-driven interim data expected as soon as early first quarter 2021
    • U.S. pivotal Phase 3 clinical trial planned to begin by end of November
      • Significant progress in large-scale manufacturing achieved with some delay from original timeline
    • Company to present data from its ongoing Phase 1/2 clinical trial, including new Phase 2 reactogenicity data, during public CDC Advisory Committee on Immunization Practices (ACIP) meeting on October 30

    GAITHERSBURG, Md., Oct. 27, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, announced updates on its Phase 3 clinical development program of NVX-CoV2373, its COVID-19 vaccine candidate. NVX‑CoV2373 is a stable, prefusion protein made using Novavax' nanoparticle technology and includes Novavax' proprietary Matrix‑M™ adjuvant. The Company also announced that it will present data from its ongoing Phase 1/2 clinical trial, including new Phase 2 reactogenicity data, on Friday, October 30 during the United States (U.S.) Center for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices' (ACIP) meeting.

    U.K. Phase 3 Clinical Trial Update

    Novavax has enrolled over 5,500 participants to date in the United Kingdom (U.K.) trial, which it has expanded to 15,000 volunteers. The increased enrollment is likely to facilitate assessment of safety and efficacy in a shorter time period. Novavax expects this trial to be fully enrolled by the end of November, and dependent on the overall COVID-19 attack rate, interim data in this event-driven trial are expected as soon as early first quarter 2021. These data are expected to serve as the basis for global licensure.

    "We are pleased with the significant progress made in our Phase 3 clinical trial since it began in the United Kingdom at the end of September," said Gregory M. Glenn, M.D., President of Research and Development at Novavax. "We are grateful for the support of the U.K. Government's Vaccines Taskforce (VTF) and the National Institute for Health Research (NIHR) for our pivotal trial. Recognizing the recent, large increase in the number of COVID-19 cases in the U.K., as well as the rapid progress in participant enrollment for our trial, in consultation with the VTF and NIHR, we adjusted our plans and increased enrollment."

    In alignment with Novavax' commitment to transparency, the Company has posted the protocol for this trial on its website at https://www.novavax.com/resources#protocols.

    U.S. Phase 3 Clinical Trial Update

    Novavax currently expects the pivotal clinical trial to begin in the United States and Mexico by the end of November. The Company has made significant progress in large-scale manufacturing, with delays experienced versus original timing estimates.

    Novavax has been developing large-scale manufacturing processes at multiple sites around the world and plans to use production from its contract manufacturing site at FUJIFILM Diosynth Biotechnologies' Morrisville, North Carolina site in this Phase 3 clinical trial.

    Additional Phase 3 Clinical Trial Information

    United Kingdom

    Novavax' first pivotal Phase 3 clinical trial, begun in September in partnership with the U.K. Government's Vaccines Taskforce, will be expanded from 10,000 to 15,000 volunteers, some of whom have been recruited through the National Health Service (NHS) Vaccine Registry. The trial protocol calls for unblinding of data once 152 participants have achieved mild, moderate or severe endpoints. Two interim analyses are planned once 66 and 110 endpoints have occurred.

    United States/Mexico

    Novavax' pivotal Phase 3 clinical trial is being conducted with support from the U.S. Government through Operation Warp Speed. The trial design is harmonized with those of other leading companies, and calls for the enrollment of up to 30,000 participants in the U.S. and Mexico, with proportional representation among diverse populations most vulnerable to COVID-19 distributed across race/ethnicity, age and those living with co-morbidities. The trial protocol will be posted on Novavax' website upon initiation.

    ACIP Presentation Friday, October 30

    Novavax' Senior Vice President and Chief Medical Officer, Filip Dubovsky, M.D., will present an update during a public meeting of the CDC's ACIP between 10:00 am and 12:30 am ET on Friday, October 30. For more information, please visit www.cdc.gov/vaccines/acip/meetings/index.html.

    About NVX-CoV2373

    NVX-CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and cannot replicate, nor can it cause COVID-19. In preclinical trials, NVX-CoV2373 demonstrated induction of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In the Phase 1 portion of its Phase 1/2 clinical trial, NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. NVX-CoV2373 is also being evaluated in a Phase 3 trial in the U.K. and two ongoing Phase 2 studies that began in August; a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undertaking clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Novavax Forward Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended June 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Contacts:         

    Investors

    Erika Trahan



    240-268-2022

    Media

    Brandzone/KOGS Communication

    Edna Kaplan



    617-974-8659

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  14. GAITHERSBURG, Md., Oct. 20, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that Gregory M. Glenn, M.D, President of Research & Development, will present on NVX-CoV2373, the Company's COVID-19 vaccine, at the 2020 World Vaccine Congress Europe. The Congress takes place virtually October 19 - 21, 2020.

    Presentation Title:Recombinant nanoparticle COVID-19 vaccine: Platform technology for Emerging Infectious Diseases (EID)
    Time:14:10 CET/8:10 am ET

    For more information on the Congress or to register, please click here.

    About NVX-CoV2373
    NVX-CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS-CoV-2…

    GAITHERSBURG, Md., Oct. 20, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that Gregory M. Glenn, M.D, President of Research & Development, will present on NVX-CoV2373, the Company's COVID-19 vaccine, at the 2020 World Vaccine Congress Europe. The Congress takes place virtually October 19 - 21, 2020.

    Presentation Title:Recombinant nanoparticle COVID-19 vaccine: Platform technology for Emerging Infectious Diseases (EID)
    Time:14:10 CET/8:10 am ET

    For more information on the Congress or to register, please click here.

    About NVX-CoV2373

    NVX-CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and cannot replicate, nor can it cause COVID-19. In preclinical trials, NVX-CoV2373 demonstrated induction of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In the Phase 1 portion of its Phase 1/2 clinical trial, NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. NVX-CoV2373 is also being evaluated in a Phase 3 trial in the UK and two ongoing Phase 2 studies that began in August; a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undertaking clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Contacts:

    Investors

    Erika Trahan



    240-268-2022

    Media

    Brandzone/KOGS Communication

    Edna Kaplan



    617-974-8659

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    • Team will focus on global NanoFlu licensure and evaluation of post-pandemic influenza/COVID-19 combination vaccine with NVX-CoV2373
    • Russell (Rip) Wilson promoted to Executive Vice President and NanoFlu General Manager

    GAITHERSBURG, Md., Oct. 13, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX) Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the formation of a leadership team to advance NanoFlu to regulatory licensure and the promotion of Russell (Rip) Wilson, J.D./M.B.A., to Executive Vice President and the newly-created role of NanoFlu™ General Manager. Mr. Wilson will focus exclusively on leading efforts to advance NanoFlu, the company's…

    • Team will focus on global NanoFlu licensure and evaluation of post-pandemic influenza/COVID-19 combination vaccine with NVX-CoV2373
    • Russell (Rip) Wilson promoted to Executive Vice President and NanoFlu General Manager

    GAITHERSBURG, Md., Oct. 13, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX) Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the formation of a leadership team to advance NanoFlu to regulatory licensure and the promotion of Russell (Rip) Wilson, J.D./M.B.A., to Executive Vice President and the newly-created role of NanoFlu™ General Manager. Mr. Wilson will focus exclusively on leading efforts to advance NanoFlu, the company's influenza vaccine candidate, through global licensure, as well as the exploration of a combined influenza/COVID-19 vaccine that could be used in a post-pandemic setting. Novavax announced results of its successful NanoFlu pivotal Phase 3 clinical trial earlier this year and intends to seek regulatory approval from the U.S. Food and Drug Administration (FDA) under the accelerated approval pathway previously granted to the company.

    "The formation of this dedicated team enables Novavax to accelerate all activities required to file a biologics licensing application (BLA) for NanoFlu in parallel with the extensive development and manufacturing work underway for NVX-CoV2373, our COVID-19 vaccine candidate," said Stanley C. Erck, President and Chief Executive Officer. "I have full confidence in Rip and our team, which has brought NanoFlu from inception through successful Phase 3 testing. I am excited about the potential to develop a combined influenza/COVID-19 vaccine for use after the pandemic."

    Mr. Wilson joined Novavax in 2011 and was most recently responsible for global business development, quality and program management functions across the company's entire pipeline. In his new role, he will lead a team that will work closely with the broader Novavax team to obtain licensure for NanoFlu from FDA and other global authorities, as well as evaluate the development of a pentavalent NanoFlu/NVX-CoV2373 vaccine.

    "Currently available flu vaccines provide inconsistent, inadequate protection against seasonal influenza," said Mr. Wilson. "NanoFlu has already completed its pivotal Phase 3 clinical trial, in which it achieved all of its primary endpoints, so I am excited about the potential to provide this important vaccine option to the patients who need it most, the difficult-to-protect older adult population. I am committed to leading our team to licensure with a strong sense of urgency."

    The new NanoFlu leadership team includes several Novavax veterans who led the successful development of the vaccine through completion of its successful pivotal Phase 3 clinical trial. This team has also recently completed key activities related to the development of NVX-CoV2373. In addition to Mr. Wilson, the team will be comprised of the following leaders:

    • Tim Hahn, Ph.D., Senior Vice President of CMC for NanoFlu, has led all CMC activities for NanoFlu since the beginning of the program. Most recently, Dr. Hahn led the establishment of a global supply chain for Novavax' Matrix-M adjuvant. Matrix-M is a key component of both the NanoFlu and NVX-CoV2373 vaccines.



    • Vivek Shinde, M.D., Vice President of Clinical Development for NanoFlu, has served as the clinical lead for the NanoFlu program since its inception and through Phase 3. Dr. Shinde also recently led the initiation of the Phase 2b clinical trial in South Africa for NVX-CoV2373.

    The new team will establish a separate NanoFlu development unit within Novavax, building on the company's established knowledge base in the discovery and development of innovative vaccines to prevent serious infectious diseases. The team will also benefit from joint shared services with key cross-functional departments within Novavax.

    About NanoFlu

    NanoFlu is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced by Novavax in its SF9 insect cell baculovirus system. NanoFlu uses HA amino acid protein sequences that are the same as the recommended wild-type circulating virus HA sequences. NanoFlu contains Novavax' patented saponin-based Matrix-M™ adjuvant.

    About NVX-CoV2373

    NVX-CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and cannot replicate, nor can it cause COVID-19. In preclinical trials, NVX-CoV2373 demonstrated induction of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In the Phase 1 portion of its Phase 1/2 clinical trial, NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. NVX-CoV2373 is also being evaluated in a Phase 3 trial in the UK and two ongoing Phase 2 studies that began in August; a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undertaking clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    Novavax Forward-Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended June 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Contacts:

    Investors

    Erika Trahan



    240-268-2022

    Media

    Brandzone/KOGS Communication

    Edna Kaplan



    617-974-8659

    Primary Logo

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  15. GAITHERSBURG, Md., Oct. 05, 2020 (GLOBE NEWSWIRE) -- Novavax Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it will participate in four upcoming investor and industry conferences. Novavax' COVID-19 vaccine candidate, NVX-CoV2373, is expected to be discussed in each conference.

    Maryland Life Sciences Bio Innovation Conference
    Date:Monday, October 5, 2020
    Time:10:25 -11:25 a.m. ET
    Panel title:Discussion on Pandemic & Risk Mitigation: A Focus on Preparation & Resiliency
    Three Maryland biotech leaders discuss how to prepare for the unforeseen and what is needed to pivot for the future.
    Panelist:John Trizzino, Executive Vice President, Chief Business Officer

    GAITHERSBURG, Md., Oct. 05, 2020 (GLOBE NEWSWIRE) -- Novavax Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it will participate in four upcoming investor and industry conferences. Novavax' COVID-19 vaccine candidate, NVX-CoV2373, is expected to be discussed in each conference.

    Maryland Life Sciences Bio Innovation Conference
    Date:Monday, October 5, 2020
    Time:10:25 -11:25 a.m. ET
    Panel title:Discussion on Pandemic & Risk Mitigation: A Focus on Preparation & Resiliency

    Three Maryland biotech leaders discuss how to prepare for the unforeseen and what is needed to pivot for the future.
    Panelist:John Trizzino, Executive Vice President, Chief Business Officer and Chief Financial Officer
    To attend:Click here to register.
     
    Guggenheim First Annual Vaccines and Infectious Diseases Conference
    Date:Monday, October 5, 2020
    Time:4:15 - 4:45 p.m. ET
    Participation:Fireside chat and investor meetings
    Novavax participants:Gregory M. Glenn, M.D., President of Research and Development, and John J. Trizzino, Executive Vice President, Chief Business Officer and Chief Financial Officer
    Webcast:A replay of the session will be available within 48 hours through the events page of the Company's website at ir.novavax.com for 90 days following the event.

     
    Goldman Sachs Virtual Event: Inoculating the Recovery --A Discussion on COVID-19 Vaccines, Treatments, Testing of the Economy
    Date:Thursday, October 8, 2020
    Time:12:00 - 12:55 p.m. ET
    Panel title:Vaccines – Approaching the Light at the End of the Tunnel
    Panelist:Gregory M. Glenn, M.D. President of Research and Development

    This event is open to Goldman Sachs clients.

     
    BioHealth Capital Region Forum
    Date:Monday, October 19, 2020
    Time:12:45 - 1:30 p.m. ET
    Panel title:Strengths of our Region: Combatting Infectious Disease
    Panelist:Vivek, Shinde, M.D., Vice President of Clinical Development
    To attend:Click here to register.
      

    About NVX-CoV2373

    NVX-CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and cannot replicate, nor can it cause COVID-19. In preclinical trials, NVX-CoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In the Phase 1 portion of its Phase 1/2 clinical trial, NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. NVX-CoV2373 is also being evaluated in a Phase 3 trial in the UK and two ongoing Phase 2 studies that began in August; a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs. For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Contacts:

    Investors

    Silvia Taylor and Erika Trahan



    240-268-2022

    Media

    Brandzone/KOGS Communication

    Edna Kaplan



    617-974-8659

    Primary Logo

    View Full Article Hide Full Article
  16. GAITHERSBURG, Md., Sept. 28, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it will present on its lead vaccine candidates, NVX-CoV2373, NanoFlu™ and ResVax™, the Company's COVID-19, influenza and respiratory syncytial virus (RSV) vaccines. The presentations are part of the 2020 World Vaccine Congress Washington, taking place virtually September 28-October1, 2020.

    Gregory Glenn, M.D, President of Research & Development, and Vivek Shinde, M.D., Vice President, Clinical Development, will join global public health, epidemiology, regulatory and industry leaders to share expertise and the latest research related…

    GAITHERSBURG, Md., Sept. 28, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it will present on its lead vaccine candidates, NVX-CoV2373, NanoFlu™ and ResVax™, the Company's COVID-19, influenza and respiratory syncytial virus (RSV) vaccines. The presentations are part of the 2020 World Vaccine Congress Washington, taking place virtually September 28-October1, 2020.

    Gregory Glenn, M.D, President of Research & Development, and Vivek Shinde, M.D., Vice President, Clinical Development, will join global public health, epidemiology, regulatory and industry leaders to share expertise and the latest research related to the SARS-CoV-2 virus and vaccine development to address global health.



    September 28 
    Presentation Title:Recombinant nanoparticle COVID-19 vaccine: Platform technology for EID (Emerging Infectious Diseases)
    Time:2:35 p.m. ET
    Presenter:Dr. Gregory Glenn
      
    October 1 
    Presentation Title:Phase 3 and beyond: Maternal RSV & older adult influenza vaccine program
    Time:8:30 am ET
    Presenter:Dr. Gregory Glenn

      
    Presentation Title:New Phase 3 NanoFlu data (features new Cell-mediated Immunity data)
    Time:4:50 pm ET
    Presenter:Dr. Vivek Shinde
      

    For more information on the congress or to register, please click here.

    About NVX-CoV2373

    NVX-CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigens and cannot replicate, nor can it cause COVID-19. In preclinical trials, NVX-CoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In its the Phase 1 portion of its Phase 1/2 clinical trial, NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. NVX-CoV2373 is also being evaluated in a Phase 3 trial in the UK and two ongoing Phase 2 studies, which began in August; a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

    About ResVax

    ResVax is an RSV fusion (F) protein recombinant nanoparticle vaccine with aluminum phosphate as an adjuvant. It is being developed to protect infants from RSV disease via maternal immunization, which may offer the best method of protection from RSV disease in infants through the first months of life. ResVax is being evaluated in Prepare™, a global Phase 3 clinical trial in 4,636 pregnant women, at least 3,000 of whom received the vaccine, and their infants. Prepare is supported by an $89.1 million grant from the Bill & Melinda Gates Foundation (BMGF).

    About NanoFlu

    NanoFlu is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced by Novavax in its SF9 insect cell baculovirus system. NanoFlu uses HA amino acid protein sequences that are the same as the recommended wild-type circulating virus HA sequences. NanoFlu contains Novavax' patented saponin-based MatrixM adjuvant.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Contacts:         

    Investors

    Silvia Taylor and Erika Trahan



    240-268-2022

    Media

    Brandzone/KOGS Communication

    Edna Kaplan



    617-974-8659

    Primary Logo

    View Full Article Hide Full Article
  17. DUBLIN, Sept. 25, 2020 /PRNewswire/ -- Endo International plc (NASDAQ:ENDP) today announced that its subsidiary, Par Sterile Products, LLC (Par Sterile) has entered into a non-exclusive agreement with Novavax, Inc. to provide fill-finish manufacturing services at its plant in Rochester, Michigan for NVX-CoV2373, Novavax' COVID-19 vaccine candidate.

    Under the terms of the agreement, Par Sterile's Rochester facility has begun production of NVX-CoV2373 final drug product, with initial batches to be used in Novavax' pivotal Phase 3 clinical trial in the United States. Par Sterile will also fill-finish NVX-CoV2373 vaccine intended for commercial distribution in the United States.  Financial and other terms of the agreement were not disclosed.

    "This agreement puts an important piece in place as we finalize our supply chain for the U.S. clinical trial and eventually, commercial distribution of NVX-CoV2373, our nanoparticle vaccine adjuvanted with Matrix-M™," said Stanley C. Erck, President and CEO, Novavax. "Endo's partnership and expertise are enabling rapid delivery of the vaccine for pivotal clinical testing, which we expect to get underway very soon."

    "We are very pleased to help bring Novavax' COVID-19 vaccine to the public," said Blaise Coleman, President and CEO of Endo. "Our Rochester, Michigan facility has a long history of manufacturing critical vaccines and sterile injectable products for the U.S. market and we are proud to partner with Novavax on such a critical initiative. This partnership further underscores Endo's commitment to helping everyone we serve live their best life through the delivery of life-enhancing therapies."

    NVX-CoV2373 is currently in multiple Phase 2 clinical trials. A Phase 2 clinical trial to evaluate the safety and immunogenicity of NVX-CoV2373 began in August 2020 in the United States and Australia building on positive Phase 1 results and expanding to include older adults. A Phase 2b clinical trial to assess efficacy began in South Africa in August 2020. Interim data for these trials is expected before the end of 2020.

    About NVX-CoV2373

    NVX–CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS–CoV–2, the virus that causes COVID-19 disease. NVX–CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. In preclinical trials, NVX–CoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In its Phase 1 portion of the Phase 1/2 clinical trial, NVX–CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. Phase 2 clinical trials began in August 2020. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    About Endo International plc

    Endo International plc (NASDAQ:ENDP) is a specialty pharmaceutical company committed to helping everyone we serve live their best life through the delivery of quality, life-enhancing therapies. Our decades of proven success come from a global team of passionate employees collaborating to bring the best treatments forward. Together, we boldly transform insights into treatments benefiting those who need them, when they need them. Endo has global headquarters in Dublin, Ireland and U.S. headquarters in Malvern, Pennsylvania. Learn more at www.endo.com.

    Forward Looking Statement

    This press release contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Canadian securities legislation, including the statements by Messrs. Erck and Coleman and other statements regarding product potential, clinical trial outcomes, quality, availability and affordability. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intend," "guidance," "future" or similar expressions are forward-looking statements. Because these statements reflect Endo's and Novavax's current views, expectations and beliefs concerning future events, they involve risks and uncertainties. Although Endo and Novavax believe that these forward-looking statements and information are based upon reasonable assumptions and expectations, readers should not place undue reliance on them, or any other forward-looking statements or information in this news release. Investors should note that many factors, as more fully described in the documents filed by Endo and Novavax with the Securities and Exchange Commission and, in Endo's case, with securities regulators in Canada on the System for Electronic Document Analysis and Retrieval, including under the caption "Risk Factors" in Endo's and Novavax's Form 10-K, Form 10-Q and Form 8-K filings, and as otherwise enumerated herein or therein, could affect Endo's and Novavax's future results and could cause Endo's and Novavax's actual results to differ materially from those expressed in forward-looking statements contained in this communication. The forward-looking statements in this press release are qualified by these risk factors. Endo and Novavax assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise, except as may be required under applicable securities laws.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/endo-announces-fill-finish-manufacturing-and-services-agreement-for-novavax-covid-19-vaccine-candidate-301138018.html

    SOURCE Endo International plc

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  18. GAITHERSBURG, Md., Sept. 24, 2020 (GLOBE NEWSWIRE) -- Today, Maryland Governor Larry Hogan and Dr. Michelle McMurry-Heath, President & CEO of Biotechnology Innovation Organization (BIO), joined Novavax President & CEO Stanley Erck to discuss the importance of the biotechnology sector in Maryland, the industry's efforts to address COVID-19, and progress being made by Novavax to develop a vaccine for the deadly virus. A video of the remarks is now available.

    A video accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/d8746b2f-e840-4d4c-a066-c88332388b2a

    "When the COVID-19 crisis began, even before we had our first confirmed cases, I said that our state was home to some of the top health…

    GAITHERSBURG, Md., Sept. 24, 2020 (GLOBE NEWSWIRE) -- Today, Maryland Governor Larry Hogan and Dr. Michelle McMurry-Heath, President & CEO of Biotechnology Innovation Organization (BIO), joined Novavax President & CEO Stanley Erck to discuss the importance of the biotechnology sector in Maryland, the industry's efforts to address COVID-19, and progress being made by Novavax to develop a vaccine for the deadly virus. A video of the remarks is now available.

    A video accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/d8746b2f-e840-4d4c-a066-c88332388b2a

    "When the COVID-19 crisis began, even before we had our first confirmed cases, I said that our state was home to some of the top health research facilities in the world, and I hoped that we might be a part of developing treatments and perhaps even a vaccine for this deadly virus," said Governor Hogan. "Novavax took that challenge and immediately hit the ground running. The State of Maryland is proud to support the efforts of Novavax and our entire hub of life sciences companies, which is at the forefront in the fight against COVID-19."

    Dr. Michelle McMurry-Heath spoke about the unprecedented response by the biotechnology industry to fight COVID-19. "Novavax is a shining example of that response, that galvanized intellectual capacity, and the ability to put the power of science to healing the world," she said. "We at the Biotechnology Innovation Organization couldn't be prouder of how our companies, our scientists, our entrepreneurs, have really mobilized to change the world."

    "We are about to enter three different phase 3 trials, including a trial that is starting imminently in the UK in 10,000 people, a trial that is starting in the U.S. in a few weeks that will be 30,000 people and a third phase 3 trial in India. We have a global presence. This is a global disease. I don't think it's sufficient that we have a vaccine that is just used for the United States. To protect the United States, you need to protect the world. It is a global economy. And that's what we're doing," Erck said. "We feel a tremendous responsibility in our role at the forefront of vaccine development and in our mission to deliver a safe and effective vaccine as rapidly as possible to help combat the COVID-19 pandemic. As a science-based organization dedicated to improving health, it has been gratifying to see many like-minded stakeholders in our region come together to that end."

    The remarks were made on-site at Novavax in Gaithersburg, Maryland. Full video of the remarks is available here.

    Media contacts:

    BIO

    Theresa Brady

    Novavax

    Investors

    Silvia Taylor and Erika Trahan



    240-268-2022

    Media

    Brandzone/KOGS Communication

    Edna Kaplan



    617-974-8659

    About BIO

    BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world's largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world.

    For more information visit: https://www.bio.org/

    Follow us on Twitter @IAmBiotech

    Find us on LinkedIn

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    About NVX-CoV2373

    NVXCoV2373 is a vaccine candidate engineered from the genetic sequence of SARSCoV2, the virus that causes COVID-19 disease. NVXCoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigens and cannot replicate, nor can it cause COVID-19. In preclinical trials, NVXCoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In its the Phase 1 portion of its Phase 1/2 clinical trial, NVXCoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. NVX-CoV2373 is also being evaluated in two ongoing Phase 2 studies, which began in August; a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    Novavax Forward-Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 8-K for the period ended June 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Primary Logo

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  19. Event Highlighted Leadership in Vaccine Development and Regional Growth in Biotechnology Innovation

    Today, Maryland Governor Larry Hogan and Dr. Michelle McMurry-Heath, President & CEO of Biotechnology Innovation Organization (BIO), joined Novavax President & CEO Stanley Erck to discuss the importance of the biotechnology sector in Maryland, the industry's efforts to address COVID-19, and progress being made by Novavax to develop a vaccine for the deadly virus. A video of the remarks is now available.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200924005894/en/

    Left to right, Novavax CEO, Stanley Erck, MD Gov Larry Hogan, BIO CEO Dr. Michelle McMurry-Heath (Photo: Business Wire)

    Left to right, Novavax CEO, Stanley Erck, MD Gov Larry Hogan, BIO CEO Dr. Michelle McMurry-Heath (Photo: Business Wire…

    Event Highlighted Leadership in Vaccine Development and Regional Growth in Biotechnology Innovation

    Today, Maryland Governor Larry Hogan and Dr. Michelle McMurry-Heath, President & CEO of Biotechnology Innovation Organization (BIO), joined Novavax President & CEO Stanley Erck to discuss the importance of the biotechnology sector in Maryland, the industry's efforts to address COVID-19, and progress being made by Novavax to develop a vaccine for the deadly virus. A video of the remarks is now available.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200924005894/en/

    Left to right, Novavax CEO, Stanley Erck, MD Gov Larry Hogan, BIO CEO Dr. Michelle McMurry-Heath (Photo: Business Wire)

    Left to right, Novavax CEO, Stanley Erck, MD Gov Larry Hogan, BIO CEO Dr. Michelle McMurry-Heath (Photo: Business Wire)

    "When the COVID-19 crisis began, even before we had our first confirmed cases, I said that our state was home to some of the top health research facilities in the world, and I hoped that we might be a part of developing treatments and perhaps even a vaccine for this deadly virus," said Governor Hogan. "Novavax took that challenge and immediately hit the ground running. The State of Maryland is proud to support the efforts of Novavax and our entire hub of life sciences companies, which is at the forefront in the fight against COVID-19."

    Dr. Michelle McMurry-Heath spoke about the unprecedented response by the biotechnology industry to fight COVID-19. "Novavax is a shining example of that response, that galvanized intellectual capacity, and the ability to put the power of science to healing the world," she said. "We at the Biotechnology Innovation Organization couldn't be prouder of how our companies, our scientists, our entrepreneurs, have really mobilized to change the world."

    "We are about to enter three different phase 3 trials, including a trial that is starting imminently in the UK in 10,000 people, a trial that is starting in the U.S. in a few weeks that will be 30,000 people and a third phase 3 trial in India. We have a global presence. This is a global disease. I don't think it's sufficient that we have a vaccine that is just used for the United States. To protect the United States, you need to protect the world. It is a global economy. And that's what we're doing," Erck said. "We feel a tremendous responsibility in our role at the forefront of vaccine development and in our mission to deliver a safe and effective vaccine as rapidly as possible to help combat the COVID-19 pandemic. As a science-based organization dedicated to improving health, it has been gratifying to see many like-minded stakeholders in our region come together to that end."

    The remarks were made on-site at Novavax in Gaithersburg, Maryland. Full video of the remarks is available here.

    About BIO

    BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world's largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    About NVX-CoV2373

    NVX‑CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS‑CoV‑2, the virus that causes COVID-19 disease. NVX‑CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigens and cannot replicate, nor can it cause COVID-19. In preclinical trials, NVX-CoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In its the Phase 1 portion of its Phase 1/2 clinical trial, NVX‑CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. NVX-CoV2373 is also being evaluated in two ongoing Phase 2 studies, which began in August; a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    Novavax Forward-Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 8-K for the period ended June 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    View Full Article Hide Full Article
  20. GAITHERSBURG, Md., Sept. 24, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it has initiated its first Phase 3 study to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373, Novavax' COVID-19 vaccine candidate. The trial is being conducted in the United Kingdom (UK), in partnership with the UK Government's Vaccines Taskforce, and is expected to enroll and immunize up to 10,000 individuals between 18-84 (inclusive) years of age, with and without relevant comorbidities, over the next four to six weeks.

    "With a high level of SARS-CoV-2 transmission observed and expected to continue in the UK, we are optimistic…

    GAITHERSBURG, Md., Sept. 24, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it has initiated its first Phase 3 study to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373, Novavax' COVID-19 vaccine candidate. The trial is being conducted in the United Kingdom (UK), in partnership with the UK Government's Vaccines Taskforce, and is expected to enroll and immunize up to 10,000 individuals between 18-84 (inclusive) years of age, with and without relevant comorbidities, over the next four to six weeks.

    "With a high level of SARS-CoV-2 transmission observed and expected to continue in the UK, we are optimistic that this pivotal Phase 3 clinical trial will enroll quickly and provide a near-term view of NVX-CoV2373's efficacy," said Gregory M. Glenn, M.D., President, Research and Development at Novavax. "The data from this trial is expected to support regulatory submissions for licensure in the UK, EU and other countries. We are grateful for the support of the UK Government, including from its Department of Health and Social Care and National Institute for Health Research, to advance this important research."

    NVX-CoV2373 is a stable, prefusion protein made using Novavax' recombinant protein nanoparticle technology that includes Novavax' proprietary MatrixM™ adjuvant. The vaccine has a favorable product profile that will allow handling in an unfrozen, liquid formulation that can be stored at 2°C to 8°C, allowing for distribution using standard vaccine channels.

    Novavax has continued to scale-up its manufacturing capacity, currently at up to 2 billion annualized doses, once all capacity has been brought online by mid-2021.

    About the Phase 3 Study

    Consistent with its long-standing commitment to transparency and in order to enhance information-sharing during the worldwide pandemic, Novavax will be publishing its UK study protocol in the coming days.

    The UK Phase 3 clinical trial is a randomized, placebo-controlled, observer-blinded study to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373 with Matrix-M in up to 10,000 subjects aged 18 to 84 years. Half the participants will receive two intramuscular injections of vaccine comprising 5 µg of protein antigen with 50 µg Matrix‑M adjuvant, administered 21 days apart, while half of the trial participants will receive placebo.

    The trial is designed to enroll at least 25 percent of participants over the age of 65 as well as to prioritize groups that are most affected by COVID-19, including racial and ethnic minorities. Additionally, up to 400 participants will also receive a licensed seasonal influenza vaccine as part of a co-administration sub-study.

    The trial has two primary endpoints. The first primary endpoint is first occurrence of PCR-confirmed symptomatic COVID-19 with onset at least 7 days after the second study vaccination in volunteers who have not been previously infected with SARS-CoV-2. The second primary endpoint is first occurrence of PCR-confirmed symptomatic moderate or severe COVID-19 with onset at least 7 days after the second study vaccination in volunteers who have not been previously infected with SARS-CoV-2. The primary efficacy analysis will be an event-driven analysis based on the number of participants with symptomatic or moderate/severe COVID-19 disease. An interim analysis will be performed when 67% of the desired number of these cases has been reached.

    For further information, including media-ready images, b-roll, downloadable resources and more, click here.

    About NVX-CoV2373

    NVXCoV2373 is a vaccine candidate engineered from the genetic sequence of SARSCoV2, the virus that causes COVID-19 disease. NVXCoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigens and cannot replicate, nor can it cause COVID-19. In preclinical trials, NVXCoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In its the Phase 1 portion of its Phase 1/2 clinical trial, NVXCoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. NVX-CoV2373 is also being evaluated in two ongoing Phase 2 studies, which began in August; a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Novavax Forward-Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 8-K for the period ended June 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Contacts:         

    Novavax

    Investors

    Silvia Taylor and Erika Trahan



    240-268-2022

    Media

    Brandzone/KOGS Communication

    Edna Kaplan



    617-974-8659

    Primary Logo

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    • Serum Institute of India to manufacture ~1 billion doses of NVX-CoV2373 in 2021

    • Increases global manufacturing capacity for NVX-CoV2373 to over 2 billion annualized doses when at full capacity in 2021

    • Agreement expands Novavax partnership with world's largest vaccine developer to increase global delivery of NVX-CoV2373

    GAITHERSBURG, Md., Sept. 15, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced an amendment to its existing agreement with Serum Institute of India Private Limited (SIIPL) under which SIIPL will also manufacture the antigen component of NVX‑CoV2373, Novavax' COVID‑19 vaccine candidate. With this agreement…

    • Serum Institute of India to manufacture ~1 billion doses of NVX-CoV2373 in 2021



    • Increases global manufacturing capacity for NVX-CoV2373 to over 2 billion annualized doses when at full capacity in 2021



    • Agreement expands Novavax partnership with world's largest vaccine developer to increase global delivery of NVX-CoV2373

    GAITHERSBURG, Md., Sept. 15, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced an amendment to its existing agreement with Serum Institute of India Private Limited (SIIPL) under which SIIPL will also manufacture the antigen component of NVX‑CoV2373, Novavax' COVID‑19 vaccine candidate. With this agreement, Novavax increases its manufacturing capacity of NVX-CoV2373 to over two billion doses annually, when all planned capacity has been brought online by mid-2021. NVX‑CoV2373 is a stable, prefusion protein made using Novavax' recombinant protein nanoparticle technology and includes Novavax' proprietary Matrix‑M™ adjuvant.

    "Today's agreement with Serum Institute enhances Novavax' commitment to equitable global delivery of our COVID-19 vaccine. With this arrangement, we have now put in place a global supply chain that includes the recently acquired Praha Vaccines and partnerships with leading biologics manufacturers, enabling production on three continents," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "We continue to work with extraordinary urgency to develop our vaccine, now in Phase 2 clinical trials, and for which we anticipate starting Phase 3 efficacy trials around the world in the coming weeks."

    The agreement with SIIPL augments a global supply chain that will deliver over two billion doses of NVX-CoV2373 annually as of 2021. 

    The antigen component of NVX-CoV2373 is being manufactured at Novavax CZ in Bohumil, Czech Republic (formerly Praha Vaccines), as well as at the following partnered manufacturing sites:

    • Biofabri in Spain
    • FUJIFILM Diosynth Biotechnologies (FDB) in both North Carolina and Texas in the United States
    • FDB in the United Kingdom
    • SIIPL in India
    • SK Bioscience in the Republic of Korea
    • Takeda Pharmaceutical Company Limited in Japan

    Novavax' Matrix-M adjuvant is now being manufactured at Novavax AB in Uppsala, Sweden and the following partnered manufacturing sites:

    • AGC Biologics in the United States and Denmark
    • PolyPeptide Group will manufacture two key intermediaries used in Matrix-M in the United States and Sweden

    "Signing of the manufacturing agreement with Novavax for NVX-CoV2373 is another great milestone for both companies, which will further strengthen our existing relationship. SIIPL expertise to scale-up and manufacture NVX-CoV2373 will help ensure the supply of this most-needed vaccine," said Adar Poonawalla, Chief Executive Officer of Serum Institute of India.

    About NVX-CoV2373

    NVX‑CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS‑CoV‑2, the virus that causes COVID-19 disease. NVX‑CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. In preclinical trials, NVX‑CoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In its Phase 1 portion of the Phase 1/2 clinical trial, NVX‑CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. Phase 2 clinical trials began in August 2020. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    About Serum Institute of India

    Serum Institute of India Pvt. Ltd. was founded in 1966 by Dr. Cyrus Poonawalla with a mission of manufacturing life-saving immuno-biologics. Serum is the world's largest vaccine manufacturer by number of doses produced and sold globally (more than 1.3 billion doses). It is estimated that about 65% of the children in the world receive at least one vaccine manufactured by Serum Institute. Vaccines manufactured by Serum are accredited by the World Health Organization, Geneva and are being used in approximately 170 countries across the globe.

    Serum is ranked as India's No. 1 biotechnology company, manufacturing highly specialized lifesaving biologics like vaccines using cutting edge genetic and cell-based technologies, antisera and other medical specialties.

    The philanthropic philosophy of Serum continues with its work on newer vaccines and biologicals.

    Learn more about Serum Institute of India at https://www.seruminstitute.com/.

    About CEPI

    CEPI is an innovative partnership between public, private, philanthropic, and civil society organizations, launched at Davos in 2017, to develop vaccines to stop future epidemics. CEPI has moved with great urgency and in coordination with WHO in response to the emergence of COVID-19. CEPI has initiated 9 partnerships to develop vaccines against the novel coronavirus. The programs will leverage rapid response platforms already supported by CEPI as well as new partnerships. The aim is to advance COVID-19 vaccine candidates into clinical testing as quickly as possible.

    Before the emergence of COVID-19 CEPI's priority diseases included Ebola virus, Lassa virus, Middle East Respiratory Syndrome coronavirus, Nipah virus, Rift Valley Fever and Chikungunya virus. CEPI also invested in platform technologies that can be used for rapid vaccine and immunoprophylactic development against unknown pathogens (Disease X).

    Novavax Forward-Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 8-K for the period ended June 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Contacts:

    Novavax

    Investors

    Silvia Taylor and Erika Trahan



    240-268-2022

    Media

    Brandzone/KOGS Communication

    Edna Kaplan



    617-974-8659

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  21. GAITHERSBURG, Md., Sept. 10, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced it will participate in five upcoming investor conferences. A topic of discussion will be Novavax' COVID-19 vaccine candidate, NVX-CoV2373.

    Conference details are as follows:

    Citi 15th Annual BioPharma Virtual Conference

    Date:September 10, 2020
    Event:Investor meetings only

    H.C. Wainwright 22nd Annual Global Investment Conference

    Date:September 14, 2020
    Time:9:30 a.m. U.S. Eastern Time (ET)
    Event:Corporate presentation and investor meetings
    Live Webcast:www.novavax.com, "Investors"/ "Events"

    Cantor Virtual Global Healthcare Conference

    Date:

    GAITHERSBURG, Md., Sept. 10, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced it will participate in five upcoming investor conferences. A topic of discussion will be Novavax' COVID-19 vaccine candidate, NVX-CoV2373.

    Conference details are as follows:

    Citi 15th Annual BioPharma Virtual Conference

    Date:September 10, 2020
    Event:Investor meetings only

    H.C. Wainwright 22nd Annual Global Investment Conference

    Date:September 14, 2020
    Time:9:30 a.m. U.S. Eastern Time (ET)
    Event:Corporate presentation and investor meetings
    Live Webcast:www.novavax.com, "Investors"/ "Events"

    Cantor Virtual Global Healthcare Conference

    Date:September 15, 2020
    Time:11:20 a.m. U.S. Eastern Time (ET)
    Event:Fireside chat and investor meetings
    Live Webcast:www.novavax.com, "Investors"/ "Events"

    Morgan Stanley Virtual 18th Annual Global Healthcare Conference

    Date:September 16, 2020
    Time:12:30 p.m. U.S. Eastern Time (ET)
    Event:Fireside chat and investor meetings
    Live Webcast:www.novavax.com, "Investors"/ "Events"

    Leerink CyberRx Series: Vaccine Forum

    Date:September 23, 2020
    Time:9:00 a.m. U.S. Eastern Time (ET)
    Event:Fireside chat

    A replay of the presentations will also be accessible under the "Investors/Events" section www.novavax.com.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Contacts:      

    Investors

    Silvia Taylor and Erika Trahan



    240-268-2022

    Media

    Brandzone/KOGS Communication

    Edna Kaplan



    617-974-8659

    Primary Logo

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    • Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines

    NEW YORK, Sept. 08, 2020 (GLOBE NEWSWIRE) -- The CEOs of AstraZeneca (NYSE:AZN), BioNTech SE (NASDAQ:BNTX), GlaxoSmithKline plc (NYSE:GSK), Johnson & Johnson (NYSE:JNJ), Merck (NYSE:MRK), known as MSD outside the United States and Canada, Moderna, Inc. (NASDAQ:MRNA), Novavax, Inc. (NASDAQ:NVAX), Pfizer Inc. (NYSE:PFE), and Sanofi (NASDAQ:SNY), today announced a historic pledge, outlining a united commitment to uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines.

    All nine CEOs signed…

    • Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines

    NEW YORK, Sept. 08, 2020 (GLOBE NEWSWIRE) -- The CEOs of AstraZeneca (NYSE:AZN), BioNTech SE (NASDAQ:BNTX), GlaxoSmithKline plc (NYSE:GSK), Johnson & Johnson (NYSE:JNJ), Merck (NYSE:MRK), known as MSD outside the United States and Canada, Moderna, Inc. (NASDAQ:MRNA), Novavax, Inc. (NASDAQ:NVAX), Pfizer Inc. (NYSE:PFE), and Sanofi (NASDAQ:SNY), today announced a historic pledge, outlining a united commitment to uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines.

    All nine CEOs signed the following pledge:

    We, the undersigned biopharmaceutical companies, want to make clear our on-going commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles.

    The safety and efficacy of vaccines, including any potential vaccine for COVID-19, is reviewed and determined by expert regulatory agencies around the world, such as the United States Food and Drug Administration (FDA). FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US. FDA's guidance and criteria are based on the scientific and medical principles necessary to clearly demonstrate the safety and efficacy of potential COVID-19 vaccines. More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations.

    Following guidance from expert regulatory authorities such as FDA regarding the development of COVID-19 vaccines, consistent with existing standards and practices, and in the interest of public health, we pledge to:

    • Always make the safety and well-being of vaccinated individuals our top priority.



    • Continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes.



    • Only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA.



    • Work to ensure a sufficient supply and range of vaccine options, including those suitable for global access.

    We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which COVID-19 vaccines are evaluated and may ultimately be approved.

    Together, these nine companies have collectively developed more than 70 novel vaccines that have helped to eradicate some of the world's most complex and deadly public health threats, underscoring their experience in clinical development and regulatory rigor, as well as their longstanding commitments to patient safety and public health.

    About AstraZeneca

    AstraZeneca (NYSE:AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.

    About BioNTech

    Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer.

    For more information, please visit https://biontech.de/.

    About GlaxoSmithKline

    GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us.

    About Johnson & Johnson

    At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That's why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world's largest and most broadly-based health care company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. We are blending our heart, science and ingenuity to profoundly change the trajectory of health for humanity. Learn more at Learn more at www.jnj.com. Follow us at @JNJNews.

    About the Janssen Pharmaceutical Companies of Johnson & Johnson

    At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology and Pulmonary Hypertension.

    Learn more at www.janssen.com. Follow us at www.twitter.com/JanssenGlobal or www.twitter.com/JanssenUS.

    About Merck

    For more than 125 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.

    About Moderna

    Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body's cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. Moderna's platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune and inflammatory diseases, independently and with strategic collaborators.

    Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca PLC and Merck & Co., Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense; the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) and the Coalition for Epidemic Preparedness Innovations (CEPI). Moderna has been named a top biopharmaceutical employer by Science for the past five years. To learn more, visit www.modernatx.com.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    About Pfizer: Breakthroughs That Change Patients' Lives

    At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

    About Sanofi

    Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

    With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

    Sanofi, Empowering Life

    For further information, please visit www.sanofi.com

    Forward Looking Statements of BioNTech

    This press release contains "forward-looking statements" of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, statements concerning BioNTech's efforts to combat COVID-19. Any forward-looking statements in this press release are based on BioNTech current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: competition to create a vaccine for COVID-19; the ability to produce comparable clinical results in larger and more diverse clinical trials; the ability to effectively scale our productions capabilities; and other potential difficulties. For a discussion of these and other risks and uncertainties, see BioNTech's Annual Report on Form 20-F filed with the SEC on March 31, 2020, which is available on the SEC's website at www.sec.gov. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law.

    Forward-Looking Statement of the Janssen Pharmaceutical Companies of Johnson & Johnson

    This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding development of potential preventive and treatment regimens for COVID-19. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 29, 2019, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in the company's most recently filed Quarterly Report on Form 10-Q, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.govwww.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

    Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

    This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the "company") includes "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

    Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the recent global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

    The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's 2019 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).

    Forward-Looking Statement of Moderna, Inc., Cambridge, MA, USA

    This news release of Moderna, Inc. ("Moderna") contains "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, as amended, including but not limited to: statements regarding the conduct of clinical trials for Moderna's vaccine candidate against COVID-19 ("mRNA-1273"), the process for obtaining regulatory approval for mRNA-1273 in the United States and other jurisdictions, and the global supply of mRNA-1273.  If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. These risks, uncertainties, and other factors include, among others:  no commercial product using mRNA technology has been approved, and may never be approved; mRNA drug development has substantial clinical development and regulatory risks due to the novel and unprecedented nature of this new class of medicines; despite having ongoing interactions with the FDA or other regulatory agencies, the FDA or such other regulatory agencies may not agree with Moderna's regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted; the fact that the rapid response technology in use by Moderna is still being developed and implemented; the fact that the safety and efficacy of mRNA-1273 has not yet been established; and those risks and uncertainties described under the heading "Risk Factors" in Moderna's most recent Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date hereof.

    Forward-Looking Statements of Novavax

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended June 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Pfizer Disclosure Notice

    The information contained in this release is as of September 8, 2020. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

    This release contains forward-looking information about Pfizer's efforts to combat COVID-19 and the collaboration between BioNTech and Pfizer to develop a potential COVID-19 vaccine, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preliminary data, including the possibility of unfavorable new preclinical or clinical trial data and further analyses of existing preclinical or clinical trial data; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from current and future preclinical and clinical studies; whether and when any biologics license and/or emergency use authorization applications may be filed in any jurisdictions for any potential vaccine candidates; whether and when any such applications may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the vaccine candidate's benefits outweigh its known risks and determination of the vaccine candidate's efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of a vaccine, including development of products or therapies by other companies; manufacturing capabilities or capacity, including whether the estimated numbers of doses can be manufactured within the projected time periods; uncertainties regarding the ability to obtain recommendations from vaccine technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; and competitive developments.

    A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

    Forward Looking Statement of Sanofi

    This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi's ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the  ultimate outcome of such litigation,  trends in exchange rates and prevailing interest rates, volatile economic and market conditions,  cost containment initiatives and subsequent changes thereto, and  the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole.  Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2019. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

    AstraZeneca Media Contact:

    Michele Meixell

    +1 (302) 885-2677

    BioNTech Media Contact:

    Jasmina Alatovic

    +49 (0)6131 9084 1513 or +49 (0)151 1978 1385

    GlaxoSmithKline Media Contact:

    Simon Moore

    +44 (0)20 8047 5502

    Johnson & Johnson Media Contact:

    Jake Sargent

    +1 (202) 569-5086

    Merck Media Contact:

    Patrick Ryan

    +1 (973) 275-7075

    Moderna Media Contact:

    Colleen Hussey

    +1 (203) 470-5620

    Novavax Media Contacts:

    Edna Kaplan



    Amy Speak

    Pfizer Media Contact:

    Amy Rose

    +1 (212) 733-7410

    Sanofi Media Contact:

    Ashleigh Koss

    +1 (908) 205-2572

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  22. -- Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines

    The CEOs of AstraZeneca (NYSE:AZN), BioNTech (NASDAQ:BNTX), GlaxoSmithKline plc (NYSE:GSK), Johnson & Johnson (NYSE:JNJ), Merck (NYSE:MRK), known as MSD outside the United States and Canada, Moderna, Inc. (NASDAQ:MRNA), Novavax, Inc. (NASDAQ:NVAX), Pfizer Inc. (NYSE:PFE), and Sanofi (NASDAQ:SNY), today announced a historic pledge, outlining a united commitment to uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines.

    All nine CEOs signed the following pledge:

    We, the undersigned…

    -- Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines

    The CEOs of AstraZeneca (NYSE:AZN), BioNTech (NASDAQ:BNTX), GlaxoSmithKline plc (NYSE:GSK), Johnson & Johnson (NYSE:JNJ), Merck (NYSE:MRK), known as MSD outside the United States and Canada, Moderna, Inc. (NASDAQ:MRNA), Novavax, Inc. (NASDAQ:NVAX), Pfizer Inc. (NYSE:PFE), and Sanofi (NASDAQ:SNY), today announced a historic pledge, outlining a united commitment to uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines.

    All nine CEOs signed the following pledge:

    We, the undersigned biopharmaceutical companies, want to make clear our on-going commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles.

    The safety and efficacy of vaccines, including any potential vaccine for COVID-19, is reviewed and determined by expert regulatory agencies around the world, such as the United States Food and Drug Administration (FDA). FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US. FDA's guidance and criteria are based on the scientific and medical principles necessary to clearly demonstrate the safety and efficacy of potential COVID-19 vaccines. More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations.

    Following guidance from expert regulatory authorities such as FDA regarding the development of COVID-19 vaccines, consistent with existing standards and practices, and in the interest of public health, we pledge to:

    • Always make the safety and well-being of vaccinated individuals our top priority.
    • Continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes.
    • Only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA.
    • Work to ensure a sufficient supply and range of vaccine options, including those suitable for global access.

    We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which COVID-19 vaccines are evaluated and may ultimately be approved.

    Together, these nine companies have collectively developed more than 70 novel vaccines that have helped to eradicate some of the world's most complex and deadly public health threats, underscoring their experience in clinical development and regulatory rigor, as well as their longstanding commitments to patient safety and public health.

    About AstraZeneca

    AstraZeneca (NYSE:AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.

    About BioNTech

    Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer.

    For more information, please visit https://biontech.de/.

    About GlaxoSmithKline

    GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us.

    About Johnson & Johnson

    At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That's why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world's largest and most broadly-based health care company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. We are blending our heart, science and ingenuity to profoundly change the trajectory of health for humanity. Learn more at Learn more at www.jnj.com. Follow us at @JNJNews.

    About the Janssen Pharmaceutical Companies of Johnson & Johnson

    At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology and Pulmonary Hypertension.

    Learn more at www.janssen.com. Follow us at www.twitter.com/JanssenGlobal or www.twitter.com/JanssenUS.

    About Merck

    For more than 125 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.

    About Moderna

    Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body's cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. Moderna's platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune and inflammatory diseases, independently and with strategic collaborators.

    Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca PLC and Merck & Co., Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense; the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) and the Coalition for Epidemic Preparedness Innovations (CEPI). Moderna has been named a top biopharmaceutical employer by Science for the past five years. To learn more, visit www.modernatx.com.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    About Pfizer: Breakthroughs That Change Patients' Lives

    At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

    About Sanofi

    Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

    With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

    Sanofi, Empowering Life

    For further information, please visit www.sanofi.com

    Forward Looking Statements of BioNTech

    This press release contains "forward-looking statements" of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, statements concerning BioNTech's efforts to combat COVID-19. Any forward-looking statements in this press release are based on BioNTech current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: competition to create a vaccine for COVID-19; the ability to produce comparable clinical results in larger and more diverse clinical trials; the ability to effectively scale our productions capabilities; and other potential difficulties. For a discussion of these and other risks and uncertainties, see BioNTech's Annual Report on Form 20-F filed with the SEC on March 31, 2020, which is available on the SEC's website at www.sec.gov. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law.

    GSK Cautionary Statement Regarding Forward-Looking Statements

    GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D "Risk Factors" in the company's Annual Report on Form 20-F for 2019 and as set out in GSK's "Principal risks and uncertainties" section of the Q2 Results and any impacts of the COVID-19 pandemic.

    Forward-Looking Statement of the Janssen Pharmaceutical Companies of Johnson & Johnson

    This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding development of potential preventive and treatment regimens for COVID-19. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 29, 2019, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in the company's most recently filed Quarterly Report on Form 10-Q, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

    Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

    This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the "company") includes "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

    Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the recent global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

    The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's 2019 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).

    Forward-Looking Statement of Moderna, Inc., Cambridge, MA, USA

    This news release of Moderna, Inc. ("Moderna") contains "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, as amended, including but not limited to: statements regarding the conduct of clinical trials for Moderna's vaccine candidate against COVID-19 ("mRNA-1273"), the process for obtaining regulatory approval for mRNA-1273 in the United States and other jurisdictions, and the global supply of mRNA-1273. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. These risks, uncertainties, and other factors include, among others: no commercial product using mRNA technology has been approved, and may never be approved; mRNA drug development has substantial clinical development and regulatory risks due to the novel and unprecedented nature of this new class of medicines; despite having ongoing interactions with the FDA or other regulatory agencies, the FDA or such other regulatory agencies may not agree with Moderna's regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted; the fact that the rapid response technology in use by Moderna is still being developed and implemented; the fact that the safety and efficacy of mRNA-1273 has not yet been established; and those risks and uncertainties described under the heading "Risk Factors" in Moderna's most recent Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date hereof.

    Forward-Looking Statements of Novavax

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended June 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Pfizer Disclosure Notice

    The information contained in this release is as of September [8], 2020. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

    This release contains forward-looking information about Pfizer's efforts to combat COVID-19 and the collaboration between BioNTech and Pfizer to develop a potential COVID-19 vaccine, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preliminary data, including the possibility of unfavorable new preclinical or clinical trial data and further analyses of existing preclinical or clinical trial data; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from current and future preclinical and clinical studies; whether and when any biologics license and/or emergency use authorization applications may be filed in any jurisdictions for any potential vaccine candidates; whether and when any such applications may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the vaccine candidate's benefits outweigh its known risks and determination of the vaccine candidate's efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of a vaccine, including development of products or therapies by other companies; manufacturing capabilities or capacity, including whether the estimated numbers of doses can be manufactured within the projected time periods; uncertainties regarding the ability to obtain recommendations from vaccine technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; and competitive developments.

    A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

    Forward Looking Statement of Sanofi

    This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi's ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2019. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

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  23. -- Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines --

    The CEOs of AstraZeneca (NYSE:AZN), BioNTech (NASDAQ:BNTX), GlaxoSmithKline plc (NYSE:GSK), Johnson & Johnson (NYSE:JNJ), Merck (NYSE:MRK), known as MSD outside the United States and Canada, Moderna, Inc. (NASDAQ:MRNA), Novavax, Inc. (NASDAQ:NVAX), Pfizer Inc. (NYSE:PFE), and Sanofi (NASDAQ:SNY), today announced a historic pledge, outlining a united commitment to uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines.

    This press release features multimedia. View the full release…

    -- Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines --

    The CEOs of AstraZeneca (NYSE:AZN), BioNTech (NASDAQ:BNTX), GlaxoSmithKline plc (NYSE:GSK), Johnson & Johnson (NYSE:JNJ), Merck (NYSE:MRK), known as MSD outside the United States and Canada, Moderna, Inc. (NASDAQ:MRNA), Novavax, Inc. (NASDAQ:NVAX), Pfizer Inc. (NYSE:PFE), and Sanofi (NASDAQ:SNY), today announced a historic pledge, outlining a united commitment to uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200908005282/en/

    All nine CEOs signed the following pledge:





    We, the undersigned biopharmaceutical companies, want to make clear our on-going commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles.

    The safety and efficacy of vaccines, including any potential vaccine for COVID-19, is reviewed and determined by expert regulatory agencies around the world, such as the United States Food and Drug Administration (FDA). FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US. FDA's guidance and criteria are based on the scientific and medical principles necessary to clearly demonstrate the safety and efficacy of potential COVID-19 vaccines. More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations.

    Following guidance from expert regulatory authorities such as FDA regarding the development of COVID-19 vaccines, consistent with existing standards and practices, and in the interest of public health, we pledge to:

    • Always make the safety and well-being of vaccinated individuals our top priority.
    • Continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes.
    • Only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA.
    • Work to ensure a sufficient supply and range of vaccine options, including those suitable for global access.

    We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which COVID-19 vaccines are evaluated and may ultimately be approved.





    Together, these nine companies have collectively developed more than 70 novel vaccines that have helped to eradicate some of the world's most complex and deadly public health threats, underscoring their experience in clinical development and regulatory rigor, as well as their longstanding commitments to patient safety and public health.

    About AstraZeneca

    AstraZeneca (NYSE:AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.

    About BioNTech

    Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer.

    For more information, please visit https://biontech.de/.

    About GlaxoSmithKline

    GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us.

    About Johnson & Johnson

    At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That's why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world's largest and most broadly-based health care company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. We are blending our heart, science and ingenuity to profoundly change the trajectory of health for humanity. Learn more at Learn more at www.jnj.com. Follow us at @JNJNews.

    About the Janssen Pharmaceutical Companies of Johnson & Johnson

    At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology and Pulmonary Hypertension.

    Learn more at www.janssen.com. Follow us at www.twitter.com/JanssenGlobal or www.twitter.com/JanssenUS.

    About Merck

    For more than 125 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.

    About Moderna

    Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body's cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. Moderna's platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune and inflammatory diseases, independently and with strategic collaborators.

    Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca PLC and Merck & Co., Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense; the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) and the Coalition for Epidemic Preparedness Innovations (CEPI). Moderna has been named a top biopharmaceutical employer by Science for the past five years. To learn more, visit www.modernatx.com.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    About Pfizer: Breakthroughs That Change Patients' Lives

    At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

    About Sanofi

    Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

    With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

    Sanofi, Empowering Life

    For further information, please visit www.sanofi.com

    Forward Looking Statements of BioNTech

    This press release contains "forward-looking statements" of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, statements concerning BioNTech's efforts to combat COVID-19. Any forward-looking statements in this press release are based on BioNTech current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: competition to create a vaccine for COVID-19; the ability to produce comparable clinical results in larger and more diverse clinical trials; the ability to effectively scale our productions capabilities; and other potential difficulties. For a discussion of these and other risks and uncertainties, see BioNTech's Annual Report on Form 20-F filed with the SEC on March 31, 2020, which is available on the SEC's website at www.sec.gov. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law.

    GSK Cautionary Statement Regarding Forward-Looking Statements

    GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D "Risk Factors" in the company's Annual Report on Form 20-F for 2019 and as set out in GSK's "Principal risks and uncertainties" section of the Q2 Results and any impacts of the COVID-19 pandemic.

    Forward-Looking Statement of the Janssen Pharmaceutical Companies of Johnson & Johnson

    This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding development of potential preventive and treatment regimens for COVID-19. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 29, 2019, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in the company's most recently filed Quarterly Report on Form 10-Q, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

    Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

    This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the "company") includes "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

    Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the recent global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

    The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's 2019 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).

    Forward-Looking Statement of Moderna, Inc., Cambridge, MA, USA

    This news release of Moderna, Inc. ("Moderna") contains "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, as amended, including but not limited to: statements regarding the conduct of clinical trials for Moderna's vaccine candidate against COVID-19 ("mRNA-1273"), the process for obtaining regulatory approval for mRNA-1273 in the United States and other jurisdictions, and the global supply of mRNA-1273. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. These risks, uncertainties, and other factors include, among others: no commercial product using mRNA technology has been approved, and may never be approved; mRNA drug development has substantial clinical development and regulatory risks due to the novel and unprecedented nature of this new class of medicines; despite having ongoing interactions with the FDA or other regulatory agencies, the FDA or such other regulatory agencies may not agree with Moderna's regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted; the fact that the rapid response technology in use by Moderna is still being developed and implemented; the fact that the safety and efficacy of mRNA-1273 has not yet been established; and those risks and uncertainties described under the heading "Risk Factors" in Moderna's most recent Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date hereof.

    Forward-Looking Statements of Novavax

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended June 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Pfizer Disclosure Notice

    The information contained in this release is as of September [8], 2020. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

    This release contains forward-looking information about Pfizer's efforts to combat COVID-19 and the collaboration between BioNTech and Pfizer to develop a potential COVID-19 vaccine, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preliminary data, including the possibility of unfavorable new preclinical or clinical trial data and further analyses of existing preclinical or clinical trial data; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from current and future preclinical and clinical studies; whether and when any biologics license and/or emergency use authorization applications may be filed in any jurisdictions for any potential vaccine candidates; whether and when any such applications may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the vaccine candidate's benefits outweigh its known risks and determination of the vaccine candidate's efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of a vaccine, including development of products or therapies by other companies; manufacturing capabilities or capacity, including whether the estimated numbers of doses can be manufactured within the projected time periods; uncertainties regarding the ability to obtain recommendations from vaccine technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; and competitive developments.

    A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

    Forward Looking Statement of Sanofi

    This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi's ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2019. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

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  24. GAITHERSBURG, Md., Sept. 02, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the publication in The New England Journal of Medicine of Phase 1 data from its Phase 1/2 clinical trial of NVX‑CoV2373, its COVID‑19 vaccine candidate adjuvanted with Matrix‑M™, in healthy adults 18-59 years of age. The publication offers further detail on the previously announced results, in which NVX‑CoV2373 demonstrated a reassuring safety and reactogenicity profile and induced robust antibody responses numerically superior to that seen in human convalescent sera. The manuscript is available at https://www.nejm.org/doi/full/10.1056/NEJMoa2026920?query=featured_coronavirus

    GAITHERSBURG, Md., Sept. 02, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the publication in The New England Journal of Medicine of Phase 1 data from its Phase 1/2 clinical trial of NVX‑CoV2373, its COVID‑19 vaccine candidate adjuvanted with Matrix‑M™, in healthy adults 18-59 years of age. The publication offers further detail on the previously announced results, in which NVX‑CoV2373 demonstrated a reassuring safety and reactogenicity profile and induced robust antibody responses numerically superior to that seen in human convalescent sera. The manuscript is available at https://www.nejm.org/doi/full/10.1056/NEJMoa2026920?query=featured_coronavirus.

    "The rapid publication of Phase 1 results from our trial in a prestigious peer-reviewed journal reflects both the importance of the data and the urgent need for an effective vaccine to slow the COVID-19 pandemic," said Gregory M. Glenn, M.D., President of Research and Development at Novavax. "Based on the positive Phase 1 results, we have begun multiple Phase 2 clinical trials, from which we expect to collect preliminary efficacy. Novavax is committed to generating the safety, immunogenicity and efficacy data that will support confident usage of the vaccine, both in the US and globally, and the data published today further bolsters our conviction that this is possible."

    The Phase 1 portion of the Phase 1/2 clinical trial was randomized, observer-blinded, and placebo-controlled.

    NVX-CoV2373 is currently in multiple Phase 2 clinical trials. The Phase 2 portion of the Phase 1/2 clinical trial to evaluate the safety and immunogenicity of NVX-CoV2373 began in August in the United States and Australia, and expands on the age range of the Phase 1 portion by including older adults 60-84 years of age as approximately 50 percent of the trial population. Secondary objectives include preliminary evaluation of efficacy. In addition, a Phase 2b clinical trial to assess efficacy began in South Africa in August.

    The trial was supported by funding from the Coalition for Epidemic Preparedness Innovations (CEPI) and was conducted at two sites in Australia.

    Phase 1 Results Summary

    • NVX-CoV2373 was well-tolerated and reactogenicity events were generally mild
    • There were no severe (Grade 3) unsolicited adverse events (AEs); the vast majority of AEs were mild and deemed not related to vaccination. No serious AEs were reported. Safety follow-up continues.
    • All subjects in the 5 µg group developed anti-spike IgG antibodies after a single dose of vaccine, many of which included neutralizing antibody responses to wild-type virus
    • 100 percent of participants developed wild-type virus neutralizing antibody responses after Dose 2
    • Both 5 µg and 25 adjuvanted doses generated peak geometric mean titer (GMT) greater than 1:3,300
    • Anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease
    • Matrix-M adjuvant was dose-sparing, with the lower 5 µg dose of NVX‑CoV2373 performing comparably with the of 25 µg dose
    • Cellular immune responses measured in a subset of participants demonstrated induction of antigen-specific polyfunctional CD4+ T cell responses with a strong Th1 phenotype bias
    • NVX-CoV2373 has a favorable product profile; it is stable and will allow handling in a liquid formulation that can be stored at 2°C to 8°C, allowing for successful cold chain management with existing infrastructure

    Further details may be found in Novavax' August 4 announcement of Phase 1 results and may be accessed here.

    About NVX-CoV2373

    NVX‑CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS‑CoV‑2, the virus that causes COVID-19 disease. NVX‑CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. In preclinical trials, NVX‑CoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In its Phase 1 portion of the Phase 1/2 clinical trial, NVX‑CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. Phase 2 clinical trials began in August 2020. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Novavax Forward-Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 8-K for the period ended June 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Contacts:

    Novavax

    Investors

    Silvia Taylor and Erika Trahan



    240-268-2022

    Media

    Brandzone/KOGS Communication

    Edna Kaplan



    617-974-8659

    Primary Logo

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  25. •  Canadian government to purchase up to 76 million doses of NVX-CoV2373

    GAITHERSBURG, Md., Aug. 31, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced it has reached an agreement in principle with the Government of Canada to supply up to 76 million doses of NVX-CoV2373, Novavax' COVID-19 vaccine.

    "We are pleased to work with the Canadian government on supply of our COVID-19 vaccine, an essential step to ensure broad access of our vaccine candidate," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "We are moving forward with clinical development of NVX-CoV2373 with a strong sense of urgency in…

    •  Canadian government to purchase up to 76 million doses of NVX-CoV2373

    GAITHERSBURG, Md., Aug. 31, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced it has reached an agreement in principle with the Government of Canada to supply up to 76 million doses of NVX-CoV2373, Novavax' COVID-19 vaccine.

    "We are pleased to work with the Canadian government on supply of our COVID-19 vaccine, an essential step to ensure broad access of our vaccine candidate," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "We are moving forward with clinical development of NVX-CoV2373 with a strong sense of urgency in our quest to deliver a vaccine to protect the world."

    "We are pleased to announce this agreement with Novavax, which will give Canadians access to a promising COVID-19 vaccine candidate. This is an important step in our government's efforts to secure a vaccine to keep Canadians safe and healthy, as the global pandemic evolves," said The Honourable Anita Anand, Minister of Public Services and Procurement, Government of Canada.

    Novavax and Canada expect to finalize an advance purchase agreement under which Novavax will supply doses of NVX-CoV2373 to Canada beginning as early as the second quarter of 2021. This purchase arrangement will be subject to licensure of the Novavax vaccine by Health Canada.

    NVX-CoV2373 is currently in multiple Phase 2 clinical trials. The Phase 2 portion of the Phase 1/2 clinical trial to evaluate the safety and immunogenicity of NVX-CoV2373 began in August in the United States and Australia, and expands on the age range of the Phase 1 portion by including older adults 60-84 years of age as approximately 50 percent of the trial population. Secondary objectives include preliminary evaluation of efficacy. In addition, a Phase 2b clinical trial to assess efficacy began in South Africa in August.

    About NVX-CoV2373

    NVX‑CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS‑CoV‑2, the virus that causes COVID-19 disease. NVX‑CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. In preclinical trials, NVX‑CoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In its Phase 1 data of the Phase 1/2 clinical trial, NVX‑CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. Phase 2 clinical trials began in August. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Novavax Forward-Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended June 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Contacts:      

    Novavax

    Investors

    Silvia Taylor and Erika Trahan



    240-268-2022

    Media

    Brandzone/Speak Life Science

    Amy Speak



    617-420-2461

    Primary Logo

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    • Primary objectives expand evaluation of immunogenicity and safety
    • Secondary objectives include preliminary efficacy assessment
    • Trial to enroll up to 1,500 volunteers in United States and Australia, with approximately 50 percent between 60 and 84 years of age
    • Interim immunogenicity and safety data expected in fourth quarter of 2020

    GAITHERSBURG, Md., Aug. 24, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the first volunteers have been enrolled in the Phase 2 portion of its ongoing clinical trial to evaluate the immunogenicity and safety of NVX-CoV2373, Novavax' COVID-19 vaccine candidate. The Phase 2 clinical trial…

    • Primary objectives expand evaluation of immunogenicity and safety

    • Secondary objectives include preliminary efficacy assessment
    • Trial to enroll up to 1,500 volunteers in United States and Australia, with approximately 50 percent between 60 and 84 years of age
    • Interim immunogenicity and safety data expected in fourth quarter of 2020

    GAITHERSBURG, Md., Aug. 24, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the first volunteers have been enrolled in the Phase 2 portion of its ongoing clinical trial to evaluate the immunogenicity and safety of NVX-CoV2373, Novavax' COVID-19 vaccine candidate. The Phase 2 clinical trial expands on the age range of the Phase 1 portion by including older adults 60-84 years of age as approximately 50 percent of the trial's population. NVX‑CoV2373 is a stable, prefusion protein made using Novavax' nanoparticle technology and includes Novavax' proprietary Matrix‑M™ adjuvant.

    "We expect this Phase 2 portion of the trial to expand on the encouraging Phase 1 safety and immunogenicity data for NVX-CoV2373, and we will now look for robust immune responses in older adults," said Gregory M. Glenn, M.D., President, Research and Development at Novavax. "Our Phase 3 trial of NanoFlu, which we reported in March of 2020, provided us with a deep understanding of the unique needs of older adults, who are particularly vulnerable to COVID-19. We know that the world is closely watching all of these trials, and we anticipate interim data from this trial in the fourth quarter of this year."

    The Phase 2 portion of the ongoing Phase 1/2 clinical trial is a randomized, placebo-controlled, observer-blinded study to evaluate the safety and immunogenicity of NVX-CoV2373 with Matrix-M in subjects aged 18 to 84 years. The clinical trial will assess two dose sizes (5 and 25 µg), each with 50 µg of Matrix‑M. Although the trial was designed to confirm immunogenicity and safety in adults, secondary objectives include preliminary evaluation of efficacy. The study is targeting enrollment of up to 1,500 healthy volunteers, with approximately 50 percent of participants ≥60 years of age, at up to 40 sites in the U.S. and Australia

    The trial is supported by funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

    In the Phase 1 portion of the Phase 1/2 clinical trial, conducted in Australia, NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. These data have been submitted for peer-review to a scientific journal and are posted online at the preprint server medRxiv.org.

    For further information, including media-ready images, b-roll, downloadable resources and more, click here.

    About NVX-CoV2373

    NVX‑CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS‑CoV‑2, the virus that causes COVID-19 disease. NVX‑CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. In preclinical trials, NVX‑CoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In its Phase 1 data of the Phase 1/2 clinical trial, NVX‑CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. Phase 2 clinical trials began in August. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NVX‑CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera in its Phase 1 data of the Phase 1/2 clinical trial. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Novavax Forward-Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 8-K for the period ended June 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Contacts:

    Novavax

    Investors and media

    Silvia Taylor and Erika Trahan



    240-268-2022

    Media

    Brandzone/KOGS Communication

    Edna Kaplan



    617-974-8659

    Primary Logo

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    • Phase 2b clinical trial in collaboration with Professor Shabir Madhi and Wits University
    • Bill & Melinda Gates Foundation providing $15 million grant toward trial
    • Mature trial infrastructure along with significant levels of seasonal transmission may allow for rapid efficacy evaluation

    GAITHERSBURG, Md., Aug. 17, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the beginning of a Phase 2b clinical trial in South Africa to evaluate the efficacy of NVX-CoV2373, Novavax' COVID-19 vaccine candidate. Dr. Shabir Madhi, Professor of Vaccinology at Wits University, will lead the clinical trial, which is supported in part by a $15…

    • Phase 2b clinical trial in collaboration with Professor Shabir Madhi and Wits University
    • Bill & Melinda Gates Foundation providing $15 million grant toward trial
    • Mature trial infrastructure along with significant levels of seasonal transmission may allow for rapid efficacy evaluation

    GAITHERSBURG, Md., Aug. 17, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the beginning of a Phase 2b clinical trial in South Africa to evaluate the efficacy of NVX-CoV2373, Novavax' COVID-19 vaccine candidate. Dr. Shabir Madhi, Professor of Vaccinology at Wits University, will lead the clinical trial, which is supported in part by a $15 million grant from the Bill & Melinda Gates Foundation. NVX‑CoV2373 is a stable, prefusion protein made using Novavax' proprietary nanoparticle technology and includes Novavax' proprietary Matrix‑M™ adjuvant.

    "Because South Africa is experiencing a winter surge of COVID-19 disease, this important Phase 2b clinical trial has the potential to provide an early indication of efficacy, along with additional safety and immunogenicity data for NVX-CoV2373," said Gregory M. Glenn, M.D., President, Research and Development at Novavax. "We appreciate the continued support of the Bill & Melinda Gates Foundation and CEPI, and our strong ongoing collaboration with Wits University, all of whom are united with us in our commitment to produce and deliver a safe, effective vaccine across the globe."

    The randomized, observer-blinded, placebo-controlled Phase 2b clinical trial of NVX-CoV2373 will include two cohorts. One cohort will evaluate efficacy, safety and immunogenicity in approximately 2,665 healthy adults. The second cohort will evaluate safety and immunogenicity in approximately 240 medically stable, HIV-positive adults. This allows for evaluation of the vaccine across a diverse, representative study population. Novavax expects that, if approved in South Africa, its COVID-19 vaccine would ultimately be supplied to South Africa through Novavax' recently announced collaboration with the Serum Institute of India.

    "The major motivation for the COVID-19 vaccines being evaluated at an early stage in South Africa is to generate evidence in the African context on how well these vaccines work in settings such as our own," said Shabir Madhi, M.B.B.C.H., FCPaeds, Ph.D. "I am pleased to work with Novavax as the principal investigator in this clinical trial, following Novavax' COVID-19 vaccine's positive Phase 1 data, which provides strong rationale for moving development forward in a larger subset of adults."

    In the Phase 1 portion of the Phase 1/2 clinical trial, conducted in Australia, NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. These data have been submitted to the U.S. Food and Drug Administration (FDA) and an independent safety monitoring committee, and have also been submitted for peer-review to a scientific journal and are posted online at the preprint server medRxiv.org. Novavax intends to initiate the Phase 2 portion of this trial in the U.S. and Australia in the near future. This trial will include approximately 1,500 subjects and will include older adults.

    The Coalition for Epidemic Preparedness Innovations (CEPI) is funding the manufacturing of doses of NVX-CoV2373 for this Phase 2b clinical trial.

    About NVX-CoV2373

    NVX‑CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS‑CoV‑2, the virus that causes COVID-19 disease. NVX‑CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. In preclinical trials, NVX‑CoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In its Phase 1 data of the Phase 1/2 clinical trial, NVX‑CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. Phase 2 clinical trials will begin in August. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NVX‑CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera in its Phase 1 data of the Phase 1/2 clinical trial. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Novavax Forward-Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 8-K for the period ended June 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Contacts:     

    Novavax

    Investors

    Silvia Taylor and Erika Trahan

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    240-268-2022

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    Brandzone/Speak Life Science

    Amy Speak



    617-420-2461 

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    • UK government to purchase 60 million doses of NVX-CoV2373
    • Novavax to partner with FUJIFILM Diosynth Biotechnologies to manufacture antigen component of NVX-CoV2373 in the UK
    • Novavax and UK government to collaborate on Phase 3 clinical trial in UK commencing in the third quarter of this year
    • Novavax intends to make additional capacity available to global markets

    GAITHERSBURG, Md., Aug. 14, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced it has signed a Heads of Terms (Term Sheet) with the Government of the United Kingdom (UK) for the purchase of 60 million doses of NVX-CoV2373, Novavax' COVID-19 vaccine, and a Phase 3…

    • UK government to purchase 60 million doses of NVX-CoV2373

    • Novavax to partner with FUJIFILM Diosynth Biotechnologies to manufacture antigen component of NVX-CoV2373 in the UK
    • Novavax and UK government to collaborate on Phase 3 clinical trial in UK commencing in the third quarter of this year
    • Novavax intends to make additional capacity available to global markets

    GAITHERSBURG, Md., Aug. 14, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced it has signed a Heads of Terms (Term Sheet) with the Government of the United Kingdom (UK) for the purchase of 60 million doses of NVX-CoV2373, Novavax' COVID-19 vaccine, and a Phase 3 clinical trial to assess the efficacy of the vaccine in the UK population. Novavax will also expand its collaboration with FUJIFILM Diosynth Biotechnologies, which will manufacture the antigen component of NVX-CoV2373 from its Billingham, Stockton-on-Tees site in the UK, in addition to its sites in North Carolina and Texas in the United States. The FUJIFILM Diosynth Biotechnologies site in the UK is expected to produce up to 180 million doses annually, which further boosts the global supply of NVX-CoV2373 for additional markets.

    "We are honored to partner with the UK government to deliver a vaccine that could provide vital protection in the fight against the global health crisis," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "Our Phase 3 clinical trial in the UK will be a critical component to assess the efficacy of NVX-CoV2373, which in a Phase 1 trial has already demonstrated to be generally well-tolerated and to elicit robust antibody responses. We are also delighted to expand our collaboration with FUJIFILM Diosynth Biotechnologies to manufacture our antigen at its UK site."

    "It is encouraging that Novavax' recent clinical data shows their vaccine triggers an immune response greater than that in patients who have recovered from the disease," said Kate Bingham, Chair of the UK Government's Vaccines Taskforce. "We believe that Novavax has a highly innovative vaccine that could be the first in its class of protein-based vaccine options. We are happy to partner with them and global organizations such as CEPI to further our mutual commitments to ensure global access to the vaccine."

    The Phase 3 clinical trial will be a randomized, double-blind, placebo-controlled efficacy study in approximately 9,000 adults 18-85 years of age in the UK. The trial is expected to begin in the third quarter of this year, with the UK government supporting and providing infrastructure to Novavax in the execution of the trial. The trial will assess the ability of NVX-CoV2373 to protect against symptomatic COVID-19 disease as well as evaluate antibody and T-cell responses.

    Under the terms of the agreement, Novavax will supply 60 million doses of NVX-CoV2373 to the UK beginning as early as the first quarter of 2021. Excess supply of antigen manufactured at the FUJIFILM Diosynth Biotechnologies site in Billingham, Stockton-on-Tees may be available for Novavax to sell to additional markets outside the UK.

    "To change the course of the pandemic, FUJIFILM Diosynth Biotechnologies is excited to expand our partnership with Novavax to manufacture their COVID-19 vaccine candidate at our UK site," said Paul Found, Chief Operating Officer, FUJIFILM Diosynth Biotechnologies, UK site. "We are honored to support the UK government and Novavax with the shared goal of delivering a safe and effective vaccine to the British people."

    About NVX-CoV2373

    NVX‑CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS‑CoV‑2, the virus that causes COVID-19 disease. NVX‑CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. In preclinical trials, NVX‑CoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In its Phase 1 data of the Phase 1/2 clinical trial, NVX‑CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. Phase 2 clinical trials will begin in August. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NVX‑CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera in its Phase 1 data of the Phase 1/2 clinical trial. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Novavax Forward-Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 8-K for the period ended June 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Contacts:

    Novavax

    Investors

    Silvia Taylor and Erika Trahan



    240-268-2022

    Media

    Brandzone/Speak Life Science

    Amy Speak



    617-420-2461

     

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    • SK bioscience to manufacture antigen component of NVX-CoV2373
    • Builds on and complements Novavax-CEPI collaboration to develop and distribute NVX-CoV2373
    • Novavax, SK bioscience and Republic of Korea intend to partner for manufacture and supply of vaccine for global markets including South Korea

    GAITHERSBURG, Md. and SEOUL, South Korea, Aug. 13, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, and SK bioscience, a vaccine business subsidiary of SK Group, today announced a development and supply agreement for the antigen component of NVX-CoV2373, Novavax' COVID-19 vaccine candidate, for supply to global markets including the COVAX Facility…

    • SK bioscience to manufacture antigen component of NVX-CoV2373

    • Builds on and complements Novavax-CEPI collaboration to develop and distribute NVX-CoV2373
    • Novavax, SK bioscience and Republic of Korea intend to partner for manufacture and supply of vaccine for global markets including South Korea

    GAITHERSBURG, Md. and SEOUL, South Korea, Aug. 13, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, and SK bioscience, a vaccine business subsidiary of SK Group, today announced a development and supply agreement for the antigen component of NVX-CoV2373, Novavax' COVID-19 vaccine candidate, for supply to global markets including the COVAX Facility. In addition, the companies have signed a letter of intent with the Republic of Korea's Ministry of Health and Welfare to work toward broad and equitable access to NVX-CoV2373 for the global market as well as to make the vaccine available in South Korea.

    Under the terms of the agreement, SK bioscience will manufacture the vaccine antigen component for use in the final drug product globally during the pandemic period.

    NVX-CoV2373 was developed using Novavax' recombinant nanoparticle technology to generate a stable, prefusion antigen derived from the coronavirus spike (S) protein. It contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Phase 1 data from the Company's Phase 1/2 randomized, observer-blinded, placebo-controlled trial shows that NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera.

    SK bioscience, using its cell culture and recombinant protein capability, will initiate the production of the NVX-CoV2373 antigen at its vaccine facility in Andong L-house, South Korea beginning in August 2020.

    This contract development and manufacturing organization agreement leverages the capacity reservation agreement between SK bioscience and the Coalition for Epidemic Preparedness Innovations (CEPI). Novavax' NVX-CoV2373 will be manufactured using a part of the reserved capacity at SK Bioscience's "L-House" facility.

    This agreement further boosts the potential global supply of the NVX-CoV2373 vaccine and is an important component of Novavax' collaboration with CEPI. Through that partnership with CEPI, Novavax has committed to develop and manufacture significant amounts of NVX-CoV2373, including vaccine derived from antigen coming from SK bioscience, if proved safe and effective, to be procured and distributed by the COVAX Facility through a globally fair allocation framework.

    "We are proud to partner with SK bioscience to fulfill our commitment to ensure global supply of NVX-CoV2373 in alignment with our partnership with CEPI," said Stanley C. Erck, President and CEO of Novavax. "SK bioscience shares our sense of urgency to ensure broad and equitable access for our COVID-19 vaccine candidate around the world."

    Jaeyong Ahn, CEO of SK bioscience said, "SK's accumulated vaccine R&D and production capability has been spotlighted by the world's most advanced global pharmaceutical companies as well as the global initiatives for the COVID-19 vaccine manufacturing and supply such as CEPI." He added, "We will cooperate with the government supporting its two-track strategy, developing vaccine in Korea and securing COVID-19 vaccine from a global manufacturer in a short period of time."

    For further information, including media-ready images, b-roll, downloadable resources and more, click here.

    About NVX-CoV2373

    NVX‑CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS‑CoV‑2, the virus that causes COVID-19 disease. NVX‑CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. In preclinical trials, NVX‑CoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In its Phase 1 data of the Phase 1/2 clinical trial, NVX‑CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NVX‑CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera in its Phase 1 data of the Phase 1/2 clinical trial. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    About SK bioscience

    SK bioscience is an innovative South Korean biopharmaceutical company specialized in the vaccine area. SK bioscience developed the cell-culture based influenza vaccine named SKYCellFluTM prequalified by WHO in 2019, SKYZosterTM, the world's second vaccine for shingles, and SKYVaricellaTM, the world's second WHO prequalified varicella vaccine for chicken pox. By leveraging the company's strengths on cutting-edge vaccine technologies, SK bioscience has been expanding its R&D portfolio including pneumococcal conjugate vaccine, human papillomavirus vaccine, typhoid conjugate vaccine and non-replicating rotavirus vaccine through in-house development or external partnership with public and private institutions around the globe pursuing global health. For the COVID-19 vaccine response, SK bioscience is undergoing development for its vaccine candidate against SARS-CoV-2 with support from the Bill and Melinda Gates Foundation.

    Novavax Forward-Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products, including statements regarding the manufacturing of vaccine antigen dose amounts and timing, are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission (SEC) and updated by any Quarterly Report on Form 10-Q, particularly the risks inherent to developing novel vaccines. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Contacts:

    Novavax

    Investors

    Silvia Taylor and Erika Trahan



    240-268-2022

    Media

    Brandzone/Speak Life Science

    Amy Speak



    617-420-2461

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  26. SEATTLE, Aug. 10, 2020 /PRNewswire/ -- AGC Biologics, a global biopharmaceutical Contract Development and Manufacturing Organization (CDMO), announced it has expanded its partnership with Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases. AGC Biologics is currently preparing to manufacture Matrix-M™, the adjuvant component of Novavax' coronavirus vaccine, NVX-CoV2373, from its facility in Copenhagen. AGC Biologics will now expand supply of Matrix-M adjuvant for the vaccine from its facility in Seattle to ensure supply for the United States.

    NVX-CoV2373 is a stable, prefusion protein made using Novavax' proprietary nanoparticle technology. AGC Biologics will optimize process development for scaled-up production of Matrix-M to enable Novavax' ability to deliver significant worldwide supply in 2020 and 2021.

    "We are extremely proud that Novavax has asked us to expand our production of its coronavirus vaccine, NVX-CoV2373, in Seattle," says AGC Biologics' CBO Mark Womack. "This enables us to further support Novavax' need to move this vaccine forward with extraordinary urgency."

    "We are pleased to expand our partnership with AGC Biologics into the United States. They have established themselves as a critical partner in our supply chain of adjuvant for NVX-CoV2373, and we are grateful for their high level of commitment and flexibility in meeting the urgent demands of this project," says Timothy J. Hahn, SVP, Process Technology at Novavax.

    "We are very happy to have the opportunity to serve Novavax at another facility in our global network and to be able to do even more in the fight against the coronavirus pandemic," says AGC Biologics' CEO Patricio Massera.

    AGC Biologics' global network spans three continents, with cGMP-compliant facilities in Seattle, Washington; Boulder, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy and Chiba, Japan. Their best in class services include development and manufacturing of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), viral vectors and genetically engineered cells.

    About Novavax:

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera in its Phase 1 data of the Phase 1/2 clinical trial. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs. Learn more at www.novavax.com.

    About AGC Biologics:

    AGC Biologics is a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to deliver the highest standard of service to clients and partners. The company currently employs more than 1,300 employees worldwide. AGC Biologics has decades of experience in CDMO development and manufacturing, including providing commercial market supply with FDA, PDMA and EMA approvals.

    AGC Biologics offers deep industry expertise and unique customized services. Integrated service offerings include cell line development, bioprocess development, formulation, analytical testing, antibody drug development and conjugation, cell banking and storage and protein expression, including the proprietary CHEF1® Expression System for mammalian production.

    AGC Biologics is committed to continuous innovation and offers the technical creativity to solve clients' most complex challenges, including specialization in fast-track projects for orphan drugs and rare diseases. Learn more at www.agcbio.com.

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/agc-biologics-expands-partnership-with-novavax-301109376.html

    SOURCE AGC Biologics

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    • Announced Positive Phase 1 data of Phase 1/2 clinical trial of NVX-CoV2373
    • Secured $2 billion in funding for global coronavirus vaccine program through CEPI, DoD, and OWS
    • Expanded large scale global manufacturing capacity through acquisition and partnering
    • Company to host conference call today at 4:30 p.m. ET

    GAITHERSBURG, Md., Aug. 10, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced its financial results and operational highlights for the second quarter ended June 30, 2020.

    "Novavax' unprecedented development activities for NVX-CoV2373 and progress continued through the second quarter," said Stanley C. Erck, President…

    • Announced Positive Phase 1 data of Phase 1/2 clinical trial of NVX-CoV2373

    • Secured $2 billion in funding for global coronavirus vaccine program through CEPI, DoD, and OWS
    • Expanded large scale global manufacturing capacity through acquisition and partnering
    • Company to host conference call today at 4:30 p.m. ET

    GAITHERSBURG, Md., Aug. 10, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced its financial results and operational highlights for the second quarter ended June 30, 2020.

    "Novavax' unprecedented development activities for NVX-CoV2373 and progress continued through the second quarter," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "Since identifying a candidate vaccine to address the COVID-19 pandemic in March, we've secured significant funding, implemented global manufacturing capacity and completed and reported our successful Phase 1 trial. We've also expanded our senior leadership team to advance our efforts to bring NVX-CoV2373 to market as rapidly as possible and grow our infrastructure to support commercial stage operations."

    Second Quarter 2020 and Recent Highlights

    COVID-19 Program

    • Announced Phase 1 data from its Phase 1/2 randomized, observer-blinded, placebo-controlled clinical trial of NVX-CoV2373 in healthy adults 18-59 years of age

      -- Neutralization levels numerically superior to convalescent serum

      -- Significantly higher immune response with 2-dose, Matrix-MTM adjuvanted vaccine

      -- Strong T cell responses

      -- Reassuringly safe and tolerable vaccine profile

      -- Presentation included on Novavax website here

      -- Data submitted for peer-review publication and posted to online preprint server at medRxiv.org

       
    • Demonstrated protection and high immunogenicity in animal models

      -- Presented data from non-human primate models that demonstrate protection in challenge studies, enhancement of multifunctional T cells, and production of anti-S IgG and neutralizing antibodies

      -- Data submitted for peer-review publication and posted to online preprint server at medRxiv.org

       
    • Secured $2 billion in funding for development and commercialization of NVX-CoV2373

      -- Coalition for Epidemic Preparedness Innovations (CEPI) funding up to $388 million

      -- U.S. Department of Defense (DoD) funding up to $60 million

      -- U.S. Government funding through Operation Warp Speed (OWS) up to $1.6 billion

       
    • Completed collaborations for global development and commercialization of NVX-CoV2373

      -- Partnered with Takeda Pharmaceutical Company Limited for development, manufacture and commercialization in Japan

        -- Novavax to receive payments based on achievement of certain development and commercial milestones

        -- Novavax shares in proceeds from vaccine sales

      -- Partnered with Serum Institute of India for development and commercialization in India and low- and middle-income countries (LMIC)

        -- Novavax and Serum Institute will split revenue from sale of product, net of agreed costs

       
    • Secured global manufacturing capacity for NVX-CoV2373

      -- Acquired Praha Vaccines in a cash transaction of approximately $167 million

        -- Includes biologics manufacturing facility and related assets in Czech Republic

        -- Facility expected to provide annual capacity approaching 1 billion antigen doses starting in 2021

      -- Entered into agreements with FUJIFILM Diosynth Biotechnologies' (FDB) to manufacture bulk drug substance at facilities in North Carolina and Texas

        -- Large scale manufacturing initiated at FDB North Carolina site

      -- Entered into manufacturing arrangements with AGC Biologics and PolyPeptide Group for large-scale production of Novavax' Matrix-M adjuvant in both U.S. and Europe

    NanoFlu™ Program

    • Successful pivotal NanoFlu Phase 3 clinical trial announced in March 2020

      -- Added important immunogenicity data regarding development of robust T cell mediated responses

      -- All results expected to support future BLA submission using U.S. FDA accelerated approval pathway

      -- Company exploring pathways to manufacture for required lot consistency clinical trial

       
    • Phase 2 and Phase 3 data submitted for peer-review publications and posted to online preprint server at medRxiv.org

    Corporate

    • Strengthened leadership with numerous executive management promotions and hiring
    • Appointed David M. Mott to Novavax' Board of Directors

      -- Brings more than three decades of global management, board and investment experience across multiple private and public biopharmaceutical companies

    Financial Results for the Three and Six Months Ended June 30, 2020

    Novavax reported a net loss of $17.5 million, or $0.30 per share, for the second quarter of 2020, compared to a net loss of $39.6 million, or $1.69 per share, for the second quarter of 2019. For the six months ended June 30, 2020, the net loss was $43.4 million, or $0.84 per share, compared to a net loss of $82.8 million, or $3.77 per share, for the same period in 2019.

    Novavax revenue in the second quarter of 2020 was $35.5 million, compared to $3.4 million in the same period in 2019. This significant increase was due to increased development activities relating to NVX-CoV2373 under the CEPI agreement.

    Research and development expenses increased 15% to $34.8 million in the second quarter of 2020, compared to $30.4 million in the same period in 2019. The increase was primarily due to increased development activities relating to NVX-CoV2373 under the CEPI agreement, partially offset by decreased employee-related and other costs and development activities of ResVax as compared to the same period in 2019.

    General and administrative expenses increased 84% to $17.7 million in the second quarter of 2020, compared to $9.6 million for the same period in 2019. This increase was primarily due to increased professional fees relating to the Novavax CZ acquisition and supporting our NVX-CoV2373 program and increased employee-related expenses.

    As of June 30, 2020, Novavax had $609.5 million in cash, cash equivalents, marketable securities and restricted cash, compared to $82.2 million as of December 31, 2019. Net cash provided by operating activities for the first six months of 2020 was $92.5 million, compared to net cash used in operating activities was $80.6 million for same period in 2019.

    Novavax has continued to strengthen its balance sheet.  Recent activities include:

    • In June, Novavax entered into an agreement to sell Series A Convertible preferred stock, convertible into 4,388,850 shares of common stock, to an investment fund affiliated with RA Capital Management (RA Capital) in a private placement. Novavax received gross proceeds of $200 million.



    • Through utilization of at-the-market (ATM) offerings during the second quarter of 2020, Novavax raised net proceeds of $206.3 million and a total of $392.3 million since the beginning of the year.

    Conference Call

    Novavax will host its quarterly conference call today at 4:30 p.m. ET. The dial-in numbers for the conference call are (866) 923-9367 (Domestic) or (707) 287-9331 (International), passcode 3048947. A replay of the conference call will be available starting at 7:30 p.m. ET on August 10, 2020 until 7:30 p.m. ET on August 17, 2020. To access the replay by telephone, dial (855) 859-2056 (Domestic) or (404) 537-3406 (International) and use passcode 3048947.

    A webcast of the conference call can also be accessed via a link on the home page of the Novavax website (novavax.com) or through the "For Investors"/"Events" tab on the Novavax website. A replay of the webcast will be available on the Novavax website until November 10, 2020.

    About NVX-CoV2373

    NVX‑CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS‑CoV‑2, the virus that causes COVID-19 disease. NVX‑CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. In preclinical trials, NVX‑CoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In its Phase 1 portion of the Phase 1/2 clinical trial, NVX‑CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. Novavax was awarded $1.6 billion by the federal government as part of Operation Warp Speed (OWS), a U.S. government program to deliver millions of doses of a safe, effective vaccine for COVID-19 to the U.S. population. The OWS funding is being used by Novavax to complete late-stage clinical development, including a pivotal Phase 3 clinical trial; establish large-scale manufacturing; and deliver 100 million doses of NVX‑CoV2373 beginning as early as late 2020. The Coalition for Epidemic Preparedness Innovations (CEPI) is also investing up to $388 million, and Department of Defense (DoD) is investing up to $60 million of funding to advance clinical development of NVX‑CoV2373.

    About NanoFlu™

    NanoFlu is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced by Novavax in its SF9 insect cell baculovirus system. NanoFlu uses HA amino acid protein sequences that are the same as the recommended wild-type circulating virus HA sequences. NanoFlu contains Novavax' patented saponin-based Matrix‑M adjuvant.

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NVX‑CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera in its Phase 1 portion of the Phase 1/2 clinical trial. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Forward-Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 8-K for the period ended June 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.



              
    NOVAVAX, INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (in thousands, except per share information)

    (unaudited)

              
       Three Months Ended

     Six Months Ended

       June 30,

     June 30,

       2020 2019 2020 2019
              
    Revenue $  35,538   $  3,357  $  38,915   $  7,339
              
    Expenses:       
     Research and development34,846  30,417 51,741  65,890
     General and administrative17,719  9,606 27,098  18,338
      Total expenses52,565  40,023 78,839  84,228
    Loss from operations(17,027) (36,666) (39,924) (76,889)
    Interest income (expense), net(3,106) (2,929) (6,074) (5,912)
    Other income (expense)2,612  (8) 2,613  (20)
    Net loss $  (17,521) $  (39,603)  $ (43,385)  $ (82,821)
              
    Basic and diluted net loss per share $  (0.30) $  (1.69)  $  (0.84)  $  (3.77)
    Basic and diluted weighted average       
     number of common shares outstanding58,618  23,473 51,401  21,966



    SELECTED CONSOLIDATED BALANCE SHEET DATA

    (in thousands)

     June 30, 2020 December 31, 2019
     (unaudited)  
    Cash and cash equivalents$  424,395 $  78,823 
    Marketable securities   77,902    -- 
    Total restricted cash   107,179    3,357 
    Total current assets   636,381    97,247 
    Working capital   423,050    71,452 
    Total assets   932,227    172,957 
    Notes payable   321,323    320,611 
    Total stockholders' equity (deficit)   184,526    (186,017)
        



    Contacts:

    Investors

    Novavax, Inc.

    Silvia Taylor and Erika Trahan



    240-268-2022

    Media

    Brandzone/KOGS Communication

    Edna Kaplan



    617-974-8659

    Primary Logo

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    • Novavax will license COVID-19 vaccine technology to Takeda for local production and commercialization in Japan
    • Matrix-M adjuvant to be supplied from Novavax
    • Government of Japan will provide funding to Takeda for technology transfer, establishment of infrastructure and scale-up of manufacturing
    • Adds to Takeda's ongoing support of influenza pandemic preparedness in Japan

    GAITHERSBURG, Md. and OSAKA, Japan, Aug. 07, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, and Takeda Pharmaceutical Company Limited (NYSE:TAK), today announced a partnership for the development, manufacturing and commercialization of NVX‑CoV2373, Novavax' COVID‑19 vaccine…

    • Novavax will license COVID-19 vaccine technology to Takeda for local production and commercialization in Japan

    • Matrix-M adjuvant to be supplied from Novavax
    • Government of Japan will provide funding to Takeda for technology transfer, establishment of infrastructure and scale-up of manufacturing
    • Adds to Takeda's ongoing support of influenza pandemic preparedness in Japan

    GAITHERSBURG, Md. and OSAKA, Japan, Aug. 07, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, and Takeda Pharmaceutical Company Limited (NYSE:TAK), today announced a partnership for the development, manufacturing and commercialization of NVX‑CoV2373, Novavax' COVID‑19 vaccine candidate, in Japan. NVX‑CoV2373 is a stable, prefusion protein made using Novavax' recombinant protein nanoparticle technology and includes Novavax' proprietary Matrix‑M™ adjuvant. Takeda will receive funding from the Government of Japan's Ministry of Health, Labour and Welfare (MHLW) to support the technology transfer, establishment of infrastructure and scale-up of manufacturing. Takeda anticipates the capacity to manufacture over 250 million doses of the COVID-19 vaccine per year1.

    "Takeda's leading position in Japan, technical expertise, regulatory know-how and manufacturing capacity make the company an ideal partner to further expand the global availability of NVX‑CoV2373," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "We look forward to collaborating with Takeda to rapidly develop, produce and commercialize the vaccine in Japan."

    Novavax and Takeda are partnering on manufacturing, clinical development and regulatory activities in Japan. Novavax will license and transfer manufacturing technologies to enable Takeda to manufacture the vaccine antigen and will supply the Matrix-M adjuvant to Takeda. Takeda will be responsible for regulatory submission to the MHLW and will produce and distribute NVX‑CoV2373 in Japan.

    "Nothing is more important right now than protecting the world against COVID-19. We are excited to collaborate with Novavax to bring their promising vaccine candidate to Japan," said Rajeev Venkayya, M.D., President of the Global Vaccine Business Unit, Takeda. "Today's announcement builds upon our ongoing support of pandemic preparedness and demonstrates Takeda's commitment to the health and well-being of the Japanese population."

    Novavax will be entitled to receive payments based on the achievement of certain development and commercial milestones, as well as a portion of proceeds from the vaccine.

    About NVX-CoV2373

    NVX‑CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS‑CoV‑2, the virus that causes COVID-19 disease. NVX‑CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. In preclinical trials, NVX‑CoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In its Phase 1 data of the Phase 1/2 clinical trial, NVX‑CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. Novavax was awarded $1.6 billion by the federal government as part of Operation Warp Speed (OWS), a U.S. government program to deliver millions of doses of a safe, effective vaccine for COVID-19 to the U.S. population. The OWS funding is being used by Novavax to complete late-stage clinical development, including a pivotal Phase 3 clinical trial; establish large-scale manufacturing; and deliver 100 million doses of NVX‑CoV2373 beginning as early as late 2020. The Coalition for Epidemic Preparedness Innovations (CEPI) is also investing up to $388 million, and Department of Defense (DoD) is investing up to $60 million of funding to advance clinical development of NVX‑CoV2373.

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NVX‑CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera in its Phase 1 data of the Phase 1/2 clinical trial. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    About Takeda Pharmaceutical Company Limited

    Takeda Pharmaceutical Company Limited (NYSE:TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Diseases, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries.

    For more information, visit https://www.takeda.com.

    Takeda's Commitment to Vaccines

    Vaccines prevent 2 to 3 million deaths each year and have transformed global public health. For the past 70 years, Takeda has supplied vaccines to protect the health of people in Japan. Today, Takeda's global vaccine business is applying innovation to tackle some of the world's most challenging infectious diseases, such as dengue, Zika and norovirus. Takeda's team brings an outstanding track record and a wealth of knowledge in vaccine development, manufacturing and global access to advance a pipeline of vaccines to address some of the world's most pressing public health needs. For more information, visit www.TakedaVaccines.com.

    Novavax Forward-Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products, including statements regarding the rights and responsibilities of each of Novavax and Takeda in their partnership, plans related to manufacturing [(including vaccine antigen dose amounts)], development, regulatory and commercial activities in Japan, potential payments to Novavax from Takeda, Novavax' expectations of third-party funding and anticipated timing of Novavax' clinical trial results are forward-looking statements. These statements may be identified by words such as "expect," "look forward," "potential," "will" and similar references to future periods. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include uncertainty of success in the development and potential commercialization of NVX-CoV2373, unexpected delays in clinical trials or regulatory review of NVX-CoV2373, potential set backs in scaling up manufacturing of NVX-CoV2373, adverse impacts of the ongoing COVID-19 pandemic on Novavax' business, Novavax' future capital requirements and availability of funding, as well as those risks identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission (SEC), and updated by any Quarterly Report on Form 10-Q, particularly the risks inherent to developing novel vaccines. Investors, potential investors, and others should give careful consideration to these risks and uncertainties. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements.

    Takeda Pharmaceutical Company Limited Forward-Looking Statements

    This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda's future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as "targets", "plans", "believes", "hopes", "continues", "expects", "aims", "intends", "ensures", "will", "may", "should", "would", "could" "anticipates", "estimates", "projects" or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda's global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations; the success of or failure of product development programs; decisions of regulatory authorities and the timing thereof; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda's operations and the timing of any such divestment(s); and other factors identified in Takeda's most recent Annual Report on Form 20-F and Takeda's other reports filed with the U.S. Securities and Exchange Commission, available on Takeda's website at: https://www.takeda.com/investors/reports/sec-filings/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda's future results.

    Contacts:

    Novavax

    Investors

    Silvia Taylor and Erika Trahan



    240-268-2022

    Media

    Brandzone/KOGS Communication

    Edna Kaplan



    617-974-8659

    Takeda Pharmaceuticals

    Media in Japan

    Kazumi Kobayashi

    +81 (0) 3-3278-2095





    Media Outside Japan

    Amy Atwood

    +1 774-571-3316




    1.     The projected capacity is an estimate only based on current assumptions from Novavax.

    Primary Logo

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    • Expected to support minimum of 1 billion doses of NVX-CoV2373 for India and low- and middle-income countries
    • Leverages Serum Institute's existing reach and infrastructure
    • Builds on and complements Novavax-CEPI collaboration to develop and distribute NVX-CoV2373 for low- and middle-income countries through the COVAX Facility
    • Serum Institute gains exclusive rights to commercialize in India and non-exclusive rights to commercialize in other LMIC countries
    • Important first step in ensuring global supply during worldwide pandemic       

    GAITHERSBURG, Md., Aug. 06, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced a license agreement…

    • Expected to support minimum of 1 billion doses of NVX-CoV2373 for India and low- and middle-income countries

    • Leverages Serum Institute's existing reach and infrastructure
    • Builds on and complements Novavax-CEPI collaboration to develop and distribute NVX-CoV2373 for low- and middle-income countries through the COVAX Facility
    • Serum Institute gains exclusive rights to commercialize in India and non-exclusive rights to commercialize in other LMIC countries
    • Important first step in ensuring global supply during worldwide pandemic       

    GAITHERSBURG, Md., Aug. 06, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced a license agreement with Serum Institute of India Private Limited (SIIPL) for the development and commercialization of NVX‑CoV2373, Novavax' COVID‑19 vaccine candidate, in low- and middle-income countries (LMIC) and India. This agreement excludes major upper-middle and high-income countries, for which Novavax continues to retain rights. NVX‑CoV2373 is a stable, prefusion protein made using Novavax' recombinant protein nanoparticle technology and includes Novavax' proprietary Matrix‑M™ adjuvant.

    "Novavax is strongly committed to ensuring a global supply of NVX‑CoV2373, including for low- and middle-income countries that are also significantly impacted by coronavirus," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "As the world's largest vaccine manufacturer in terms of doses delivered, Serum Institute is the ideal partner to advance NVX‑CoV2373 throughout India and the LMIC countries. This partnership continues to build on our companies' collaborative history."

    For LMICs and India, Novavax and SIIPL are partnering on clinical development, co-formulation, filling and finishing and commercialization of NVX-CoV2373. SIIPL will be responsible for regulatory submissions and marketing authorizations. Novavax will provide to SIIPL both vaccine antigen and Matrix‑M adjuvant, and Novavax and SIIPL are in discussions to have SIIPL manufacture vaccine antigen in India. Novavax and SIIPL will split the revenue from the sale of product, net of agreed costs.

    "We believe that Novavax' NVX-CoV2373 has significant potential to successfully prevent COVID-19. Given our experience with Novavax on the development of a malaria vaccine, we know the power of their vaccine technologies," said Adar Poonawalla, Chief Executive Officer of Serum Institute of India. "We will work urgently together to bring this vaccine to patients in these geographies."

    This agreement further boosts the global supply of the NVX-CoV2373 vaccine and builds on and complements Novavax' collaboration with the Coalition for Epidemic Preparedness Innovations (CEPI). Through that partnership with CEPI, Novavax has committed to develop and manufacture significant amounts of NVX-CoV2373, if proved safe and effective, to be procured and distributed equitably by the COVAX Facility through a globally fair allocation framework.

    About NVX-CoV2373

    NVX‑CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS‑CoV‑2, the virus that causes COVID-19 disease. NVX‑CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. In preclinical trials, NVX‑CoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In its Phase 1 portion of the Phase 1/2 clinical trial, NVX‑CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. Novavax was awarded $1.6 billion by the federal government as part of Operation Warp Speed (OWS), a U.S. government program to deliver millions of doses of a safe, effective vaccine for COVID-19 to the U.S. population. The OWS funding is being used by Novavax to complete late-stage clinical development, including a pivotal Phase 3 clinical trial; establish large-scale manufacturing; and deliver 100 million doses of NVX‑CoV2373 beginning as early as late 2020. The Coalition for Epidemic Preparedness Innovations (CEPI) is also investing up to $388 million, and Department of Defense (DoD) is investing up to $60 million of funding to advance clinical development of NVX‑CoV2373.

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NVX‑CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera in its Phase 1 portion of the Phase 1/2 clinical trial. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    About Serum Institute of India

    Serum Institute of India Pvt. Ltd. was founded in 1966 by Dr. Cyrus Poonawalla with a mission of manufacturing life-saving immuno-biologics. Serum is the world's largest vaccine manufacturer by number of doses produced and sold globally (more than 1.3 billion doses). It is estimated that about 65% of the children in the world receive at least one vaccine manufactured by Serum Institute. Vaccines manufactured by Serum are accredited by the World Health Organization, Geneva and are being used in approximately 170 countries across the globe.

    Serum is ranked as India's No. 1 biotechnology company, manufacturing highly specialized lifesaving biologics like vaccines using cutting edge genetic and cell-based technologies, antisera and other medical specialties.

    The philanthropic philosophy of Serum continues with its work on newer vaccines and biologicals.

    Learn more about Serum Institute of India at https://www.seruminstitute.com/.

    About CEPI

    CEPI is an innovative partnership between public, private, philanthropic, and civil society organizations, launched at Davos in 2017, to develop vaccines to stop future epidemics. CEPI has moved with great urgency and in coordination with WHO in response to the emergence of COVID-19. CEPI has initiated 9 partnerships to develop vaccines against the novel coronavirus. The programs will leverage rapid response platforms already supported by CEPI as well as new partnerships. The aim is to advance COVID-19 vaccine candidates into clinical testing as quickly as possible.

    Before the emergence of COVID-19 CEPI's priority diseases included Ebola virus, Lassa virus, Middle East Respiratory Syndrome coronavirus, Nipah virus, Rift Valley Fever and Chikungunya virus. CEPI also invested in platform technologies that can be used for rapid vaccine and immunoprophylactic development against unknown pathogens (Disease X).

    Novavax Forward-Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products, including statements regarding the manufacturing of vaccine antigen dose amounts and timing, are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission (SEC) and updated by any Quarterly Report on Form 10-Q, particularly the risks inherent to developing novel vaccines. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Contacts:      

    Novavax

    Investors

    Silvia Taylor and Erika Trahan



    240-268-2022

    Media

    Brandzone/KOGS Communication

    Edna Kaplan



    617-974-8659

    Primary Logo

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  27. GAITHERSBURG, Md., Aug. 06, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced it will report its second quarter 2020 financial and operating results following the close of U.S. financial markets on Monday, August 10, 2020.

    Conference call details are as follows:

    Date:August 10, 2020
    Time:4:30 p.m. U.S. Eastern Time (ET)
    Dial-in number:(877) 923-9376 (Domestic) or (720) 545-0026 (International)
    Passcode:3048947
    Webcast:www.novavax.com, "For Investors"/ "Events"

    Conference call and webcast replay:

    Dates:Starting at 7:30 p.m. ET, August 10, 2020 until 7:30 p.m. ET August 17, 2020
    Dial-in number:(855) 859-2056 (Domestic) or (404)

    GAITHERSBURG, Md., Aug. 06, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced it will report its second quarter 2020 financial and operating results following the close of U.S. financial markets on Monday, August 10, 2020.

    Conference call details are as follows:

    Date:August 10, 2020
    Time:4:30 p.m. U.S. Eastern Time (ET)
    Dial-in number:(877) 923-9376 (Domestic) or (720) 545-0026 (International)
    Passcode:3048947
    Webcast:www.novavax.com, "For Investors"/ "Events"

    Conference call and webcast replay:

    Dates:Starting at 7:30 p.m. ET, August 10, 2020 until 7:30 p.m. ET August 17, 2020
    Dial-in number:(855) 859-2056 (Domestic) or (404) 537-3406 (International)
    Passcode:3048947
    Webcast:www.novavax.com, "For Investors"/ "Events", until November 10, 2020

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NVX‑CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera in its Phase 1 portion of the Phase 1/2 clinical trial. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Contacts:      

    Investors

    Silvia Taylor and Erika Trahan



    240-268-2022

    Media

    Amy Speak



    617-420-2461

     

    Primary Logo

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    • Phase 1 portion of the Phase 1/2 clinical trial evaluated two doses of Novavax' COVID-19 vaccine across two dose levels (5 and 25 µg) in 131 healthy adults ages 18-59 years
    • NVX-CoV2373 was generally well-tolerated and had a reassuring safety profile
    • The vaccine induced neutralization titers in 100% of participants
      • Both 5 µg and 25 µg adjuvanted doses generated peak geometric mean titer (GMT) greater than 1:3,300
    • Matrix-M™ adjuvant induced robust polyfunctional CD4+ T cell responses
    • Conference call to be held on Tuesday, August 4 at 5:00 p.m. ET. Detailed data slides will be posted at 4:30 p.m. ET on novavax.com.

    GAITHERSBURG, Md., Aug. 04, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation…

    • Phase 1 portion of the Phase 1/2 clinical trial evaluated two doses of Novavax' COVID-19 vaccine across two dose levels (5 and 25 µg) in 131 healthy adults ages 18-59 years
    • NVX-CoV2373 was generally well-tolerated and had a reassuring safety profile
    • The vaccine induced neutralization titers in 100% of participants
      • Both 5 µg and 25 µg adjuvanted doses generated peak geometric mean titer (GMT) greater than 1:3,300
    • Matrix-M™ adjuvant induced robust polyfunctional CD4+ T cell responses
    • Conference call to be held on Tuesday, August 4 at 5:00 p.m. ET. Detailed data slides will be posted at 4:30 p.m. ET on novavax.com.

    GAITHERSBURG, Md., Aug. 04, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced Phase 1 data from its Phase 1/2 randomized, observer-blinded, placebo-controlled trial of its COVID‑19 vaccine with and without Matrix‑M™ adjuvant in healthy adults 18-59 years of age. NVX‑CoV2373, the Company's recombinant COVID-19 vaccine candidate adjuvanted with Matrix-M, was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. The data have been submitted for peer-review to a scientific journal and to an online preprint server at medRxiv.org.

    NVX-CoV2373 was well-tolerated and had a reassuring safety profile.

    Overall, the vaccine was well-tolerated and reactogenicity events were generally mild. Following Dose 1, tenderness and pain were the most frequent local symptoms and systemic events were individually less frequent with headache, fatigue and myalgia being reported most commonly. As expected, following Dose 2, greater reactogenicity was reported, although the majority of symptoms were reported as ≤ Grade 1. The average duration of events was < 2 days.

    Unsolicited adverse events were collected through 28 days after Dose 2. There were no severe (Grade 3) unsolicited adverse events, and the vast majority of adverse events were mild and deemed not related to vaccination. No serious adverse events (SAEs) were reported and safety follow-up continues.

    NVX-CoV2373 induced neutralization titers in 100% of participants; 5 µg adjuvanted dose group peak GMT: 3,906 (95% CI: 2,556; 5,970).

    All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

    Matrix-M™ adjuvant induced robust polyfunctional CD4+ T cell responses.

    The adjuvant was dose-sparing, with the lower 5 µg dose of NVX‑CoV2373 performing comparably with the 25 µg dose. Cellular immune responses were measured in a subset of participants, and NVX‑CoV2373 induced antigen-specific polyfunctional CD4+ T cell responses with a strong bias toward the Th1 phenotype (IFN-g, IL-2, and TNF-a).

    Favorable product profile.

    NVX-CoV2373 is stable and will allow handling in a liquid formulation that can be stored at 2°C to 8°C, allowing for successful cold chain management with existing infrastructure.

    "The Phase 1 data demonstrate that NVX-CoV2373 with our Matrix-M adjuvant is a well‑tolerated COVID-19 vaccine with a robust immunogenicity profile," said Gregory M. Glenn, M.D., President, Research and Development at Novavax. "Using a stringent wild-type virus assay performed by investigators at the University of Maryland School of Medicine, NVX‑CoV2373 elicited neutralizing antibody titers greater than those observed in a pool of COVID‑19 patients with clinically significant disease."

    The trial was supported by funding from the Coalition for Epidemic Preparedness Innovations (CEPI) and was conducted at two sites in Australia.

    Novavax also submitted to a peer-reviewed journal data showing results of NVX‑CoV2373 immunization in cynomolgus macaques. The vaccine induced sterile immunity that prevented viral replication in the upper and lower respiratory tracts, thus showing potential to reduce COVID-19 transmission. There was no evidence of enhanced disease following challenge. These data have also been submitted to an online preprint server at medRxiv.org.

    For further information, including media-ready images, b-roll, downloadable resources and more, click here.

    Conference Call



    Novavax will host a conference call today at 5:00 p.m. ET. The dial-in numbers for the conference call are (866) 324-3683 (Domestic) or (509) 844-0959 (International), passcode 4319447. A replay of the conference call will be available starting at 8:00 p.m. ET on August 4, 2020 until 11:59 p.m. ET on August 11, 2020. To access the replay by telephone, dial (855) 859-2056 (Domestic) or (404) 537-3406 (International) and use passcode 4319447.

    A webcast of the conference call can also be accessed via a link on the home page of the Novavax website (novavax.com) or through the "For Investors"/"Events" tab on the Novavax website. A replay of the webcast will be available on the Novavax website until November 4, 2020.

    About NVX-CoV2373



    NVX‑CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS‑CoV‑2, the virus that causes COVID-19 disease. NVX‑CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. In preclinical trials, NVX‑CoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. Novavax was awarded $1.6 billion by the federal government as part of Operation Warp Speed (OWS), a U.S. government program to deliver millions of doses of a safe, effective vaccine for COVID-19 to the U.S. population. The OWS funding is being used by Novavax to complete late-stage clinical development, including a pivotal Phase 3 clinical trial; establish large-scale manufacturing; and deliver 100 million doses of NVX‑CoV2373 beginning as early as late 2020. The Coalition for Epidemic Preparedness Innovations (CEPI) is also investing up to $388 million, and Department of Defense (DoD) is investing up to $60 million of funding to advance clinical development of NVX‑CoV2373.

    About Matrix-M™



    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    About Novavax



    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Forward-Looking Statements



    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products, including statements regarding the manufacturing of vaccine antigen dose amounts and timing, are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission (SEC) and updated by any Quarterly Report on Form 10-Q, particularly the risks inherent to developing novel vaccines. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Contacts:      

    Investors and Media

    Silvia Taylor and Erika Trahan



    240-268-2022

    Media

    Brandzone/KOGS Communication

    Edna Kaplan



    617-974-8659

    Primary Logo

    View Full Article Hide Full Article
  28. GAITHERSBURG, Md. and MORRISVILLE, N.C., July 23, 2020 /PRNewswire/ -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, and FUJIFILM Diosynth Biotechnologies (FDB), a world leading contract development and manufacturing organization (CDMO) for biologics, viral vaccines and gene therapies, announced today an agreement to manufacture bulk drug substance for NVX-CoV2373, Novavax' COVID-19 vaccine candidate. FDB's site in Morrisville, North Carolina has begun production of the first batch of NVX-CoV2373.  

    This arrangement falls under Novavax' recent $1.6 billion award by the federal government as part of Operation Warp Speed (OWS), a U.S. government program that aims to begin delivering millions of doses of a safe, effective vaccine for COVID-19 to the U.S. population. The OWS funding is being used by Novavax to complete late-stage clinical development, including a pivotal Phase 3 clinical trial; establish large-scale manufacturing; and deliver 100 million doses of NVX–CoV2373 beginning as early as late 2020.  NVX-CoV2373 consists of a stable, prefusion protein made using Novavax' proprietary nanoparticle technology and includes Novavax' proprietary Matrix–M™ adjuvant.  The batches produced at the FDB site in North Carolina will be utilized in a future pivotal Phase 3 clinical trial of up to 30,000 subjects which is expected to begin in the fall of 2020 and which will determine the safety and efficacy of NVX-CoV2373.

    "We are grateful to partner with the team at FUJIFILM Diosynth Biotechnologies to ensure the large-scale manufacture of our COVID-19 vaccine candidate," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "We are committed to working together with unprecedented speed to deliver a vaccine to protect our nation's population."

    "We are delighted to bring our leading technical expertise in baculovirus systems and our proven manufacturing excellence to support Novavax' response to this global crisis," said Martin Meeson, Chief Executive Officer of FUJIFILM Diosynth Biotechnologies. "As a critical partner to Novavax, our focus is to advance the delivery of a vaccine that can have a profound impact."

    Novavax' Phase 1/2 clinical trial of NVX-CoV2373 in 130 healthy participants 18 to 59 years of age began in Australia in May.  Novavax will announce the Phase 1 data, which will consist of preliminary immunogenicity and safety results, during the first week of August. The Phase 2 portion to assess immunity, safety, and COVID-19 disease reduction is expected to begin shortly thereafter. The Phase 1/2 clinical trial is being supported by an up-to $388 million funding arrangement with the Coalition for Epidemic Preparedness Innovations (CEPI).

    For further information, including media-ready images, b-roll, downloadable resources and more, click here.

    About Operation Warp Speed

    Operation Warp Speed is facilitating, at an unprecedented pace, the development, manufacturing, and distribution of COVID-19 countermeasures, between components of Department of Health and Human Services (HHS), including the Centers for Disease Control and Prevention (CDC), FDA, the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA, part of the HHS Office of the Assistant Secretary for Preparedness and Response); the Department of Defense. OWS is coordinating existing HHS-wide efforts, including the NIH's ACTIV partnership for vaccine and therapeutic development, NIH's RADx initiative for diagnostic development, and work by BARDA.

    About NVX-CoV2373

    NVX–CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS–CoV–2, the virus that causes COVID-19 disease. NVX–CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. In preclinical trials, NVX–CoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. A Phase 1 clinical trial of NVX–CoV2373 initiated in May 2020, with preliminary immunogenicity and safety results expected to be announced during the first week of August. The Coalition for Epidemic Preparedness Innovations (CEPI) is investing up to $388 million, and Department of Defense (DoD) is investing up to $60 million of funding to advance clinical development of NVX–CoV2373.

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax recently initiated development of NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19, with preliminary immunogenicity and safety results expected to be announced during the first week of August. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    About FUJIFILM

    FUJIFILM Diosynth Biotechnologies is an industry-leading Biologics Contract  Development and Manufacturing Organization (CDMO) with locations in Teesside, UK, RTP, North Carolina, College Station, Texas and Hillerød, Denmark.  FUJIFILM Diosynth Biotechnologies has over thirty years of experience in the development and manufacturing of recombinant proteins, vaccines, monoclonal antibodies, among other large molecules, viral products and medical countermeasures expressed in a wide array of microbial, mammalian, and host/virus systems. The company offers a comprehensive list of services from cell line development using its proprietary pAVEway™ microbial and Apollo™X cell line systems to process development, analytical development, clinical and FDA-approved commercial manufacturing. FUJIFILM Diosynth Biotechnologies is a partnership between FUJIFILM Corporation and Mitsubishi Corporation.  For more information, go to: www.fujifilmdiosynth.com

    FUJIFILM Holdings Corporation, Tokyo, Japan, brings cutting edge solutions to a broad range of global industries by leveraging its depth of knowledge and fundamental technologies developed in its relentless pursuit of innovation. Its proprietary core technologies contribute to the various fields including healthcare, graphic systems, highly functional materials, optical devices, digital imaging and document products. These products and services are based on its extensive portfolio of chemical, mechanical, optical, electronic and imaging technologies. For the year ended March 31, 2020, the company had global revenues of $21 billion, at an exchange rate of 109 yen to the dollar. Fujifilm is committed to responsible environmental stewardship and good corporate citizenship. For more information, please visit: www.fujifilmholdings.com

    Forward-Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products, including statements regarding the manufacturing of vaccine antigen dose amounts and timing, are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission (SEC) and updated by any Quarterly Report on Form 10-Q, particularly the risks inherent to developing novel vaccines. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/novavax-and-fujifilm-diosynth-biotechnologies-initiate-large-scale-manufacturing-of-covid-19-vaccine-candidate-301099139.html

    SOURCE FUJIFILM Diosynth Biotechnologies

    View Full Article Hide Full Article
  29. GAITHERSBURG, Md. and MORRISVILLE, N.C., July 23, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, and FUJIFILM Diosynth Biotechnologies (FDB), a world leading contract development and manufacturing organization (CDMO) for biologics, viral vaccines and gene therapies, announced today an agreement to manufacture bulk drug substance for NVX-CoV2373, Novavax' COVID-19 vaccine candidate. FDB's site in Morrisville, North Carolina has begun production of the first batch of NVX-CoV2373.

    This arrangement falls under Novavax' recent $1.6 billion award by the federal government as part of Operation Warp Speed (OWS), a U.S. government program…

    GAITHERSBURG, Md. and MORRISVILLE, N.C., July 23, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, and FUJIFILM Diosynth Biotechnologies (FDB), a world leading contract development and manufacturing organization (CDMO) for biologics, viral vaccines and gene therapies, announced today an agreement to manufacture bulk drug substance for NVX-CoV2373, Novavax' COVID-19 vaccine candidate. FDB's site in Morrisville, North Carolina has begun production of the first batch of NVX-CoV2373.

    This arrangement falls under Novavax' recent $1.6 billion award by the federal government as part of Operation Warp Speed (OWS), a U.S. government program that aims to begin delivering millions of doses of a safe, effective vaccine for COVID-19 to the U.S. population. The OWS funding is being used by Novavax to complete late-stage clinical development, including a pivotal Phase 3 clinical trial; establish large-scale manufacturing; and deliver 100 million doses of NVX‑CoV2373 beginning as early as late 2020. NVX-CoV2373 consists of a stable, prefusion protein made using Novavax' proprietary nanoparticle technology and includes Novavax' proprietary Matrix‑M™ adjuvant. The batches produced at the FDB site in North Carolina will be utilized in a future pivotal Phase 3 clinical trial of up to 30,000 subjects which is expected to begin in the fall of 2020 and which will determine the safety and efficacy of NVX-CoV2373.

    "We are grateful to partner with the team at FUJIFILM Diosynth Biotechnologies to ensure the large-scale manufacture of our COVID-19 vaccine candidate," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "We are committed to working together with unprecedented speed to deliver a vaccine to protect our nation's population."

    "We are delighted to bring our leading technical expertise in baculovirus systems and our proven manufacturing excellence to support Novavax' response to this global crisis," said Martin Meeson, Chief Executive Officer of FUJIFILM Diosynth Biotechnologies. "As a critical partner to Novavax, our focus is to advance the delivery of a vaccine that can have a profound impact."

    Novavax' Phase 1/2 clinical trial of NVX-CoV2373 in 130 healthy participants 18 to 59 years of age began in Australia in May.  Novavax will announce the Phase 1 data, which will consist of preliminary immunogenicity and safety results, during the first week of August. The Phase 2 portion to assess immunity, safety, and COVID-19 disease reduction is expected to begin shortly thereafter. The Phase 1/2 clinical trial is being supported by an up-to $388 million funding arrangement with the Coalition for Epidemic Preparedness Innovations (CEPI).

    For further information, including media-ready images, b-roll, downloadable resources and more, click here.

    About Operation Warp Speed

    Operation Warp Speed is facilitating, at an unprecedented pace, the development, manufacturing, and distribution of COVID-19 countermeasures, between components of Department of Health and Human Services (HHS), including the Centers for Disease Control and Prevention (CDC), FDA, the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA, part of the HHS Office of the Assistant Secretary for Preparedness and Response); the Department of Defense. OWS is coordinating existing HHS-wide efforts, including the NIH's ACTIV partnership for vaccine and therapeutic development, NIH's RADx initiative for diagnostic development, and work by BARDA.

    About NVX-CoV2373

    NVX‑CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS‑CoV‑2, the virus that causes COVID-19 disease. NVX‑CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. In preclinical trials, NVX‑CoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. A Phase 1 clinical trial of NVX‑CoV2373 initiated in May 2020, with preliminary immunogenicity and safety results expected to be announced during the first week of August. The Coalition for Epidemic Preparedness Innovations (CEPI) is investing up to $388 million, and Department of Defense (DoD) is investing up to $60 million of funding to advance clinical development of NVX‑CoV2373.

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax recently initiated development of NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19, with preliminary immunogenicity and safety results expected to be announced during the first week of August. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    About FUJIFILM

    FUJIFILM Diosynth Biotechnologies is an industry-leading Biologics Contract  Development and Manufacturing Organization (CDMO) with locations in Teesside, UK, RTP, North Carolina, College Station, Texas and Hillerød, Denmark.  FUJIFILM Diosynth Biotechnologies has over thirty years of experience in the development and manufacturing of recombinant proteins, vaccines, monoclonal antibodies, among other large molecules, viral products and medical countermeasures expressed in a wide array of microbial, mammalian, and host/virus systems. The company offers a comprehensive list of services from cell line development using its proprietary pAVEway™ microbial and Apollo™X cell line systems to process development, analytical development, clinical and FDA-approved commercial manufacturing. FUJIFILM Diosynth Biotechnologies is a partnership between FUJIFILM Corporation and Mitsubishi Corporation.  For more information, go to: www.fujifilmdiosynth.com

    FUJIFILM Holdings Corporation, Tokyo, Japan, brings cutting edge solutions to a broad range of global industries by leveraging its depth of knowledge and fundamental technologies developed in its relentless pursuit of innovation. Its proprietary core technologies contribute to the various fields including healthcare, graphic systems, highly functional materials, optical devices, digital imaging and document products. These products and services are based on its extensive portfolio of chemical, mechanical, optical, electronic and imaging technologies. For the year ended March 31, 2020, the company had global revenues of $21 billion, at an exchange rate of 109 yen to the dollar. Fujifilm is committed to responsible environmental stewardship and good corporate citizenship. For more information, please visit: www.fujifilmholdings.com

    Forward-Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products, including statements regarding the manufacturing of vaccine antigen dose amounts and timing, are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission (SEC) and updated by any Quarterly Report on Form 10-Q, particularly the risks inherent to developing novel vaccines. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Contacts:      

    Investors and Media

    Silvia Taylor and Erika Trahan



    240-268-2022

    Media

    Brandzone/KOGS Communication

    Edna Kaplan



    617-974-8659

    Joe Metzger



    978-273-5187

    Liza M. Rivera



    919-325-6972

    Primary Logo

    View Full Article Hide Full Article
  30. ATLANTA, July 22, 2020 (GLOBE NEWSWIRE) -- According to Premier Miton Fund Manager Nick Ford in a recent CNBC's "Squawk Box Europe" interviewi, U.S. small cap stocks are set to outperform the S&P 500 in the uncertain aftermath of the coronavirus crisis. This is big news for small investors who normally shy away from more expensive stocks like Tesla, AutoZone, Alphabet (Google), Amazon, and Cable One, all of which trade well in excess of $1,000.00 per share, making it almost impossible for the average investor to become a shareholder.

    Taking it one step further, investors also might want to consider Micro Cap stocks. Micro Cap stocks are often defined as the smallest public companies in the U.S. equity market. The Russell Micro Cap Index is…

    ATLANTA, July 22, 2020 (GLOBE NEWSWIRE) -- According to Premier Miton Fund Manager Nick Ford in a recent CNBC's "Squawk Box Europe" interviewi, U.S. small cap stocks are set to outperform the S&P 500 in the uncertain aftermath of the coronavirus crisis. This is big news for small investors who normally shy away from more expensive stocks like Tesla, AutoZone, Alphabet (Google), Amazon, and Cable One, all of which trade well in excess of $1,000.00 per share, making it almost impossible for the average investor to become a shareholder.

    Taking it one step further, investors also might want to consider Micro Cap stocks. Micro Cap stocks are often defined as the smallest public companies in the U.S. equity market. The Russell Micro Cap Index is basically the bottom half of the Russell 2000 Index and includes some other eligible stocks with as little as a $30 million market cap. Most Micro Caps are not as liquid as their larger peers, so larger investors tend to stay away from them. This is actually a benefit for the smaller investor, since little, or no, institutional ownership means a stock could be a huge winner as the big guys pile in. Companies mentioned in today's commentary include: Novavax (NASDAQ:NVAX); Nabriva Therapeutics (NASDAQ:NBRV); Ehave, Inc. (OTC:EHVVF); and Allena Pharmaceuticals (NASDAQ: ALNA).

    The Covid-19 pandemic has been one of the main catalysts for big gains in the stock market, as people around the globe have made major changes to the way they live and work. We believe this trend will continue and look for leadership from cloud computing companies like NVIDIA, Microsoft, and Alibaba; teleconferencing companies like Zoom Video Communications, Slack Technologies, and RingCentral; electronic payments companies like MasterCard and Global Payments; Ecommerce companies like Baozun, MercadoLibre, and Shopify; and streaming, gaming and video content platform companies like Netflix, Electronic Arts, Take-Two Interactive Software, Nintendo, and NetEase.

    Other areas of interest to Micro Cap investors are mental health and psychedelic medicine companies, as well as biotech companies working on a vaccine for Covid 19. In the biotech industry speculation has been swirling for months regarding a vaccine for Covid 19.

    Novavax (NASDAQ:NVAX) is why investors invest in Micro Cap stocks. It is not classified as a Micro Cap any longer, but it is certainly worthy of mention here. The Company won a $1.6 billion contract from the US Government to make a coronavirus vaccine, which was the Trump administration's largest vaccine contract. According to a recent report in the Wall Street Journal by Gregory Zeckerman, Novavax was trading at $0.36 a share a little over a year ago.ii Even after a 1 for 20 reverse split, the stock was down 39% for the year. However, in June Novavax received a $200 million investment from RA Capital. Right after the $200 million investment, the Company announced it was working on a COVID-19 vaccine and the government contract. Now, Novavax is up 2,300% for the year. According to Mr. Zeckerman's article, RA Capital is up $255 million in less than four weeks from their June investment in Novavax. That, my friends, is the reason investors speculate with Micro Cap stocks.

    Nabriva Therapeutics (NASDAQ:NBRV) is a Dublin, Ireland based biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections. Nabriva received U.S. Food and Drug Administration approval for XENLETA™ (lefamulin injection, lefamulin tablets), the first systemic pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP). Xenleta is the first IV and oral antibiotic monotherapy treatment option approved by the FDA for adults with CABP in nearly two decades. Nabriva Therapeutics is also developing CONTEPO (fosfomycin) for injection, a potential first-in-class epoxide antibiotic for complicated urinary tract infections (cUTIs), including acute pyelonephritis.

    Nabriva Therapeutics plc recently announced an exclusive agreement to sell and distribute Cubist Pharmaceuticals' anti-bacterial medicine Sivextro (tedizolid phosphate) in the United States and across its certain territories. Cubist Pharmaceuticals is a wholly owned subsidiary of Merck. Sivextro is used to treat acute bacterial skin infections and was approved by the FDA. The financial terms of the agreement were not disclosed, but Nabriva will be exclusively responsible for marketing, sales and distribution of Sivextro in the United States until Dec 31, 2023 with renewable three-year extensions. Shares of Nabriva were up more than 50% following the announcement of the deal with Merck, but still trade 70% off of their 52-week high of $2.77.

    Psychedelic Medicine is an area of the market that has caught the attention of billionaire investors, celebrities, and successful business executives as they endorse the psychedelic medicine market by joining strategic advisory boards or making sizable investments. Data Bridge Market Research expects the psychedelic drugs market to grow at a CAGR of 16.3% over the next eight years to reach $6.85 billion by 2027.iii Total annual spending on mental healthcare in America tops $195 billion.iv The Covid 19 pandemic has made matters worse as many individuals become depressed as they suffer from growing feelings of isolation. Currently, in the United States, magic mushrooms are still illegal in all 50 states. Denver, Colorado and Oakland, California have both signed legislation to decriminalize magic mushrooms opening the door for researchers to explore potential medical benefits. Additionally, voters in Oregon are expected to see a measure to legalize the use of psilocybin in therapeutic settings on the ballot this fall.

    Ehave, Inc. (OTC:EHVVF) planted its feet smack dab in the middle of the Psychedelic Medicine industry by acquiring PsychedeliTech, a division of Israel based Israel Cannabis Limited ("iCAN"). PsychedeliTech is the parent of PsyTech, which had originally planned to host an inaugural PsyTech Summit last March at the Hilton Hotel, on the Mediterranean Sea in Tel Aviv, Israel. The event was cancelled as a result of the Covid 19 pandemic, but Ehave and PsyTech have hosted a successful series of PsyTech Virtual Summits, which have been held online. These Psychedelic Industry Webinars have featured distinguished players in the Psychedelic Medicine industry such as Rick Doblin, Executive Director of Multidisciplinary Association for Psychedelic Studies (MAPS); Todd Shapiro, CEO of Red Light Holland; Bruce Linton, Founder and Former Chairman and Co-CEO of Canopy Growth; Saul Kaye, Founder CEO, can: Israel Cannabis; Shlomi Raz, Chairman/Founder, Eleusis; JR Rahn, Co-Founder/Director, MindMed; Matthew Johnson, PhD., Professor of Psychiatry and Behavior, Johns Hopkins; Tyler Bryden, Founder Speak Ai & Sessions; Sarah Hashkes, CEO of Radix Motion; Christian Angermayer, Founder, ATAI Life Sciences; Dr. Rosalid Watts, Clinical Psychologist at the Psychedelic Research Group at Imperial College London; and James Stephens, Chief Science Office and Co-Founder of Aurelius Data. The next webinar presented by Ehave and PsyTech will be July 29, 2020 at 12:00 PM Eastern Time. The webinar is titled Mystical Experience, Religion, and Psychedelics. Interested investors can sign up here for free https://www.psytech.biz/psytech-mystical-experience-july-29th/

    The company believes that its Dash platform will play a crucial role in the global advancement of psychedelic research. As a HIPAA and GDPR compliant platform, Dash is secure and compliant with some of the world's strictest privacy laws. It's an optimal way to compile psychedelic research and results to provide easy access for scientists globally. Ehave recently acquired 51% of MDLink, a Jamaican Telemedicine provider. MDLink is licensed for all CARICOM Countries which include Antigua and Barbuda, Belize, Dominica, Grenada, Guyana, Haiti, Jamaica, Montserrat, Saint Kitts, Nevis, Saint Lucia, Saint Vincent, Rhe Grenadines, Suriname and Trinidad and Tobago. MDLink currently has over 10,000 patients. Ehave plans to develop a platform for MDLink Mental Health Therapy. Additionally, MDLink has entered into a technical cooperation agreement with the Inter-American Development Bank IDB Lab to design and test a digital screening solution for COVID-19 on the MDLink platform. The digital screening solution will allow vulnerable patients, such as those with pre-existing conditions and the elderly, to connect virtually from their homes with licensed physicians.

    Psychedelics are quickly picking up steam among both researchers and investors. As the market opens up, forward-thinking companies are building an early presence in the space before it grows into a large and mainstream industry. Micro Cap investors may want to consider building a position in some of these companies given the similarities.

    Allena Pharmaceuticals (NASDAQ: ALNA) is a late-stage clinical biopharmaceutical company dedicated to developing and commercializing first in-class, oral enzyme therapeutics to treat patients with rare and severe metabolic and kidney disorders. The company is focused on metabolic disorders that result in excess accumulation of certain metabolites, such as oxalate and urate, which can cause kidney stones, damage the kidney, and potentially lead to chronic kidney disease, or CKD, and end-stage renal disease. Reloxaliase is an orally administered enzyme designed for the treatment of enteric hyperoxaluria (EH) currently being evaluated in the second pivotal Phase 3 study with the FDA.

    H.C. Wainwright analyst Edward White covers Allena Pharmaceuticals with a Buy rating and a price target of $10.00. The analyst commented, "Reloxaliase, an orally administered enzyme, is in development for the treatment of enteric hyperoxaluria (EH) in the Phase 3 URIROX-2 study that comes on the heels of the Phase 3 URIROX-1 trial. We are unaware of any other companies that trade at a market cap of under $50M that are in the second of two Phase 3 studies that could lead to an FDA filing in 2022. While there is a financial overhang on the stock due to the need for a capital raise to progress to Phase 3 completion, we believe the promise of a commercially successful drug for EH outweighs the risks."

    The potential size of the EH population in the U.S. is around 250,000 people. As a result, White expects the product to launch at the end of 2023, with sales landing at $18 million in 2023 and $350 million in 2028.

    DISCLAIMER: Atlanta Capital Partners, LLC (ATLCP), which owns and operates Otcstockreview.com, is a third-party publisher and news dissemination service provider, which disseminates electronic information through multiple online media channels. ATLCP is NOT affiliated in any manner with any company mentioned herein. ATLCP and its affiliated companies are news dissemination solutions providers and are not a registered broker/dealer/analyst/adviser, holds no investment licenses and may NOT sell, offer to sell or offer to buy any security. ATLCP's market updates, news alerts and corporate profiles are NOT a solicitation or recommendation to buy, sell or hold securities. The material in this release is intended to be strictly informational and is never to be construed or interpreted as research material. All readers are strongly urged to perform research and due diligence on their own and consult a licensed financial professional before considering any level of investing in stocks. All material included herein is republished content and details which were previously disseminated by the companies mentioned in this release. ATLCP is not liable for any investment decisions by its readers or subscribers. Investors are cautioned that they may lose all or a portion of their investment when investing in stocks. For current services performed ATLCP was compensated one thousand five hundred dollars for news coverage of current press releases issued by Ehave, Inc. by a non-affiliated third party. ATLCP holds no shares of any company named in this release.

    This release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. "Forward-looking statements" describe future expectations, plans, results, or strategies and are generally preceded by words such as "may", "future", "plan" or "planned", "will" or "should", "expected," "anticipates", "draft", "eventually" or "projected". You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in a company's annual report on Form 10-K or 10-KSB and other filings made by such company with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and ATLCP undertakes no obligation to update such statements.

    OTC Stock Review

    David Kugelman

    (866) 692-6847


    i https://www.cnbc.com/2020/07/10/miton-us-small-cap-stocks-are-poised-to-outperform-during-the-recovery.html

    ii https://www.wsj.com/articles/vaccine-stock-soars-rewarding-investors-big-bet-11594294901?mod=markets_lead_pos2

    iii https://www.openpr.com/news/2068844/psychedelic-drugs-market-2020-to-grow-at-16-3-cagr-by-2027

    iv https://www.openminds.com/intelligence-report/u-s-mental-health-market-195-6-billion-spending-2015/

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  31. GAITHERSBURG, Md., July 20, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that Gregory M. Glenn, M.D., President of Research and Development, will present progress of NVX-CoV2373, Novavax' COVID-19 vaccine candidate, at the 2nd International Society for Vaccines Virtual Congress.

    Dr. Glenn's presentation will be followed by a Q&A discussion. Webinar details are as follows:

    Topic:Progress with the Full Length Recombinant Spike Protein
    Nanoparticle Vaccine
    Date and Time:Tuesday, July 21, 9:55 a.m. ET

    The webinar is free to attend. To register, please click here.

    About NVX-CoV2373

    NVX‑CoV2373 is a vaccine candidate…

    GAITHERSBURG, Md., July 20, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that Gregory M. Glenn, M.D., President of Research and Development, will present progress of NVX-CoV2373, Novavax' COVID-19 vaccine candidate, at the 2nd International Society for Vaccines Virtual Congress.

    Dr. Glenn's presentation will be followed by a Q&A discussion. Webinar details are as follows:

    Topic:Progress with the Full Length Recombinant Spike Protein

    Nanoparticle Vaccine
    Date and Time:Tuesday, July 21, 9:55 a.m. ET

    The webinar is free to attend. To register, please click here.

    About NVX-CoV2373

    NVX‑CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS‑CoV‑2, the virus that causes COVID-19 disease. NVX‑CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. In preclinical trials, NVX‑CoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. A Phase 1 clinical trial of NVX‑CoV2373 initiated in May 2020, with preliminary immunogenicity and safety results expected in July 2020. NVX‑CoV2373 is being funded by the U.S. Government, through Operation Warp Speed up to $1.6 billion, and the U.S. Department of Defense up to $70 million, as well as by the Coalition for Epidemic Preparedness Innovations (CEPI) up to $388 million.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax recently initiated development of NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19, with Phase 1 clinical trial results expected in July of 2020. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Contacts:

    Investors

    Novavax, Inc.

    Silvia Taylor and Erika Trahan



    240-268-2022

    Media

    Brandzone/KOGS Communication

    Edna Kaplan



    617-974-8659

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    • Funding supports late-stage clinical development, including pivotal Phase 3 clinical trial to support licensure
    • OWS award funds large-scale manufacturing of NVX-CoV2373, including production of 100 million doses starting in late 2020

    GAITHERSBURG, Md., July 07, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it has been selected to participate in Operation Warp Speed (OWS), a U.S. government program that aims to begin delivering millions of doses of a safe, effective vaccine for COVID-19 in 2021. Novavax has been awarded $1.6 billion by the federal government to complete late-stage clinical development, including…

    • Funding supports late-stage clinical development, including pivotal Phase 3 clinical trial to support licensure
    • OWS award funds large-scale manufacturing of NVX-CoV2373, including production of 100 million doses starting in late 2020

    GAITHERSBURG, Md., July 07, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it has been selected to participate in Operation Warp Speed (OWS), a U.S. government program that aims to begin delivering millions of doses of a safe, effective vaccine for COVID-19 in 2021. Novavax has been awarded $1.6 billion by the federal government to complete late-stage clinical development, including a pivotal Phase 3 clinical trial; establish large-scale manufacturing; and deliver 100 million doses of NVX‑CoV2373, Novavax' COVID-19 vaccine candidate, as early as late 2020. NVX‑CoV2373 consists of a stable, prefusion protein made using its proprietary nanoparticle technology and includes Novavax' proprietary Matrix‑M™ adjuvant.

    "The pandemic has caused an unprecedented public health crisis, making it more important than ever that industry, government and funding entities join forces to defeat the novel coronavirus together. We are honored to partner with Operation Warp Speed to move our vaccine candidate forward with extraordinary urgency in the quest to provide vital protection to our nation's population," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "We are grateful to the U.S. government for its confidence in our technology platform, and are working tirelessly to develop and produce a vaccine for this global health crisis."

    Under the terms of the agreement, Novavax will demonstrate it can rapidly stand up large-scale manufacturing and transition into ongoing production, including the capability to stockpile and distribute large quantities of NVX-CoV2373 when needed. The agreement will fund the late-stage clinical studies necessary to determine the safety and efficacy of NVX-CoV2373, including a pivotal Phase 3 clinical trial with up to 30,000 subjects beginning in the fall of 2020.

    "Adding Novavax' candidate to Operation Warp Speed's diverse portfolio of vaccines increases the odds that we will have a safe, effective vaccine as soon as the end of this year," said U.S. Health and Human Services Secretary Alex Azar. "Today's $1.6 billion investment supports the Novavax candidate, depending on success in clinical trials, all the way through to manufacturing 100 million doses for the American people."

    Today's agreement also allows for a follow-on agreement with the U.S. government for additional production and procurement to support OWS' vaccine production goal. This latest federal funding supports Novavax plans to file submissions for licensure with the U.S. Food and Drug Administration (FDA).

    A Phase 1/2 clinical trial of NVX-CoV2373 in 130 healthy participants 18 to 59 years of age began in Australia in May. Preliminary immunogenicity and safety results are expected at the end of July, and the Phase 2 portion to assess immunity, safety, and COVID-19 disease reduction is expected to begin thereafter. The Phase 1/2 clinical trial is being supported by an up-to $388 million funding arrangement with the Coalition for Epidemic Preparedness Innovations (CEPI).

    For further information, including media-ready images, b-roll, downloadable resources and more, click here.

    About Operation Warp Speed

    Operation Warp Speed is facilitating, at an unprecedented pace, the development, manufacturing, and distribution of COVID-19 countermeasures, between components of Department of Health and Human Services (HHS), including the Centers for Disease Control and Prevention (CDC), FDA, the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA, part of the HHS Office of the Assistant Secretary for Preparedness and Response); the Department of Defense. OWS is coordinate existing HHS-wide efforts, including the NIH's ACTIV partnership for vaccine and therapeutic development, NIH's RADx initiative for diagnostic development, and work by BARDA.

    About NVX-CoV2373

    NVX‑CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS‑CoV‑2, the virus that causes COVID-19 disease. NVX‑CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. In preclinical trials, NVX‑CoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. A Phase 1 clinical trial of NVX‑CoV2373 initiated in May 2020, with preliminary immunogenicity and safety results expected in July 2020. The Coalition for Epidemic Preparedness Innovations (CEPI) is investing up to $388 million, and Department of Defense (DoD) is investing up to $60 million of funding to advance clinical development of NVX‑CoV2373.

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax recently initiated development of NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19, with Phase 1 clinical trial results expected in July of 2020. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Forward-Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products, including statements regarding the manufacturing of vaccine antigen dose amounts and timing, are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission (SEC) and updated by any Quarterly Report on Form 10-Q, particularly the risks inherent to developing novel vaccines. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Contacts:

    Investors

    Silvia Taylor and Erika Trahan



    240-268-2022

    Media

    Brandzone/KOGS Communication

    Edna Kaplan



    617-974-8659

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  32. Frank Czworka appointed SVP, Global Sales

    Brian Webb promoted to SVP, Manufacturing

    GAITHERSBURG, Md., July 02, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the appointment of Frank Czworka as Senior Vice President, Global Sales, with responsibility for leading sales planning and distribution. Novavax also announced the promotion of Brian Webb to Senior Vice President, Manufacturing, with responsibility for overseeing antigen manufacturing and supply activities in support of Novavax' vaccine candidates.

    "Frank's extensive commercial and sales expertise will be invaluable to Novavax' transformation into a commercial…

    Frank Czworka appointed SVP, Global Sales

    Brian Webb promoted to SVP, Manufacturing

    GAITHERSBURG, Md., July 02, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the appointment of Frank Czworka as Senior Vice President, Global Sales, with responsibility for leading sales planning and distribution. Novavax also announced the promotion of Brian Webb to Senior Vice President, Manufacturing, with responsibility for overseeing antigen manufacturing and supply activities in support of Novavax' vaccine candidates.

    "Frank's extensive commercial and sales expertise will be invaluable to Novavax' transformation into a commercial stage organization," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "Brian has been instrumental in the recent expansion and alignment of our manufacturing capabilities and supply partnerships. I am confident that the company will benefit greatly from their mutual expertise as we advance our efforts to bring NVX‑CoV2373 and NanoFlu to market."

    Mr. Czworka brings more than two decades of biopharmaceutical experience to Novavax, most recently serving as Vice President, Global Customer Engagement at U.S. Pharmacopeia. In sales and marketing leadership positions at Osiris Therapeutics, Auxilium Pharmaceuticals, MedImmune and TAP Pharmaceuticals, Mr. Czworka has assembled, developed, deployed and directed award-winning global sales and marketing teams to achieve business objectives. He has launched multiple medications across a variety of therapeutic areas while increasing patient access to vital treatments. Mr. Czworka received a bachelor of science degree in business administration – marketing from the University of Central Florida.

    "This is an exciting time to join Novavax, with much to be accomplished as we advance our COVID-19 candidate and prepare the regulatory submission for NanoFlu," said Mr. Czworka. "I'm excited to contribute to the team so that we can positively impact the lives of patients and reduce the global burden of these infectious diseases."

    Mr. Webb joined Novavax in May 2014 with responsibility for internal and external manufacturing. Prior to joining Novavax, Mr. Webb held numerous operational leadership roles at GlaxoSmithKline and Human Genome Sciences where he had the opportunity to take multiple products from early clinical stage through licensure and launch. He received a bachelor of science degree in biology from Salisbury University and a master of science degree in biotechnology from Johns Hopkins University.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax recently initiated development of NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19, with Phase 1 clinical trial results expected in July of 2020. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Forward-Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products, including statements regarding the manufacturing of vaccine antigen dose amounts and timing, are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission (SEC) and updated by any Quarterly Report on Form 10-Q, particularly the risks inherent to developing novel vaccines. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Contacts:

    Investors

    Novavax, Inc.

    Silvia Taylor and Erika Trahan 

     

    240-268-2022

    Media

    Brandzone/KOGS Communication

    Edna Kaplan



    617-974-8659

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  33. GAITHERSBURG, Md., June 29, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the appointment of Ben Machielse as Executive Vice President, CMC, with responsibility for overseeing Novavax' manufacturing, process technology, quality and regulatory functions. The Company also announced several leadership promotions:

    • John J. Trizzino to Executive Vice President, Chief Business Officer and Chief Financial Officer
    • John A. Herrmann III, to Executive Vice President, Chief Legal Officer
    • Jill Hoyt to Executive Vice President, Chief Human Resources Officer

    "Ben's extensive manufacturing and operations expertise will be vital to our…

    GAITHERSBURG, Md., June 29, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the appointment of Ben Machielse as Executive Vice President, CMC, with responsibility for overseeing Novavax' manufacturing, process technology, quality and regulatory functions. The Company also announced several leadership promotions:

    • John J. Trizzino to Executive Vice President, Chief Business Officer and Chief Financial Officer
    • John A. Herrmann III, to Executive Vice President, Chief Legal Officer
    • Jill Hoyt to Executive Vice President, Chief Human Resources Officer

    "Ben's extensive manufacturing and operations expertise will be vital to our leadership team as we evolve to commercial stage," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "The addition of Ben supports our continued commitment to progressing our pipeline programs as we scale up to produce a global supply of NVX-CoV2373, our COVID-19 vaccine candidate, and grow our NanoFlu production capabilities. In addition, I also want to congratulate John, John, and Jill on their promotions as they are all a critical part of Novavax' growth."

    Mr. Machielse brings more than 25 years of biotechnology industry experience to Novavax. He was most recently Chief Executive Officer of rare disease company Vtesse, before its acquisition by Sucampo Pharmaceuticals, Inc., now a part of Mallinckrodt. Previously, he was Chief Operating Officer at Omthera Pharmaceuticals, where he oversaw development and approval of a treatment for hypertriglyceridemia and was integral to the Company's IPO and acquisition by AstraZeneca. Earlier, as Executive Vice President of Operations for MedImmune, later acquired by AstraZeneca, he led worldwide development and operations of the company's therapeutic antibodies, small molecules and vaccine products. Additionally, he was responsible for development of MedImmune's H1N1 influenza vaccine, which was the first to be approved by FDA. He currently sits on the board of directors of Comet Therapeutics, Complexa Therapeutics and Polyneuron. Mr. Machielse received a bachelor of science degree in medical biology and a master of science degree in biochemistry from the University of Utrecht in the Netherlands.

    "The rapid and precise steps Novavax is taking to increase manufacturing capacity for NVX-CoV2373 demonstrate both the validity and the viability of our program as a significant part of the world's COVID-19 vaccine solution," said Mr. Machielse. "I am excited to work with the team as we rapidly advance development activities and manufacturing capabilities and ensure we deliver safe, innovative vaccines to prevent a broad range of infectious diseases worldwide."

    Mr. Trizzino originally joined Novavax in 2009 with responsibility for business development. In 2011, Mr. Trizzino joined Immunovaccine as its CEO and successfully led the company into clinical development of its lead candidate. In 2014, Mr. Trizzino rejoined Novavax and in 2018 was promoted to Chief Business Officer and Chief Financial Officer. Prior to his tenure at Novavax, Mr. Trizzino held leadership roles at several companies focused on infectious disease, including MedImmune, later acquired by AstraZeneca, ID Biomedical, acquired by GSK, and Henry Schein, Inc. Mr. Trizzino received a bachelor of science degree from Long Island University, CW Post and a master of business administration degree from New York University, Stern School of Business.

    Mr. Herrmann has been our general counsel and corporate secretary since 2010, and will now also lead corporate and business development. Prior to joining Novavax, Mr. Herrmann was General Counsel at Ore Pharmaceuticals and Deputy General Counsel at Gene Logic before it became Ore Pharmaceuticals. He has also served as Senior Corporate Counsel for Celera Genomics and Baxter Healthcare. Mr. Herrmann received a bachelor of arts degree from Brown University and a juris doctorate from the University of Illinois.

    Ms. Hoyt joined Novavax in 2008 with responsibility for human resources. Since joining the company, she has played a key role in expansion of the company's talent base and geographic footprint, including the acquisition of manufacturing subsidiaries in Europe. She has held senior positions in HR at a number of technology companies, including TRW and Choicepoint. Ms. Hoyt received a bachelor of science degree in business administration from Shepherd University and a master of science degree in human resource management from Marymount University.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax recently initiated development of NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19, with Phase 1 clinical trial results expected in July of 2020. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Forward-Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products, including statements regarding the manufacturing of vaccine antigen dose amounts and timing, are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission (SEC) and updated by any Quarterly Report on Form 10-Q, particularly the risks inherent to developing novel vaccines. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Contacts:

    Investors

    Novavax, Inc.

    Silvia Taylor and Erika Trahan



    240-268-2022

    Media

    Brandzone/KOGS Communication

    Edna Kaplan



    617-974-8659

     

    Primary Logo

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  34. GAITHERSBURG, Md., June 24, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that John J. Trizzino, Senior Vice President, Chief Business Officer and Chief Financial Officer, will participate in the H.C. Wainwright Virtual Fireside Chat Series on Thursday, June 25. A topic of discussion will be Novavax' COVID-19 vaccine candidate, NVX-CoV2373.

    Fireside chat details are as follows:

    Date:  June 25, 2020
    Time:  10:00 a.m. U.S. Eastern Time (ET)
    Webcast:  www.novavax.com, "Investors"/ "Events", until September 25, 2020

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved…

    GAITHERSBURG, Md., June 24, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that John J. Trizzino, Senior Vice President, Chief Business Officer and Chief Financial Officer, will participate in the H.C. Wainwright Virtual Fireside Chat Series on Thursday, June 25. A topic of discussion will be Novavax' COVID-19 vaccine candidate, NVX-CoV2373.

    Fireside chat details are as follows:

    Date:  June 25, 2020
    Time:  10:00 a.m. U.S. Eastern Time (ET)
    Webcast:  www.novavax.com, "Investors"/ "Events", until September 25, 2020

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax recently initiated development of NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19, with Phase 1 clinical trial results expected in July of 2020. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Contacts:      

    Investors

    Silvia Taylor and Erika Trahan



    240-268-2022

    Media

    Brandzone/KOGS Communication

    Edna Kaplan



    617-974-8659

    Primary Logo

    View Full Article Hide Full Article
  35. GAITHERSBURG, Md., June 17, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the appointment of two senior executives to the leadership team. Filip Dubovsky, M.D., MPH, FAAP, has been appointed Senior Vice President and Chief Medical Officer, where he will oversee Novavax' medical and clinical affairs and related activities. Novavax also appointed Silvia Taylor, MBA, as Senior Vice President, Investor Relations and Corporate Affairs, overseeing Novavax' investor relations, public relations and corporate communications activities.

    "Novavax' considerable progress and significant near-term milestones make the additions…

    GAITHERSBURG, Md., June 17, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the appointment of two senior executives to the leadership team. Filip Dubovsky, M.D., MPH, FAAP, has been appointed Senior Vice President and Chief Medical Officer, where he will oversee Novavax' medical and clinical affairs and related activities. Novavax also appointed Silvia Taylor, MBA, as Senior Vice President, Investor Relations and Corporate Affairs, overseeing Novavax' investor relations, public relations and corporate communications activities.

    "Novavax' considerable progress and significant near-term milestones make the additions of Filip and Silvia to our leadership team both timely and important," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "With the addition of these two senior leaders, we are adding expertise to critical areas of the organization. We welcome them both."

    A recognized leader in vaccine development, Dr. Dubovsky brings more than 20 years of infectious disease experience to Novavax. He joins Novavax from AstraZeneca, where he was Head of Clinical Engagement and Policy and Deputy Chief Medical Officer for clinical affairs. He joined MedImmune, the global biologics arm of AstraZeneca, where he oversaw the clinical development of early and late-stage infectious disease and vaccine assets. Previously, he created and managed a portfolio of 25 malaria vaccine candidates spanning early candidate optimization to Phase 3 clinical studies at PATH's Malaria Vaccine Initiative. He has co-authored more than 50 peer-reviewed scientific publications and currently sits on the Board of Directors of the Sabin Institute. Dr. Dubovsky earned his Master of Public Health degree from Johns Hopkins University and his Doctor of Medicine degree from the University of Alabama. He completed his pediatric training at Stanford University, his pediatric infectious disease fellowship at the Center for Vaccine Development at the University of Maryland, and his preventive medicine training at Johns Hopkins University.

    "The recent scientific achievements by the Novavax team, including positive Phase 3 NanoFlu results and Phase 1/2 clinical trial initiation of NVX-CoV2373 to address the global coronavirus pandemic are impressive," said Dr. Dubovsky. "I am eager to put my experience to work to help Novavax deliver these novel vaccines to healthcare practitioners and reduce the spread of these harmful diseases worldwide."

    Ms. Taylor brings more than 25 years of communications and commercial leadership to Novavax. Most recently, she was Vice President of Global Corporate Affairs and Communications at Autolus Therapeutics plc, where she led all financial, scientific and corporate communications. Prior to Autolus, Ms. Taylor was Senior Vice President of Global Investor Relations and Corporate Affairs at Sucampo. Earlier in her career, she held positions of increasing responsibility at MedImmune, the global biologics arm of AstraZeneca, including head of marketing responsible for the commercialization of the company's respiratory syncytial virus and influenza franchises, as well as roles at Pfizer, where she served in key brand and consumer marketing roles. She has also worked in public relations and communications roles in agency and non-profit settings. Ms. Taylor earned a Master of Business Administration degree from Columbia University and a Bachelor of Arts in Foreign Affairs from University of Virginia.

    "I am delighted to join Novavax during this incredibly productive period," said Ms. Taylor. "It is an exciting opportunity to help tell the company's compelling story as it brings innovative vaccines to patients, and to help deepen Novavax' relationships with a broad array of important stakeholders."

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax recently initiated development of NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19, with Phase 1 clinical trial results expected in July of 2020. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Forward-Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products, including statements regarding the manufacturing of vaccine antigen dose amounts and timing, are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission (SEC) and updated by any Quarterly Report on Form 10-Q, particularly the risks inherent to developing novel vaccines. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Contacts:

    Investors

    Novavax, Inc.

    Silvia Taylor and Erika Trahan



    240-268-2022

    Media

    Brandzone/KOGS Communication

    Edna Kaplan



    617-974-8659

     

    Primary Logo

    View Full Article Hide Full Article
  36. GAITHERSBURG, Md., June 16, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it has appointed David Mott as an independent director to its Board of Directors. Mr. Mott brings more than three decades of global management, board and investment experience across numerous private and public biopharmaceutical companies. Prior to February 2020, he was the global head of healthcare investing at New Enterprise Associates (NEA).

    "David's extensive experience building, leading and financing biopharmaceutical companies will add significant value to Novavax' board, especially now as we laser-focus on contributing to…

    GAITHERSBURG, Md., June 16, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it has appointed David Mott as an independent director to its Board of Directors. Mr. Mott brings more than three decades of global management, board and investment experience across numerous private and public biopharmaceutical companies. Prior to February 2020, he was the global head of healthcare investing at New Enterprise Associates (NEA).

    "David's extensive experience building, leading and financing biopharmaceutical companies will add significant value to Novavax' board, especially now as we laser-focus on contributing to some of the world's most daunting healthcare challenges," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "We welcome his insights and guidance as we continue rapid clinical development of NVX-CoV2373, our COVID-19 vaccine candidate, prepare for NanoFlu™ regulatory submission, and explore paths forward for ResVax™ against RSV+ (respiratory syncytial virus)."

    "I am delighted to join the Board of Directors of Novavax and look forward to working with my fellow Board members to help advance the company's critical mission to prevent serious infectious disease, which is more important today than ever," said Mr. Mott. "I look forward to supporting the Novavax team as it continues clinical development of its vaccine candidates and prepares for potential commercialization."

    Mr. Mott is currently a private investor through Mott Family Capital. Mr. Mott has recently acquired nearly 65,000 shares of Novavax common stock prior to his appointment. He serves as Chairman of the Board for Adaptimmune, Ardelyx, Epizyme, Imara and Mersana. From 2008 to 2020, Mr. Mott was general partner at NEA, one of the world's largest venture capital firms, which invests in companies across all stages in healthcare and technology. He led the NEA healthcare investing practice, with a primary focus on biopharmaceuticals. Mr. Mott served as President and Chief Executive Officer, Vice Chairman of MedImmune from 2000 through 2008, during which he led the sale of the company to AstraZeneca in June 2007 for $15.6 billion. He joined MedImmune in 1992 and served in various senior roles during his tenure, including Chief Operating Officer and Chief Financial Officer. Earlier in his career he was a Vice President in healthcare investment banking at Smith Barney, Harris Upham & Co., Inc. During the course of his career, Mr. Mott has been involved in over $40 billion in corporate acquisitions, fundraising, partnerships and other capital formation. He has been involved in more than 35 initial public offerings or corporate acquisitions, in bringing over a dozen new drugs through development to commercialization and has served on 25 corporate boards. Mr. Mott holds a Bachelor of Arts degree from Dartmouth College.

    Mr. Mott will serve on the Compensation Committee of Novavax' Board. 

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax recently initiated development of NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19, with Phase 1 clinical trial results expected in July of 2020. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Forward-Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products, including statements regarding the manufacturing of vaccine antigen dose amounts and timing, are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission (SEC) and updated by any Quarterly Report on Form 10-Q, particularly the risks inherent to developing novel vaccines. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Contacts:

    Investors

    Novavax, Inc.

    Silvia Taylor and Erika Trahan



    240-268-2022

    Media

    Brandzone/KOGS Communication

    Edna Kaplan



    617-974-8659

    Primary Logo

    View Full Article Hide Full Article
  37. GAITHERSBURG, Md., June 15, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it has entered into an agreement to sell Series A Convertible preferred stock, convertible into 4,388,852 shares of common stock, to an investment fund affiliated with RA Capital Management (RA Capital) in a private placement, at an effective purchase price per share of common stock equal to the June 12, 2020 closing price. Upon closing Novavax will receive gross proceeds of approximately $200 million.

    "We are extremely pleased to receive this tremendous support from RA Capital, which we believe signals a high level of confidence in the…

    GAITHERSBURG, Md., June 15, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it has entered into an agreement to sell Series A Convertible preferred stock, convertible into 4,388,852 shares of common stock, to an investment fund affiliated with RA Capital Management (RA Capital) in a private placement, at an effective purchase price per share of common stock equal to the June 12, 2020 closing price. Upon closing Novavax will receive gross proceeds of approximately $200 million.

    "We are extremely pleased to receive this tremendous support from RA Capital, which we believe signals a high level of confidence in the significant progress of our COVID-19 and influenza vaccine programs," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "This additional infusion of capital supplements our strong cash position and the significant funding from CEPI and the U.S. Department of Defense, providing us with the capacity to execute on our critical priority of providing a vaccine against the COVID-19 pandemic as quickly as possible, and to progress NanoFlu to BLA filing."

    "The global vaccine effort is searching for candidates that are capable of both generating the highest neutralizing antibody titers and large-scale production. We are excited to increase our investment in Novavax, which along with resources from CEPI and the U.S. Department of Defense, will support Novavax in its important work developing an effective, scalable vaccine for SARS-CoV-2," said Peter Kolchinsky, Ph.D., Managing Partner at RA Capital Management.

    The preferred stock is not entitled to cumulative dividends, and is not entitled to vote on matters submitted to the holders of Novavax common stock.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy any security. The shares of preferred stock referenced herein have not been registered under the Securities Act of 1933, as amended (Securities Act), or applicable state securities laws and may not be offered or sold in the United States or any state thereof absent registration under the Securities Act and applicable state securities laws or an applicable exemption from registration requirements.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax recently initiated development of NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19, with Phase 1 clinical trial results expected in July of 2020. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    About RA Capital Management

    RA Capital Management is a multi-stage investment manager dedicated to evidence-based investing in public and private healthcare and life science companies developing drugs, medical devices, and diagnostics. RA Capital's flexible strategy allows it to provide seed funding to startups and lead private, IPO, and follow-on financings for its portfolio companies, thereby driving value creation from idea inception through commercialization.

    Forward-Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products, including statements regarding the manufacturing of vaccine antigen dose amounts and timing, are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission (SEC) and updated by any Quarterly Report on Form 10-Q, particularly the risks inherent to developing novel vaccines. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Contacts:

    Investors

    Novavax, Inc.

    Silvia Taylor and Erika Trahan



    240-268-2022

    Media

    Brandzone/KOGS Communication

    Edna Kaplan



    617-974-8659

    Primary Logo

    View Full Article Hide Full Article
  38. GAITHERSBURG, Md., June 08, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that Gregory M. Glenn, M.D., President of Research and Development, will join other vaccine industry leaders for a panel discussion at 2020 BIO Digital. Taking place on Tuesday, June 9 at 11:30 a.m. EDT, the panel will discuss COVID-19 vaccines. The conversation will consider the complex path from lab to clinical trials, the impact of the evolving science on candidate development and consider how collaboration will bring life-saving vaccines to the world.

    Details for the panel are as follows:

    Title: "Leveraging Platforms and Partnerships to

    GAITHERSBURG, Md., June 08, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that Gregory M. Glenn, M.D., President of Research and Development, will join other vaccine industry leaders for a panel discussion at 2020 BIO Digital. Taking place on Tuesday, June 9 at 11:30 a.m. EDT, the panel will discuss COVID-19 vaccines. The conversation will consider the complex path from lab to clinical trials, the impact of the evolving science on candidate development and consider how collaboration will bring life-saving vaccines to the world.

    Details for the panel are as follows:

    Title: "Leveraging Platforms and Partnerships to Develop COVID-19 Vaccines in Record Time"
       
    Date and Time: Tuesday, June 9, 11:30 a.m. PDT
       
    Moderator: Mark McClellan, M.D., Director, Duke Margolis Center for Health Policy
       
    Panelists: Dr. Glenn

    Margaret Hamburg, M.D., Foreign Secretary, National Academy of Medicine

    Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research, United States Food and Drug Administration

    Paul Stoffels, M.D., Vice Chairman of the Executive Committee, Chief Scientific Officer, Johnson & Johnson

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax recently initiated development of NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19, with Phase 1 clinical trial results expected in July of 2020. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Contacts:

    Investors

    Novavax, Inc.

    Erika Trahan



    240-268-2022

    Westwicke

    John Woolford



    443-213-0506

    Media

    Brandzone/KOGS Communication

    Edna Kaplan



    617-974-8659

    Primary Logo

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    • $60 million funding for manufacturing of NVX-CoV2373
    • 10 million doses to be delivered to DoD in 2020

    GAITHERSBURG, Md., June 04, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the company has been awarded a contract by the U.S. Department of Defense (DoD) for the manufacturing of NVX‑CoV2373, Novavax' COVID-19 vaccine candidate. NVX‑CoV2373 consists of a stable, prefusion protein antigen made using its proprietary nanoparticle technology and includes Novavax' proprietary Matrix‑M™ adjuvant.

    JPEO-CRBND-EB through funding provided by the Defense Health Program, has agreed to fund up to $60 million to support Novavax…

    • $60 million funding for manufacturing of NVX-CoV2373
    • 10 million doses to be delivered to DoD in 2020

    GAITHERSBURG, Md., June 04, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the company has been awarded a contract by the U.S. Department of Defense (DoD) for the manufacturing of NVX‑CoV2373, Novavax' COVID-19 vaccine candidate. NVX‑CoV2373 consists of a stable, prefusion protein antigen made using its proprietary nanoparticle technology and includes Novavax' proprietary Matrix‑M™ adjuvant.

    JPEO-CRBND-EB through funding provided by the Defense Health Program, has agreed to fund up to $60 million to support Novavax in its production of several components of the vaccine that will be manufactured in the U.S. The agreement includes a 2020 delivery of 10 million doses of NVX‑CoV2373 for DoD that could be used in Phase 2/3 clinical trials or under an Emergency Use Authorization (EUA) if approved by the U.S. FDA.

    "We are genuinely honored at the opportunity to protect our military personnel and their families who have devoted themselves to the needs of U.S. citizens and others worldwide," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "Importantly, this award will allow Novavax to significantly expand its U.S. production capacity of NVX-CoV2373, a critical step in our ability to provide vaccine support to the COVID-19 pandemic."

    As part of the contract, Novavax will work with a U.S.-based biologics contract development manufacturing organization (CDMO) to manufacture the antigen component of NVX-CoV2373 for at least 10 million doses of vaccine. Novavax will also collaborate with U.S.-based CDMOs to scale up production and manufacture of the Matrix-M adjuvant component of the vaccine.

    About the JPEO-CBRND

    The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense is the Joint Service's lead for development, acquisition, fielding and life-cycle support of chemical, biological, radiological and nuclear defense equipment and medical countermeasures. As an effective acquisition program, we put capable and supportable systems in the hands of the service members and first responders, when and where it is needed, at an affordable price. Our vision is a resilient Joint Force enabled to fight and win unencumbered by a chemical, biological, radiological, or nuclear environment; championed by innovative and state-of-the-art solutions. JPEO Enabling Biotechnologies (EB) is an organization established for the purpose of providing medical solutions, during a crisis, against future threats.

    About NVX-CoV2373

    NVX‑CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS‑CoV‑2, the virus that causes COVID-19 disease. NVX‑CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. In preclinical trials, NVX‑CoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. A Phase 1 clinical trial of NVX‑CoV2373 initiated in May 2020, with preliminary immunogenicity and safety results expected in July 2020. The Coalition for Epidemic Preparedness Innovations (CEPI) is investing up to $388 million of funding to advance clinical development of NVX‑CoV2373.

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax recently initiated development of NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19, with Phase 1 clinical trial results expected in July of 2020. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Forward-Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products, including statements regarding the manufacturing of vaccine antigen dose amounts and timing, are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission (SEC) and updated by any Quarterly Report on Form 10-Q, particularly the risks inherent to developing novel vaccines. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Contacts:

    Investors
    Novavax, Inc.
    Erika Trahan

    240-268-2022

    Westwicke
    John Woolford

    443-213-0506

    Media
    Brandzone/KOGS Communication
    Edna Kaplan

    617-974-8659

    Primary Logo

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  39. SEATTLE, June 3, 2020 /PRNewswire/ -- AGC Biologics, a global biopharmaceutical Contract Development and Manufacturing Organization (CDMO), has announced that it will partner with Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, on large-scale GMP production of a critical component of Novavax' coronavirus vaccine candidate, NVX-CoV2373. AGC Biologics will manufacture Matrix-M™, the  adjuvant component of the vaccine, in order to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 is a stable, prefusion protein made using Novavax' proprietary nanoparticle technology. AGC Biologics will optimize process development for…

    SEATTLE, June 3, 2020 /PRNewswire/ -- AGC Biologics, a global biopharmaceutical Contract Development and Manufacturing Organization (CDMO), has announced that it will partner with Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, on large-scale GMP production of a critical component of Novavax' coronavirus vaccine candidate, NVX-CoV2373. AGC Biologics will manufacture Matrix-M™, the  adjuvant component of the vaccine, in order to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 is a stable, prefusion protein made using Novavax' proprietary nanoparticle technology. AGC Biologics will optimize process development for scaled-up production of Matrix-M to significantly increase Novavax' capacity to deliver doses in 2020 and 2021.

    "We are quickly ramping up to successfully deliver this vital vaccine component to Novavax," says AGC Biologics' CEO Patricio Massera. "The urgency to help produce a vaccine to combat COVID-19 could not be higher."

    "AGC Biologics' mission is to work side-by-side with our partners to produce life-saving and extending products," says Mark Womack, CBO of AGC Biologics. "Partnering with Novavax to manufacture this vaccine component is an amazing opportunity to make a profoundly positive difference."

    "We have been impressed with AGC Biologics' level of collaboration and commitment," says Timothy J. Hahn, SVP, Process Technology at Novavax. "They are an important strategic partner in expanding our supply chain of adjuvant for NVX-CoV2373 and for other vaccines being developed at Novavax, including our recombinant seasonal influenza vaccine, NanoFlu™."

    About Novavax:
    Novavax, Inc. (NASDAQ:NVAX), is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax recently initiated development of NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19, with Phase 1 clinical trial results expected in July of 2020. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant inorder to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs. Learn more at www.novavax.com.

    About AGC Biologics:
    AGC Biologics is a leading global Contract Development and Manufacturing Organization (CDMO) with a strong commitment to deliver the highest standard of service to clients and partners. The company currently employs more than 1000 employees worldwide. AGC Biologics' global network spans three continents, with cGMP-compliant facilities in Seattle, Washington; Boulder, Colorado; Copenhagen, Denmark; Heidelberg, Germany; and Chiba, Japan.

    AGC Biologics offers deep industry expertise and unique customized services for the scale-up and cGMP manufacture of protein-based therapeutics, from pre-clinical to commercial mammalian and microbial production. Integrated service offerings include plasmid (GMP pDNA) manufacturing, cell line development, bioprocess development, formulation, analytical testing, antibody drug development and conjugation, cell banking and storage and protein expression, including the proprietary CHEF1® Expression System for mammalian production. Learn more at www.agcbio.com.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/novavax-selects-agc-biologics-to-manufacture-matrix-m-adjuvant-for-novel-covid-19-vaccine-301069543.html

    SOURCE AGC Biologics

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    • First participants enrolled in Phase 1 portion of clinical trial of NVX‑CoV2373
    • Preliminary immunogenicity and safety results expected in July 2020
    • Phase 2 portion to begin promptly following successful Phase 1 results

    GAITHERSBURG, Md., May 25, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced enrollment of the first participants in a Phase 1/2 clinical trial of its coronavirus vaccine candidate, NVX‑CoV2373, a stable, prefusion protein made using its proprietary nanoparticle technology. NVX‑CoV2373 includes Novavax' proprietary Matrix‑M™ adjuvant to enhance immune responses and stimulate high levels of neutralizing…

    • First participants enrolled in Phase 1 portion of clinical trial of NVX‑CoV2373
    • Preliminary immunogenicity and safety results expected in July 2020
    • Phase 2 portion to begin promptly following successful Phase 1 results

    GAITHERSBURG, Md., May 25, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced enrollment of the first participants in a Phase 1/2 clinical trial of its coronavirus vaccine candidate, NVX‑CoV2373, a stable, prefusion protein made using its proprietary nanoparticle technology. NVX‑CoV2373 includes Novavax' proprietary Matrix‑M™ adjuvant to enhance immune responses and stimulate high levels of neutralizing antibodies. Preliminary immunogenicity and safety results from the Phase 1 portion of the trial are expected in July 2020.

    "Administering our vaccine in the first participants of this clinical trial is a significant achievement, bringing us one step closer toward addressing the fundamental need for a vaccine in the fight against the global COVID‑19 pandemic," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "We look forward to sharing the clinical results in July and, if promising, quickly initiating the Phase 2 portion of the trial."

    The Phase 1/2 clinical trial is being conducted in two parts. The Phase 1 portion is a randomized, observer-blinded, placebo-controlled trial designed to evaluate the immunogenicity and safety of NVX‑CoV2373, both adjuvanted with Matrix‑M and unadjuvanted. The trial is enrolling approximately 130 healthy participants 18 to 59 years of age at two sites in Australia. The protocol's two-dose trial regimen assesses two dose sizes (5 and 25 micrograms) with Matrix‑M and without.

    The Phase 2 portion is expected to be conducted in multiple countries, including the United States, and would assess immunity, safety and COVID‑19 disease reduction in a broader age range. This Phase 1/2 approach allows for rapid advancement of NVX‑CoV2373 during the pandemic. The trial is being supported by the recently announced funding arrangement with the Coalition for Epidemic Preparedness Innovations (CEPI).

    Novavax identified NVX‑CoV2373 as its lead SARS-CoV-2 candidate following pre-clinical testing that demonstrated high immunogenicity and high levels of neutralizing antibodies. These results provide strong evidence that the vaccine candidate will be highly immunogenic in humans, potentially leading to protection from COVID‑19 and thus helping to control the spread of this disease.

    Dr. Richard Hatchett, CEO of CEPI said, "Entering clinical trials is an important step on the path to delivering a safe, effective and globally accessible vaccine against COVID-19. Vaccines provide our best hope of permanently defeating this pandemic, so it is encouraging to see rapid progress being made in the development of Novavax' vaccine candidate. CEPI's priority in building our portfolio has been to focus on vaccine candidates with the potential to be developed at speed and scale and made globally accessible. Our investment in Novavax allows us to focus on manufacturing in parallel with the clinical development of the vaccine, so that if the vaccine is proven to be safe and effective, we can make doses available to those who need them without delay."

    For more information about the trial, read here on clinicaltrials.gov.

    About CEPI

    CEPI is an innovative partnership between public, private, philanthropic, and civil society organizations, launched at Davos in 2017, to develop vaccines to stop future epidemics. CEPI has moved with great urgency and in coordination with WHO in response to the emergence of COVID-19. CEPI has initiated 9 partnerships to develop vaccines against the novel coronavirus. The programs will leverage rapid response platforms already supported by CEPI as well as new partnerships. The aim is to advance COVID-19 vaccine candidates into clinical testing as quickly as possible.

    Before the emergence of COVID-19 CEPI's priority diseases included Ebola virus, Lassa virus, Middle East Respiratory Syndrome coronavirus, Nipah virus, Rift Valley Fever and Chikungunya virus. CEPI also invested in platform technologies that can be used for rapid vaccine and immunoprophylactic development against unknown pathogens (Disease X).

    About NVX-CoV2373

    NVX‑CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS‑CoV‑2, the virus that causes COVID-19 disease. NVX‑CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. In preclinical trials, NVX‑CoV2373 demonstrated efficient binding with receptors targeted by the virus, a critical aspect for effective vaccine protection. A Phase 1 clinical trial of NVX‑CoV2373 initiated in May 2020, with preliminary immunogenicity and safety results expected in July 2020. The Coalition for Epidemic Preparedness Innovations (CEPI) is investing up to $388 million of funding to advance clinical development of NVX‑CoV2373.

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax recently initiated development of NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19, with Phase 1 clinical trial results expected in July of 2020. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Forward-Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Contacts:

    Investors
    Novavax, Inc.
    Erika Trahan

    240-268-2022

    Westwicke
    John Woolford

    443-213-0506

    Media
    Brandzone/KOGS Communication
    Edna Kaplan

    617-974-8659

    Primary Logo

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    • CEPI increases investment up to $388 million for NVX‑CoV2373 vaccine development & manufacturing
    • NVXCoV2373 Phase I trial initiating in May with preliminary results in July
    • NanoFlu recently achieved all primary endpoints in pivotal Phase 3 clinical trial
    • Company to host conference call today at 4:30 p.m. ET

    GAITHERSBURG, Md., May 11, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced its financial results and operational highlights for the first quarter ended March 31, 2020.

    "Our accomplishments to-date in 2020, including significant progress in our influenza and COVID‑19 vaccine programs, are the most impressive in the…

    • CEPI increases investment up to $388 million for NVX‑CoV2373 vaccine development & manufacturing
    • NVXCoV2373 Phase I trial initiating in May with preliminary results in July
    • NanoFlu recently achieved all primary endpoints in pivotal Phase 3 clinical trial
    • Company to host conference call today at 4:30 p.m. ET

    GAITHERSBURG, Md., May 11, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced its financial results and operational highlights for the first quarter ended March 31, 2020.

    "Our accomplishments to-date in 2020, including significant progress in our influenza and COVID‑19 vaccine programs, are the most impressive in the company's history," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "We shared successful pivotal Phase 3 results for NanoFlu that demonstrated both efficacy and safety in a pivotal trial, a significant milestone towards bringing this innovative product to an influenza market in need of new options. We also reacted quickly to the coronavirus pandemic by developing and quickly advancing NVX‑CoV2373, our COVID‑19 vaccine candidate, which shows strong potential to have a positive impact on this global health crisis. Looking ahead, with a strengthened balance sheet and CEPI's substantial funding, we will focus on scaling up manufacturing and delivering clinical data for NVX‑CoV2373, while simultaneously completing the necessary actions needed to prepare our BLA filing for NanoFlu."

    First Quarter 2020 and Subsequent Operational Highlights

    NanoFlu™ Program

    • Novavax announced in March that NanoFlu, its recombinant quadrivalent seasonal influenza vaccine candidate with Matrix‑M™ adjuvant, achieved all primary objectives in its pivotal Phase 3 clinical trial in older adults. As required by the FDA's accelerated approval pathway, the trial's primary objectives were to demonstrate non-inferior immunogenicity of NanoFlu compared to a licensed vaccine (Fluzone® Quadrivalent), using the day 28 ratio of geometric mean titers (GMT) and the difference in seroconversion rates (SCR), as well as the overall safety of NanoFlu. These endpoints were met for all four strains included in NanoFlu. Immunogenicity was measured by hemagglutination inhibition (HAI) assays using egg-derived reagents. NanoFlu was well-tolerated, with a safety profile comparable to Fluzone Quadrivalent with a modest increase in local adverse events (AEs).
       
    • NanoFlu also achieved statistical significance for key secondary endpoints. These key endpoints assessed GMT and SCR, but with an HAI assay based on wild-type reagents. NanoFlu demonstrated significantly higher GMT and SCR than Fluzone Quadrivalent across all four strains included in the vaccine and, importantly, for four tested drifted H3N2 strains not included in the vaccine but circulating this year.
       
    • Results from this Phase 3 clinical trial will support a U.S. biologics license application (BLA) and licensure of NanoFlu using the U.S. Food and Drug Administration's (FDA) accelerated approval pathway.

    COVID-19 Program

    • As announced today, the Coalition for Epidemic Preparedness Innovations (CEPI) will invest up to an additional $384 million to advance clinical development of NVX‑CoV2373. Novavax will use the CEPI funds to advance NVX‑CoV2373 into clinical testing. With its earlier $4 million commitment in March, the extended collaboration brings CEPI's total investment in NVX‑CoV2373 to $388 million.
       
    • In January, Novavax identified its coronavirus vaccine candidate, NVX‑CoV2373, a stable, prefusion protein made using its proprietary nanoparticle technology. Novavax' proprietary Matrix‑M adjuvant is included in NVX‑CoV2373, to enhance immune responses and stimulate high levels of neutralizing antibodies.
       
    • NVX‑CoV2373 was highly immunogenic in animal models measuring spike protein-specific antibodies, with ACE‑2 human receptor binding domain blocking activity and SARS‑CoV‑2 wild-type virus neutralizing antibodies observed. Blocking of the binding of the spike protein to the receptor as well as wild-type virus neutralizing antibodies was also observed, with high levels of spike protein-specific antibodies after a single immunization. The already high microneutralization titers seen after one dose increased eight fold with a second dose. High titer microneutralizing antibodies are generally accepted evidence that a vaccine is likely to be protective in humans.
       
    • The NVX‑CoV2373 clinical development plan combines a Phase 1/Phase 2 approach to allow rapid advancement during the current coronavirus pandemic. The Phase 1 portion of this trial will be placebo-controlled and observer blinded in ~130 healthy adults and will include assessment of dosage and vaccination. Recruiting for the trial began this month with preliminary immunogenicity and safety results expected in July.
       
    • Novavax entered into an agreement with Emergent BioSolutions to provide contract development and manufacturing services, supplying Novavax with GMP vaccine product for use in its clinical trials. This agreement offers the potential to leverage Emergent's rapid deployment capabilities and expertise that provide Novavax scalability and capacity to produce vaccine product.

    ResVax™ Program

    • Novavax is currently discussing the opportunity to bring ResVax to market globally with multiple potential commercial partners. In addition, Novavax continues to define regulatory licensure requirements and pathways in the U.S., the European Union and other geographies.

    Matrix-M Partnership

    • In March, Novavax announced a commercial license agreement related to its Matrix‑M vaccine adjuvant. Matrix‑M is a key component of Serum Institute of India's malaria vaccine candidate, which it licensed from Jenner Institute at Oxford University. The vaccine candidate is currently in a Phase 2b clinical trial being conducted in Burkina Faso with top-line data expected in the second quarter of 2020.

    Corporate

    • Through utilization of At-the-market (ATM) offerings during the first quarter of 2020, Novavax raised net proceeds of $186 million. Subsequent to quarter-end, through May 8, 2020, Novavax raised additional net proceeds of $74 million, for a total of $260 million since the beginning of the year.

    Financial Results for the Three Months Ended March 31, 2020

    Novavax reported a net loss of $25.9 million, or $0.58 per share, for the first quarter of 2020, compared to a net loss of $43.2 million, or $2.11 per share, for the first quarter of 2019.

    Novavax revenue in the first quarter of 2020 was $3.4 million, compared to $4.0 million in the same period in 2019. This 15% decrease was primarly due to the conclusion of the Prepare™ trial in 2019, partially offset by revenue from CEPI's funding.

    Research and development expenses decreased 52% to $16.9 million in the first quarter of 2020, compared to $35.5 million in the same period in 2019. This decrease was primarily due to decreased development activities of ResVax, lower employee-related costs and other cost savings due to the Catalent transaction in 2019.

    General and administrative expenses increased to $9.4 million in the first quarter of 2020, compared to $8.7 million for the same period in 2019.

    Interest income (expense), net for the first quarter of 2020 and 2019 was ($3.0) million.

    As of March 31, 2020, Novavax had $244.7 million in cash, cash equivalents, marketable securities and restricted cash, compared to $82.2 million as of December 31, 2019. Net cash used in operating activities for the first quarter of 2020 was $23.1 million, compared to $50.6 million for same period in 2019.

    Share and per share data have been restated to reflect the reverse stock split that was completed in May 2019.

    Conference Call

    Novavax will host its quarterly conference call today at 4:30 p.m. ET. The dial-in numbers for the conference call are (877) 212-6076 (Domestic) or (707) 287-9331 (International), passcode 1274143. A replay of the conference call will be available starting at 7:30 p.m. ET on May 11, 2020 until 7:30 p.m. ET on May 18, 2020. To access the replay by telephone, dial (855) 859-2056 (Domestic) or (404) 537-3406 (International) and use passcode 1274143.

    A webcast of the conference call can also be accessed via a link on the home page of the Novavax website (novavax.com) or through the "Investor Info"/"Events" tab on the Novavax website. A replay of the webcast will be available on the Novavax website until August 11, 2020.

    About NanoFlu™

    NanoFlu is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced by Novavax in its SF9 insect cell baculovirus system. NanoFlu uses HA amino acid protein sequences that are the same as the recommended wild-type circulating virus HA sequences. NanoFlu contains Novavax' patented saponin-based Matrix‑M adjuvant. Top-line data from Novavax' ongoing Phase 3 clinical trial of NanoFlu is expected late in the first quarter of 2020.

    About NVX-CoV2373

    NVX‑CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS‑CoV‑2, the virus that causes COVID-19 disease. NVX‑CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. In preclinical trials, NVX‑CoV2373 demonstrated efficient binding with receptors targeted by the virus, a critical aspect for effective vaccine protection. A Phase 1 clinical trial of NVX‑CoV2373 will initiate in May 2020 with preliminary immunogenicity and safety results expected in July 2020. The Coalition for Epidemic Preparedness Innovations (CEPI) is investing up to $388 million of funding to advance clinical development of NVX‑CoV2373.

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases and address urgent, global health needs. Novavax recently initiated development of NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19, with Phase 1 clinical trial results expected in July of 2020. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Forward-Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    NOVAVAX, INC.
    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
    (in thousands, except per share information)
    (unaudited)

                   
      Three Months Ended
      March 31
        2020       2019  
           
           
    Revenue $     3,377     $ 3,982  
           
    Expenses:      
    Research and development   16,895       35,473  
    General and administrative   9,379       8,732  
    Total expenses   26,274       44,205  
    Loss from operations   (22,897 )     (40,223 )
    Interest income (expense), net   (2,967 )     (2,983 )
    Other income (expense)   --       (12 )
    Net loss $     (25,864 )   $ (43,218 )
           
    Basic and diluted net loss per share $     (0.58 )   $ (2.11 )
    Basic and diluted weighted average number of common shares outstanding   44,421       20,442  
                   

    SELECTED CONSOLIDATED BALANCE SHEET DATA
    (in thousands)

      March 31,
    2020
      December 31,
    2019
     
      (unaudited)        
           
    Cash and cash equivalents $   179,881     $ 78,823  
    Marketable securities   57,474       --  
    Total restricted cash   7,311       3,357  
    Total current assets   255,232       97,247  
    Working capital   236,250       71,452  
    Total assets   328,068       172,957  
    Notes payable   320,967       320,611  
    Total stockholders' deficit   (23,971 )     (186,017 )
                   

    Contacts:

    Investors
    Novavax, Inc.
    Erika Trahan

    240-268-2022

    Westwicke
    John Woolford

    443-213-0506

    Media
    Brandzone/COGS Communication
    Edna Kaplan

    617-974-8659

    Primary Logo

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    • Funds clinical development of NVX-CoV2373 through Phase 2
    • Supports rapid scale-up of vaccine manufacturing
    • Allows for increased production of Matrix-M adjuvant
    • Reserves global large-scale manufacturing capacity

    GAITHERSBURG, Md., May 11, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the Coalition for Epidemic Preparedness Innovations (CEPI) will invest up to $384 million of additional funding, on top of $4 million it invested in March, to advance clinical development of NVX-CoV2373, Novavax' coronavirus vaccine candidate against SARS-CoV-2. The additional funding from CEPI will also support rapid scale-up of…

    • Funds clinical development of NVX-CoV2373 through Phase 2
    • Supports rapid scale-up of vaccine manufacturing
    • Allows for increased production of Matrix-M adjuvant
    • Reserves global large-scale manufacturing capacity

    GAITHERSBURG, Md., May 11, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the Coalition for Epidemic Preparedness Innovations (CEPI) will invest up to $384 million of additional funding, on top of $4 million it invested in March, to advance clinical development of NVX-CoV2373, Novavax' coronavirus vaccine candidate against SARS-CoV-2. The additional funding from CEPI will also support rapid scale-up of the NVX-CoV2373 vaccine antigen, as well as Novavax' proprietary Matrix-M™ adjuvant, which is expected to enhance immune responses by stimulating high levels of neutralizing antibodies. In addition, the CEPI funding will allow Novavax to dramatically increase its large-scale manufacturing capacity for both antigen and adjuvant in multiple locations.

    "CEPI plays a vital role in advancing innovative technologies against the COVID-19 pandemic. Their partnership and support allows Novavax to leverage its innovative vaccine platform and expertise in this global crisis," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "For the last few months, the entire Novavax team has been working nonstop in an ongoing effort to make our vaccine a reality, and we appreciate CEPI's confidence in our technology platform and our progress."

    Novavax plans to use CEPI funding to advance NVX-CoV2373 with:

    • A Phase 1/2 clinical trial with the Phase I portion starting this month in Australia and the Phase 2 portion conducted in multiple countries following successful Phase 1 top-line results that are expected in July.
    • Process development for scaled-up production to potentially allow manufacturing of up to 100 million vaccine doses by end of 2020.
    • Access to large-scale manufacturing capacity in multiple countries with a goal of potentially producing over one billion doses during 2021.

    Novavax and CEPI agree on the importance of global equitable access to the vaccines produced out of the partnership. It is anticipated that vaccines will be procured and allocated through global mechanisms now under discussion as part of the Access to COVID-19 Tools (ACT) Accelerator, an international initiative launched by the WHO and global leaders earlier this month.

    "The expansion of our partnership with Novavax represents CEPI's single biggest investment to date", said Richard Hatchett, Chief Executive Officer of CEPI. "Our vaccine R&D programmes are starting to show progress, so it is vital that we invest now to boost manufacturing capacity, so that our partners have the ability to produce vaccines at a global scale. We still have a long way to go, but we're making important steps forward to deliver a safe, effective, and globally accessible vaccine as quickly as possible."

    About Coronavirus

    SARS-CoV-2 first appeared in late 2019 in China before beginning its rapid spread across the globe. The disease, named COVID-19, continues to cause severe pneumonia-like symptoms in many of those infected. Coronaviruses, so named for their "crown-like" appearance, are a large family of viruses that are believed to have spread from animals to humans and include the viruses causing SARS (severe acute respiratory syndrome) and MERS (Middle East respiratory syndrome). While much remains unknown about the latest coronavirus, it is known to spread via human-to-human transmission before symptoms appear.

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response and helping an immunized person make antibodies against the virus.

    About CEPI

    CEPI is an innovative partnership between public, private, philanthropic, and civil society organizations, launched at Davos in 2017, to develop vaccines to stop future epidemics. CEPI has moved with great urgency and in coordination with WHO in response to the emergence of COVID-19. CEPI has initiated 9 partnerships to develop vaccines against the novel coronavirus. The programs will leverage rapid response platforms already supported by CEPI as well as new partnerships. The aim is to advance COVID-19 vaccine candidates into clinical testing as quickly as possible.

    Before the emergence of COVID-19 CEPI's priority diseases included Ebola virus, Lassa virus, Middle East Respiratory Syndrome coronavirus, Nipah virus, Rift Valley Fever and Chikungunya virus. CEPI also invested in platform technologies that can be used for rapid vaccine and immunoprophylactic development against unknown pathogens (Disease X).

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX), is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases and address urgent, global health needs. Novavax recently initiated development of NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19, with Phase 1 clinical trial results expected in July of 2020. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Forward-Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Contacts:

    Investors
    Novavax, Inc.
    Erika Trahan

    240-268-2022

    Westwicke
    John Woolford

    443-213-0506

    Media
    Brandzone/COGS Communication
    Edna Kaplan

    617-974-8659

    Primary Logo

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  40. GAITHERSBURG, Md., May 11, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that Gregory Glenn, M.D., President of Research and Development, will present progress of NVX-CoV2373, Novavax' coronavirus vaccine candidate, on Wednesday, May 13, 2020 as part of the World Vaccine Congress' COVID-19 webinar series. Dr. Glenn joins a distinguished group of global public health, epidemiology, regulatory and industry leaders in sharing expertise and information related to the SARS-Cov-2 virus, as well as ongoing efforts to develop vaccines to address the global health pandemic.

    Dr. Glenn's presentation will be followed by a live…

    GAITHERSBURG, Md., May 11, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that Gregory Glenn, M.D., President of Research and Development, will present progress of NVX-CoV2373, Novavax' coronavirus vaccine candidate, on Wednesday, May 13, 2020 as part of the World Vaccine Congress' COVID-19 webinar series. Dr. Glenn joins a distinguished group of global public health, epidemiology, regulatory and industry leaders in sharing expertise and information related to the SARS-Cov-2 virus, as well as ongoing efforts to develop vaccines to address the global health pandemic.

    Dr. Glenn's presentation will be followed by a live Q&A discussion. Webinar details are as follows:

    Topic:                          Recombinant Nanoparticle COVID-19 Vaccine: Platform Technology for Emerging Infectious Diseases (EID)
    Date and Time:           Wednesday, May 13, 11:00 a.m. ET
    Moderator:                  Philip Krause, M.D., Deputy Director, OVRR, CBER, FDA

    The webinar is free to attend. To register, please click here.

    About NVX-CoV2373

    NVX-CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. In preclinical trials, NVX-CoV2373 demonstrated efficient binding with receptors targeted by the virus, a critical aspect for effective vaccine protection. A Phase 1 clinical trial of NVX-CoV2373 will initiate in May 2020 with preliminary immunogenicity and safety results expected in July 2020. The Coalition for Epidemic Preparedness Innovations (CEPI) has awarded an initial funding of $4 million to support Novavax' NVX-CoV2373 efforts, with additional funding discussions ongoing.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX), is a late-stage biotechnology company that addresses urgent global health needs through the discovery, development, and commercialization of innovative vaccines. Novavax recently initiated development of NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19, with Phase 1 clinical trial results expected in July of 2020. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant nanoparticle vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Contacts:

    Investors
    Erika Trahan

    240-268-2022

    Westwicke
    John Woolford

    443-213-0506

    Media
    Brandzone/KOGS Communication
    Edna Kaplan

    617-974-8659

    Primary Logo

    View Full Article Hide Full Article
  41. “global Nanopharmaceuticals market”
    A new market study, titled "Covid-19 Impact on Global Nanopharmaceuticals Market Size, Status and Forecast 2020-2026" has been featured on WiseGuyReports.

    The global Nanopharmaceuticals market report is a systematic analysis that seeks to provide insight into the size and volume of the market at global, regional, and corporate levels. As part of the industry summary, the introductory segment includes a full business and product description along with the main applications. The market prediction was focused on current developments in the industry and trends of consumption. The industry research provides the total size of the business as well as industry forecasts. Main market analysis related details and…

    “global Nanopharmaceuticals market”
    A new market study, titled "Covid-19 Impact on Global Nanopharmaceuticals Market Size, Status and Forecast 2020-2026" has been featured on WiseGuyReports.

    The global Nanopharmaceuticals market report is a systematic analysis that seeks to provide insight into the size and volume of the market at global, regional, and corporate levels. As part of the industry summary, the introductory segment includes a full business and product description along with the main applications. The market prediction was focused on current developments in the industry and trends of consumption. The industry research provides the total size of the business as well as industry forecasts. Main market analysis related details and figures span the period from 2020 to 2026.

    Nanopharmaceuticals are colloidal particles of 10 to 1,000 nanometers (1 micron) in size. They are widely used in drug delivery. Nanopharmaceuticals are diverse both in their shape and composition and often offer an advantage as compared to their “bulk” counterparts primarily because of size.

    There are two types of nanopharmaceuticals: (1) those where the therapeutic molecules are themselves the drug (i.e.,the therapeutic compound itself also functions as its own carrier); and (2) those where the therapeutic molecules are directly coupled (functionalized, entrapped, or coated) to a nanoparticle carrier.

    This report also analyses the impact of Coronavirus COVID-19 on the Nanopharmaceuticals 3900 industry.

    Competition Analysis

    In the competitive analysis section of the report, leading as well as prominent players of the global Nanopharmaceuticals market are broadly studied on the basis of key factors. The report offers comprehensive analysis and accurate statistics on sales by the player for the period 2015-2020. It also offers detailed analysis supported by reliable statistics on price and revenue (global level) by player for the period 2015-2020.

    The following manufacturers are covered in this report:

    Merck (NYSE:MRK)

    Pfizer (NYSE:PFE)

    Novartis (SWX: NOVN)

    Abbott (NYSE:ABT)

    GlaxoSmithKline (LON: GSK)

    Roche (SWX: RO)

    Sanofi (EPA: SAN)

    Eli Lilly (NYSE:LLY)

    Astrazeneca (LON: AZN)

    Johnson & Johnson (NYSE:JNJ)

    Celgene

    Novavax (NASDAQ:NVAX)

    Stryker (NYSE:SYK)

    Gilead Sciences (NASDAQ:GILD)

    OSI Pharmaceuticals (NASDAQ:OSIP)

    Kadmon Pharmaceuticals (NYSE:KDMN)

    Samyang Biopharm

    Mitsubishi Pharma (OTC:MTZPY)

    Kaken Pharmaceutical (TYO:4521)

    Selecta Biosciences (NASDAQ:SELB)

    Par Pharmaceutical (NYSE:PRX)

    Cerulean Pharma

    Navidea Biopharmaceuticals (NYSEAMERICAN: NAVB)

    Lummy (SZSE:300006)

    Sales and Pricing Analyses

    Readers are provided with deeper sales analysis and pricing analysis for the global Nanopharmaceuticals market. As part of sales analysis, the report offers accurate statistics and figures for sales and revenue by region, by each type segment for the period 2015-2026.

    In the pricing analysis section of the report, readers are provided with validated statistics and figures for the price by players and price by region for the period 2015-2020 and price by each type segment for the period 2015-2020.

    Request For Free Sample Report: https://www.wiseguyreports.com/sample-request/5252333-covid-19-impact-on-global-nanopharmaceuticals-market-size

    Regional and Country-level Analysis

    The report offers an exhaustive geographical analysis of the global Nanopharmaceuticals market, covering important regions, viz, North America, Europe, China and Japan. It also covers key countries (regions), viz, U.S., Canada, Germany, France, U.K., Italy, Russia, China, Japan, South Korea, India, Australia, Taiwan, Indonesia, Thailand, Malaysia, Philippines, Vietnam, Mexico, Brazil, Turkey, Saudi Arabia, UAE, etc.

    The report includes country-wise and region-wise market size for the period 2015-2026. It also includes market size and forecast by each application segment in terms of sales for the period 2015-2026.

    Nanopharmaceuticals Breakdown Data by Type

    Liposomes

    Polymeric Micelles

    Solid Lipid Nanoparticles

    Microemulsion and Nnanoemulsion

    Nanosuspension

    Nanopharmaceuticals Breakdown Data by Application

    Cancer and Tumor

    Autoimmune Disorders

    Inflammation

    Others

     

    Table of Contents