NVAX Novavax Inc.

140.16
+8.47  (+6%)
Previous Close 131.69
Open 133.01
52 Week Low 40.5
52 Week High 331.68
Market Cap $10,385,076,010
Shares 74,094,435
Float 73,687,058
Enterprise Value $8,219,994,145
Volume 2,816,518
Av. Daily Volume 3,707,695
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Upcoming Catalysts

Drug Stage Catalyst Date
NVX-CoV2373
COVID-19 vaccine
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
NanoFlu vaccine
Influenza
Phase 3
Phase 3
Phase 3 top-line data met primary endpoints - March 24, 2020.
RSV vaccine - prepare trial
Respiratory Syncytial Virus (RSV) in healthy pregnant women - protect infants via maternal immunization
Phase 3
Phase 3
Phase 3 top-line data released March 28, 2019 - primary endpoint not met. Noted June 10, 2019 that a further Phase 3 trial is required.
RSV vaccine - Resolve trial
Respiratory Syncytial Virus (RSV) in older adults
Phase 3
Phase 3
Phase 3 released September 15, 2016 did not demonstrate efficacy.

Latest News

  1. GAITHERSBURG, Md., May 10, 2021 /PRNewswire/ -- Novavax, Inc. (NASDAQ:NVAX), a 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, 2021.

    "Novavax made great strides over the first quarter to pave the path for our COVID-19 vaccine candidate, NVX-CoV2373, notably achieving statistically significant efficacy across our Phase 3 UK and Phase 2b South Africa trials," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "In parallel, we have secured additional manufacturing and supply agreements, expanding our global supply chain to over 10 countries. In the coming months, we look forward to…

    GAITHERSBURG, Md., May 10, 2021 /PRNewswire/ -- Novavax, Inc. (NASDAQ:NVAX), a 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, 2021.

    "Novavax made great strides over the first quarter to pave the path for our COVID-19 vaccine candidate, NVX-CoV2373, notably achieving statistically significant efficacy across our Phase 3 UK and Phase 2b South Africa trials," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "In parallel, we have secured additional manufacturing and supply agreements, expanding our global supply chain to over 10 countries. In the coming months, we look forward to delivering on critical milestones, including announcing final data from our PREVENT-19 Phase 3 trial, completing our regulatory submissions, evaluating NVX-CoV2373 in younger populations and continuing to develop our booster strategy to address the evolving COVID-19 pandemic. As we continue our dialogue with regulatory authorities for authorization, we remain committed to promptly delivering our vaccine globally, ensuring equitable access and expansive distribution."

    First Quarter 2021 and Recent Highlights

    COVID-19 Clinical Development

    • Reported final efficacy analysis from UK Phase 3 trial and complete analysis from South Africa Phase 2b trial, expanding upon previously reported interim results
      • Demonstrated 100% protection against severe disease
      • Confirmed 96.4% efficacy against original strain of COVID-19 and 86.3% efficacy against B.1.1.7 variant strain in UK Phase 3 trial
      • Demonstrated efficacy of 88.9% in adults over the age of 65 and efficacy of 90.9% in adults with high-risk medical comorbidities in UK Phase 3 trial
      • Demonstrated efficacy of 55.4% among HIV-negative participants in South Africa Phase 2b trial, with the vast majority of cases due to the B.1.351 escape variant
      • South Africa Phase 2b results published in the New England Journal of Medicine
      • UK Phase 3 results submitted for publication to peer-reviewed journal and posted to medRxiv.org
    • Completed successful enrollment of 30,000 participants for PREVENT-19; final analysis to be reported in the second quarter of 2021
    • Initiated pediatric expansion of PREVENT-19 to evaluate efficacy, safety and immunogenicity of NVX-CoV2373 in adolescents
      • Enrolling up to 3,000 adolescent participants aged 12-17 across up to 75 sites in the U.S.
      • Blinded crossover expected to begin six months after initial set of vaccinations
    • Initiated crossovers and progressed booster studies of NVX-CoV2373
      • Initiated crossovers in PREVENT-19, UK Phase 3 and South Africa Phase 2b trials to ensure all trial participants have access to active vaccine
      • Completed 6-month booster doses in the U.S. and Australia Phase 2 study with immunology results expected in the third quarter of 2021
      • Com-COV2 Phase 2 clinical trial conducted by University of Oxford and UK Vaccines Taskforce
        • NVX-CoV2373 is one of four COVID-19 vaccines administered during trial to evaluate combined vaccine regimens in 1,050 participants
        • Top-line data expected in the third quarter of 2021
    • Advanced development of variant strain vaccines into preclinical studies
      • Preclinical data from study of B.1.351 variant strain vaccine candidate showed strong antibody response and functional immune response in non-human primates when boosted one year after receiving NVX-CoV2373
      • Expect to initiate clinical evaluation of one or more candidates
    • Successful collaboration on partner-initiated trials to advance clinical developmentof NVX-CoV2373
      • Takeda completed enrollment of 200 participants in Phase 1/2 clinical trial in Japan
      • Serum Institute of India (Serum Institute) completed enrollment of initial cohort in Phase 2/3 clinical trial in India, with total study including 1,600 participants

    COVID-19 Manufacturing and Supply

    • Secured additional manufacturing capacity for NVX-CoV2373 globally, with continued progress toward achieving full manufacturing capacity
      • Anticipated capacity revised to 100 million doses per month by the end of the third quarter of 2021, with remainder of capacity expected to come online in the fourth quarter to support 150 million doses per month
      • Reached agreement in principle with GSK to support 'fill and finish' manufacturing of up to 60 million doses of NVX-CoV2373 for use in the UK
      • Established manufacturing presence in Canada through Memorandum of Understanding with Canadian government to produce NVX-CoV2373 at National Research Council's Biologics Manufacturing Centre
    • Advanced purchase agreements globally, ensuring equitable access to low, middle and high income countries
      • Finalized advance purchase agreement with Government of Canada to supply 52 million doses with an option for up to an additional 24 million doses
      • Finalized advance purchase agreement with Gavi, the Vaccine Alliance, to provide 1.1 billion doses to the COVAX Facility
        • Novavax to manufacture and distribute 350 million doses to participants of the COVAX Facility
        • Serum Institute to manufacture and distribute remaining balance of the 1.1 billion doses to low- and middle-income countries
    • Furthered existing partnerships to expand global access of NVX-CoV2373
      • Finalized exclusive license agreement with Takeda for the development, manufacturing and commercialization of NVX-CoV2373
        • Takeda to manufacture over 250 million doses of NVX-CoV2373 annually
        • Takeda in discussions with Government of Japan to potentially purchase 150 million doses of NVX-CoV2373
      • Expanded existing partnership with SK bioscience to include license agreement for the manufacturing and commercialization of NVX-CoV2373
        • SK bioscience to supply 40 million doses to the Republic of Korea

    COVID-19 Regulatory Pathway

    • Progressed regulatory processes for authorization of NVX-CoV2373 with multiple regulatory agencies globally
      • Intend to file for authorization with the U.S. Food and Drug Administration (FDA), the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA) in Europe in the third quarter of 2021
      • Rolling reviews initiated with regulatory authorities, including Health Canada, Australian Therapeutic Goods Administration, New Zealand Medsafe, MHRA and EMA
      • SK bioscience initiated regulatory submission process in collaboration with Novavax to the Republic of Korea's Ministry of Food and Drug Safety

    Combination Vaccine

    • NanoFlu/NVX-CoV2373 combination vaccine candidate induced protective responses in preclinical studies
      • Preclinical data manuscript submitted for publication to a peer-reviewed journal and posted on bioRxiv.org
      • Expect to initiate clinical evaluation later this year

    Malaria R21 Vaccine / Matrix-M Adjuvant Collaboration

    • Phase 2b clinical trial results for the University of Oxford's malaria vaccine candidate (R21), including Matrix-M adjuvant, published in Preprints with The Lancet
      • Trial included 450 participants aged 5-17 months in Burkina Faso
      • Demonstrated high efficacy of 77% when using 5 micrograms of antigen and 50 micrograms of Matrix-M adjuvant
      • Novavax to manufacture and supply Matrix-M adjuvant to Serum Institute for use in R21
      • Serum Institute has rights to use the vaccine, comprised of R21 with Matrix-M adjuvant, in endemic regions, while Novavax will have rights to sell and distribute the vaccine in travelers' and military vaccine markets
    • Phase 3 licensure trial underway in 4,800 participants, aged 5-36 months, across four countries in Africa to evaluate the safety and efficacy of R21

    Corporate Highlights

    • Strengthened corporate leadership with executive management promotions and hiring
      • Gale E. Smith, Ph.D. promoted to Senior Vice President, Discovery and Preclinical Research and Chief Scientist
      • Madelyn 'Lyn' Caltabiano, Ph.D. as Senior Vice President, Global Program Management
      • Troy Morgan, J.D. as Senior Vice President, Chief Compliance Officer
      • Henrietta Ukwu, M.D. as Senior Vice President, Chief Regulatory and Quality Officer

    Financial Results for the Three Months Ended March 31, 2021

    Novavax reported a net loss of $223 million, or $3.05 per share, for the first quarter of 2021, compared to a net loss of $26 million, or $0.58 per share, for the first quarter of 2020. 

    Novavax revenue in the first quarter of 2021 was $447 million, compared to $3 million in the same period in 2020. This significant increase was due to increased development activities relating to NVX-CoV2373 for services performed under the U.S. government and Coalition for Epidemic Preparedness Innovations agreements.

    Research and development expenses increased to $593 million in the first quarter of 2021, compared to $17 million in the same period in 2020. The significant increase was primarily due to the development of NVX-CoV2373.

    General and administrative expenses increased to $63 million in the first quarter of 2021, compared to $9 million for the same period in 2020. The increase was primarily due to increased employee-related costs, stock-based compensation expenses, and supporting our NVX-CoV2373 program.

    As of March 31, 2021, Novavax had $2 billion in cash, cash equivalents, marketable securities and restricted cash, compared to $806 million as of December 31, 2020. Net cash provided by operating activities for the first three months of 2021 was $663 million, compared to net cash used in operating activities of $23 million for same period in 2020. The increase in cash provided was primarily due to $772 million in payments under advance purchase agreements recorded as deferred revenue and the timing of payments to third parties.

    Through utilization of At-the-market (ATM) offerings during the first quarter of 2021, Novavax raised net proceeds of $565 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 (866) 652-5200 (Domestic) or (412) 317-6060 (International). Participants will be prompted to request to join the Novavax, Inc. call. A replay of the conference call will be available starting at 7:30 p.m. ET on May 10, 2021 until 11:59 p.m. ET on May 17, 2021. To access the replay by telephone, dial (877) 344-7529 (Domestic) or (412) 317-0088 (International) and use passcode 10155684.

    A webcast of the conference call can also be accessed on the Novavax website at https://ir.novavax.com/events. A replay of the webcast will be available on the Novavax website until August 10, 2021.

    About NVX-CoV2373

    NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of the first strain 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 blocked the binding of spike protein to cellular receptors and provided protection from infection and disease. It was generally well-tolerated and elicited robust antibody response in Phase 1/2 clinical testing.

    NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials: a trial in the U.K. that demonstrated 100% protection against severe disease, efficacy of 96.4% against the original virus strain, 86.3% against the B.1.1.7/501Y.V1 variant and 89.7% overall; and the PREVENT-19 trial in the U.S. and Mexico that began in December 2020. It is also being tested in two ongoing Phase 2 studies that began in August 2020: A Phase 2b trial in South Africa that demonstrated 100% protection against severe disease and 48.6% efficacy against a newly emerging escape variant first described in South Africa, and a Phase 1/2 continuation in the U.S. and Australia.

    NVX-CoV2373 is stored and stable at 2°- 8°C, allowing the use of existing vaccine supply chain channels for its distribution. It is packaged in a ready-to-use liquid formulation in 10-dose vials.

    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 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.

    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, 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





    March 31,





    2021



    2020





















    Revenue



    $                    447,229



    $                     3,377











    Expenses:









    Research and development



    592,671



    16,895

    General and administrative



    63,190



    9,379

    Total expenses



    655,861



    26,274

    Loss from operations



    (208,632)



    (22,897)

    Interest income (expense), net



    (4,477)



    (2,967)

    Other income (expense)



    (6,593)



    --

    Net loss before income tax expense



    $                 (219,702)



    $                 (25,864)

    Income tax expense



    3,017



    --

    Net loss



    $                 (222,719)



    $                 (25,864)











    Basic and diluted net loss per share



    $                    (3.05)



    $                    (0.58)

    Basic and diluted weighted average









    number of common shares outstanding



    73,035



    44,421







    SELECTED CONSOLIDATED BALANCE SHEET DATA

    (in thousands)







    March 31,

    2021



    December 31,

    2020





    (unaudited)















    Cash and cash equivalents



    $          1,995,482



    $          553,398

    Marketable securities



    2,250



    157,649

    Total restricted cash



    33,588



    95,340

    Total current assets



    2,246,784



    1,248,203

    Working capital



    1,038,229



    668,531

    Total assets



    2,608,366



    1,582,479

    Notes payable



    322,390



    322,035

    Total stockholders' equity



    1,039,127



    627,209

     

    Contacts:

    Investors

    Novavax, Inc.

    Erika Schultz | 240-268-2022

    Solebury Trout

    Alexandra Roy | 617-221-9197

    Media

    Laura Keenan | 202-709-7521 

    Amy Speak | 617-420-2461

    Novavax Logo

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/novavax-reports-first-quarter-2021-financial-results-and-operational-highlights-301287742.html

    SOURCE Novavax, Inc.

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  2. - Manuscript highlights development of robust responses to both influenza and COVID-19 and protection against the SARS-CoV-2 virus

    - Data shared via preprint server for biology, bioRxiv, ahead of publication

    GAITHERSBURG, Md., May 10, 2021 /PRNewswire/ -- Novavax, Inc. (NASDAQ:NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced data from a preclinical study of the company's combination quadrivalent seasonal flu vaccine (NanoFlu™) and COVID-19 vaccine candidate (NVX-CoV2373). The NanoFlu/NVX-CoV2373 combination vaccine demonstrated positive immune responses to both influenza and SARS-CoV-2. A pre-print of the manuscript is available at bioRxiv.org.

    The manuscript, titled 'Combination…

    - Manuscript highlights development of robust responses to both influenza and COVID-19 and protection against the SARS-CoV-2 virus

    - Data shared via preprint server for biology, bioRxiv, ahead of publication

    GAITHERSBURG, Md., May 10, 2021 /PRNewswire/ -- Novavax, Inc. (NASDAQ:NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced data from a preclinical study of the company's combination quadrivalent seasonal flu vaccine (NanoFlu™) and COVID-19 vaccine candidate (NVX-CoV2373). The NanoFlu/NVX-CoV2373 combination vaccine demonstrated positive immune responses to both influenza and SARS-CoV-2. A pre-print of the manuscript is available at bioRxiv.org.

    The manuscript, titled 'Combination Respiratory Vaccine Containing Recombinant SARS-CoV-2 Spike and Quadrivalent Seasonal Influenza Hemagglutinin Nanoparticles with Matrix-M™ Adjuvant,' studied a combination vaccine comprising a quadrivalent nanoparticle influenza vaccine formulated together with a recombinant SARS-CoV-2 spike protein vaccine and Matrix-M™ adjuvant. The combination vaccine elicited robust responses to both influenza A and B and protected against the SARS-CoV-2 virus. Clinical studies of the combination vaccine are expected to begin by the end of the year.

    "Despite low rates during the COVID-19 pandemic, influenza remains a significant risk to global public health and the need for versatile, more effective vaccines is as important as ever, including against the flu. This study's results build on our success to-date with NVX-CoV2373, and with NanoFlu, which successfully achieved all of its objectives in a pivotal Phase 3 trial announced last year," said Gregory M. Glenn, M.D., President of Research and Development, Novavax. "We believe that this novel combination vaccine candidate, which leverages Novavax' technology platform and Matrix-M™ adjuvant, could be an important future tool in the long-term fight against both of these harmful respiratory viruses."

    Immunogenicity Results

    The preclinical study found that the combination NanoFlu/NVX-CoV2373 (qNIV/CoV2373) vaccine induced functional influenza and COVID antibodies in ferrets. Hemagglutination inhibition (HAI) and ACE2 receptor-inhibiting titers were comparable between immunization with the combination vaccine and with its respective component vaccines. Antibody titers were elevated two weeks after a single dose and increased even further two weeks following a second immunization.

    Hamsters that received the combination NanoFlu/NVX-CoV2373 vaccine had elevated levels of SARS-CoV-2 anti-S IgG two weeks after the first immunization, which increased significantly after a second dose, with levels comparable to animals that received the NVX-CoV2373 vaccine alone. Human ACE2 receptor inhibiting antibody levels responded similarly. The immune responses to influenza A and B strains elicited by NanoFlu/NVX-CoV2373 were comparable to immunization with NanoFlu alone. Further, the combination vaccine induced antibodies against SARS-CoV-2 neutralizing epitopes, including at hidden or cryptic sites, that are common between USA-WA1 and the B.1.351 variant.

    Protection after SARS-CoV-2 challenge

    When hamsters were challenged with SARS-CoV-2, animals immunized with NanoFlu/NVX-CoV2373 retained their body weight comparably to non-infected animals and those immunized with NVX-CoV2373 alone. An examination of viral load in the upper and lower respiratory tract showed that little or no virus was detected four days after COVID-19 infection in animals immunized with NanoFlu/NVX-CoV2373 or with just NVX-CoV2373. Microscopic and macroscopic observations of the lungs showed no remarkable findings in animals immunized with either the combination vaccine or with NVX-CoV2373 alone.

    "Seasonal influenza and COVID-19 combination vaccines will likely be critical to combating emerging COVID-19 variants," said Russell 'Rip' Wilson, Executive Vice President and NanoFlu General Manager, Novavax. "Millions of people are affected by influenza each year in the U.S., and despite our vaccination efforts, currently available flu vaccines are only partially effective. Our NanoFlu vaccine Phase 3 clinical trial achieved all of its primary endpoints, and we expect this combination vaccine will help control both COVID-19 and influenza illness."

    About NVX-CoV2373

    NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of the first strain 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 blocked the binding of spike protein to cellular receptors and provided protection from infection and disease. It was generally well-tolerated and elicited robust antibody response in Phase 1/2 clinical testing.

    NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials: a trial in the U.K. that demonstrated 100% protection against severe disease, efficacy of 96.4% against the original virus strain, 86.3% against the B.1.1.7/501Y.V1 variant and 89.7% overall; and the PREVENT-19 trial in the U.S. and Mexico that began in December 2020. It is also being tested in two ongoing Phase 2 studies that began in August 2020: A Phase 2b trial in South Africa that demonstrated 100% protection against severe disease and 48.6% efficacy against a newly emerging escape variant first described in South Africa, and a Phase 1/2 continuation in the U.S. and Australia.

    NVX-CoV2373 is stored and stable at 2°- 8°C, allowing the use of existing vaccine supply chain channels for its distribution. It is packaged in a ready-to-use liquid formulation in 10-dose vials.

    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 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 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, 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

    Novavax, Inc.

    Erika Schultz | 240-268-2022

    Solebury Trout

    Alexandra Roy | 617-221-9197

    Novavax Media

    Amy Speak | 617-420-2461

    Laura Keenan | 202-709-7521

    Logo

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/novavax-announces-positive-preclinical-data-for-combination-influenza-and-covid-19-vaccine-candidate-301287543.html

    SOURCE Novavax, Inc.

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    • Novavax to deliver 350 million doses beginning Q3 2021
    • 1.1 billion doses of Novavax vaccine to be available to countries participating in COVAX
    • Serum Institute of India to provide balance of doses for LMICs
    • Underscores commitment to global equitable access to Novavax vaccine

    GAITHERSBURG, Md., May 6, 2021 /PRNewswire/ -- Novavax, Inc. (NASDAQ:NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it has finalized an advance purchase agreement (APA) with Gavi, the Vaccine Alliance (Gavi) for supply of its recombinant protein-based COVID-19 vaccine candidate to the COVAX Facility. Under the APA, Novavax is expected to manufacture and distribute 350 million doses of NVX-CoV2373 to…

    • Novavax to deliver 350 million doses beginning Q3 2021
    • 1.1 billion doses of Novavax vaccine to be available to countries participating in COVAX
    • Serum Institute of India to provide balance of doses for LMICs
    • Underscores commitment to global equitable access to Novavax vaccine

    GAITHERSBURG, Md., May 6, 2021 /PRNewswire/ -- Novavax, Inc. (NASDAQ:NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it has finalized an advance purchase agreement (APA) with Gavi, the Vaccine Alliance (Gavi) for supply of its recombinant protein-based COVID-19 vaccine candidate to the COVAX Facility. Under the APA, Novavax is expected to manufacture and distribute 350 million doses of NVX-CoV2373 to countries participating under the COVAX Facility, which was established to allocate and distribute vaccines equitably to participating countries and economies. Under a separate purchase agreement with Gavi, the Serum Institute of India (Serum Institute) is expected to manufacture and deliver the balance of the 1.1 billion doses of Novavax' vaccine.

    "This is a tremendous opportunity to partner with global organizations focused on accelerating equitable access to safe and effective COVID-19 vaccines, particularly in countries where vaccination rates are currently low," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "This arrangement is the culmination of a collaboration among CEPI, Gavi, Serum Institute and Novavax, who are partnering in our urgent mission to deliver significant amounts of vaccines to all countries, regardless of income level. Novavax thanks CEPI for its longstanding support and tireless work with Gavi as the curators of the COVAX Facility."

    Under the APA, Novavax expects to deliver doses with antigen and adjuvant manufactured at facilities directly funded by the investments Novavax received from the Coalition for Epidemic Preparedness Innovations (CEPI). CEPI invested nearly $400 million in Novavax in the spring of 2020 to advance preclinical and early clinical development, manufacturing scale-up, technology transfer, and manufacturing capacity reservation for NVX-CoV2373.

    "CEPI's investments to accelerate the clinical development and manufacturing of this vaccine candidate have been critical to enabling equitable access to the vaccine through COVAX," said Dr. Richard Hatchett, CEO of CEPI. "With this agreement in place, the Novavax vaccine candidate will play a vital role in our mission to protect those most at risk from COVID-19, wherever they are in the world."

    "Today's agreement with Novavax marks a major step towards COVAX's objective of building the world's largest and most diverse portfolio of COVID-19 vaccines, and a major step towards our goal of delivering 2 billion doses of safe and effective vaccines in 2021," said Dr Seth Berkley, CEO of Gavi. "Novavax' commitment not only to support COVAX directly, but also through technology transfer via other manufacturers, shines a light on the end-to-end nature of COVAX and the kind of collaboration needed to bring this pandemic under control."

    Together, Novavax and Serum Institute expect to initiate delivery of the cumulative 1.1 billion doses in the third quarter of 2021, pending receipt of appropriate regulatory authorizations. Under the APA, Novavax will receive an upfront payment from Gavi later this month and an additional payment after it secures Emergency Use Listing for its vaccine by the WHO. In addition, Novavax has agreed to provide additional doses in the event that Serum Institute cannot materially deliver expected vaccine doses to the COVAX Facility.

    Vaccine dose allocation will be determined by Gavi across the AMC-eligible and self-financing participants under a tiered pricing schedule.

    "CEPI's early support served as a catapult for Novavax to create a global supply network that we expect could provide a significant percent of the world's vaccine supply via COVAX," Erck continued. "We look forward to the ongoing collaboration with Serum Institute to deliver on our manufacturing capacity and to working with WHO to secure authorization as rapidly as possible for NVX-CoV2373."

    About the COVAX Facility

    The COVAX Facility is a global risk-sharing mechanism for pooled procurement and equitable distribution of COVID-19 vaccines that currently includes more than 190 participating economies, designed and administered by Gavi, the Vaccine Alliance. It is part of COVAX, co-led by CEPI, Gavi and the World Health Organization (WHO), which are working in partnership with developed and developing country vaccine manufacturers, UNICEF, PAHO, the World Bank, civil society organizations and others to guarantee fair and equitable access to the vaccine.

    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 blocked the binding of spike protein to cellular receptors and provided protection from infection and disease. It was generally well-tolerated and elicited robust antibody response in Phase 1/2 clinical testing.

    NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials, a trial in the U.K. that demonstrated 100% protection against severe disease, efficacy of 96.4% against the original virus strain and 89.7% overall, and the PREVENT-19 trial in the U.S. and Mexico that began in December 2020. It is also being tested in two ongoing Phase 2 studies that began in August 2020: A Phase 2b trial in South Africa that demonstrated 100% protection against severe disease and 48.6% efficacy against a newly emerging escape variant, and a Phase 1/2 continuation in the U.S. and Australia.

    NVX-CoV2373 is stored and stable at 2°- 8°C, allowing the use of existing vaccine supply chain channels for its distribution. It is packaged in a ready-to-use liquid formulation in 10-dose vials.

    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 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, 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

    Novavax, Inc. 

    Erika Schultz | 240-268-2022

    Solebury Trout

    Alexandra Roy | 617-221-9197

    Novavax Media

    Laura Keenan | 202-709-7521

    Novavax Logo (PRNewsfoto/Novavax, Inc.)

     

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    SOURCE Novavax, Inc.

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  3. GAITHERSBURG, Md., May 5, 2021 /PRNewswire/ -- Novavax, Inc. (NASDAQ:NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the publication of results from the initial primary analysis of a Phase 2b clinical trial conducted in South Africa of its NVX-CoV2373 COVID-19 vaccine candidate in the New England Journal of Medicine (NEJM). The published data provide additional detail of an initial analysis conducted in January, while more robust data from a complete analysis of the study was subsequently shared in March 2021. The data on the initial analysis will be published online ahead of print in NEJM's May 6, 2021 issue.

    GAITHERSBURG, Md., May 5, 2021 /PRNewswire/ -- Novavax, Inc. (NASDAQ:NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the publication of results from the initial primary analysis of a Phase 2b clinical trial conducted in South Africa of its NVX-CoV2373 COVID-19 vaccine candidate in the New England Journal of Medicine (NEJM). The published data provide additional detail of an initial analysis conducted in January, while more robust data from a complete analysis of the study was subsequently shared in March 2021. The data on the initial analysis will be published online ahead of print in NEJM's May 6, 2021 issue.

    "This data publication reinforces the encouraging safety profile and cross-protective effect across variants seen in studies of our vaccine to-date," said Gregory M. Glenn, M.D., President of Research and Development, Novavax. "It also demonstrates that ongoing evaluation of COVID-19 vaccine efficacy against SARS-CoV-2 variants is urgently needed to inform vaccine development and use."

    The Phase 2b randomized, observer-blinded, placebo-controlled trial conducted in South Africa evaluated efficacy, safety and immunogenicity in healthy adults, and in a small cohort of medically stable adults living with human immunodeficiency virus (HIV). The study met its primary endpoint. NVX-CoV2373 demonstrated an overall efficacy of 49% in the initial analysis (published NEJM), and 49% in the subsequent complete analysis (unpublished). Among healthy adults without HIV, NVX-CoV2373 demonstrated efficacy of 60% in the initial analysis and 55% in the subsequent complete analysis. In the initial analysis, cases were predominantly mild-to-moderate and due to the B.1.351 variant. In the subsequent complete analysis, circulation of the B.1.351 variant continued to dominate, and all five cases of severe disease observed in the trial occurred in the placebo group.

    The initial analysis, now being published in NEJM, suggested that prior infection with the original COVID-19 strain did not protect against subsequent infection by the variant predominantly circulating in South Africa through 60 days of follow-up. However, with additional follow-up, the complete analysis of the South Africa trial indicates that there may be a modest protective effect of prior exposure with the original COVID-19 strain. Among placebo recipients, at 90 days of follow-up, the illness rate was 8.0% in baseline seronegative participants and 5.9% in baseline seropositive participants.

    About NVX-CoV2373

    NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of the first strain 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 blocked the binding of spike protein to cellular receptors and provided protection from infection and disease. It was generally well-tolerated and elicited robust antibody response in Phase 1/2 clinical testing.

    NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials: a trial in the U.K. that demonstrated 100% protection against severe disease, efficacy of 96.4% against the original virus strain, 86.3% against the B.1.1.7/501Y.V1 variant and 89.7% overall; and the PREVENT-19 trial in the U.S. and Mexico that began in December 2020. It is also being tested in two ongoing Phase 2 studies that began in August 2020: A Phase 2b trial in South Africa that demonstrated 100% protection against severe disease and 48.6% efficacy against a newly emerging escape variant first described in South Africa, and a Phase 1/2 continuation in the U.S. and Australia.

    NVX-CoV2373 is stored and stable at 2°- 8°C, allowing the use of existing vaccine supply chain channels for its distribution. It is packaged in a ready-to-use liquid formulation in 10-dose vials.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a 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, 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

    Novavax, Inc.

    Erika Schultz | 240-268-2022

     

    Solebury Trout

    Alexandra Roy | 617-221-9197

     

    Novavax Media

    Amy Speak | 617-420-2461

    Laura Keenan | 202-709-7521

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    SOURCE Novavax, Inc.

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  4. GAITHERSBURG, Md., May 3, 2021 /PRNewswire/ -- Novavax, Inc. (NASDAQ:NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it has initiated a pediatric expansion of its Phase 3 clinical trial for NVX-CoV2373, the company's recombinant protein vaccine candidate against COVID-19. The additional arm of the ongoing PREVENT-19 pivotal trial will evaluate the efficacy, safety and immunogenicity of NVX-CoV2373 in up to 3,000 adolescents aged 12-17 across up to 75 sites in the United States.

    Participants will randomly receive either the vaccine candidate or placebo in two doses, administered 21 days apart. Two-thirds of volunteers will receive intramuscular injections of the vaccine…

    GAITHERSBURG, Md., May 3, 2021 /PRNewswire/ -- Novavax, Inc. (NASDAQ:NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it has initiated a pediatric expansion of its Phase 3 clinical trial for NVX-CoV2373, the company's recombinant protein vaccine candidate against COVID-19. The additional arm of the ongoing PREVENT-19 pivotal trial will evaluate the efficacy, safety and immunogenicity of NVX-CoV2373 in up to 3,000 adolescents aged 12-17 across up to 75 sites in the United States.

    Participants will randomly receive either the vaccine candidate or placebo in two doses, administered 21 days apart. Two-thirds of volunteers will receive intramuscular injections of the vaccine and one-third will receive placebo. A blinded crossover is planned to take place six months after the initial set of vaccinations to ensure that all trial participants receive active vaccine. Participants will be monitored for safety for up to two years following the final dose.

    "Through the expansion of our PREVENT-19 clinical trial, we hope to build upon the encouraging safety and efficacy data generated to-date in adults for our vaccine candidate and to play a significant global role in offering vaccination to as many people as possible across age groups to end the suffering caused by the pandemic," said Gregory M. Glenn, M.D., President, Research and Development, Novavax.

    Dr. Glenn will share an update regarding this arm of the PREVENT-19 trial during the 21st annual World Vaccine Congress taking place online, May 4-6. He will participate in two sessions during the congress, including a presentation and a panel discussion. Details are as follows:

    Morning Plenary:

    Date: Tuesday, May 4

    Time: 9:10am10:40am EST

    Title: Safety, efficacy, and uptake of COVID-19 vaccines

    Moderator: Jakob Cramer, M.D., Head of Clinical Development, CEPI

    Afternoon Session: COVID-19: Vaccine Response & Approaches

    Date: Tuesday, May 4

    Time: 3:30pm3:45pm EST

    Title: Novavax COVID-19 Program Update

    To register, please visit the World Vaccine Congress website here. Dr. Glenn's presentation slides will be posted to the company's website following the presentation here.

    About NVX-CoV2373

    NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of the first strain 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 blocked the binding of spike protein to cellular receptors and provided protection from infection and disease. It was generally well-tolerated and elicited robust antibody response in Phase 1/2 clinical testing.

    NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials: a trial in the U.K. that demonstrated 100% protection against severe disease, efficacy of 96.4% against the original virus strain, 86.3% against the B.1.1.7/501Y.V1 variant and 89.7% overall; and the PREVENT-19 trial in the U.S. and Mexico that began in December 2020. It is also being tested in two ongoing Phase 2 studies that began in August 2020: A Phase 2b trial in South Africa that demonstrated 100% protection against severe disease and 48.6% efficacy against a newly emerging escape variant first described in South Africa, and a Phase 1/2 continuation in the U.S. and Australia.

    NVX-CoV2373 is stored and stable at 2°- 8°C, allowing the use of existing vaccine supply chain channels for its distribution. It is packaged in a ready-to-use liquid formulation in 10-dose vials.

    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 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, 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

    Novavax, Inc.

    Erika Schultz | 240-268-2022

    Solebury Trout

    Alexandra Roy | 617-221-9197

    Novavax Media

    Laura Keenan | 202-709-7521

     

    Novavax Logo (PRNewsfoto/Novavax, Inc.)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/novavax-initiates-pediatric-expansion-for-phase-3-clinical-trial-of-covid-19-vaccine-301282123.html

    SOURCE Novavax, Inc.

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