NVAX Novavax Inc.

125.48
+2.01  (+2%)
Previous Close 123.47
Open 121.01
52 Week Low 3.6518
52 Week High 189.4
Market Cap $7,988,050,777
Shares 63,659,952
Float 61,424,003
Enterprise Value $7,938,026,366
Volume 3,962,290
Av. Daily Volume 3,530,229
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Upcoming Catalysts

Drug Stage Catalyst Date
NVX-CoV2373
COVID-19 vaccine
Phase 2/3
Phase 2/3
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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

    • 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

    Primary Logo

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  1. 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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  2. 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

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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

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