DVAX Dynavax Technologies Corporation

9.34
-0.15  -2%
Previous Close 9.49
Open 9.46
52 Week Low 3.58
52 Week High 11.84
Market Cap $1,097,491,675
Shares 117,504,462
Float 93,568,156
Enterprise Value $1,071,808,131
Volume 1,287,779
Av. Daily Volume 1,772,412
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Upcoming Catalysts

Drug Stage Catalyst Date
S-Trimer COVID-19 Vaccine + CpG 1018 adjuvant plus alum (SPECTRA)
COVID-19 vaccine
Phase 2/3
Phase 2/3
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CpG 1018 adjuvanted Tdap vaccine
Tetanus/Diphtheria/Pertussis Booster Vaccine
Phase 1
Phase 1
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HEPLISAV-B
End Stage Renal Disease on Dialysis undergoing hemodialysis
Phase 1
Phase 1
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Drug Pipeline

Drug Stage Notes
Biological E. vaccine with CpG 1018
COVID-19 vaccine
Phase 2/3
Phase 2/3
Phase 2/3 trial initiated June 2021.
VLA2001-301 + alum and CpG 1018
COVID-19 vaccine
Phase 1/2
Phase 1/2
Phase 3 trial initiation announced April 21, 2021.
Medigen with CpG 1018
COVID-19 vaccine
Phase 1
Phase 1
Phase 2 initiated January 2021.
AZD1419
Asthma
Phase 2a
Phase 2a
Phase 2a trial did not meet primary endpoint - November 29, 2018.
HEPLISAV-B
Hepatitis B
Approved
Approved
CRL February 25, 2013 and November 14, 2016. Advisory Committee Meeting July 28, 2017 voted 21 -1 in favor of recommending approval. Final approval announced November 9, 2017.

Latest News

  1. EMERYVILLE, Calif., July 21, 2021 /PRNewswire/ -- Dynavax Technologies Corporation (NASDAQ:DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, will report second quarter 2021 financial results on Wednesday, August 4, 2021, after the U.S. financial markets close.

    Dynavax will host a conference call and live audio webcast on Wednesday, August 4, 2021 at 4:30 p.m. (ET)/1:30 p.m. (PT).

    The live audio webcast may be accessed through the "Events & Presentations" page on the "Investors" section of the Company's website at http://investors.dynavax.com/events-presentations.  Alternatively, participants may dial (866) 420-4066 (domestic) or (409) 217-8237 (international) and refer to conference ID 9970706.  A replay…

    EMERYVILLE, Calif., July 21, 2021 /PRNewswire/ -- Dynavax Technologies Corporation (NASDAQ:DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, will report second quarter 2021 financial results on Wednesday, August 4, 2021, after the U.S. financial markets close.

    Dynavax will host a conference call and live audio webcast on Wednesday, August 4, 2021 at 4:30 p.m. (ET)/1:30 p.m. (PT).

    The live audio webcast may be accessed through the "Events & Presentations" page on the "Investors" section of the Company's website at http://investors.dynavax.com/events-presentations.  Alternatively, participants may dial (866) 420-4066 (domestic) or (409) 217-8237 (international) and refer to conference ID 9970706.  A replay of the webcast will be available for 30 days following the live event.

    About Dynavax

    Dynavax is a commercial stage biopharmaceutical company developing and commercializing novel vaccines. The Company's first commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], is approved in the U.S. and the European Union for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. Dynavax is also advancing CpG 1018 adjuvant as a premier vaccine adjuvant through research collaborations and partnerships. Current collaborations are focused on adjuvanted vaccines for COVID-19, pertussis and universal influenza. For more information, visit www.dynavax.com and follow the company on LinkedIn.

    Contacts:

    Nicole Arndt, Senior Manager, Investor Relations



    510-665-7264

    Derek Cole, President

    Investor Relations Advisory Solutions

    Cision View original content:https://www.prnewswire.com/news-releases/dynavax-to-report-second-quarter-2021-financial-results-and-host-conference-call-on-august-4-2021-301338367.html

    SOURCE Dynavax Technologies

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  2. EMERYVILLE, Calif. and HYDERABAD, India, July 6, 2021 /PRNewswire/ --  Dynavax Technologies Corporation ((Dynavax, NASDAQ:DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines and Biological E. Limited (BE), a Hyderabad-based vaccine and pharmaceutical company, today announced the execution of a commercial supply agreement of Dynavax's CpG 1018TM advanced adjuvant, for use in BE's subunit COVID-19 vaccine candidate, CORBEVAX™. The commercial supply agreement extends through 2022. The agreement includes doses for delivery in 2021, which were manufactured under the previously announced funding agreement between the Coalition for Epidemic Preparedness Innovations (CEPI) and Dynavax. Pending conditional regulatory…

    EMERYVILLE, Calif. and HYDERABAD, India, July 6, 2021 /PRNewswire/ --  Dynavax Technologies Corporation ((Dynavax, NASDAQ:DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines and Biological E. Limited (BE), a Hyderabad-based vaccine and pharmaceutical company, today announced the execution of a commercial supply agreement of Dynavax's CpG 1018TM advanced adjuvant, for use in BE's subunit COVID-19 vaccine candidate, CORBEVAX™. The commercial supply agreement extends through 2022. The agreement includes doses for delivery in 2021, which were manufactured under the previously announced funding agreement between the Coalition for Epidemic Preparedness Innovations (CEPI) and Dynavax. Pending conditional regulatory approvals in India, BE expects to commence product launch of CORBEVAX™ later this year.

    In June 2021, India's Union Ministry of Health announced that it had finalized arrangements with BE to reserve 300 million doses of CORBEVAX™. The arrangement with BE is part of the wider endeavor from the Government of India to encourage indigenous vaccine manufacturers by providing financial support.

    Ryan Spencer, Chief Executive Officer of Dynavax commented, "Dynavax is proud to extend our collaboration with Biological E with a commercial supply agreement and deliver significant amounts of CpG 1018 in hopes that CORBEVAX™ will be an important COVID-19 vaccine protecting people globally regardless of income level."

    "We are pleased to collaborate with Dynavax, and our collaboration will produce yet another vital vaccine against the spread of COVID-19. We believe CORBEVAX™ will play a critical role in eradicating the global pandemic," said Ms. Mahima Datla, Managing Director, Biological E. Limited.

    About CpG 1018 Adjuvant

    CpG 1018 is the adjuvant used in HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], an adult hepatitis B vaccine approved by the U.S. Food and Drug Administration (FDA) and the European Commission. Dynavax developed CpG 1018 adjuvant to provide an increased vaccine immune response, which has been demonstrated in HEPLISAV-B. CpG 1018 adjuvant provides a well-developed technology and a significant safety database, potentially accelerating the development and large-scale manufacturing of a COVID-19 vaccine.

    About Dynavax

    Dynavax is a commercial stage biopharmaceutical company developing and commercializing novel vaccines. The Company's first commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], is approved in the U.S. and the European Union for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. Dynavax is also advancing CpG 1018 adjuvant as a premier vaccine adjuvant through research collaborations and partnerships. Current collaborations are focused on adjuvanted vaccines for COVID-19, pertussis and universal influenza. For more information, visit www.dynavax.com and follow the company on LinkedIn.

    About Biological E. Limited

    Biological E. Limited (BE), a Hyderabad-based Pharmaceuticals & Biologics Company founded in 1953, is the first private sector biological products company in India and the first pharmaceutical company in Southern India. BE develops, manufactures and supplies vaccines and therapeutics. BE supplies its vaccines to over 100 countries and its therapeutic products are sold in India and the USA. BE currently has 8 WHO-prequalified vaccines in its portfolio.

    In recent years, BE has embarked on new initiatives for organizational expansion such as developing generic injectable products for the regulated markets, exploring synthetic biology and metabolic engineering as a means to manufacture APIs sustainably and developing novel vaccines for the global market.

    For further details, please visit www.biologicale.com and follow us on Facebook, LinkedIn and Twitter.

    Forward-Looking Statements

    This press release contains "forward-looking" statements, including statements regarding the potential to develop a COVID-19 vaccine containing CpG 1018 adjuvant, the timing and amount of potential sales to Biological E and timing of regulatory approvals and the potential to help eradicate the COVID-19 pandemic. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in vaccine research and development, including the timing of completing development, whether CpG 1018 combined with the antigen in BE's subunit vaccine candidate will prove to be beneficial in clinical trials, whether use of CpG 1018 will reduce the amount of antigen required per dose, whether and when the vaccine will be approved for use, protection rates realized and whether sufficient quantities of CpG 1018 and of vaccine will be able to be manufactured, as well as other risks detailed in the "Risk Factors" section of our Annual Report on Form 10-K for the fiscal year ended December 31, 2020, as well as discussions of potential risks, uncertainties and other important factors in our other filings with the U.S. Securities and Exchange Commission. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Information on Dynavax's website at www.dynavax.com is not incorporated by reference in our current periodic reports with the SEC.

    Contacts:

    Dynavax

    Biological E. Limited

    Nicole Arndt, Senior Manager, Investor Relations

    Vijay Amruth Raj K., Lead, Corporate Communications

    510-665-7264

    +91 83740 77433



    www.biologicale.com/news

    Derek Cole, President

    Investor Relations Advisory Solutions



    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/dynavax-and-biological-e-announce-commercial-supply-agreement-of-dynavaxs-cpg-1018-adjuvant-for-biological-es-covid-19-vaccine-candidate-301325291.html

    SOURCE Dynavax Technologies

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  3. Saint Herblain (France), July 5, 2021Valneva SE (NASDAQ:VALN, Euronext Paris: VLA))), a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, announced today it will host a virtual symposium titled, "Developing new vaccines to protect against infectious diseases at home and abroad" on July 9, 2021 at 14:15 CEST at the 31st European Congress of Clinical Microbiology & Infectious Diseases (ECCMID).

    The symposium will be chaired by Prof. Thea Kølsen Fischer, Danish epidemiologist and member of the WHO team investigating the origins of SARS-CoV-2, and Katrin Dubischar, VP Program Director Chikungunya Vaccine at Valneva.

    Adam Finn, Principal…

    Saint Herblain (France), July 5, 2021Valneva SE (NASDAQ:VALN, Euronext Paris: VLA))), a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, announced today it will host a virtual symposium titled, "Developing new vaccines to protect against infectious diseases at home and abroad" on July 9, 2021 at 14:15 CEST at the 31st European Congress of Clinical Microbiology & Infectious Diseases (ECCMID).

    The symposium will be chaired by Prof. Thea Kølsen Fischer, Danish epidemiologist and member of the WHO team investigating the origins of SARS-CoV-2, and Katrin Dubischar, VP Program Director Chikungunya Vaccine at Valneva.

    Adam Finn, Principal investigator for Valneva's COVID-19 program, Professor of Paediatrics at the University of Bristol and Consultant at the Bristol Royal Hospital for Children, will discuss Phase 1/2 data of VLA2001, the only whole-virus, inactivated adjuvanted COVID-19 vaccine candidate in clinical trials in Europe.

    Prof. Thomas Jelinek, renowned key opinion leader and Medical Director of Berlin Centre for Travel and Tropical Medicine, will present on chikungunya disease and results of the Phase 1 study of Valneva's single-shot chikungunya vaccine candidate VLA1553.

    To attend the ECCMID conference and participate in Valneva's symposium, you can register here.

    About VLA2001

    VLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine candidate in clinical trials against COVID-19 in Europe. It is intended for active immunization of at-risk populations to prevent carriage and symptomatic infection with COVID-19 during the ongoing pandemic and potentially later for routine vaccination including addressing new variants. VLA2001 may also be suited for boosting, as repeat booster vaccinations have been shown to work well with whole virus inactivated vaccines. VLA2001 is produced on Valneva's established Vero-cell platform, leveraging the manufacturing technology for Valneva's licensed Japanese encephalitis vaccine, IXIARO®. VLA2001 consists of inactivated whole virus particles of SARS-CoV-2 with high S-protein density, in combination with two adjuvants, alum and CpG 1018. This adjuvant combination has consistently induced higher antibody levels in preclinical experiments than alum-only formulations and shown a shift of the immune response towards Th1. CpG 1018 adjuvant, supplied by Dynavax Technologies Corporation (NASDAQ:DVAX), is a component of the US FDA- and EMA-approved HEPLISAV-B® vaccine. The manufacturing process for VLA2001, which has already been upscaled to final industrial scale, includes inactivation with BPL to preserve the native structure of the S-protein. VLA2001 is expected to conform with standard cold chain requirements (2 degrees to 8 degrees Celsius).

    About VLA1553

    VLA1553 targets the chikungunya virus, which has spread to more than 100 countries. VLA1553 is a live-attenuated, single dose vaccine candidate for protection against chikungunya disease. It has been designed by deleting a part of the chikungunya virus genome.

    To Valneva's knowledge, VLA1553 is currently the only chikungunya vaccine candidate in Phase 3 clinical trials that targets long-term protection with a single administration.

    In the Phase 1 clinical trial of VLA1553, Valneva observed development of antibodies to chikungunya virus resulting in 100% seroconversion of the 120 healthy participants. Antibody titers were sustained after 12 months. Based on these results and Valneva's discussions with regulators, VLA1553 has advanced directly into Phase 3 clinical development. The Company has also received confirmation for its proposal to seek licensure under the accelerated approval pathway from the FDA. Under this pathway, Valneva plans to seek licensure of the vaccine based on a surrogate of protection agreed with the FDA that is reasonably likely to predict protection from chikungunya infection.

    The program was granted Fast Track designation by the FDA in December 20181 and PRIME designation by the European Medicines Agency (EMA) in October 20202.

    VLA1553 would expand Valneva's existing travel vaccine portfolio and as such, Valneva intends to commercialize this vaccine, if approved, leveraging its existing manufacturing and commercial operations. The global market for vaccines against chikungunya is estimated to exceed $500 million annually by 20323.

    To make VLA1553 more accessible to Low and Middle Income Countries (LMIC), Valneva and Instituto Butantan in Brazil signed an agreement for the development, manufacturing and marketing of VLA15534. The collaboration falls within the framework of the funding agreement between Valneva and the Coalition for Epidemic Preparedness Innovations (CEPI) signed in July 2019, which provides funding of up to $23.4 million5.

    Valneva Investor and Media Contacts

    Laetitia Bachelot-Fontaine

    Global Head of Investor Relations &

    Corporate Communications

    M +33 (0)6 4516 7099

            
     



    Teresa Pinzolits

    Corporate Communications Specialist

    T +43 (0)1 20620 1116

    Forward-Looking Statements

    This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to the progress, timing, results and completion of research, development and clinical trials for product candidates and estimates for future performance. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be sustained in the future. In some cases, you can identify forward-looking statements by words such as "could," "should," "may," "expects," "anticipates," "believes," "intends," "estimates," "aims," "targets," or similar words. These forward-looking statements are based largely on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Valneva could be affected by, among other things, uncertainties involved in the development and manufacture of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, and the ability to obtain or maintain patent or other proprietary intellectual property protection. Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made during this presentation will in fact be realized. Valneva is providing the information in these materials as of this press release, and disclaim any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.


    1 Valneva PR: Valneva Awarded FDA Fast Track Designation for Chikungunya vaccine candidate

    2 Valneva's Chikungunya Vaccine Candidate Awarded EMA Prime Designation

    3 VacZine Analytics Chikungunya virus vaccines Global demand analysis. February 2020

    4 Valneva and Instituto Butantan Sign Final Agreement on Single-Shot Chikungunya Vaccine for Low and Middle Income Countries

    5 CEPI awards up to US$23.4 million to Valneva for late-stage development of a single-dose chikungunya vaccine

     

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  4. EMERYVILLE, Calif., July 2, 2021 /PRNewswire/ -- Dynavax Technologies Corporation (NASDAQ:DVAX) today reported that it has granted nonstatutory stock options to purchase an aggregate of 51,000 shares of Dynavax common stock as inducements to 5 newly-hired employees in connection with commencement of employment with the Company.

    The stock options were granted on July 1, 2021 at an exercise price of $10.23 per share, which is equal to the closing price of Dynavax common stock on the date of grant. Each stock option granted has a 7-year term and vests over three years, with one-third of the shares underlying the option vesting on the one-year anniversary of the grant date, and the remaining shares vesting 1/36 per month in equal installments, subject to continued service with Dynavax through the applicable vesting dates. The options were granted as a material inducement to employment in accordance with Nasdaq Listing Rule 5635(c)(4) and are subject to the terms and conditions of a stock option agreement covering the grant and Dynavax' 2021 Inducement Award Plan, which was adopted January 9, 2021 and provides for the granting of stock options to new employees.

    About Dynavax

    Dynavax is a commercial stage biopharmaceutical company developing and commercializing novel vaccines. The Company's first commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], is approved in the U.S. and the European Union for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. Dynavax is also advancing CpG 1018 adjuvant as a premier vaccine adjuvant through research collaborations and partnerships. Current collaborations are focused on adjuvanted vaccines for COVID-19, pertussis and universal influenza. For more information, visit www.dynavax.com and follow the company on LinkedIn.

    Dynavax Contacts:

    Nicole Arndt, Senior Manager, Investor Relations

     

    510-665-7264

    Derek Cole, President

    Investor Relations Advisory Solutions

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/dynavax-reports-inducement-grants-under-nasdaq-listing-rule-5635c4-301324808.html

    SOURCE Dynavax Technologies

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  5. CHENGDU, China, and EMERYVILLE, Calif., June 30, 2021 /PRNewswire/ -- Clover Biopharmaceuticals (Clover), a global clinical-stage biotechnology company developing novel vaccines and biologic therapeutic candidates to address the world's most life-threatening diseases and public health threats, and Dynavax Technologies Corporation ((Dynavax, NASDAQ:DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, today announced the execution of a commercial supply agreement of Dynavax's CpG 1018 advanced adjuvant, for use in Clover's protein-based COVID-19 vaccine candidate, SCB-2019 (CpG 1018/Alum). The commercial supply agreement extends to the end of 2022.The agreement includes doses for delivery in 2021, which…

    CHENGDU, China, and EMERYVILLE, Calif., June 30, 2021 /PRNewswire/ -- Clover Biopharmaceuticals (Clover), a global clinical-stage biotechnology company developing novel vaccines and biologic therapeutic candidates to address the world's most life-threatening diseases and public health threats, and Dynavax Technologies Corporation ((Dynavax, NASDAQ:DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, today announced the execution of a commercial supply agreement of Dynavax's CpG 1018 advanced adjuvant, for use in Clover's protein-based COVID-19 vaccine candidate, SCB-2019 (CpG 1018/Alum). The commercial supply agreement extends to the end of 2022.The agreement includes doses for delivery in 2021, which were manufactured under the previously announced funding agreement between Coalition for Epidemic Preparedness Innovations (CEPI) and Dynavax.

    Clover separately announced today an advanced purchase agreement with Gavi, the Vaccine Alliance, for supplying up to 414 million doses of SCB-2019 (CpG 1018/Alum) through 2022 for the COVAX Facility. The COVAX Facility is a global risk-sharing mechanism for pooled procurement and equitable distribution of COVID-19 vaccines, regardless of income level. Pending conditional regulatory approvals, Clover expects to commence product launch of SCB-2019 (CpG 1018/Alum) by the end of 2021, supplying the COVAX Facility and countries directly via government procurement and/or bilateral supply agreements.

    "Throughout the development of our COVID-19 vaccine candidate, Dynavax has been an invaluable partner with a shared goal of maximizing our collective impacts in fighting the unprecedented COVID-19 pandemic. We look forward to the continued partnership as we accelerate large-scale production of SCB-2019 (CpG 1018/Alum) for potential commercial supply to communities in need around the globe," stated Joshua Liang, Chief Executive Officer of Clover Biopharmaceuticals.

    Ryan Spencer, Chief Executive Officer of Dynavax commented, "Dynavax is excited for the opportunity to expand our partnership with Clover into an important commercial supply agreement to provide significant amounts of CpG 1018 for combatting the ongoing pandemic. We are proud to support the ongoing development and the potential near-term commercialization of SCB-2019 (CpG 1018/Alum)."

    About SCB-2019 (CpG 1018/Alum)

    SCB-2019 (CpG 1018/Alum), Clover's COVID-19 vaccine candidate, is anticipated to be one of the first commercialized protein-based COVID-19 vaccines globally through the COVAX Facility. Employing the Trimer-Tag© technology platform, Clover developed the SCB-2019 antigen, a stabilized trimeric form of the S-protein (S-Trimer) based on the original strain of the SARS-CoV-2 virus. Clover's COVID-19 vaccine candidate is the combination of SCB-2019 and two adjuvants, Dynavax's CpG 1018 advanced adjuvant and aluminum hydroxide (alum).

    Clover is currently advancing SPECTRA, a global pivotal Phase 2/3 clinical trial evaluating the efficacy, safety, and immunogenicity of SCB-2019 (CpG 1018/Alum), and expects interim data for vaccine efficacy around the middle of 2021. Pending positive interim data, Clover plans to submit conditional regulatory approval applications to the EMA, the NMPA and the WHO in the second half of 2021, and plans to commence product launch by the end of 2021.

    About Clover Biopharmaceuticals

    We are a global clinical-stage biotechnology company committed to developing novel vaccines and biologic therapeutic candidates to address the world's most life-threatening diseases and public health threats. The Trimer-Tag© technology is a product development platform for the creation of novel vaccines and biologic therapies. We have leveraged our Trimer-Tag© technology platform to become a COVID-19 vaccine developer and potentially one of the first companies to commercialize a protein-based COVID-19 vaccine globally through the COVAX Facility. For more information, please visit our website:  www.cloverbiopharma.com  and follow the company on LinkedIn.

    Clover Forward-looking Statements

    This press release contains certain forward-looking statements and information relating to us and our subsidiaries that are based on the beliefs of our management as well as assumptions made by and information currently available to our management. When used in this [document], the words "aim," "anticipate," "believe," "could," "estimate," "expect," "going forward," "intend," "may," "might," "ought to," "plan," "potential," "predict," "project," "seek," "should," "will," "would" and the negative of these words and other similar expressions, as they relate to us or our management, are intended to identify forward-looking statements. 

    Forward-looking statements are based on our current expectations and assumptions regarding our business, the economy and other future conditions. We give no assurance that these expectations and assumptions will prove to have been correct. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Our results may differ materially from those contemplated by the forward-looking statements. They are neither statements of historical fact nor guarantees or assurances of future performance. We caution you therefore against placing undue reliance on any of these forward-looking statements. Any forward-looking statement made by us in this document speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. Subject to the requirements of applicable laws, rules and regulations, we undertake no obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. All forward-looking statements contained in this document are qualified by reference to this cautionary statement.

    About CpG 1018

    CpG 1018 is the adjuvant used in HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], an adult hepatitis B vaccine approved by the U.S. Food and Drug Administration (FDA) and the European Commission. Dynavax developed CpG 1018 to provide an increased vaccine immune response, which has been demonstrated in HEPLISAV-B. CpG 1018 provides a well-developed technology and a significant safety database, potentially accelerating the development and large-scale manufacturing of a COVID-19 vaccine.

    About Dynavax

    Dynavax is a commercial stage biopharmaceutical company developing and commercializing novel vaccines. The Company's first commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], is approved in the U.S. and Europe for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. Dynavax is also advancing CpG 1018 as a premier vaccine adjuvant through research collaborations and partnerships. Current collaborations are focused on adjuvanted vaccines for COVID-19, pertussis and universal influenza. For more information, visit www.dynavax.com and follow the company on LinkedIn.

    Dynavax Forward-Looking Statements

    This press release contains "forward-looking" statements, including statements regarding the potential to develop a COVID-19 vaccine containing CpG 1018, the timing and amount of potential sales to Clover and the timing of regulatory approvals. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in vaccine research and development, including the timing of initiating clinical trials and completing development, whether CpG 1018 plus aluminum combined with Clover's protein subunit vaccine will prove to be beneficial in clinical trials, whether and when the vaccine will be approved for use, whether CEPI will continue to fund the Clover program through development and licensure, whether or how much Gavi or other commercial customers purchase from Clover, and whether sufficient quantities of CpG 1018 will be able to be manufactured, as well as other risks detailed in the "Risk Factors" section of our Annual Report on Form 10-K for the fiscal year ended December 31, 2020, as well as discussions of potential risks, uncertainties and other important factors in our other filings with the U.S. Securities and Exchange Commission. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Information on Dynavax's website at www.dynavax.com is not incorporated by reference in our current periodic reports with the SEC.

    Clover Biopharmaceuticals:

    Cindy Min

    Vice President, Public Affairs





    Naomi Eichenbaum

    Vice President, Investor Relations





    Dynavax Contacts:

    Nicole Arndt

    Senior Manager Investor Relations



    510-665-7264



    Derek Cole

    President, Investor Relations Advisory Solutions





    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/clover-and-dynavax-announce-commercial-supply-agreement-of-dynavaxs-cpg-1018-adjuvant-for-clovers-covid-19-vaccine-candidate-301322674.html

    SOURCE Dynavax Technologies

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