1. EMERYVILLE, Calif., Sept. 22, 2021 /PRNewswire/ -- Dynavax Technologies Corporation (NASDAQ:DVAX), a biopharmaceutical company focused on developing and commercializing vaccines, today announced that Clover Biopharmaceuticals (Clover) reported positive data for their protein-based COVID-19 vaccine candidate, SCB-2019 (CpG 1018/Alum) adjuvanted with Dynavax's CpG 1018 adjuvant, which achieved the primary and secondary efficacy endpoints in SPECTRA, a global pivotal Phase 2/3 clinical trial that enrolled over 30,000 participants. Vaccine efficacy was successfully demonstrated in an environment where 100% of SARS-CoV-2 strains observed in the efficacy analysis were variants.

    EMERYVILLE, Calif., Sept. 22, 2021 /PRNewswire/ -- Dynavax Technologies Corporation (NASDAQ:DVAX), a biopharmaceutical company focused on developing and commercializing vaccines, today announced that Clover Biopharmaceuticals (Clover) reported positive data for their protein-based COVID-19 vaccine candidate, SCB-2019 (CpG 1018/Alum) adjuvanted with Dynavax's CpG 1018 adjuvant, which achieved the primary and secondary efficacy endpoints in SPECTRA, a global pivotal Phase 2/3 clinical trial that enrolled over 30,000 participants. Vaccine efficacy was successfully demonstrated in an environment where 100% of SARS-CoV-2 strains observed in the efficacy analysis were variants.

    Clover reported the following data from their Phase 2/3 SPECTRA trial in a press release issued September 22, 2021. SCB-2019 (CpG 1018/Alum) demonstrated 100% efficacy against severe COVID-19 and hospitalizations and 84% efficacy against moderate-to-severe COVID-19 caused by any strain of SARS-CoV-2. SCB-2019 (CpG 1018/Alum) demonstrated 79% overall efficacy against COVID-19 of any severity caused by the globally dominant Delta variant. Efficacy was 92% against the Gamma variant and 59% against the Mu variant, and collectively these three strains (Delta, Gamma and Mu) comprised 73% of all strains identified in the study. Overall efficacy was 67% against COVID-19 of any severity caused by any strain in the study, successfully meeting the primary endpoint of the trial. Clover's vaccine candidate is one of the first to demonstrate significant efficacy against Delta in a double-blind, randomized clinical trial.  

    SCB-2019 (CpG 1018/Alum) demonstrated a favorable safety profile. Severe and serious adverse events (AEs) were infrequent and balanced between vaccine and placebo groups. Solicited local AEs were mostly mild and transient cases of pain at the injection site and decreased in frequency after the second dose. Importantly, the frequency of solicited systemic AEs monitored (fatigue, headache, muscle pain, joint pain, loss of appetite, nausea, chills, fever), were similar between vaccine and placebo groups.

    Ryan Spencer, Chief Executive Officer of Dynavax commented, "We are very pleased with the reported efficacy results demonstrated in the SPECTRA trial, especially considering that all cases were from variants. In addition to the positive efficacy results, the remarkable tolerability profile of the Clover vaccine adjuvanted with CpG 1018 could be a useful tool in overcoming vaccine hesitancy for more reactogenic platforms and for booster doses in the future. We believe these trial results demonstrate the value of our CpG 1018 adjuvant as part of the response to this pandemic and as a platform for the development of new and improved vaccines.  We look forward to continuing to support Clover and the development of their COVID-19 vaccine, making it available to those in need around the world."

    Additional data from the SPECTRA final analysis have been made available in a presentation that can be found on Clover's corporate website.  Clover intends to submit the trial results for peer-reviewed publication.

    Clover plans to submit conditional approval applications to global regulatory authorities including China's National Medical Products Administration, the European Medicines Agency, and the World Health Organization (WHO) in the fourth quarter of 2021. Contingent upon receiving a conditional approval, Clover plans to commence initial product launch of SCB-2019 (CpG 1018/Alum) potentially by the end of 2021. Subject to receiving Emergency Use Listing (EUL) from the WHO, Clover plans to supply up to 414 million doses of its COVID-19 vaccine candidate globally through the COVAX Facility as previously announced.

    SPECTRA (Study Evaluating Protective-Efficacy and Safety of Clover's Trimeric Recombinant Protein-based and Adjuvanted COVID-19 Vaccine) is Clover's double-blind, randomized, placebo-controlled study of SCB-2019 (CpG 1018/Alum) administered in a two-dose regimen, 21 days apart. Global enrollment surpassed 30,000 participants aged 18 years or older in five countries across four continents resulting in one of the most ethnically diverse COVID-19 clinical trials conducted to date, including 49% of participants from Asia, 45% from Latin America and the remainder from Europe and Africa.

    About CpG 1018 Adjuvant

    CpG 1018 is the adjuvant used in HEPLISAV-B. 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 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 adjuvant as an advanced 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.

    Forward-Looking Statements

    This press release contains "forward-looking statements," including statements regarding expected results for an ongoing contractual relationship and expected business results. Forward-looking statements can generally be identified by the use of words such as "anticipate," "believe," "continue," "could," "estimate," "expect," "forecast," "intend," "will," "may," "plan," "project," "potential," "seek," "should," "think," "will," "would" and similar expressions, or they may use future dates. Forward-looking statements in this document include, without limitation, statements regarding our expectations as to outcomes relating to ongoing collaborations and contractual relationships, the timing of regulatory approvals and product launch, our ability to reallocate certain quantities of CpG 1018 to different programs and our expected financial performance. These forward-looking statements are subject to assumptions, risks and uncertainties that may change at any time, and readers are therefore cautioned that actual results could differ materially from those expressed in any forward-looking statements. Factors that could cause actual results to differ include, among other things: risks and uncertainties associated with  actual results of clinical trials  conducted by Clover as well as our other collaborators; whether and when Clover's vaccine will be approved for use and launched; whether sufficient quantities of CpG 1018 will be able to be manufactured; whether or how much Gavi or other commercial customers purchase from Clover; and other risks and uncertainties discussed in the Company's filings with the SEC, including the "Risk Factors" sections of the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2021. The Company undertakes no obligation to update any forward-looking statements as a result of new information, future developments or otherwise, except as expressly required by law. All forward-looking statements in this document are qualified in their entirety by this cautionary statement.

    Contacts:

    Nicole Arndt, Investor Relations

    narndt@dynavax.com 

    510-665-7264

    Derek Cole, President

    Investor Relations Advisory Solutions

    derek.cole@IRadvisory.com 

     

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    SOURCE Dynavax Technologies

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    • Trial enrolled over 30,000 adult & elderly participants across 4 continents; 100% of SARS-CoV-2 strains observed in efficacy analysis were variants (Delta was predominant strain)
    • Primary and secondary efficacy endpoints were successfully met
    • 100% efficacy against severe COVID-19 & hospitalization and 84% efficacy against moderate-to-severe COVID-19 caused by any strain of SARS-CoV-2 in SPECTRA
    • 79% efficacy against COVID-19 of any severity caused by the globally dominant Delta variant
    • Favorable safety profile; no significant differences in systemic adverse events or severe/serious adverse events compared to placebo
    • First COVID-19 vaccine to demonstrate significantly reduced risk of COVID-19 disease in previously infected individuals
    • Additional
    • Trial enrolled over 30,000 adult & elderly participants across 4 continents; 100% of SARS-CoV-2 strains observed in efficacy analysis were variants (Delta was predominant strain)
    • Primary and secondary efficacy endpoints were successfully met
    • 100% efficacy against severe COVID-19 & hospitalization and 84% efficacy against moderate-to-severe COVID-19 caused by any strain of SARS-CoV-2 in SPECTRA
    • 79% efficacy against COVID-19 of any severity caused by the globally dominant Delta variant
    • Favorable safety profile; no significant differences in systemic adverse events or severe/serious adverse events compared to placebo
    • First COVID-19 vaccine to demonstrate significantly reduced risk of COVID-19 disease in previously infected individuals
    • Additional SPECTRA results are available on Clover's corporate website

    CHENGDU, China and OSLO, Norway, Sept. 22, 2021 /PRNewswire/ -- Clover Biopharmaceuticals, Ltd. (Clover), a global clinical-stage biotechnology company developing novel vaccines and biologic therapeutic candidates, and CEPI, the Coalition for Epidemic Preparedness Innovations, today announced that Clover's adjuvanted protein-based COVID-19 vaccine candidate, SCB-2019 (CpG 1018/Alum) achieved the primary efficacy endpoint and secondary efficacy endpoints in SPECTRA, a global pivotal Phase 2/3 clinical trial. Vaccine efficacy was successfully demonstrated in an environment where 100% of SARS-CoV-2 strains observed in the efficacy analysis were variants. SCB-2019 (CpG 1018/Alum) demonstrated 79% overall efficacy against COVID-19 of any severity caused by the globally dominant Delta variant, which currently comprises over 90% of all cases worldwide. Efficacy was 92% against the Gamma variant and 59% against the Mu variant, and collectively these three strains (Delta, Gamma and Mu) comprised 73% of all strains identified in the study. Overall efficacy was 67% against COVID-19 of any severity caused by any strain in the study, successfully meeting the primary endpoint of the trial.Clover's vaccine candidate is one of the first to demonstrate significant efficacy against Delta in a double-blind, randomized clinical trial.

    Clover's Manufacturing Facility in Changxing, China

    The SPECTRA clinical trial enrolled over 30,000 adult and elderly (≥18 years of age) participants at 31 sites in five countries (Philippines, Brazil, Colombia, South Africa, Belgium) across four continents, resulting in one of the most diverse COVID-19 vaccine clinical trials conducted to-date. SPECTRA was funded by CEPI as part of a up to $328 million investment to develop and enable equitable access to SCB-2019 (CpG 1018/Alum).

    "SPECTRA enrolled participants during a time when the world encountered the rapid spread of increasingly transmissible SARS-CoV-2 variants and a takeover by Delta. Amidst this backdrop, we are pleased that SCB-2019 (CpG 1018/Alum) has successfully demonstrated efficacy against the globally dominant Delta strain and other concerning variants." stated Joshua Liang, Chief Executive Officer of Clover Biopharmaceuticals, Ltd. "Based on our pioneering data, we believe that SCB-2019 (CpG 1018/Alum) could be utilized as an important tool to combat this pandemic, and we remain dedicated to expediting the availability and equitable access of our COVID-19 vaccine candidate for global distribution."

    Clover's Manufacturing Facility in Changxing, China

    Dr. Ralf Clemens, Chairman of Clover's Scientific Advisory Board commented: "SCB-2019 (CpG 1018/Alum) successfully demonstrated significant vaccine efficacy against COVID-19 of any severity caused by Delta and other Variants of Concern and Interest. The safety profile of this adjuvanted protein-based vaccine candidate was favorable, with no significant differences in systemic adverse events or severe/serious adverse events compared to placebo. It is also the first COVID-19 vaccine candidate in the world to demonstrate in a randomized trial significantly reduced risk of COVID-19 disease in previously infected individuals, a growing and increasingly important population as SARS-CoV-2 continues to spread worldwide. We sincerely thank all study participants, trial staff and the national regulatory authorities and ethical review committees of the countries involved that made this landmark study possible."

    Dr. Richard Hatchett, CEO of CEPI added, "This very encouraging data demonstrates the favorable safety profile of Clover's vaccine and its efficacy against multiple variants of SARS-CoV-2 – including the predominant Delta variant – so it will be a crucial addition to our weaponry in the fight against COVID-19. CEPI's significant early investments have accelerated the clinical development and manufacturing of the vaccine and will enable equitable access to hundreds of millions of doses through COVAX. As a result of CEPI's partnership with Clover, this vaccine is poised to play a significant role in protecting those most at risk from COVID-19, wherever they are in the world." 

    SPECTRA is a 1:1 randomized, double-blinded, placebo-controlled Phase 2/3 trial to evaluate the efficacy, safety and immunogenicity of SCB-2019 (CpG 1018/Alum) compared to placebo. 30,128 adult and elderly subjects (≥18 years of age) were randomized and dosed with SCB-2019 (CpG 1018/Alum) or placebo administered in a two-dose regimen (21 days apart).

    Efficacy Results: SPECTRA Meets Primary and Secondary Endpoints

    Accrual of COVID-19 disease cases for the final efficacy analysis occurred from April 28 through August 10, 2021 – a time when the Delta variant of SARS-CoV-2 became the dominant strain globally. A total of 207 cases of PCR-confirmed symptomatic COVID-19 of any severity occurring ≥14 days after the second dose in participants without evidence of prior SARS-CoV-2 infection ("SARS-CoV-2 naïve") were adjudicated by an independent Endpoint Adjudication Committee (EAC) and included in the primary efficacy analysis.

    Strain sequencing data are available for 146 of the 207 COVID-19 cases. 100% of these sequenced strains were variants, and no cases of the original SARS-CoV-2 strain were observed. The three most prevalent strains in the study comprising 73% of all sequenced cases were Delta which was predominant and accounted for 38% (56 cases) of all sequenced strains, Mu (37 cases) and Gamma (13 cases).

    Severe COVID-19, Hospitalizations, Deaths: There were no cases of hospitalization due to COVID-19 and no cases of severe COVID-19 disease caused by any strain in the vaccine group, resulting in 100% efficacy (95% CI: 42.7,100) against hospitalization due to COVID-19 and 100% efficacy (97.86% CI: 25.3,100) against severe COVID-19, meeting predefined success criteria in the protocol. All deaths due to COVID-19 (3 cases) occurred in the placebo group (none in the vaccine group).

    Moderate-to-Severe COVID-19: Efficacy against moderate-to-severe COVID-19 disease was 83.7% (97.86% CI: 55.9,95.4) against any strain and 81.7% (95% CI: 35.9,96.6) against Delta.

    COVID-19 of Any Severity: Overall efficacy against COVID-19 disease of any severity caused by any strain was 67.2% (95.72% CI: 54.3,76.8), successfully achieving the primary endpoint. For the 3 most prevalent strains, efficacy was 91.8% (95% CI: 44.9,99.8) against Gamma, 78.7% (95% CI: 57.3,90.4) against Delta and 58.6% (95% CI: 13.3,81.5) against Mu. SCB-2019 (CpG 1018/Alum) is the first vaccine candidate to demonstrate significant efficacy against all three of these variants. Differences in vaccine efficacy across variant strains are driven by the unique mutation profiles of each variant, which can make some strains more transmissible and/or virulent than others and may enable immune escape.

    High-Risk Populations: While enrollment of elderly participants was limited due to ongoing vaccination campaigns in countries where recruitment occurred in SPECTRA, all five cases of COVID-19 in participants 65 years of age or older occurred in the placebo group (none in the vaccine group). 18% of participants randomized in SPECTRA had co-morbidities for COVID-19 (i.e. participants at high risk for severe COVID-19), and no differences in vaccine efficacy were observed in participants with or without co-morbidities for COVID-19.

    Efficacy Results: Vaccine Significantly Reduces Risk of COVID-19 Disease in Previously Infected Individuals

    As SARS-CoV-2 continues to spread across the world, evaluating the efficacy and safety of COVID-19 vaccines in previously infected populations has become increasingly important.

    49% of all participants randomized in SPECTRA were seropositive (evidence of prior SARS-CoV-2 infection) at baseline prior to enrollment. The baseline seropositivity rate varied by country: 65% in the Philippines, 46% in Colombia, 46% in South Africa, 30% in Brazil and 13% in Belgium. 41 cases of PCR-confirmed symptomatic COVID-19 reinfections of any severity were accrued in baseline seropositive participants, of which 17 cases were caused by Delta.

    Vaccination with SCB-2019 (CpG 1018/Alum) reduced the risk of symptomatic COVID-19 reinfection caused by any strain by 64.2% (95% CI: 26.5,83.8) in previously infected participants. The risk of symptomatic COVID-19 reinfection caused by Delta was reduced by 79.1% (95% CI: 25.1,96.1).

    SCB-2019 (CpG 1018/Alum) is the first COVID-19 vaccine candidate to successfully demonstrate significant incremental protection against COVID-19 in previously infected individuals in a randomized clinical trial.

    Safety Results: Favorable Safety Profile and No Significant Difference in Systemic AEs Compared to Placebo

    SCB-2019 (CpG 1018/Alum) demonstrated a favorable safety profile. Severe and serious adverse events (AEs) were infrequent and balanced between vaccine and placebo groups. Solicited local AEs were mostly mild and transient cases of pain at the injection site and decreased in frequency after the second dose. For all solicited systemic AEs monitored (fatigue, headache, muscle pain, joint pain, loss of appetite, nausea, chills, fever), no significant differences were observed between vaccine and placebo groups.

    The independent Data & Safety Monitoring Board (DSMB) has reviewed the safety data on an ongoing basis, and no safety concerns have been identified warranting a pause or modification to the trial conduct to-date.

    Additional data from the SPECTRA final analysis have been made available in a presentation that can be found on Clover's corporate website. The results will also be submitted for peer-review publication.

    Clover plans to make submissions for conditional approval applications to global regulatory authorities (including China NMPA, EMA and WHO) in the fourth quarter of 2021. Upon receiving a conditional approval, Clover plans to commence initial product launch of SCB-2019 (CpG 1018/Alum) potentially by the end of 2021. Subject to receiving Emergency Use Listing (EUL) from the WHO, Clover plans to supply up to 414 million doses of its COVID-19 vaccine candidate globally through the COVAX Facility as previously announced.

    About SPECTRA

    SPECTRA (Study Evaluating Protective-Efficacy and Safety of Clover's Trimeric Recombinant Protein-based and Adjuvanted COVID-19 Vaccine) is a 1:1 randomized, placebo-controlled, double-blinded study to evaluate the efficacy, safety and immunogenicity of SCB-2019 (CpG 1018/Alum) compared to placebo in over 30,000 participants 18 years of age and older in 31 study sites in the Philippines, Brazil, Colombia, South Africa and Belgium. Participants received SCB-2019 (CpG 1018/Alum) administered in a two-dose regimen, 21 days apart, or placebo. Efficacy and safety result are reviewed by the independent Data and Safety Monitoring Board (DSMB), and all COVID-19 cases included in the efficacy analysis were adjudicated by an independent Endpoint Adjudication Committee (EAC).  The SPECTRA study is sponsored by Clover and is funded by CEPI.

    Study Endpoints

    The primary endpoint for SPECTRA was prevention of PCR-confirmed symptomatic COVID-19 of any severity (mild, moderate or severe) with onset ≥14 days after the second dose in adult and elderly participants (≥18 years of age) without evidence of prior SARS-CoV-2 infection (seronegative) at baseline. The statistical success criterion was lower bound 95.72% CI >30%.

    Predefined key secondary endpoints with available results included prevention of PCR-confirmed moderate-to-severe COVID-19 and severe COVID-19 with onset ≥14 days after the second dose in adult and elderly participants (≥18 years of age) without evidence of prior SARS-CoV-2 infection (seronegative) at baseline. The statistical success criterion was lower bound 97.86% CI >0%.

    About SCB-2019 (CpG 1018/Alum)

    SCB-2019 (CpG 1018/Alum), our COVID-19 vaccine candidate, is anticipated to potentially be one of the first protein-based COVID-19 vaccines commercialized 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 (referred to as S-Trimer™) based on the original strain of the SARS-CoV-2 virus. We created our COVID-19 vaccine candidate by combining SCB-2019 with Dynavax's (NASDAQ:DVAX) CpG 1018 advanced adjuvant and aluminum hydroxide (alum).

    About Clover Biopharmaceuticals

    Clover Biopharmaceuticals is a global clinical-stage biotechnology company committed to developing novel vaccines and biologic therapeutic candidates. The Trimer-Tag™ technology platform is a product development platform for the creation of novel vaccines and biologic therapies. We have leveraged the Trimer-Tag™ technology platform to become a COVID-19 vaccine developer and created SCB-2019 (CpG 1018/Alum) to address the COVID-19 pandemic caused by SARS-CoV-2.

    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 participant 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. Participant 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 CEPI

    CEPI is an innovative partnership between public, private, philanthropic, and civil organisations, launched at Davos in 2017, to develop vaccines against future epidemics. Prior to COVID-19 CEPI's work focused on developing vaccines against Ebola virus, Lassa virus, Middle East Respiratory Syndrome coronavirus, Nipah virus, Rift Valley Fever virus and Chikungunya virus - it has over 20 vaccine candidates against these pathogens in development. CEPI has also invested in new platform technologies for rapid vaccine development against unknown pathogens (Disease X).

    During the current pandemic, CEPI initiated multiple programmes to develop vaccines against SARS-CoV-2 and its variants with a focus on speed, scale, and access. These programmes leverage the rapid response platforms previously developed by CEPI's partners prior to the emergence of COVID-19 as well as new collaborations. The aim is to advance clinical development of a diverse portfolio of safe and effective COVID-19 candidates and to enable fair allocation to these vaccines worldwide through COVAX.

    CEPI's 5-year plan lays out a $3.5 billion roadmap to compress vaccine development timelines to 100 days, develop a universal vaccine against COVID-19 and other Betacoronaviruses, and create a "library" of vaccine candidates for use against known and unknown pathogens. The plan is available at endpandemics.cepi.net.

    Follow our news page for the latest updates. Follow us on Twitter and LinkedIn.

    About COVAX

    COVAX, the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator, is co-convened by CEPI, Gavi, the Vaccine Alliance, and the World Health Organization (WHO) – working in partnership with UNICEF as key implementing partner, developed and developing country vaccine manufacturers, the World Bank, and others. It is the only global initiative that is working with governments and manufacturers to ensure COVID-19 vaccines are available worldwide to both higher-income and lower-income countries.

    Clover Biopharmaceuticals:

    Cindy Min

    SVP, Public Affairs

    media@cloverbiopharma.com

    Naomi Eichenbaum

    VP, Investor Relations

    investors@cloverbiopharma.com  

    CEPI

    Email: press@cepi.net

    Phone: +44 7387 055214

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    SOURCE Clover Biopharmaceuticals

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  2. Saint-Herblain (France), September 14, 2021Valneva SE, a specialty vaccine company, today announced that it has completed recruitment of the initial cohort of elderly participants in Valneva's Phase 3 trial, VLA2001-304, of its inactivated COVID-19 vaccine candidate, VLA2001.

    300 volunteers aged 56 years and older have been recruited in New Zealand into the VLA2001-304 trial with the objective to generate further safety and immunogenicity data for this age group. The cohort size has been increased to 300, from 150, in consultation with the European Medicines Agency ("EMA"). Topline data from this cohort will read out in early 2022, and it is expected that the data will support additional regulatory submissions.

    Juan Carlos Jaramillo, M.D.,

    Saint-Herblain (France), September 14, 2021Valneva SE, a specialty vaccine company, today announced that it has completed recruitment of the initial cohort of elderly participants in Valneva's Phase 3 trial, VLA2001-304, of its inactivated COVID-19 vaccine candidate, VLA2001.

    300 volunteers aged 56 years and older have been recruited in New Zealand into the VLA2001-304 trial with the objective to generate further safety and immunogenicity data for this age group. The cohort size has been increased to 300, from 150, in consultation with the European Medicines Agency ("EMA"). Topline data from this cohort will read out in early 2022, and it is expected that the data will support additional regulatory submissions.

    Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented, "We initiated this trial approximately a month ago, so we are extremely pleased to achieve this important milestone in such a short period of time. We believe that our differentiated vaccine candidate can make a major contribution to the ongoing fight against the COVID-19 pandemic."

    VLA2001 is currently the only inactivated vaccine candidate in clinical trials against COVID-19 in Europe. In parallel to the VLA2001-304 trial in New Zealand, VLA2001 is currently being studied in the United Kingdom (UK) in a pivotal Phase 3 trial, "Cov-Compare" (VLA2001-301), for which top-line results are currently expected early in the fourth quarter 2021. Valneva has commenced rolling submission for conditional approval with the UK's Medicines and Healthcare products Regulatory Agency (MHRA).

    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. VLA2001's manufacturing process, which has already been upscaled to final industrial scale, includes chemical inactivation to preserve the native structure of the S-protein. VLA2001 is expected to conform with standard cold chain requirements (2 to 8 degrees Celsius).

    About VLA2001-304

    Trial VLA2001-304 is expected to enroll two cohorts. Cohort 1 includes 300 volunteers aged 56 years and older in an open-label manner in order to generate safety and immunogenicity data for VLA2001 in this age group. Cohort 2 of the trial is expected to include approximately 600 volunteers aged 12 years and older in order to compare immunogenicity data of Valneva's original COVID-19 vaccine candidate, VLA2001, to an additional COVID-19 vaccine candidate, VLA2101, based on a variant strain to be confirmed. In both cohorts, vaccinations will be administered in a two-dose immunization schedule 28 days apart. The trial will be conducted at approximately 10 trial sites in New Zealand. ClinicalTrials.gov Identifier: NCT04956224

    About Valneva SE

    Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. The Company takes a highly specialized and targeted approach to vaccine development, beginning with the identification of deadly and debilitating infectious diseases that lack a prophylactic vaccine solution and for which there are limited therapeutic treatment options. It then applies its deep understanding of vaccine science, including its expertise across multiple vaccine modalities, as well as its established vaccine development capabilities, to develop prophylactic vaccines to address these diseases. The Company has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, COVID-19 and the chikungunya virus.

    Media & Investor Contacts

    Laëtitia Bachelot-Fontaine

    VP Global Communications & European Investor Relations

    M +33 (0)6 4516 7099

    laetitia.bachelot-fontaine@valneva.com        
     



    Joshua Drumm, Ph.D.

    VP Global Investor Relations

    M +001 917 815 4520

    joshua.drumm@valneva.com

    Forward-Looking Statements

    This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to the progress, timing, design, data read-outs, anticipated results and completion of clinical trials for VLA2001. 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 indicative of future results. 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 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, the ability to obtain or maintain patent or other proprietary intellectual property protection and the impact of the COVID-19 pandemic. 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 this press release as of the date hereof and disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

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  3. EMERYVILLE, Calif., Sept. 13, 2021 /PRNewswire/ -- Dynavax Technologies Corporation (NASDAQ:DVAX), a biopharmaceutical company focused on developing and commercializing vaccines, today announced that Valneva SE has received a termination notice from the United Kingdom Government in relation to Valneva's supply agreement for its COVID-19 vaccine candidate, VLA2001. Valneva stated that they intend to continue clinical development of VLA2001 and the pivotal Phase 3 trial for VLA2001, Cov-Compare, remains ongoing at Public Health England.  Based on its portfolio of COVID-19 collaborations Dynavax reiterates its belief that its CpG 1018 supply contracts continue to represent an approximately $300 - $400 million dollars aggregate revenue opportunity…

    EMERYVILLE, Calif., Sept. 13, 2021 /PRNewswire/ -- Dynavax Technologies Corporation (NASDAQ:DVAX), a biopharmaceutical company focused on developing and commercializing vaccines, today announced that Valneva SE has received a termination notice from the United Kingdom Government in relation to Valneva's supply agreement for its COVID-19 vaccine candidate, VLA2001. Valneva stated that they intend to continue clinical development of VLA2001 and the pivotal Phase 3 trial for VLA2001, Cov-Compare, remains ongoing at Public Health England.  Based on its portfolio of COVID-19 collaborations Dynavax reiterates its belief that its CpG 1018 supply contracts continue to represent an approximately $300 - $400 million dollars aggregate revenue opportunity in 2021.

    Valneva recently announced that its Phase 3 results for VLA2001 are expected to be available early in the fourth quarter of 2021 and these results are expected to form part of Valneva's planned rolling submission for conditional approval of VLA2001 with the UK's Medicines and Healthcare products Regulatory Agency ("MHRA"). Subject to these data and MHRA approval, Valneva has indicated that it believes initial approval for VLA2001 could be granted in late 2021.

    Ryan Spencer, Chief Executive Officer of Dynavax commented, "Valneva is one of a number of companies developing COVID vaccines using CpG 1018 as an adjuvant and we continue to look forward to the upcoming Phase 3 clinical trial results for Valneva's inactivated COVID-19 vaccine adjuvanted with CpG 1018. The first COVID-19 vaccine that uses CpG 1018 was recently authorized by regulatory authorities and we look forward to the potential authorization of additional Dynavax-enabled COVID-19 vaccines in the months and quarters ahead."

    Under Dynavax's existing supply agreement for CpG 1018, purchase orders submitted by Valneva are cancellable if the UK Government reduces or terminates its order for VLA2001, in which case, Valneva would not be obligated to pay Dynavax the final portion of an outstanding purchase order. Valneva has not yet cancelled any outstanding purchase orders for CpG 1018. Dynavax has the right to retain any portion of the purchase price for CpG 1018 made in advance by Valneva as well as any CpG 1018 manufactured but not yet delivered.

    Dynavax intends to continue to monitor the situation but can make no assurances regarding the outstanding orders. If Valneva's existing purchase orders are cancelled, Dynavax will work to reallocate CpG 1018 inventory to its other COVID-19 collaborators. Dynavax's revenue opportunity associated with its CpG 1018 commercial supply agreements in 2021, as well as its corresponding profit margin, are contingent on many variables including continued success of each of Dynavax's partners' programs and timing of product delivery. 

    About CpG 1018 Adjuvant

    CpG 1018 is the adjuvant used in HEPLISAV-B. 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 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 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.

    Forward-Looking Statements

    This press release contains "forward-looking statements," including statements regarding expected results for an ongoing contractual relationship and expected business results. Forward-looking statements can generally be identified by the use of words such as "anticipate," "believe," "continue," "could," "estimate," "expect," "forecast," "intend," "will," "may," "plan," "project," "potential," "seek," "should," "think," "will," "would" and similar expressions, or they may use future dates. Forward-looking statements in this document include, without limitation, statements regarding our expectations as to outcomes relating to ongoing collaborations and contractual relationships, our ability to reallocate certain quantities of CpG 1018 to different programs and our expected financial performance. These forward-looking statements are subject to assumptions, risks and uncertainties that may change at any time, and readers are therefore cautioned that actual results could differ materially from those expressed in any forward-looking statements. Factors that could cause actual results to differ include, among other things: risks and uncertainties associated with Valneva's relationship with the UK Government, results of clinical trials being conducted by Valneva as well as our other collaborators; and other risks and uncertainties discussed in the Company's filings with the SEC, including the "Risk Factors" sections of the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2021. The Company undertakes no obligation to update any forward-looking statements as a result of new information, future developments or otherwise, except as expressly required by law. All forward-looking statements in this document are qualified in their entirety by this cautionary statement.

    Contacts:

    Nicole Arndt, Investor Relations

    narndt@dynavax.com

    510-665-7264

    Derek Cole, President

    Investor Relations Advisory Solutions

    derek.cole@IRadvisory.com

     

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  4. Saint-Herblain (France), September 13, 2021Valneva SE, a specialty vaccine company, today announced that it has received a termination notice from the UK Government ("HMG") in relation to the Supply Agreement for its COVID-19 vaccine candidate, VLA2001. The contract provides HMG with the right to terminate. HMG has alleged that the Company is in breach of its obligations under the Supply Agreement, but the Company strenuously denies this.

    Valneva is continuing its VLA2001 development plan. Testing for the Company's pivotal Phase 3 trial, Cov-Compare, is ongoing at Public Health England ("PHE"). Valneva recently announced that its Phase 3 results are expected to be available early in the fourth quarter and that these results will form part…

    Saint-Herblain (France), September 13, 2021Valneva SE, a specialty vaccine company, today announced that it has received a termination notice from the UK Government ("HMG") in relation to the Supply Agreement for its COVID-19 vaccine candidate, VLA2001. The contract provides HMG with the right to terminate. HMG has alleged that the Company is in breach of its obligations under the Supply Agreement, but the Company strenuously denies this.

    Valneva is continuing its VLA2001 development plan. Testing for the Company's pivotal Phase 3 trial, Cov-Compare, is ongoing at Public Health England ("PHE"). Valneva recently announced that its Phase 3 results are expected to be available early in the fourth quarter and that these results will form part of its rolling submission for conditional approval of VLA2001 with the UK's Medicines and Healthcare products Regulatory Agency ("MHRA"). Subject to these data and MHRA approval, Valneva believes that initial approval for VLA2001 could be granted in late 2021.

    Valneva has worked tirelessly, and to its best efforts, on the collaboration with HMG including investing significant resources and effort to respond to HMG's requests for variant-derived vaccines. Valneva continues to be committed to the development of VLA2001 and will increase its efforts with other potential customers to ensure that its inactivated vaccine can be used in the fight against the pandemic.

    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. VLA2001's manufacturing process, which has already been upscaled to final industrial scale, includes chemical inactivation to preserve the native structure of the S-protein. VLA2001 is expected to conform with standard cold chain requirements (2 to 8 degrees Celsius).

    About Valneva SE

    Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. The Company takes a highly specialized and targeted approach to vaccine development, beginning with the identification of deadly and debilitating infectious diseases that lack a prophylactic vaccine solution and for which there are limited therapeutic treatment options. It then applies its deep understanding of vaccine science, including its expertise across multiple vaccine modalities, as well as its established vaccine development capabilities, to develop prophylactic vaccines to address these diseases. The Company has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, COVID-19 and the chikungunya virus.

    Media & Investor Contacts

    Laëtitia Bachelot-Fontaine

    VP Global Communications & European Investor Relations

    M +33 (0)6 4516 7099

    laetitia.bachelot-fontaine@valneva.com        
     



    Joshua Drumm, Ph.D.

    VP Global Investor Relations

    M +001 917 815 4520

    joshua.drumm@valneva.com

    Forward-Looking Statements

    This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to the progress, timing, design, data read-outs, anticipated results and completion of clinical trials for VLA2001. 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 indicative of future results. 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 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, the ability to obtain or maintain patent or other proprietary intellectual property protection, the cancellation of existing contracts, including but not limited to the HMG Supply Agreement, and the impact of the COVID-19 pandemic, the occurrence of any of which could substantially harm Valneva's business, financial condition, prospects and results of operations. 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 this press release as of the date hereof and disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

     

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  5. EMERYVILLE, Calif., Sept. 9, 2021 /PRNewswire/ -- Dynavax Technologies Corporation (NASDAQ:DVAX), a biopharmaceutical company focused on developing and commercializing vaccines, today announced that Ryan Spencer, Chief Executive Officer, will present at the H.C. Wainwright 23rd Annual Global Investment Conference being held virtually September 13-15, 2021.

    The on demand presentation will be available, beginning Monday, September 13, 2021 at 7:00 a.m. E.T. and may be accessed through the "Events & Presentations" page on the "Investors" section of the Company's website at http://investors.dynavax.com/events-presentations.

    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 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

    narndt@dynavax.com 

    510-665-7264

    Derek Cole, President

    Investor Relations Advisory Solutions

    derek.cole@IRadvisory.com

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/dynavax-to-present-at-the-hc-wainwright-23rd-annual-global-investment-conference-301372861.html

    SOURCE Dynavax Technologies

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  6. EMERYVILLE, Calif., Sept. 2, 2021 /PRNewswire/ -- Dynavax Technologies Corporation (NASDAQ:DVAX) today reported that it has granted nonstatutory stock options to purchase an aggregate of 224,000 shares of Dynavax common stock as inducements to 8 newly-hired employees in connection with commencement of employment with the Company.

    The stock options were granted on September 1, 2021 at an exercise price of $19.00 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

    narndt@dynavax.com 

    510-665-7264

    Derek Cole, President

    Investor Relations Advisory Solutions

    derek.cole@IRadvisory.com

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/dynavax-reports-inducement-grants-under-nasdaq-listing-rule-5635c4-301368650.html

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  7. TAIPEI, Taiwan and EMERYVILLE, Calif., Aug. 23, 2021 /PRNewswire/ -- Medigen Vaccine Biologics Corporation (MVC) (TPEx: 6547.TWO), a biopharmaceutical company focusing on the development and production of vaccines and biologics, and Dynavax Technologies Corporation (NASDAQ:DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, today announced the rollout of its COVID-19 vaccine, MVC-COV1901. Approximately 600,000 people are anticipated to receive the Medigen vaccine this week.

    Charles Chen, Chief Executive Officer at Medigen commented, "Medigen is honored to be able to serve the people of Taiwan and participate in the global response to this pandemic. We were grateful to have received emergency use authorization from the Taiwan FDA and greatly appreciate the time and effort of both the TFDA staff and the experts that participated in the risk and benefit analysis meeting. It is heartening to see a productive outcome from the dedicated effort from the team at Medigen."

    Ryan Spencer, Chief Executive Officer of Dynavax commented, "We are pleased that Medigen's vaccine is now available for the people of Taiwan. We are very excited for this first, of hopefully multiple, EUAs and approvals for COVID-19 vaccines that include CpG 1018 adjuvant. Considering the limitations of current vaccines and the global vaccine shortage, we believe adjuvanted vaccines can contribute significantly to current vaccination efforts."

    In July, MVC received Taiwan Emergency Use Authorization and approval for inclusion in Taiwan's COVID-19 vaccine immunization program, MVC-COV1901. MVC COVID-19 vaccine is indicated for adults over 20 years old and is administered in two doses 28 days apart for prevention of COVID-19. The Advisory Committee recommended that MVC should submit safety monitoring report monthly during the declared EUA period and should submit a vaccine effectiveness report within one year after obtaining EUA approval.

    About MVC-COV1901

    MVC-COV1901 is a subunit vaccine with recombinant S-2P antigen adjuvanted with CpG 1018 supplied by Dynavax and aluminum hydroxide. The S-2P antigen is a trimeric and prefusion-stable recombinant spike protein developed by the U.S. NIH. MVC has obtained a global technology license for S-2P from the U.S. Vaccine Research Center at National Institutes of Health (NIH). MVC-COV1901 vaccine's Phase 1 and 3,815-participant Phase 2 clinical study data has shown robust safety and promising immunogenicity responses and as a result obtained Taiwan's EUA approval on July 19th, 2021. MVC will continue to collaborate with international partners for phase 3 clinical trial development and assist the global community in its fight against the COVID-19 pandemic. 

    About Medigen Vaccine Biologics Corporation (MVC)

    MVC is a biopharmaceutical company using cell-based technologies to develop novel vaccines and biosimilars. MVC's pipeline includes EV71 vaccine, dengue vaccine, quadrivalent influenza vaccine and COVID-19 vaccine which all have entered late clinical stage. MVC's large-scale production facility is state-of-the-art and adherent to international PIC/s GMP requirements. For more information, visit www.medigenvac.com.

    About CpG 1018 Adjuvant 

    CpG 1018 is the adjuvant used in HEPLISAV-B. Dynavax developed CpG 1018 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.

    MVC's Forward Looking Statements

    This press release contains certain forward-looking statements relating to the business of Medigen Vaccine Biologics Corporation (MVC, TPEx: 6547.TWO) including with respect to the progress, timing and completion of research, development and clinical trials for MVC's COVID 19 vaccine candidate, MVC-COV1901, and the ability to manufacture, market, commercialize and achieve market acceptance thereof. These forward-looking statements are based largely on the current expectations of MVC as applicable, 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, such could be affected by, among other things, uncertainties involved in the development and manufacture of MVC's COVID19 vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, changes in global financial markets and the ability to obtain or maintain patent or other proprietary intellectual property protection. In light of these risks and uncertainties, there can be no assurance that such forward-looking statements will in fact be realized. MVC and is providing the information in this press release as the date hereof, 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.

    Dynavax Forward-Looking Statements

    This press release contains "forward-looking" statements, including statements regarding the potential to develop and manufacture a COVID-19 vaccine containing CpG 1018 adjuvant, potential for other collaborators to receive EUAs for their vaccine candidates and recombinant subunit protein vaccines' potential contribution to global vaccination efforts. 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 or receiving EUAs, whether CpG 1018 adjuvant plus aluminum combined with MVC's subunit vaccine will prove to be safe and efficacious in remaining clinical trials and ongoing monitoring, whether and when any vaccine will receive final approval for use, and whether sufficient quantities of CpG 1018 adjuvant 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.

    Medigen Contact:

    Paul Torkehagen

    Director, International Business Development

    paul@medigenvac.com

    Dynavax Contacts: 

    Nicole Arndt, Senior Manager, Investor Relations 

    narndt@dynavax.com 

    510-665-7264 

    Derek Cole, President 

    Investor Relations Advisory Solutions 

    derek.cole@IRadvisory.com  

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    SOURCE Dynavax Technologies

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  8. Saint-Herblain (France), August 23, 2021Valneva SE (NASDAQ:VALN, Euronext Paris: VLA))), a specialty vaccine company focused on prophylactic vaccines for infectious diseases, today commenced rolling submission, for initial approval of its COVID-19 vaccine candidate, VLA2001, with the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK). VLA2001 is a whole virus, inactivated, adjuvanted vaccine candidate and is the only vaccine candidate of this type currently in clinical trials in Europe.

    VLA2001 is currently being studied in the UK in a pivotal Phase 3 trial, "Cov-Compare" (VLA2001-301), for which topline results are currently expected early in the fourth quarter 2021. Subject to positive Cov-Compare data…

    Saint-Herblain (France), August 23, 2021Valneva SE (NASDAQ:VALN, Euronext Paris: VLA))), a specialty vaccine company focused on prophylactic vaccines for infectious diseases, today commenced rolling submission, for initial approval of its COVID-19 vaccine candidate, VLA2001, with the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK). VLA2001 is a whole virus, inactivated, adjuvanted vaccine candidate and is the only vaccine candidate of this type currently in clinical trials in Europe.

    VLA2001 is currently being studied in the UK in a pivotal Phase 3 trial, "Cov-Compare" (VLA2001-301), for which topline results are currently expected early in the fourth quarter 2021. Subject to positive Cov-Compare data and MHRA review, Valneva believes that initial approval could be granted before the end of 2021.

    In September 2020, Valneva announced a collaboration with the UK Government, which has the option to purchase up to 190 million doses through 2025. So far, the UK Government has ordered 100 million doses for supply in 2021 and 2022.

    Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva, said, "We are pleased to begin the regulatory review process for our COVID-19 vaccine with the MHRA. Valneva believes that everyone should have access to technology best suited to protect them against this virus. We are working hard to make our vaccine candidate available as soon as possible. We are grateful to the National Institute for Health Research (NIHR), Public Health England (PHE), and other partners for their unstinting support and hard work."

    Valneva recently initiated a further Phase 3 clinical trial, VLA2001-304, to generate data in the elderly and as part of the Company's strategy to evaluate variant-based vaccines. Data from VLA2001-304 will complement Cov-Compare and other clinical trials. In parallel, the UK Government is funding a clinical trial, "COV-Boost", which is evaluating different COVID-19 vaccines, including VLA2001, as potential boosters.

    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 chemical inactivation 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 Valneva SE

    Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. The Company takes a highly specialized and targeted approach to vaccine development, beginning with the identification of deadly and debilitating infectious diseases that lack a prophylactic vaccine solution and for which there are limited therapeutic treatment options. It then applies its deep understanding of vaccine science, including its expertise across multiple vaccine modalities, as well as its established vaccine development capabilities, to develop prophylactic vaccines to address these diseases. The Company has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

    Media & Investor Contacts

    Laëtitia Bachelot-Fontaine

    VP Global Communications & European Investor Relations

    M +33 (0)6 4516 7099

    laetitia.bachelot-fontaine@valneva.com     
     



    Joshua Drumm, Ph.D.

    VP Global Investor Relations

    M +001 917 815 4520

    joshua.drumm@valneva.com

    Forward-Looking Statements

    This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to the progress, timing, design, data read-outs, anticipated results and completion of clinical trials for VLA2001. 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 indicative of future results. 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 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, the ability to obtain or maintain patent or other proprietary intellectual property protection and the impact of the COVID-19 pandemic. 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 this press release as of the date hereof and disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

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  9. Saint-Herblain (France), August 11th, 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, today announced the initiation of a further Phase 3 trial (VLA2001-304) for its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001.

    VLA2001-304 aims to generate data in the elderly and is also designed to potentially enable variant-bridging through immune-comparability. Data from this study are expected to complement ongoing clinical trials and support additional regulatory submissions.

    VLA2001-304, which will be conducted in New Zealand, will recruit approximately 150 participants…

    Saint-Herblain (France), August 11th, 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, today announced the initiation of a further Phase 3 trial (VLA2001-304) for its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001.

    VLA2001-304 aims to generate data in the elderly and is also designed to potentially enable variant-bridging through immune-comparability. Data from this study are expected to complement ongoing clinical trials and support additional regulatory submissions.

    VLA2001-304, which will be conducted in New Zealand, will recruit approximately 150 participants aged 56 years and older (Cohort 1) with the aim of generating additional safety and immunogenicity data in this age group following vaccination with VLA2001 (two doses 28 days apart).

    Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva, said, "The fight against COVID-19 continues and it's extremely important that we continue to gather as much data as possible in all age groups across the population. Everyone should have access to technology best suited to protect them against this virus. We have also been working on Variants of Concern as part of our continued efforts to stay ahead of the virus causing COVID-19 especially since we believe that our inactivated, whole-virus platform will be adaptable across variants. Hence we are extremely pleased to be able to invest in this very important additional clinical trial".

    In June 2021, Valneva announced that it had completed recruitment for VLA2001's pivotal Phase 3 trial "Cov-Compare" (VLA2001-301) with over 4,000 randomized participants. Valneva plans to make regulatory submissions for initial approval in the fourth quarter of 2021, subject to successful Cov-Compare data.

    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 chemical inactivation 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 VLA2001-304

    Trial VLA2001-304 will enroll two cohorts. Cohort 1 will include approximately 150 volunteers aged 56 years and older in an open-label manner in order to generate safety and immunogenicity data for this age group. Cohort 2 will include approximately 600 volunteers aged 12 years and older in order to compare immunogenicity data of Valneva's original COVID-19 vaccine candidate, VLA2001, to an additional COVID-19 vaccine candidate, VLA2101, to be based on a variant strain to be confirmed. In both cohorts, vaccinations will be administered in a 2-dose immunization schedule 28 days apart. The trial will be conducted at approximately 10 trial sites in New Zealand.  

    https://www.clinicaltrials.gov/ct2/show/NCT04956224

    ClinicalTrials.gov Identifier: NCT04956224

    About Valneva SE

    Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. The Company takes a highly specialized and targeted approach to vaccine development, beginning with the identification of deadly and debilitating infectious diseases that lack a prophylactic vaccine solution and for which there are limited therapeutic treatment options. It then applies its deep understanding of vaccine science, including its expertise across multiple vaccine modalities, as well as its established vaccine development capabilities, to develop prophylactic vaccines to address these diseases. The Company has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

    Media & Investor Contacts

    Laëtitia Bachelot-Fontaine

    VP Global Communications & European Investor Relations

    M +33 (0)6 4516 7099

    laetitia.bachelot-fontaine@valneva.com     
     



    Joshua Drumm, Ph.D.

    VP Global Investor Relations

    M +001 917 815 4520

    joshua.drumm@valneva.com

    Forward-Looking Statements

    This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to the progress, timing, design, data read-outs, anticipated results and completion of clinical trials for VLA2001. 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 indicative of future results. 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 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, the ability to obtain or maintain patent or other proprietary intellectual property protection and the impact of the COVID-19 pandemic. 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 this press release as of the date hereof and disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

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  10. EMERYVILLE, Calif., Aug. 4, 2021 /PRNewswire/ -- Dynavax Technologies Corporation (NASDAQ:DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, today reported financial results for the second quarter of 2021.

    "Our successful execution in the second quarter of 2021 continued to build on the progress made in 2020. With the combined strength of opportunities from HEPLISAV-B and CpG 1018, we believe 2021 will be a transformational year for Dynavax," commented Ryan Spencer, Chief Executive Officer of Dynavax. "HEPLISAV-B achieved its highest quarterly revenue at $13.7 million and continues to increase market share, which reinforces our belief that it will become the standard of care in the U.S. for adult hepatitis B vaccinations."

    Mr. Spencer continued, "Dynavax is also making progress on numerous collaborations for its proven CpG 1018 vaccine adjuvant across multiple indications, including COVID-19, pertussis, and universal flu. Our COVID-19 collaborations have advanced significantly in recent months with the execution of commercial supply agreements with Biological E and Clover Biopharmaceuticals, in addition to the two previously executed agreements with Valneva and Medigen. Multiple partners have reported that they currently intend to apply for emergency or conditional authorization for their COVID-19 vaccines in the second half of 2021. Importantly, these collaborations are generating meaningful revenue for Dynavax, with second quarter CpG 1018 revenue of $39 million.  We continue to be excited about each of our partners' clinical programs and believe that the emerging portfolio of product opportunities with CpG 1018 adjuvant has the potential to continue generating meaningful future value for Dynavax."

    HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted]

    • Net product revenue for HEPLISAV-B was $13.7 million during the second quarter 2021, representing the highest quarterly HEPLISAV-B net sales to date, compared to $2.4 million for the second quarter 2020.  This increase was primarily driven by continued success in the field targeted accounts and ongoing progress in national accounts.
    • Market share in accounts targeted by the field sales team increased to 30%, up from 21% in the second quarter of 2020.
    • Dynavax and Bavarian Nordic entered into a commercialization agreement for the marketing and distribution of HEPLISAV B in Germany.

    CpG 1018®  (Advanced Vaccine Adjuvant)

    • Net product revenue for CpG 1018 adjuvant during the second quarter 2021 was $39.0 million.
    • Dynavax and Biological E (Bio E) entered into a commercial supply agreement for the use of CpG 1018 adjuvant in the commercial production of Bio E's subunit COVID-19 vaccine candidate, CORBEVAX™. Upon completion of their Phase 2/3 and subsequently emergency use authorization (EUA) India's Union Ministry of Health has reserved 300 million doses of CORBEVAX™.
    • Dynavax and Clover Biopharmaceuticals entered into a commercial supply agreement for the use of CpG 1018 adjuvant in the commercial production of Clover's COVID-19 vaccine candidate, SCB-2019 (CpG 1018/Alum). In parallel, Clover announced an advanced purchase agreement with GAVI to supply up to 414 million doses of SCB-2019 (CpG 1018/Alum) through 2022 for the COVAX Facility.
    • The Coalition for Epidemic Preparedness Innovations (CEPI) expanded its agreement with Dynavax to provide funding to manufacture CpG 1018 for CEPI's COVID-19 vaccine grantees, increasing total funding under the loan agreement from $99.0 million to $176.4 million to support Dynavax's manufacturing costs.
    • Medigen Vaccine Biologics Corporation received EUA from the Taiwan Food and Drug Administration and received approval for inclusion in Taiwan's COVID-19 vaccination immunization program for MVC-COV1901, its COVID-19 vaccine adjuvanted with CpG 1018.
    • Valneva SE reported positive initial results for Part A of the Phase 1/2 clinical trial of its COVID-19 vaccine candidate, VLA2001 adjuvanted with CpG 1018. Based on the positive results Valneva initiated a pivotal Phase 3 clinical trial, which is now fully enrolled. Valneva is also participating in a UK government-funded clinical trial looking at various COVID-19 'booster' vaccines.

    Convertible Debt Offering

    • In May 2020, we issued $225.5 million in aggregate principal amount of 2.50% convertible senior notes due 2026. As of June 30, 2021, the aggregate principal amount of our Convertible Notes was $225.5 million, excluding debt discount of $5.5 million.
    • A portion of the net proceeds from the offering were used to pay off an existing $190.2 million term loan in full, including the termination payment. In connection with the offering, we also entered into capped call transactions with certain financial institutions that are expected generally to reduce the potential dilution to common stock in certain circumstances, upon conversion of the notes. 
    • This debt refinancing is expected to reduce interest expense by approximately $12.1 million on an annualized basis.

    Upcoming Milestones

    • CDC Advisory Committee on Immunization Practices expected to vote on a universal hepatitis b recommendation for all previously unvaccinated adults in October.
    • Multiple data readouts from our CpG 1018 COVID-19 collaboration partners with potential for emergency or conditional use authorization by the end of 2021.
    • Data from Tdap-1018 in the ongoing Phase 1 clinical trial, for an improved tetanus, diphtheria, and acellular pertussis booster vaccine candidate adjuvanted with CpG 1018 expected in first quarter 2022.

    Financial Results

    Total Revenue. Total revenues for the second quarter of 2021 were $52.8 million, including $52.7 million of net product revenue, an increase from total revenue for the second quarter of 2020 of $2.7 million.

    Product Revenue, Net. HEPLISAV-B product revenue, net was $13.7 million in the second quarter of 2021 compared to $2.4 million in the same period in 2020. CpG 1018 product revenue, net was $39.0 million in the second quarter of 2021 and there was no revenue in the same period in 2020. As CpG 1018 revenues are generally recorded upon shipment to a customer, there may be fluctuations in revenues between quarters as shipments often consist of large-sized batches.

    Cost of Sales - Product. Cost of sales - product for the second quarter 2021 increased to $14.8 million, compared to $1.0 million for the second quarter of 2020. The increase was primarily due to manufacturing costs for increased volumes of CpG 1018 and HEPLISAV-B sold to customers.

    Research and Development Expenses (R&D). R&D expenses for the second quarter of 2021 increased to $7.2 million, compared to $5.9 million for the second quarter of 2020. The increase is primarily associated with higher headcount and outside services to support vaccine clinical and development activities.

    Selling, General and Administrative Expenses (SG&A). SG&A expenses for the second quarter of 2021 increased to $21.6 million, compared to $19.0 million for the second quarter of 2020. This increase is primarily driven by compensation and related personnel costs, including non-cash stock-based compensation, associated with higher headcount.

    Income (loss) from Operations and Net Income (loss). Income from operations for the second quarter of 2021 was $9.2 million compared to a loss from operations of $23.3 million in the second quarter of 2020. Net income for the second quarter of 2021 was $4.5 million compared to a net loss of $51.6 million for the second quarter of 2020.

    Earnings per share. Basic and diluted net income per share were $0.04 and $0.02, respectively, for the second quarter of 2021, compared to basic and diluted net loss per share of ($0.53) and ($0.53), respectively, in the second quarter of 2020.

    Cash Position. Cash, cash equivalents and marketable securities totaled $345.8 million at June 30, 2021.

    Conference Call and Webcast Information

    Dynavax will hold a conference call today 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 www.dynavax.com.  Alternatively, participants may dial (866) 420-4066 or (409) 217-8237 and refer to conference ID 9970706. A replay of the webcast will be available for 30 days following the live event.

    Please see Important Safety Information below.

    For more information about HEPLISAV-B, visit http://heplisavb.com.

    About Hepatitis B

    Hepatitis B is a viral disease of the liver that can become chronic and lead to cirrhosis, liver cancer and death. The hepatitis B virus is 50 to 100 times more infectious than HIV,i and transmission is on the rise. There is no cure for hepatitis B, but effective vaccination can prevent the disease.

    In adults, hepatitis B is spread through contact with infected blood and through unprotected sex with an infected person. The U.S. Centers for Disease Control (CDC) recommends vaccination for those at high risk for infection due to their jobs, lifestyle, living situations and travel to certain areas.ii Because people with diabetes are particularly vulnerable to infection, the CDC recommends vaccination for adults age 19 to 59 with diabetes as soon as possible after their diagnosis, and for people age 60 and older with diabetes at their physician's discretion.iii Approximately 20 million U.S. adults have diabetes, and 1.5 million new cases of diabetes are diagnosed each year.iv

    About HEPLISAV-B

    HEPLISAV-B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with Dynavax's proprietary Toll-like Receptor (TLR) 9 agonist CpG 1018 to enhance the immune response. Dynavax has worldwide commercial rights to HEPLISAV-B.

    Important U.S. Product Information

    HEPLISAV-B is indicated for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.

    Safety and effectiveness of HEPLISAV-B have not been established in adults on hemodialysis.

    For full U.S. Prescribing Information for HEPLISAV-B, click here.

    Important U.S. Safety Information (ISI)

    Do not administer HEPLISAV-B to individuals with a history of severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV-B. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV-B. Hepatitis B has a long incubation period. HEPLISAV-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration. The most common patient reported adverse reactions reported within 7 days of vaccination were injection site pain (23% to 39%), fatigue (11% to 17%) and headache (8% to 17%).

    Important EU/EEA Product Information

    HEPLISAV B is indicated for active immunisation against hepatitis B virus infection (HBV) caused by all known subtypes of hepatitis B virus in adults 18 years of age and older.

    The use of HEPLISAV B should be in accordance with official recommendations.

    It can be expected that hepatitis D will also be prevented by immunization with HEPLISAV B as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.

    For full EU/EEA. Prescribing Information for HEPLISAV-B, click here.

    Important EU/EEA Safety information

    Do not receive HEPLISAV B if you have had a sudden life-threatening, allergic reaction after receiving HEPLISAV B in the past, or if you are allergic to any of components of this vaccine, including yeast. Signs of an allergic reaction may include itchy skin, rash, shortness of breath and swelling of the face or tongue.

    Appropriate medical treatment and supervision should be readily available in case of rare anaphylactic reactions following the administration of the vaccine.

    The administration of HEPLISAV B should be postponed in subjects suffering from acute severe febrile illness.

    Immunocompromised persons may have a diminished immune response to HEPLISAV B.

    Because of the long incubation period of hepatitis B, it is possible for unrecognised HBV infection to be present at the time of immunisation. HEPLISAV B may not prevent HBV infection in such cases.

    There are very limited data on the immune response to HEPLISAV B in individuals who did not mount a protective immune response to another hepatitis B vaccine.

    As a precautionary measure, it is preferable to avoid the use of HEPLISAV B during pregnancy. Vaccination during pregnancy should only be performed if the risk-benefit ratio at the individual level outweighs possible risks for the fetus.

    The most common patient-reported side effects reported within 7 days of vaccination were pain, swelling or redness at the injection site, feeling tired, headache, muscle aches, feeling unwell and fever.

    About CpG 1018 Adjuvant

    CpG 1018 is the adjuvant used in HEPLISAV-B. 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.

    Forward-Looking Statements This press release contains "forward-looking" statements, including statements regarding the potential for HEPLISAV-B to become the standard of care adult hepatitis B vaccine in the U.S., establishing CpG 1018 as a leading adjuvant, the development and potential approval of vaccines containing CpG 1018 and potential future sales of CpG 1018 or HEPLISAV-B, the timing of initiation and completion of clinical studies and the publication of results, the timing of our collaborators seeking emergency use authorization of COVID-19 vaccines containing CpG 1018 adjuvant, our ability to scale manufacturing capacity, the expected demand for our products, our efforts to develop an improved pertussis vaccine and a seasonal flu vaccine, our collaboration partners' efforts to develop a vaccine for COVID-19 and a universal flu vaccine, entering into strategic relationships and expected results of such relationships, the potential for CpG 1018 to accelerate development and large scale manufacturing of a COVID-19 vaccine and sales potential under certain agreements. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including, the risk that HEPLISAV-B may not become the standard of care adult hepatitis B vaccine in the U.S., risks related to whether and when prescribers and other key decision-makers at potential purchasing entities will make the decision to switch to HEPLISAV-B, and the timing and quantity of actual purchases, risks related to the timing and result of the ACIP vote on a universal hepatitis b recommendation, risks related to the timing of completion and results of current clinical studies, risks that our collaborators will not get approval of their vaccine candidates, risks related to the development and pre-clinical and clinical testing of vaccines containing CpG 1018, and whether use of CpG 1018 will prove to be beneficial in these vaccines, risks related to whether, when and the quantity of CpG 1018 actually purchased by vaccine companies, risks related to the use of contract manufacturers to supply CpG 1018 and financial commitments made to them, 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:

    Nicole Arndt, Senior Manager, Investor Relations

    narndt@dynavax.com

    510-665-7264

    Derek Cole, President

    Investor Relations Advisory Solutions

    derek.cole@IRadvisory.com

    i CDC. https://www.cdc.gov/hepatitis/hbv/bfaq.htm.

    ii CDC. https://www.cdc.gov/hepatitis/hbv/hbvfaq.htm.

    iii CDC. https://www.cdc.gov/diabetes/pubs/pdf/hepb_vaccination.pdf.

    iv CDC. https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf

    DYNAVAX TECHNOLOGIES CORPORATION

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (In thousands, except per share amounts)

    (Unaudited)







    Three Months Ended





    Six Months Ended







    June 30,





    June 30,







    2021





    2020





    2021





    2020



    Revenues:

































    Product revenues, net



    $

    52,677





    $

    2,405





    $

    135,562





    $

    12,919



    Other revenue





    90







    263







    540







    668



    Total revenues





    52,767







    2,668







    136,102







    13,587





































    Operating expenses:

































    Cost of sales – product





    14,845







    967







    39,470







    3,321



    Cost of sales - amortization of intangible assets





    -







    202







    -







    2,500



    Research and development





    7,167







    5,884







    14,925







    10,537



    Selling, general and administrative





    21,583







    18,954







    44,006







    39,880



    Total operating expenses





    43,595







    26,007







    98,401







    56,238





































    Income (loss) from operations





    9,172







    (23,339)







    37,701







    (76,825)





































    Other income (expense):

































    Interest income





    48







    331







    95







    921



    Interest expense





    (3,109)







    (4,732)







    (7,821)







    (9,463)



    Sublease income





    1,670







    1,927







    3,692







    3,853



    Loss on debt extinguishment





    (5,232)







    -







    (5,232)







    -



    Change in fair value of warrant liability





    2,097







    (25,655)







    (23,455)







    (17,045)



    Other





    (173)







    (111)







    384







    211



    Net income (loss)



    $

    4,473





    $

    (51,579)





    $

    5,364





    $

    (64,174)



    Net income (loss) per share – basic



    $

    0.04





    $

    (0.53)





    $

    0.04





    $

    (0.70)



    Weighted average shares used to compute basic net income (loss) per share





    114,629







    97,339







    113,339







    91,408



    Net income (loss) per share – diluted



    $

    0.02





    $

    (0.53)





    $

    0.04





    $

    (0.70)



    Weighted average shares used to compute diluted net income (loss) per share





    118,830







    97,339







    114,978







    91,408



     

    DYNAVAX TECHNOLOGIES CORPORATION

    SELECTED BALANCE SHEET DATA

    (In thousands)

    (Unaudited)







    June 30,





    December 31,







    2021





    2020



    Assets

















    Cash, cash equivalents and marketable securities



    $

    345,804





    $

    165,036



    Inventories, net





    86,451







    63,689



    Property and equipment, net





    32,547







    30,567



    Operating lease right-of-use assets





    25,164







    26,583



    Goodwill





    2,225







    2,297



    Other assets





    155,718







    65,100



    Total assets



    $

    647,909





    $

    353,272





















    Liabilities and stockholders' equity

















    Total current liabilities



    $

    204,642





    $

    77,411



    Total long-term liabilities





    359,887







    217,168



    Stockholders' equity





    83,380







    58,693



    Total liabilities and stockholders' equity



    $

    647,909





    $

    353,272



     

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/dynavax-announces-second-quarter-2021-financial-results-301348607.html

    SOURCE Dynavax Technologies

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  11. EMERYVILLE, Calif., Aug. 3, 2021 /PRNewswire/ -- Dynavax Technologies Corporation (NASDAQ:DVAX) today reported that it has granted nonstatutory stock options to purchase an aggregate of 438,000 shares of Dynavax common stock as inducements to 44 newly-hired employees in connection with commencement of employment with the Company.

    The stock options were granted on August 2, 2021 at an exercise price of $9.45 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

    narndt@dynavax.com 

    510-665-7264

    Derek Cole, President

    Investor Relations Advisory Solutions

    derek.cole@IRadvisory.com

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/dynavax-reports-inducement-grants-under-nasdaq-listing-rule-5635c4-301347545.html

    SOURCE Dynavax Technologies

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  12. 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

    narndt@dynavax.com

    510-665-7264

    Derek Cole, President

    Investor Relations Advisory Solutions

    derek.cole@IRadvisory.com

    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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  13. 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

    narndt@dynavax.com

    vijay.kammari@biologicale.com

    510-665-7264

    +91 83740 77433



    www.biologicale.com/news

    Derek Cole, President

    Investor Relations Advisory Solutions

    derek.cole@IRadvisory.com



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    SOURCE Dynavax Technologies

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  14. 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

    investors@valneva.com        
     



    Teresa Pinzolits

    Corporate Communications Specialist

    T +43 (0)1 20620 1116

    communications@valneva.com

    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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  15. 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

    narndt@dynavax.com 

    510-665-7264

    Derek Cole, President

    Investor Relations Advisory Solutions

    derek.cole@IRadvisory.com

    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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  16. 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

    media@cloverbiopharma.com



    Naomi Eichenbaum

    Vice President, Investor Relations

    investors@cloverbiopharma.com



    Dynavax Contacts:

    Nicole Arndt

    Senior Manager Investor Relations

    narndt@dynavax.com

    510-665-7264



    Derek Cole

    President, Investor Relations Advisory Solutions

    derek.cole@IRadvisory.com



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    SOURCE Dynavax Technologies

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    • Clover to procure CpG 1018 adjuvant from Dynavax for use in the commercial production of Clover's COVID-19 vaccine candidate, SCB-2019 (CpG 1018/Alum)
    • Pending conditional regulatory approvals, Clover expects to commence product launch of SCB-2019 (CpG 1018/Alum) by the end of 2021

    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…

    • Clover to procure CpG 1018 adjuvant from Dynavax for use in the commercial production of Clover's COVID-19 vaccine candidate, SCB-2019 (CpG 1018/Alum)
    • Pending conditional regulatory approvals, Clover expects to commence product launch of SCB-2019 (CpG 1018/Alum) by the end of 2021

    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 1018TM 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.

    Logo (PRNewsfoto/Clover Biopharmaceuticals)

    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

    Clover Biopharmaceuticals is 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 platform is a product development platform for the creation of novel vaccines and biologic therapies. We have leveraged the 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

    media@cloverbiopharma.com

    Naomi Eichenbaum

    Vice President, Investor Relations

    investors@cloverbiopharma.com

    Dynavax Contacts:

    Nicole Arndt

    Senior Manager Investor Relations

    narndt@dynavax.com

    510-665-7264

    Derek Cole

    President, Investor Relations Advisory Solutions

    derek.cole@IRadvisory.com

    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-301322855.html

    SOURCE Clover Biopharmaceuticals

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  17. EMERYVILLE, Calif., June 29, 2021 /PRNewswire/ -- Dynavax Technologies Corporation (NASDAQ:DVAX) today announced that, in connection with the appointment of John Slebir as Senior Vice President, General Counsel on June 28, 2021, the Company granted him a non-statutory stock option to purchase 300,000 shares of Dynavax common stock.

    The stock option 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 Mr. Slebir's continued service with Dynavax through the applicable vesting dates. The stock option was granted with an exercise price of $9.29 per share, which is equal to the closing price of Dynavax common stock on the date of grant, and was provided as a material inducement to Mr. Slebir's employment in accordance with Nasdaq Listing Rule 5635(c)(4). The option is subject to the terms and conditions of a stock option agreement covering the grant and Dynavax's 2021 Inducement Award Plan, which was adopted on 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

    narndt@dynavax.com

    510-665-7264

    Derek Cole, President

    Investor Relations Advisory Solutions

    derek.cole@IRadvisory.com

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/dynavax-reports-inducement-grant-under-nasdaq-listing-rule-5635c4-301322461.html

    SOURCE Dynavax Technologies

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  18. EMERYVILLE, Calif., June 9, 2021 /PRNewswire/ -- Dynavax Technologies Corporation (NASDAQ:DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, today announced that Ryan Spencer, Chief Executive Officer, will present virtually at the Goldman Sachs 42nd Annual Global Healthcare Conference on Thursday, June 10, 2021 at 3:50 p.m. E.T.

    The presentation will be webcast and may be accessed through the "Events & Presentations" page on the "Investors" section of the Company's website at http://investors.dynavax.com/events-presentations.

    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

    narndt@dynavax.com 

    510-665-7264

    Derek Cole, President

    Investor Relations Advisory Solutions

    derek.cole@IRadvisory.com

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/dynavax-to-present-at-the-goldman-sachs-42nd-annual-global-healthcare-conference-301309437.html

    SOURCE Dynavax Technologies

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  19. Saint-Herblain (France), June 3, 2021Valneva SE, a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, today announced that it has completed recruitment for the pivotal Phase 3 trial of its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001.

    Over 4,000 volunteers in the United Kingdom have been randomized in the Phase 3 trial "Cov-Compare" (VLA2001-301), which compares Valneva's SARS-CoV-2 vaccine candidate, VLA2001, against AstraZeneca's conditionally approved vaccine, Vaxzevria1. Cov-Compare's primary endpoint is to determine the immune response (Geometric Mean Titer – GMT of SARS-CoV-2-specific neutralizing antibodies…

    Saint-Herblain (France), June 3, 2021Valneva SE, a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, today announced that it has completed recruitment for the pivotal Phase 3 trial of its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001.

    Over 4,000 volunteers in the United Kingdom have been randomized in the Phase 3 trial "Cov-Compare" (VLA2001-301), which compares Valneva's SARS-CoV-2 vaccine candidate, VLA2001, against AstraZeneca's conditionally approved vaccine, Vaxzevria1. Cov-Compare's primary endpoint is to determine the immune response (Geometric Mean Titer – GMT of SARS-CoV-2-specific neutralizing antibodies) two weeks after completion of a two-dose immunization schedule administered in a four-week interval. Topline data are expected by September 2021 and submission to the UK's Medicines and Healthcare products Regulatory Agency for regulatory approval will follow, subject to the topline data.

    Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented, "We are extremely pleased to have achieved this important milestone in such a short period of time. I would like to thank the UK Vaccines Taskforce, the National Institute for Health Research and trial sites who have played vital roles in the rapid recruitment and enrollment of volunteers for the clinical trial. Based on our Phase 1/2 clinical data and, assuming successful Phase 3 results, we believe that our inactivated vaccine can make a major contribution to the ongoing fight against the COVID-19 pandemic."

    UK Health and Social Care Secretary, Matt Hancock, said, "The UK government has fully supported this promising COVID-19 vaccine by funding the early stage clinical trials and helping to recruit patients through the National Institute for Health Research. I'm delighted to see over 4,000 participants have been recruited rapidly, demonstrating the brilliance of our research teams and the dedication of the public across the UK to beat this virus. Our phenomenal vaccine rollout has shown the strength of our union and this vaccine will be made onshore in Livingston in Scotland which, if approved, will play an important role in protecting our country in the future."

    Professor Andrew Ustianowski, National Clinical Lead for the UK NIHR COVID Vaccine Research Programme, said, "The National Institute for Health Research and each of the research sites we support across the UK have worked tirelessly over the past two months to help recruit to his important study. Calling on the hundreds of thousands of members on the NHS COVID-19 Vaccine Research Registry, and various other channels, it is great to see this phase 3 study has reached its recruitment target. All of the participants involved in each phase of the Valneva vaccine studies are playing a key role in helping us understand how the study vaccine will perform in a large population, and hopefully provide us with another effective vaccine in our defence against coronavirus."

    VLA2001 is currently the only inactivated vaccine candidate in clinical trials against COVID-19 in Europe. Valneva recently announced that it is participating in the world's first COVID-19 vaccine booster trial in the UK2. The COV-Boost trial will look at seven different COVID-19 vaccines and provide vital data on how effective a booster of each vaccine is in protecting individuals from the virus. Initial findings for the COV-Boost study are expected in September 2021.

    About Phase 3 Trial Cov-Compare (VLA2001-301)

    Cov-Compare (VLA2001-301) is a randomized, observer-blind, controlled, comparative immunogenicity trial in over 4,000 adults.

    Primary objectives are to demonstrate the superiority of VLA2001 compared to Vaxzevria administered in a two-dose immunization schedule four weeks apart, in terms of Geometric Mean Titer ratio of SARS-CoV-2-specific neutralizing antibodies at two weeks after the second vaccination (i.e. Day 43) in adults aged 30 years and older. It will also evaluate the safety and tolerability of VLA2001 at two weeks after the second vaccination in adults aged 18 years and older.

    The trial is conducted at 26 sites in the U.K. Approximately 3,000 participants 30 years of age and older have been randomized in a 2:1 ratio to receive two intramuscular doses of either VLA2001 (n=2,000) or Vaxzevria (n=1,000) at the recommended dose level, 28 days apart, on Days 1 and 29. For immunogenicity analyses, samples from approximately 1,200 participants (600 per group) who have been tested sero-negative for SARS-CoV-2 at screening will be analyzed. Approximately 1,000 participants that are under 30 years of age have been placed in a non-randomized treatment group and will receive VLA2001 28 days apart.

    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 Valneva SE

    Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. We take a highly specialized and targeted approach to vaccine development, beginning with the identification of deadly and debilitating infectious diseases that lack a prophylactic vaccine solution and for which there are limited therapeutic treatment options. We then apply our deep understanding of vaccine science, including our expertise across multiple vaccine modalities, as well as our established vaccine development capabilities, to develop prophylactic vaccines to address these diseases. We have leveraged our expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

     



    Valneva Investor and Media Contacts

    Laetitia Bachelot-Fontaine

    Director Investor Relations & Corporate Communications

    M +33 (0)6 4516 7099

    investors@valneva.com

            
     



     



    Dan Sharp

    Government & Public Affairs Manager

    T +44-(0)7436-244309

    communications@valneva.com
     



            
     



     

    Valneva 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 Approved by MHRA under reg. 174 and by the European Commission as conditional approval

    2 Valneva to Participate in the World's First COVID-19 Vaccine Booster Trial in the UK

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  20. EMERYVILLE, Calif., May 27, 2021 /PRNewswire/ -- Dynavax Technologies Corporation (NASDAQ:DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, today announced it has entered into a commercialization agreement with Bavarian Nordic for the marketing and distribution of HEPLISAV B [Hepatitis B Vaccine (Recombinant), Adjuvanted] in Germany with an expected launch in the fourth quarter of 2021.    

    In February 2021, the European Commission (EC) granted marketing authorization for HEPLISAV B for the active immunization against hepatitis B virus infection (HBV) caused by all known subtypes of hepatitis B virus in adults 18 years of age and older.  HEPLISAV B is the only U.S. Food and Drug Administration (FDA) and EC approved hepatitis B vaccine for adults with a two-dose regimen that is completed in one month.

    Hepatitis B is a highly infectious and potentially deadly virus with increasing infection rates, and over 250 million people infected worldwide.  Hepatitis B can be prevented with effective vaccination. HEPLISAV B, with a two-dose regimen that takes only one month to complete and a statistically significantly higher seroprotection rate in head-to-head clinical trials, provides a unique opportunity to address known challenges with compliance, while delivering higher levels of protection compared to the three-dose regimen of the comparator vaccine.

    Ryan Spencer, Chief Executive Officer of Dynavax, commented: "We are excited to work with Bavarian Nordic on the commercialization of HEPLISAV B in Germany. Their existing marketing and distribution network in Germany provides an excellent platform to make HEPLISAV B available to patients. The strong overlap with the existing target audience within general practitioners, occupational health groups and travel medicine specialists provides a good strategic fit and clear commercial synergies for the dedicated sales force Bavarian Nordic has established in Germany."

    Paul Chaplin, President and CEO of Bavarian Nordic, commented: "We are pleased to expand our commercial footprint in the largest EU market by adding a complementary product to our marketing and distribution and we look forward to assisting Dynavax in a successful market entry in Europe later this year."

    About Hepatitis B

    Hepatitis B is a viral disease of the liver that can become chronic and lead to cirrhosis, liver cancer and death. The hepatitis B virus is 50 to 100 times more infectious than HIV,i and transmission is on the rise. There is no cure for hepatitis B, but effective vaccination can prevent the disease.

    In adults, hepatitis B is spread through contact with infected blood and through unprotected sex with an infected person. The U.S. Centers for Disease Control (CDC) recommends vaccination for those at high risk for infection due to their jobs, lifestyle, living situations and travel to certain areas.ii Because people with diabetes are particularly vulnerable to infection, the CDC recommends vaccination for adults age 19 to 59 with diabetes as soon as possible after their diagnosis, and for people age 60 and older with diabetes at their physician's discretion.iii Approximately 20 million U.S. adults have diabetes, and 1.5 million new cases of diabetes are diagnosed each year.iv

    About HEPLISAV-B

    HEPLISAV-B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with Dynavax's proprietary Toll-like Receptor (TLR) 9 agonist CpG 1018 adjuvant to enhance the immune response. Dynavax has worldwide commercial rights to HEPLISAV-B.

    Important EU/EEA Product Information

    HEPLISAV B is indicated for active immunisation against hepatitis B virus infection (HBV) caused by all known subtypes of hepatitis B virus in adults 18 years of age and older.

    The use of HEPLISAV B should be in accordance with official recommendations.

    It can be expected that hepatitis D will also be prevented by immunisation with HEPLISAV B as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.

    For full E.U. Prescribing Information for HEPLISAV-B, click here.

    Important EU/EEA Safety information

    Do not receive HEPLISAV B if you have had a sudden life-threatening, allergic reaction after receiving HEPLISAV B in the past, or if you are allergic to any components of this vaccine, including yeast. Signs of an allergic reaction may include itchy skin, rash, shortness of breath and swelling of the face or tongue.

    Appropriate medical treatment and supervision should be readily available in case of rare anaphylactic reactions following the administration of the vaccine.

    The administration of HEPLISAV B should be postponed in subjects suffering from acute severe febrile illness.

    Immunocompromised persons may have a diminished immune response to HEPLISAV B.

    Because of the long incubation period of hepatitis B, it is possible for unrecognised HBV infection to be present at the time of immunisation. HEPLISAV B may not prevent HBV infection in such cases.

    There are very limited data on the immune response to HEPLISAV B in individuals who did not mount a protective immune response to another hepatitis B vaccine.

    As a precautionary measure, it is preferable to avoid the use of HEPLISAV B during pregnancy. Vaccination during pregnancy should only be performed if the risk-benefit ratio at the individual level outweighs possible risks for the fetus.

    The most common patient-reported side effects reported within 7 days of vaccination were pain, swelling or redness at the injection site, feeling tired, headache, muscle aches, feeling unwell and fever.

    Important U.S. Product Information

    HEPLISAV-B is indicated for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.

    For full U.S. Prescribing Information for HEPLISAV-B, click here.

    Important U.S. Safety Information (ISI)

    Do not administer HEPLISAV-B to individuals with a history of severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV-B. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV-B. Hepatitis B has a long incubation period. HEPLISAV-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration. The most common patient reported adverse reactions reported within 7 days of vaccination were injection site pain (23% to 39%), fatigue (11% to 17%) and headache (8% to 17%).

    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 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 its 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

    About Bavarian Nordic

    Bavarian Nordic is a fully integrated vaccines company focused on the development, manufacture and commercialization of life-saving vaccines. We are a global leader in smallpox vaccines and have been a long-term supplier to the U.S. government of a non-replicating smallpox vaccine, which has been approved by the FDA under the trade name JYNNEOS®, also for the protection against monkeypox. The vaccine is approved as a smallpox vaccine in Europe under the trade name IMVANEX® and in Canada under the trade name IMVAMUNE®. Our commercial product portfolio furthermore contains the market-leading vaccine Rabipur®/RabAvert® against rabies and Encepur® against tick-borne encephalitis. Using our live virus vaccine platform technology, MVA-BN®, we have created a diverse portfolio of proprietary and partnered product candidates designed to save and improve lives by unlocking the power of the immune system, including an Ebola vaccine, MVABEA®, which is licensed to the Janssen Pharmaceutical Companies of Johnson & Johnson. We are also committed to the development of a next generation COVID-19 vaccine based on an in-licensed capsid virus-like particle technology. The vaccine candidate, ABNCoV2, is currently being investigated in clinical trials. For more information visit www.bavarian-nordic.com.

    Forward-Looking Statements

    This press release contains "forward-looking" statements, including statements regarding the European launch of HEPLISAV B timing and success of launch and anticipated synergies.  Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including, the timing of the launch of HEPLISAV B in Europe, what countries it will be launched in and when, whether commercialization of HEPLISAV B in Europe will be successful, 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, 2019, 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:

    Nicole Arndt, Senior Manager, Investor Relations

    narndt@dynavax.com

    510-665-7264

    Derek Cole, President

    Investor Relations Advisory Solutions

    derek.cole@IRadvisory.com

    i CDC. https://www.cdc.gov/hepatitis/hbv/bfaq.htm.

    ii CDC. https://www.cdc.gov/hepatitis/hbv/hbvfaq.htm.

    iii CDC. https://www.cdc.gov/diabetes/pubs/pdf/hepb_vaccination.pdf.

    iv CDC. https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/dynavax-announces-agreement-with-bavarian-nordic-for-commercialization-of-heplisav-b-a-two-dose-adult-hepatitis-b-adjuvanted-vaccine-in-germany-301300398.html

    SOURCE Dynavax Technologies

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  21. COPENHAGEN, Denmark, May 27 2021 – Bavarian Nordic A/S ((OMX: BAVA, OTC:BVNRY) has entered a partnership with Dynavax Technologies Corporation (NASDAQ:DVAX) a biopharmaceutical company focused on developing and commercializing novel vaccines for the marketing and distribution of their HEPLISAV B® [Hepatitis B Vaccine (Recombinant), Adjuvanted] Hepatitis B vaccine in Germany with an expected launch in the fourth quarter of 2021.

    In February 2021, the European Commission (EC) granted marketing authorization for HEPLISAV B for the active immunization against hepatitis B virus infection (HBV) caused by all known subtypes of hepatitis B virus in adults 18 years of age and older. HEPLISAV B is the only FDA- and EC-approved hepatitis B vaccine with…

    COPENHAGEN, Denmark, May 27 2021 – Bavarian Nordic A/S ((OMX: BAVA, OTC:BVNRY) has entered a partnership with Dynavax Technologies Corporation (NASDAQ:DVAX) a biopharmaceutical company focused on developing and commercializing novel vaccines for the marketing and distribution of their HEPLISAV B® [Hepatitis B Vaccine (Recombinant), Adjuvanted] Hepatitis B vaccine in Germany with an expected launch in the fourth quarter of 2021.

    In February 2021, the European Commission (EC) granted marketing authorization for HEPLISAV B for the active immunization against hepatitis B virus infection (HBV) caused by all known subtypes of hepatitis B virus in adults 18 years of age and older. HEPLISAV B is the only FDA- and EC-approved hepatitis B vaccine with a two-dose schedule for adults that is completed in one month.

    HEPLISAV B will complement and strengthen Bavarian Nordic's commercial portfolio by leveraging its existing marketing and distribution network in Germany, which, in addition to the Company's own vaccines for rabies and tick-borne encephalitis, also will include Valneva's vaccines for Japanese Encephalitis and cholera as part of the mutual marketing and distribution agreement entered last year. The strong overlap with the existing target audience within general practitioners, occupational health groups and travel medicine specialists provides a good strategic fit and clear commercial synergies for the dedicated sales force, Bavarian Nordic has established in Germany.

    Ryan Spencer, Chief Executive Officer of Dynavax, commented: "We are excited to work with Bavarian Nordic on the commercialization of HEPLISAV B in Germany. Hepatitis B is a highly infectious and potentially deadly virus with increasing infection rates, and over 250 million people infected worldwide. Thankfully, hepatitis B can be prevented with effective vaccination. With a two-dose regimen that takes only one month to complete and a statistically significantly higher seroprotection rate in head-to-head clinical trials, HEPLISAV B provides a unique opportunity to address known challenges with compliance, while delivering higher levels of protection compared to the three-dose regimen of the comparator vaccine."

    Paul Chaplin, President and CEO of Bavarian Nordic, commented: "We are pleased to expand our commercial footprint in the largest EU market by adding a complementary product to our marketing and distribution and we look forward to assisting Dynavax in a successful market entry in Europe later this year."

    About Hepatitis B

    Hepatitis B is a viral disease of the liver that can become chronic and lead to cirrhosis, liver cancer and death. The hepatitis B virus is 50 to 100 times more infectious than HIV,i and transmission is on the rise. There is no cure for hepatitis B, but effective vaccination can prevent the disease.

    In adults, hepatitis B is spread through contact with infected blood and through unprotected sex with an infected person. The U.S. Centers for Disease Control (CDC) recommends vaccination for those at high risk for infection due to their jobs, lifestyle, living situations and travel to certain areas.ii Because people with diabetes are particularly vulnerable to infection, the CDC recommends vaccination for adults age 19 to 59 with diabetes as soon as possible after their diagnosis, and for people age 60 and older with diabetes at their physician's discretion.iii Approximately 20 million U.S. adults have diabetes, and 1.5 million new cases of diabetes are diagnosed each year.iv

    About HEPLISAV B

    HEPLISAV B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with Dynavax's proprietary Toll-like Receptor (TLR) 9 agonist CpG 1018 adjuvant to enhance the immune response. Dynavax has worldwide commercial rights to HEPLISAV B.

    Important EU/EEA Product Information

    HEPLISAV B is indicated for active immunisation against hepatitis B virus infection (HBV) caused by all known subtypes of hepatitis B virus in adults 18 years of age and older.

    The use of HEPLISAV B should be in accordance with official recommendations.

    It can be expected that hepatitis D will also be prevented by immunisation with HEPLISAV B as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.

    For full E.U. Prescribing Information for HEPLISAV B, click here.

    Important EU/EEA Safety information

    Do not receive HEPLISAV B if you have had a sudden life-threatening, allergic reaction after receiving HEPLISAV B in the past, or if you are allergic to any of components of this vaccine, including yeast. Signs of an allergic reaction may include itchy skin, rash, shortness of breath and swelling of the face or tongue.

    Appropriate medical treatment and supervision should be readily available in case of rare anaphylactic reactions following the administration of the vaccine.

    The administration of HEPLISAV B should be postponed in subjects suffering from acute severe febrile illness.

    Immunocompromised persons may have a diminished immune response to HEPLISAV B.

    Because of the long incubation period of hepatitis B, it is possible for unrecognised HBV infection to be present at the time of immunisation. HEPLISAV B may not prevent HBV infection in such cases.

    There are very limited data on the immune response to HEPLISAV B in individuals who did not mount a protective immune response to another hepatitis B vaccine.

    As a precautionary measure, it is preferable to avoid the use of HEPLISAV B during pregnancy. Vaccination during pregnancy should only be performed if the risk-benefit ratio at the individual level outweighs possible risks for the fetus.

    The most common patient-reported side effects reported within 7 days of vaccination were pain, swelling or redness at the injection site, feeling tired, headache, muscle aches, feeling unwell and fever.

    Important U.S. Product Information

    HEPLISAV B is indicated for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.

    For full U.S. Prescribing Information for HEPLISAV B, click here.

    Important U.S. Safety Information (ISI)

    Do not administer HEPLISAV B to individuals with a history of severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV B, including yeast. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV B. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV B. Hepatitis B has a long incubation period. HEPLISAV B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration. The most common patient reported adverse reactions reported within 7 days of vaccination were injection site pain (23% to 39%), fatigue (11% to 17%) and headache (8% to 17%).

    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 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 its 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

    About Bavarian Nordic

    Bavarian Nordic is a fully integrated vaccines company focused on the development, manufacture and commercialization of life-saving vaccines. We are a global leader in smallpox vaccines and have been a long-term supplier to the U.S. government of a non-replicating smallpox vaccine, which has been approved by the FDA under the trade name JYNNEOS®, also for the protection against monkeypox. The vaccine is approved as a smallpox vaccine in Europe under the trade name IMVANEX® and in Canada under the trade name IMVAMUNE®. Our commercial product portfolio furthermore contains the market-leading vaccine Rabipur®/RabAvert® against rabies and Encepur® against tick-borne encephalitis. Using our live virus vaccine platform technology, MVA-BN®, we have created a diverse portfolio of proprietary and partnered product candidates designed to save and improve lives by unlocking the power of the immune system, including an Ebola vaccine, MVABEA®, which is licensed to the Janssen Pharmaceutical Companies of Johnson & Johnson. We are also committed to the development of a next generation COVID-19 vaccine based on an in-licensed capsid virus-like particle technology. The vaccine candidate, ABNCoV2, is currently being investigated in clinical trials. For more information visit www.bavarian-nordic.com.

    Forward-looking statements

    This announcement includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside of our control, that could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements concerning our plans, objectives, goals, future events, performance and/or other information that is not historical information. All such forward-looking statements are expressly qualified by these cautionary statements and any other cautionary statements which may accompany the forward-looking statements. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law.

    Contacts

    Europe: Rolf Sass Sørensen, Vice President Investor Relations, Tel: +45 61 77 47 43

    US: Graham Morrell, Paddock Circle Advisors, graham@paddockcircle.com, Tel: +1 781 686 9600

    Company Announcement no. 19 / 2021

    i CDC. https://www.cdc.gov/hepatitis/hbv/bfaq.htm 

    ii CDC. https://www.cdc.gov/hepatitis/hbv/hbvfaq.htm 

    iii CDC. https://www.cdc.gov/diabetes/pubs/pdf/hepb_vaccination.pdf 

    iv CDC. https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf

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  22. EMERYVILLE, Calif., May 19, 2021 /PRNewswire/ -- Dynavax Technologies Corporation (NASDAQ:DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, today announced that Ryan Spencer, Chief Executive Officer, will participate in a virtual fireside chat at the William Blair 41th Annual Growth Stock Conference on Tuesday, June 1, 2021 at 2:40 p.m. C.T.

    The presentation will be webcast and may be accessed through the "Events & Presentations" page on the "Investors" section of the Company's website at http://investors.dynavax.com/events-presentations.

    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

    narndt@dynavax.com

    510-665-7264

    Derek Cole, President

    Investor Relations Advisory Solutions

    derek.cole@IRadvisory.com

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/dynavax-to-present-at-the-william-blair-41st-annual-growth-stock-conference-301295334.html

    SOURCE Dynavax Technologies

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  23. Saint-Herblain (France), May 19, 2021Valneva SE, a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, today announced it will participate in a UK government-funded clinical trial looking at different COVID-19 ‘booster' vaccines that launches today.     
       

    The Cov-Boost trial, led by University Hospital Southampton NHS Foundation Trust, will look at seven different COVID-19 vaccines, including Valneva's inactivated vaccine VLA2001, as potential boosters. It will be the first trial in the world to provide vital data on how effective a booster of each vaccine is in protecting individuals from the virus.

    The vaccines will be given…

    Saint-Herblain (France), May 19, 2021Valneva SE, a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, today announced it will participate in a UK government-funded clinical trial looking at different COVID-19 ‘booster' vaccines that launches today.     

       

    The Cov-Boost trial, led by University Hospital Southampton NHS Foundation Trust, will look at seven different COVID-19 vaccines, including Valneva's inactivated vaccine VLA2001, as potential boosters. It will be the first trial in the world to provide vital data on how effective a booster of each vaccine is in protecting individuals from the virus.

    The vaccines will be given at least three months after a second dose as part of the ongoing vaccination programme. One booster will be provided to each volunteer and could be a different brand to the one they were originally vaccinated with. The trial will also include a control group.

    Initial results from the trial, expected in September, will help inform decisions by the UK Joint Committee on Vaccination and Immunisation (JCVI) on any potential booster programme from autumn this year, ensuring the UK's most vulnerable people are given the strongest possible protection over the winter period.

    Thomas Lingelbach, Chief Executive Officer of Valneva, commented, "We are pleased to be involved in this new Cov-Boost trial. Valneva has the only whole virus, inactivated, adjuvanted vaccine candidate in clinical trials against COVID-19 in Europe and we believe our VLA2001 vaccine has an important role to play in the ongoing pandemic, including as a booster. We remain fully committed to completing development and bringing our inactivated vaccine solution to the market."

    In parallel to the Cov-Boost trial, Valneva will continue working on its pivotal Phase 3 clinical trial "Cov-Compare", (VLA2001-301) which the Company launched in April 20211. This trial compares Valneva's SARS-CoV-2 vaccine candidate, VLA2001, against AstraZeneca's conditionally approved vaccine, Vaxzevria2. Recruitment for the trial, conducted in the U.K. and supported by the National Institute for Health Research (NIHR), is ongoing (https://www.ukcovid19study.com/). Subject to successful Phase 3 data, Valneva aims to make regulatory submissions for initial approval in the autumn of 2021.

    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 Valneva SE

    Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. We take a highly specialized and targeted approach to vaccine development, beginning with the identification of deadly and debilitating infectious diseases that lack a prophylactic vaccine solution and for which there are limited therapeutic treatment options. We then apply our deep understanding of vaccine science, including our expertise across multiple vaccine modalities, as well as our established vaccine development capabilities, to develop prophylactic vaccines to address these diseases. We have leveraged our expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

     



    Valneva Investor and Media Contacts

    Laetitia Bachelot-Fontaine

    Director Investor Relations & Corporate Communications

    M +33 (0)6 4516 7099

    investors@valneva.com

            
     



     



    Dan Sharp

    Government & Public Affairs Manager

    T +44-(0)7436-244309

    communications@valneva.com
     



            
     



     

    Valneva 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 Initiates Phase 3 Clinical Trial for its Inactivated, Adjuvanted COVID-19 Vaccine Candidate, VLA2001

    2 Approved by MHRA under reg. 174 and by the European Commission as conditional approval

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  24. EMERYVILLE, Calif., May 11, 2021 /PRNewswire/ -- Dynavax Technologies Corporation ("Dynavax") (NASDAQ:DVAX) today announced the pricing of $200.0 million aggregate principal amount of 2.50% convertible senior notes due 2026 (the "notes") in a private placement to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"). Dynavax also granted the initial purchasers of the notes an option to purchase up to an additional $30.0 million aggregate principal amount of notes. The sale of the notes is expected to close on May 13, 2021, subject to customary closing conditions.

    EMERYVILLE, Calif., May 11, 2021 /PRNewswire/ -- Dynavax Technologies Corporation ("Dynavax") (NASDAQ:DVAX) today announced the pricing of $200.0 million aggregate principal amount of 2.50% convertible senior notes due 2026 (the "notes") in a private placement to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"). Dynavax also granted the initial purchasers of the notes an option to purchase up to an additional $30.0 million aggregate principal amount of notes. The sale of the notes is expected to close on May 13, 2021, subject to customary closing conditions.

    The notes will be general unsecured obligations of Dynavax and will accrue interest payable semiannually in arrears on May 15 and November 15 of each year, beginning on November 15, 2021, at a rate of 2.50% per year. The notes will mature on May 15, 2026, unless earlier converted, redeemed or repurchased. The initial conversion rate of the notes will be 95.5338 shares of Dynavax's common stock per $1,000 principal amount of notes (equivalent to an initial conversion price of approximately $10.47 per share of Dynavax's common stock). The initial conversion price of the notes represents a premium of approximately 32.5% over the last reported sale price of Dynavax's common stock on May 10, 2021. The notes will be convertible by the holders thereof into cash, shares of Dynavax's common stock or a combination of cash and shares of Dynavax's common stock, at Dynavax's election.

    Dynavax may redeem for cash all or any portion of the notes, at its option on or after May 20, 2024 and prior to the 31st scheduled trading day immediately preceding the maturity date, if the last reported sale price of Dynavax's common stock has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on, and including, the trading day immediately preceding the date on which Dynavax provides notice of redemption, at a redemption price equal to 100% of the principal amount of the notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date.

    If Dynavax undergoes a "fundamental change" (as defined in the indenture governing the notes), subject to certain conditions and exceptions, noteholders may require Dynavax to repurchase for cash all or any portion of their notes at a fundamental change repurchase price equal to 100% of the principal amount of the notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date. In addition, following certain corporate events that occur prior to the maturity date or if Dynavax delivers a notice of redemption, Dynavax will, in certain circumstances, increase the conversion rate for a noteholder who elects to convert its notes in connection with such a corporate event or convert its notes called (or deemed called) for redemption in connection with such notice of redemption, as the case may be.

    Dynavax estimates that the net proceeds from the offering of the notes will be approximately $195.1 million (or approximately $224.4 million if the initial purchasers exercise their option to purchase additional notes in full), after deducting the initial purchasers' discounts and commissions and estimated offering expenses payable by Dynavax. Dynavax expects to use the net proceeds from the offering of the notes, together with cash on hand, to repay in full the outstanding debt and other obligations under Dynavax's term loan agreement and to pay the costs of the capped call transactions described below. Dynavax expects that approximately $190.2 million will be needed to repay the outstanding debt and other obligations under the term loan agreement and approximately $24.2 million will be needed to pay the cost of the capped call transactions.

    If the initial purchasers exercise their option to purchase additional notes in full, Dynavax expects to use approximately $3.6 million of the net proceeds from the sale of such additional notes to enter into additional capped call transactions. Dynavax expects to use any remaining net proceeds from the sale of such additional notes for general corporate purposes.

    In connection with the pricing of the notes, Dynavax entered into capped call transactions with one of the initial purchasers and other financial institutions (the "option counterparties"). The capped call transactions will cover, subject to customary adjustments, the number of shares of Dynavax's common stock that initially underlie the notes. The capped call transactions are expected to offset the potential dilution to Dynavax's common stock as a result of any conversion of notes, with such offset subject to a cap initially equal to $15.80 (which represents a premium of 100% over the last reported sale price of Dynavax's common stock on May 10, 2021).

    In connection with establishing their initial hedges of the capped call transactions, Dynavax has been advised that the option counterparties and/or their respective affiliates expect to enter into various derivative transactions with respect to Dynavax's common stock concurrently with or shortly after the pricing of the notes and/or purchase shares of Dynavax's common stock concurrently with or shortly after the pricing of the notes. This activity could increase (or reduce the size of any decrease in) the market price of Dynavax's common stock or the trading price of the notes at that time.

    In addition, the option counterparties and/or their respective affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to Dynavax's common stock and/or purchasing or selling Dynavax's common stock or other securities of Dynavax in secondary market transactions following the pricing of the notes and prior to the maturity of the notes (and are likely to do so on each exercise date of the capped call transactions, which are expected to occur during the 30 trading day period beginning on the 31st scheduled trading day prior to the maturity date of the notes, or following any termination of any portion of the capped call transactions in connection with any repurchase, redemption or early conversion of the notes). This activity could also cause or avoid an increase or a decrease in the market price of Dynavax's common stock or the notes, which could affect a noteholder's ability to convert its notes and, to the extent the activity occurs during any observation period related to a conversion of notes, it could affect the amount and value of the consideration that a noteholder will receive upon conversion of such notes.  

    Neither the notes, nor any shares of Dynavax's common stock issuable upon conversion of the notes, have been registered under the Securities Act or any state securities laws, and unless so registered, may not be offered or sold in the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and other applicable securities laws.

    This press release is neither an offer to sell nor a solicitation of an offer to buy any securities, nor shall it constitute an offer, solicitation or sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

    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 1018TM 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.

    Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of federal securities laws, including statements concerning the expected closing of the offering, the potential dilution to Dynavax's common stock and the anticipated use of net proceeds from the offering. These forward-looking statements include all statements contained in this press release that are not historical facts and such statements are, in some cases, identified by words such as "anticipate," "could," "expect," "intend," "may," "plan," "will," "would" or the negative or plural of these words or similar expressions or variations. These forward-looking statements are based on the information currently available to Dynavax and on assumptions Dynavax has made. Actual results may differ materially from those described in the forward-looking statements and are subject to a variety of assumptions, uncertainties, risks and factors that are beyond Dynavax's control including, without limitation: market risks, trends and conditions; and those risks detailed from time-to-time under the caption "Risk Factors" and elsewhere in Dynavax's Securities and Exchange Commission filings and reports, including Dynavax's Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, as well as future filings and reports by Dynavax. Except as required by law, Dynavax undertakes no duty or obligation to update any forward-looking statements contained in this press release as a result of new information, future events, changes in expectations or otherwise.

    Contacts:

    Nicole Arndt, Senior Manager, Investor Relations

    narndt@dynavax.com

    510-665-7264

    Derek Cole, President

    Investor Relations Advisory Solutions

    derek.cole@IRadvisory.com

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/dynavax-announces-pricing-of-200-million-convertible-senior-notes-offering-301288119.html

    SOURCE Dynavax Technologies

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  25. EMERYVILLE, Calif., May 10, 2021 /PRNewswire/ -- Dynavax Technologies Corporation ("Dynavax") (NASDAQ:DVAX) today announced that it intends to offer, subject to market conditions and other factors, $200 million aggregate principal amount of convertible senior notes due 2026 (the "notes") in a private placement to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"). Dynavax also intends to grant the initial purchasers of the notes an option to purchase up to an additional $30 million aggregate principal amount of notes.

    The notes will be general unsecured obligations of Dynavax and will accrue interest payable semiannually in arrears. The notes will be convertible by the holders thereof into cash, shares of Dynavax's common stock or a combination of cash and shares of Dynavax's common stock, at Dynavax's election. The interest rate, initial conversion rate and other terms of the notes will be determined at the time of pricing of the offering.

    Dynavax expects to use the net proceeds from the offering of the notes, together with cash on hand, to repay in full the outstanding debt and other obligations under Dynavax's term loan agreement and to pay the costs of the capped call transactions described below.

    If the initial purchasers exercise their option to purchase additional notes, Dynavax expects to use a portion of the net proceeds from the sale of such additional notes to enter into additional capped call transactions. Dynavax expects to use any remaining net proceeds from the sale of such additional notes for general corporate purposes. Dynavax's management will have broad discretion in the application of the net proceeds from this offering and investors will be relying on the judgment of Dynavax's management regarding the application of the proceeds.

    In connection with the pricing of the notes, Dynavax expects to enter into capped call transactions with one or more of the initial purchasers and/or their respective affiliates or other financial institutions (the "option counterparties"). The capped call transactions will cover, subject to customary adjustments, the number of shares of Dynavax's common stock that initially underlie the notes. The capped call transactions are expected to offset the potential dilution to Dynavax's common stock as a result of any conversion of notes, with such offset subject to a cap.

    In connection with establishing their initial hedges of the capped call transactions, Dynavax has been advised that the option counterparties and/or their respective affiliates expect to enter into various derivative transactions with respect to Dynavax's common stock concurrently with or shortly after the pricing of the notes and/or purchase shares of Dynavax's common stock concurrently with or shortly after the pricing of the notes. This activity could increase (or reduce the size of any decrease in) the market price of Dynavax's common stock or the trading price of the notes at that time.

    In addition, the option counterparties and/or their respective affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to Dynavax's common stock and/or purchasing or selling Dynavax's common stock or other securities of Dynavax in secondary market transactions following the pricing of the notes and prior to the maturity of the notes (and are likely to do so on each exercise date of the capped call transactions, which are expected to occur during the 30 trading day period beginning on the 31st scheduled trading day prior to the maturity date of the notes, or following any termination of any portion of the capped call transactions in connection with any repurchase, redemption or early conversion of the notes). This activity could also cause or avoid an increase or a decrease in the market price of Dynavax's common stock or the notes, which could affect a noteholder's ability to convert its notes and, to the extent the activity occurs during any observation period related to a conversion of notes, it could affect the amount and value of the consideration that a noteholder will receive upon conversion of such notes.  

    Neither the notes, nor any shares of Dynavax's common stock issuable upon conversion of the notes, have been registered under the Securities Act or any state securities laws, and unless so registered, may not be offered or sold in the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and other applicable securities laws.

    This press release is neither an offer to sell nor a solicitation of an offer to buy any securities, nor shall it constitute an offer, solicitation or sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

    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 1018TM 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.

    Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of federal securities laws, including statements concerning the proposed terms of the notes, the capped call transactions, the completion, timing and size of the proposed offering and capped call transactions, the potential dilution to Dynavax's common stock and the anticipated use of net proceeds from the offering. These forward-looking statements include all statements contained in this press release that are not historical facts and such statements are, in some cases, identified by words such as "anticipate," "could," "expect," "intend," "may," "plan," "will," "would" or the negative or plural of these words or similar expressions or variations. These forward-looking statements are based on the information currently available to Dynavax and on assumptions Dynavax has made. Actual results may differ materially from those described in the forward-looking statements and are subject to a variety of assumptions, uncertainties, risks and factors that are beyond Dynavax's control including, without limitation: market risks, trends and conditions; and those risks detailed from time-to-time under the caption "Risk Factors" and elsewhere in Dynavax's Securities and Exchange Commission filings and reports, including Dynavax's Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, as well as future filings and reports by Dynavax. Except as required by law, Dynavax undertakes no duty or obligation to update any forward-looking statements contained in this press release as a result of new information, future events, changes in expectations or otherwise.

    Contacts:

    Nicole Arndt, Senior Manager, Investor Relations

    narndt@dynavax.com   

    510-665-7264

    Derek Cole, President

    Investor Relations Advisory Solutions

    derek.cole@IRadvisory.com

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/dynavax-announces-proposed-private-offering-of-200-million-of-convertible-senior-notes-301287421.html

    SOURCE Dynavax Technologies

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  26. EMERYVILLE, Calif., May 6, 2021 /PRNewswire/ -- Dynavax Technologies Corporation (NASDAQ:DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, today reported financial results for the first quarter of 2021.

    "The first quarter of 2021 continued to build on our successful execution in 2020. With the combined strength of opportunities from HEPLISAV-B and CpG 1018, we believe 2021 will be a transformational year for Dynavax," commented Ryan Spencer, Chief Executive Officer of Dynavax. "HEPLISAV-B continues to take market share in accounts targeted by our field sales team, reaching a new high this quarter, which reinforces our belief that it will become the standard of care in the U.S. for adult hepatitis B vaccination."

    Mr. Spencer continued, "Dynavax is making progress on numerous collaborations for its proven vaccine adjuvant CpG 1018 across multiple indications, including COVID-19, pertussis, and universal flu.  Our COVID-19 collaborations have advanced significantly in recent months with multiple partners targeting emergency or conditional authorization in the second half of 2021.  Importantly, these collaborations are now generating significant revenue for Dynavax, with first quarter CpG 1018 revenue of $74.6 million. Additionally, last week we expanded our agreement with CEPI whereby they fund manufacturing of CpG 1018 for future sales to CEPI grantees, providing the opportunity for additional revenue in 2021 from COVID-19 collaborations. The emerging portfolio of product opportunities with CpG 1018 has the potential to drive significant revenue growth beyond this year."

    HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted]

    • Net product revenue for HEPLISAV-B during the first quarter 2021 was $8.3 million compared to $10.5 million for the first quarter 2020, driven by increased market share offset by a reduction in vaccine utilization due to the COVID-19 pandemic.
    • Market share in accounts targeted by the field sales team increased to 27%, up from 21% market share in the first quarter of 2020.
    • Final immunogenicity and interim safety results of the ongoing clinical trial (HBV-24) evaluating HEPLISAV-B in patients undergoing hemodialysis evaluating a new 4-dose regimen of HEPLISAV-B demonstrated a seroprotection rate of 89.3%.  Interim safety data showed HEPLISAV-B is well tolerated and no safety concerns were observed. Full safety data are expected by the end of 2021.
    • Positive results from the post-marketing observational surveillance study (HBV-25) in over 69,000 patients demonstrated the study met the primary endpoint and showed no evidence of an increased risk of acute myocardial infarction associated with vaccination with HEPLISAV-B compared to Engerix-B.

    CpG 1018 (Advanced Vaccine Adjuvant)

    • Net product revenue for CpG 1018 during the first quarter 2021 was $74.6 million.
    • In February, Dynavax initiated a Phase 1 clinical trial of Tdap-1018, its tetanus, diphtheria, and acellular pertussis (Tdap) booster vaccine product candidate adjuvanted with CpG 1018.
    • In March, Clover Biopharmaceuticals dosed the first participant in SPECTRA, a global Phase 2/3 clinical trial for its trimeric SARS-CoV 2 spike (S) protein vaccine adjuvanted with CpG 1018.
    • In April, Valneva reported positive initial results for Part A of the Phase 1/2 clinical trial  of its VLA2001 COVID-19 vaccine candidate adjuvanted with CpG 1018 and subsequently initiated a pivotal Phase 3 clinical trial.
    • In April, Medigen published positive Phase 1 clinical study data demonstrating neutralizing antibody titers 1.8 to 3.9 times that of human convalescent sera for its COVID-19 vaccine candidate adjuvanted with CpG 1018 and has completed enrollment of over 4,000 participants in its on-going Phase 2 clinical trial.
    • In April, CEPI expanded its agreement with the Company to provide funding to manufacture CpG 1018 for its COVID-19 vaccine grantees, increasing total funding under the loan agreement from $99 million to $176 million.

    2021 Milestones

    • Multiple data readouts from our CpG 1018 COVID-19 collaboration partners throughout the year
    • Data from the ongoing Phase 1 clinical trial of Tdap-1018 in the fourth quarter
    • Launch HEPLISAV-B in the EU in the fourth quarter

    Financial Results

    Total Revenue. Total revenues for the first quarter of 2021 were $83.3 million, including $82.9 million of net product revenue, an increase from total revenue for the first quarter of 2020 of $10.9 million.

    Product Revenue, Net. HEPLISAV-B product revenue, net was $8.3 million in the first quarter of 2021 compared to $10.5 million in the same period in 2020. CpG 1018 product revenue, net was $74.6 million in the first quarter of 2021 compared to $0.0 million in the same period in 2020.

    Cost of Sales - Product. Cost of sales - product for the first quarter 2021 increased to $24.6 million, compared to $2.4 million for the first quarter of 2020. The increase was primarily due to manufacturing costs for CpG 1018.

    Research and Development Expenses (R&D). R&D expenses for the first quarter of 2021 increased to $7.8 million, compared to $4.7 million for the first quarter of 2020. The increase is primarily due to development activities related to process improvements at our Dusseldorf facility and higher headcount, partially offset by a decrease in business travel due to COVID-19 travel restrictions. In addition, non-cash stock-based compensation in the first quarter of 2020 included reversal of expenses related to cancellation of certain equity grants.

    Selling, General and Administrative Expenses (SG&A). SG&A expenses for the first quarter of 2021 increased to $22.4 million, compared to $20.9 million for the first quarter of 2020. Compensation and related personnel costs increased due to higher headcount and an accrual of benefits for a former executive in connection with his retirement, offset by the decrease in business travel due to COVID-19 travel restrictions.  Non-cash stock-based compensation increased due to higher headcount.

    Income from Operations and Net Income. Income from operations for the first quarter of 2021 was $28.5 million compared to a loss of $19.3 million in the first quarter of 2020. Net income for the first quarter of 2021 was $0.9 million compared to a net loss of $12.6 million for the first quarter of 2020. Basic and diluted net income per share was $0.01 for the first quarter of 2021, compared to a basic net loss of $0.15 per share and diluted net loss per share of $0.25 in the first quarter of 2020.

    Cash Position. Cash, cash equivalents and marketable securities totaled $232.7 million at March 31, 2021.

    Conference Call and Webcast Information

    Dynavax will hold a conference call today 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 www.dynavax.com. Alternatively, participants may dial (866) 420-4066 or (409) 217-8237 and refer to conference ID 4533398. A replay of the webcast will be available for 30 days following the live event.

    Please see Important Safety Information below.

    For more information about HEPLISAV-B, visit http://heplisavb.com.

    About Hepatitis B

    Hepatitis B is a viral disease of the liver that can become chronic and lead to cirrhosis, liver cancer and death. The hepatitis B virus is 50 to 100 times more infectious than HIV,i and transmission is on the rise. There is no cure for hepatitis B, but effective vaccination can prevent the disease.

    In adults, hepatitis B is spread through contact with infected blood and through unprotected sex with an infected person. The U.S. Centers for Disease Control (CDC) recommends vaccination for those at high risk for infection due to their jobs, lifestyle, living situations and travel to certain areas.ii Because people with diabetes are particularly vulnerable to infection, the CDC recommends vaccination for adults age 19 to 59 with diabetes as soon as possible after their diagnosis, and for people age 60 and older with diabetes at their physician's discretion.iii Approximately 20 million U.S. adults have diabetes, and 1.5 million new cases of diabetes are diagnosed each year.iv

    About HEPLISAV-B

    HEPLISAV-B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with Dynavax's proprietary Toll-like Receptor (TLR) 9 agonist CpG 1018 to enhance the immune response. Dynavax has worldwide commercial rights to HEPLISAV-B.

    Important U.S. Product Information

    HEPLISAV-B is indicated for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.

    Safety and effectiveness of HEPLISAV-B have not been established in adults on hemodialysis.

    For full U.S. Prescribing Information for HEPLISAV-B, click here.

    Important U.S. Safety Information (ISI)

    Do not administer HEPLISAV-B to individuals with a history of severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV-B. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV-B. Hepatitis B has a long incubation period. HEPLISAV-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration. The most common patient reported adverse reactions reported within 7 days of vaccination were injection site pain (23% to 39%), fatigue (11% to 17%) and headache (8% to 17%).

    Important EU/EEA Product Information

    HEPLISAV B is indicated for active immunisation against hepatitis B virus infection (HBV) caused by all known subtypes of hepatitis B virus in adults 18 years of age and older.

    The use of HEPLISAV B should be in accordance with official recommendations.

    It can be expected that hepatitis D will also be prevented by immunisation with HEPLISAV B as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.

    For full EU/EEA. Prescribing Information for HEPLISAV-B, click here.

    Important EU/EEA Safety information

    Do not receive HEPLISAV B if you have had a sudden life-threatening, allergic reaction after receiving HEPLISAV B in the past, or if you are allergic to any of components of this vaccine, including yeast. Signs of an allergic reaction may include itchy skin, rash, shortness of breath and swelling of the face or tongue.

    Appropriate medical treatment and supervision should be readily available in case of rare anaphylactic reactions following the administration of the vaccine.

    The administration of HEPLISAV B should be postponed in subjects suffering from acute severe febrile illness.

    Immunocompromised persons may have a diminished immune response to HEPLISAV B.

    Because of the long incubation period of hepatitis B, it is possible for unrecognised HBV infection to be present at the time of immunisation. HEPLISAV B may not prevent HBV infection in such cases.

    There are very limited data on the immune response to HEPLISAV B in individuals who did not mount a protective immune response to another hepatitis B vaccine.

    As a precautionary measure, it is preferable to avoid the use of HEPLISAV B during pregnancy. Vaccination during pregnancy should only be performed if the risk-benefit ratio at the individual level outweighs possible risks for the fetus.

    The most common patient-reported side effects reported within 7 days of vaccination were pain, swelling or redness at the injection site, feeling tired, headache, muscle aches, feeling unwell and fever.

    About CpG 1018 Adjuvant

    CpG 1018 is the adjuvant used in HEPLISAV-B. 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.

    Forward-Looking Statements

    This press release contains "forward-looking" statements, including statements regarding the potential for HEPLISAV-B to become the standard of care adult hepatitis B vaccine in the U.S., establishing CpG 1018 as a leading adjuvant, the development of vaccines containing CpG 1018 and potential future sales of CpG 1018, the timing of initiation and completion of  clinical studies and the publication of results, the timing of our collaborators seeking emergency use authorization of COVID-19 vaccines containing CpG 1018 adjuvant, our ability to scale manufacturing capacity, the expected demand for our products, our efforts to develop an improved pertussis vaccine, a vaccine for COVID-19, and a universal flu vaccine, entering into strategic relationships and expected results of such relationships, the potential for CpG 1018 to accelerate development and large scale manufacturing of a COVID-19 vaccine and sales potential under certain agreements. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including, the risk that HEPLISAV-B may not become the standard of care adult hepatitis B vaccine in the U.S., risks related to whether and when prescribers and other key decision-makers at potential purchasing entities will make the decision to switch to HEPLISAV-B, and the timing and quantity of actual purchases, risks related to the timing of completion and results of current clinical studies, risks that our collaborators will not get approval of their vaccine candidates, risks related to the development and pre-clinical and clinical testing of vaccines containing CpG 1018, and whether use of CpG 1018 will prove to be beneficial in these vaccines, risks related to whether, when and the quantity of CpG 1018 actually purchased by vaccine companies, risks related to the use of contract manufacturers to supply CpG 1018 and financial commitments made to them, 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:

    Nicole Arndt, Senior Manager, Investor Relations

    narndt@dynavax.com

    510-665-7264

    Derek Cole, President

    Investor Relations Advisory Solutions

    derek.cole@IRadvisory.com

    i CDC. https://www.cdc.gov/hepatitis/hbv/bfaq.htm.

    ii CDC. https://www.cdc.gov/hepatitis/hbv/hbvfaq.htm.

    iii CDC. https://www.cdc.gov/diabetes/pubs/pdf/hepb_vaccination.pdf.

    iv CDC. https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-r

     

    DYNAVAX TECHNOLOGIES CORPORATION

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (In thousands, except per share amounts)

    (Unaudited)



    Three Months Ended



    March 31,



    2021





    2020

    Revenues:













    Product revenue, net

    $

    82,885





    $

    10,514

    Other revenue



    450







    405

    Total revenues



    83,335







    10,919















    Operating expenses:













    Cost of sales – product



    24,625







    2,354

    Cost of sales - amortization of intangible assets



    -







    2,298

    Research and development



    7,758







    4,653

    Selling, general and administrative



    22,423







    20,926

    Total operating expenses



    54,806







    30,231















    Income (loss) from operations



    28,529







    (19,312)















    Other income (expense):













    Interest income



    47







    590

    Interest expense



    (4,712)







    (4,731)

    Sublease income



    2,022







    1,926

    Change in fair value of warrant liability



    (25,552)







    8,610

    Other



    557







    322

    Net income (loss)

    $

    891





    $

    (12,595)

    Basic net income (loss) per share

    $

    0.01





    $

    (0.15)

    Weighted average shares used to compute basic net income (loss) per share



     

    112,035







     

    85,477

    Diluted net income (loss) per share

    $

    0.01





    $

    (0.25)

    Weighted average shares used to compute diluted net income (loss) per share



     

    113,469







     

    85,648

     

    DYNAVAX TECHNOLOGIES CORPORATION

    SELECTED BALANCE SHEET DATA

    (In thousands)

    (Unaudited)

     





    March 31,





    December 31,







    2021





    2020



    Assets

















    Cash, cash equivalents and marketable securities



    $

    232,674





    $

    165,036



    Inventories, net





    68,846







    63,689



    Property and equipment, net





    30,696







    30,567



    Operating lease right-of-use assets





    25,799







    26,583



    Goodwill





    2,197







    2,297



    Other assets





    129,907







    65,100



    Total assets



    $

    490,119





    $

    353,272





















    Liabilities and stockholders' equity

















    Total current liabilities



    $

    109,422





    $

    77,411



    Total long-term liabilities





    280,935







    217,168



    Stockholders' equity





    99,762







    58,693



    Total liabilities and stockholders' equity



    $

    490,119





    $

    353,272



     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/dynavax-announces-first-quarter-2021-financial-results-301285853.html

    SOURCE Dynavax Technologies

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  27. EMERYVILLE, Calif., May 4, 2021 /PRNewswire/ -- Dynavax Technologies Corporation (NASDAQ:DVAX) today reported that it has granted nonstatutory stock options to purchase an aggregate of 148,500 shares of Dynavax common stock as inducements to seven newly-hired employees in connection with commencement of employment with the Company.

    The stock options were granted on May 3, 2021 at an exercise price of $9.74 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 employment 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 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 

    narndt@dynavax.com 

    510-665-7264

    Derek Cole, President 

    Investor Relations Advisory Solutions 

    derek.cole@IRadvisory.com

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/dynavax-reports-inducement-grants-under-nasdaq-listing-rule-5635c4-301283645.html

    SOURCE Dynavax Technologies

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  28. EMERYVILLE, Calif., April 27, 2021 /PRNewswire/ -- Dynavax Technologies Corporation (NASDAQ:DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, today announced the results of the post-marketing study assessing the rates of occurrence of acute myocardial infarction (AMI) in persons receiving HEPLISAV-B compared with Engerix-B. The results were selected for an oral presentation at the National Foundation for Infectious Diseases (NFID) 2021 Annual Conference on Vaccinology Research (ACVR), a premier forum for the exchange of scientific and clinical knowledge in vaccinology, being held virtually April 26-27, 2021.

    The post-marketing observational, non-inferiority surveillance study (HBV-25) evaluated the…

    EMERYVILLE, Calif., April 27, 2021 /PRNewswire/ -- Dynavax Technologies Corporation (NASDAQ:DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, today announced the results of the post-marketing study assessing the rates of occurrence of acute myocardial infarction (AMI) in persons receiving HEPLISAV-B compared with Engerix-B. The results were selected for an oral presentation at the National Foundation for Infectious Diseases (NFID) 2021 Annual Conference on Vaccinology Research (ACVR), a premier forum for the exchange of scientific and clinical knowledge in vaccinology, being held virtually April 26-27, 2021.

    The post-marketing observational, non-inferiority surveillance study (HBV-25) evaluated the occurrence of AMI in approximately 31,000 patients who received HEPLISAV-B® and approximately 38,000 patients who received Engerix-B. The AMI rate per 1000 person years was 1.67 for HEPLISAV-B and 1.86 for Engerix-B. The hazard ratio comparing the rate of AMI in the HEPLISAV-B group with the Engerix-B group was 0.92 with a 95% confidence interval of 0.63 to 1.32. The upper bound of the 95% confidence interval of the hazard ratio comparing the rate of AMI in the HEPLISAV-B group to the Engerix-B group was less than 2.0, meeting the primary endpoint. Thus, these results provide evidence there is no increased risk of AMI associated with vaccination with HEPLISAV-B compared to Engerix-B. The study was conducted by Kaiser Permanente Southern California's Center for Vaccine Safety and Effectiveness.

    "These results reinforce our previous clinical data regarding the safety of HEPLISAV-B and support our confidence in its ability to prevent hepatitis B infection in adults," commented Robert Janssen, MD, Chief Medical Officer. "We are pleased to collaborate with Kaiser Permanente Southern California's Center for Vaccine Safety and Effectiveness and appreciate their rigorous conduct of this study."

    Abstract presentations are available for on-demand viewing for registered attendees April 26, 2021, through June 30, 2021. A conference virtual Oral Abstract Q&A Session is scheduled for Tuesday, April 27, 2021, from 3:00 – 4:00pm ET.

    About the Annual Conference on Vaccinology Research (ACVR)

    Sponsored by the National Foundation for Infectious Diseases (NFID) for more than 20 years, the Annual Conference for Vaccinology Research (ACVR) is a well-established forum for the exchange of the latest scientific and clinical research in vaccinology between healthcare professionals, trainees and young investigators, government officials, and representatives from industry and academia. The 2021 ACVR sponsored by NFID will be held virtually on April 26-27, 2021. Visit www.nfid.org/acvr for more information.

    Please see Important Safety Information below.

    For more information about HEPLISAV-B, visit http://heplisavb.com

    About Hepatitis B

    Hepatitis B is a viral disease of the liver that can become chronic and lead to cirrhosis, liver cancer, and death. The hepatitis B virus is 50 to 100 times more infectious than HIV,i and transmission is on the rise. There is no cure for hepatitis B but effective vaccination can prevent the disease.

    In adults, hepatitis B is spread through contact with infected blood and through unprotected sex with an infected person. The CDC recommends vaccination for those at high risk for infection due to their jobs, lifestyle, living situations and travel to certain areas.ii Because people with diabetes are particularly vulnerable to infection, the CDC recommends vaccination for adults age 19 to 59 years with diabetes as soon as possible after their diagnosis, and for people age 60 years and older with diabetes at their physician's discretion.iii Approximately 20 million U.S. adults have diabetes and 1.5 million new cases of diabetes are diagnosed each year.iv

    About HEPLISAV-B

    HEPLISAV-B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with Dynavax's proprietary Toll-like Receptor (TLR) 9 agonist CpG 1018 to enhance the immune response. Dynavax has worldwide commercial rights to HEPLISAV-B.

    Indication and Use

    HEPLISAV-B is indicated for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.

    Important Safety Information (ISI)

    Do not administer HEPLISAV-B to individuals with a history of severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV-B. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV-B. Hepatitis B has a long incubation period. HEPLISAV-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration. The most common patient reported adverse reactions reported within 7 days of vaccination were injection site pain (23% to 39%), fatigue (11% to 17%) and headache (8% to 17%).

    For full Prescribing Information for HEPLISAV-B, click here.

    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 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 its 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.

    Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the observational comparative study.  These forward-looking statements are based upon management's current expectations, are subject to known and unknown risks, and involve assumptions that may never materialize or may prove to be incorrect.  Actual results and the timing of events may differ materially from those anticipated in such forward-looking statements due to various risks and uncertainties inherent in our business, including, without limitation; the risk that prescribers and other key decision-makers at potential purchasing entities may not make the decision to switch to or continue prescribing HEPLISAV-B; risks related to market adoption and competing therapies; and risks related to whether payors will cover and provide timely and adequate reimbursement for HEPLISAV-B. These and other risks are described in the "Risk Factors" section of our most recent periodic report, 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.

    Contacts:

    Nicole Arndt, Senior Manager, Investor Relations

    narndt@dynavax.com 

    510-665-7264

    Derek Cole, President

    Investor Relations Advisory Solutions

    derek.cole@IRadvisory.com

    i CDC. https://www.cdc.gov/hepatitis/hbv/bfaq.htm.

    ii CDC. https://www.cdc.gov/hepatitis/hbv/hbvfaq.htm.

    iii CDC. https://www.cdc.gov/diabetes/pubs/pdf/hepb_vaccination.pdf.

    iv CDC. https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf.

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  29. EMERYVILLE, Calif., April 22, 2021 /PRNewswire/ -- Dynavax Technologies Corporation (NASDAQ:DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, will report first quarter 2021 financial results on Thursday, May 6, 2021, after the U.S. financial markets close.

    Dynavax will host a conference call and live audio webcast on Thursday, May 6, 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 4533398.  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

    narndt@dynavax.com 

    510-665-7264

    Derek Cole, President

    Investor Relations Advisory Solutions

    derek.cole@IRadvisory.com

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/dynavax-to-report-first-quarter-2021-financial-results-and-host-conference-call-on-may-6-2021-301275359.html

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  30. EMERYVILLE, Calif., April 21, 2021 /PRNewswire/ -- Dynavax Technologies Corporation (NASDAQ:DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, today announced Valneva SE has initiated a pivotal Phase 3 clinical trial for its inactivated, COVID-19 vaccine candidate, VLA2001, using Dynavax's CpG 1018 adjuvant.  The Phase 3 trial "Cov-Compare", (VLA2001-301), will compare Valneva's SARS-CoV-2 vaccine candidate, VLA2001, against AstraZeneca's conditionally approved vaccine, Vaxzevria, in a comparative immunogenicity trial.

    The initiation of the Cov-Compare trial follows positive initial results from Valneva's Phase 1/2 clinical trial, which demonstrated that the safety profile and immunogenicity were supportive of further development.

    Ryan Spencer, Chief Executive Officer of Dynavax commented: "We are excited to see the rapid initiation of the comparative Phase 3 clinical trial, providing an opportunity for Valneva's inactivated whole virus vaccine candidate adjuvanted with CpG 1018 to demonstrate superior immunogenicity with respect to the comparator. We are proud to be collaborating with Valneva on the development of this vaccine for COVID-19 and are committed to supporting Valneva in making the vaccine available."

    Cov-Compare (VLA2001-301) is a randomized, observer-blind, controlled, comparative immunogenicity trial in approximately 4,000 adults. Its primary objective is to demonstrate the superiority of VLA2001 compared to Vaxzevria administered in a two-dose immunization schedule four weeks apart, in terms of Geometric Mean Titer ratio of SARS-CoV-2-specific neutralizing antibodies at two weeks after the second vaccination (i.e. Day 43) in adults aged 30 years and older. It will also evaluate the safety and tolerability of VLA2001 at two weeks after the second vaccination in adults aged 18 years and older.

    The trial will be conducted at approximately 25 sites in the U.K. and is supported by the U.K. National Institute for Health Research. Approximately 3,000 participants 30 years of age and older will be randomized in a 2:1 ratio to receive two intramuscular doses of either VLA2001 (n=2,000) or Vaxzevria (n=1,000) at the recommended dose level, 28 days apart, on Days 1 and 29. For immunogenicity analyses, samples from approximately 1,200 participants (600 per group) who have been tested sero-negative for SARS-CoV-2 at screening will be analyzed. Approximately 1,000 participants that are under 30 years of age will be placed in a non-randomized treatment group and receive VLA2001 28 days apart.

    Subject to successful Phase 3 data, Valneva intends to make a regulatory submission in the autumn of 2021 for initial approval.

    About VLA2001

    VLA2001 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 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. The process includes inactivation with BPL to preserve the native structure of the S-protein. Valneva expects VLA2001 to conform with standard cold chain requirements (2 degrees to 8 degrees Celsius).

    About CpG 1018 Adjuvant

    CpG 1018 adjuvant is 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 Medicines Agency. 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 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 its 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 Forward Looking Statements

    This press release contains "forward-looking statements", including statements regarding the potential development (including but not limited to the timing and potential outcome) of the Phase 3 clinical trial of VLA-2001, regulatory submission and importance of a COVID-19 vaccine containing CpG 1018 adjuvant, the potential of the platform to address variants, and the evaluation of the other trials. 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, dose selection, the results of clinical trials, whether and when the vaccine containing CpG 1018 adjuvant will be approved for use, whether and when purchases of CpG 1018 adjuvant will occur, and the ability to manufacture sufficient supply to meet the purchase needs, as well as other risks detailed in the "Risks 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 obligations to revise or update information herein to reflect events or circumstances in the future, even if now 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:

    Nicole Arndt, Senior Manager, Investor Relations

    narndt@dynavax.com 

    510-665-7264

    Derek Cole, President

    Investor Relations Advisory Solutions

    derek.cole@IRadvisory.com 

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/valneva-initiates-pivotal-phase-3-clinical-trial-for-its-inactivated-covid-19-vaccine-candidate-using-dynavaxs-cpg-1018-adjuvant-301274236.html

    SOURCE Dynavax Technologies

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  31. Saint-Herblain (France), April 21, 2021Valneva SE, a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, today announced it has initiated a pivotal Phase 3 clinical trial for its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001.

    The Phase 3 trial "Cov-Compare", (VLA2001-301), will compare Valneva's SARS-CoV-2 vaccine candidate, VLA2001, against AstraZeneca's conditionally approved vaccine, Vaxzevria1, in a comparative immunogenicity trial.

    Approximately 4,000 participants will receive two doses of either vaccine. The primary endpoint of Cov-Compare will be to determine the immune response (Geometric Mean Titer (GMT)) of…

    Saint-Herblain (France), April 21, 2021Valneva SE, a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, today announced it has initiated a pivotal Phase 3 clinical trial for its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001.

    The Phase 3 trial "Cov-Compare", (VLA2001-301), will compare Valneva's SARS-CoV-2 vaccine candidate, VLA2001, against AstraZeneca's conditionally approved vaccine, Vaxzevria1, in a comparative immunogenicity trial.

    Approximately 4,000 participants will receive two doses of either vaccine. The primary endpoint of Cov-Compare will be to determine the immune response (Geometric Mean Titer (GMT)) of SARS-CoV-2-specific neutralizing antibodies) two weeks after completion of a two-dose immunization schedule administered in a four-week interval. The trial is powered to demonstrate superiority of VLA2001 in terms of GMT ratio (VLA2001/Vaxzevria). The trial will be conducted in the U.K. and is supported by the National Institute for Health Research (NIHR).

    Adam Finn, Chief investigator for the VLA 2001-301 program, Professor of Paediatrics at the University of Bristol and Consultant at the Bristol Royal Hospital for Children said, "Following very encouraging safety and immune response results from our Phase 1/2 trial, along with my investigator colleagues, I am really looking forward to starting on this important next stage of the clinical development of this important new vaccine. We definitely need more vaccines to help us out of this pandemic and this one is a very promising candidate."

    Thomas Lingelbach, Chief Executive Officer of Valneva, commented, "This Phase 3 initiation marks a significant milestone in the development of the only inactivated vaccine candidate against COVID-19 in clinical trials in Europe. As COVID-19 continues to impact people's daily lives, we remain fully focused on developing another safe and efficacious vaccine solution. We believe that VLA2001 has an important role to play including boosters or potential modifications to the vaccine to address variants. While Cov-Compare is progressing we are planning to conduct additional, complementary trials."

    UK Minister for COVID-19 Vaccine Deployment, Nadhim Zahawi, added, "The UK has been at the forefront of cutting-edge innovation throughout this pandemic, with Valneva's vaccine set to be made in Scotland, if approved. We have an incredible infrastructure in place for trialing these extraordinary medical advances, and I am delighted the UK will be home to another promising vaccine trial. I've taken part in a vaccine clinical trial myself and would urge all those thinking about signing up to go for it, and to play a part in helping protect your loved ones and saving lives."

    The initiation of the Cov-Compare trial follows the announcement of initial results from Valneva's Phase 1/2 clinical trial, which demonstrated that the safety profile and immunogenicity were supportive of further development2. Subject to successful Phase 3 data, Valneva aims to make regulatory submissions for initial approval in the autumn of 2021.

    About the Novel Coronavirus SARS-CoV-2 and COVID-19 Disease

    SARS-CoV-2 is a new coronavirus identified in late 2019 and belongs to a family of enveloped RNA viruses that include MERS and SARS, both of which caused serious human infections of the respiratory system. The virus, which causes a disease named COVID-19, has never before been found in humans. Since this outbreak was first reported, the virus has caused millions of deaths globally3. It has been declared a pandemic by the World Health Organization (WHO).

    About Phase 3 Trial Cov-Compare (VLA2001-301)

    Cov-Compare (VLA2001-301) is a randomized, observer-blind, controlled, comparative immunogenicity trial in approximately 4,000 Adults.

    Primary objectives are to demonstrate the superiority of VLA2001 compared to Vaxzevria administered in a two-dose immunization schedule four weeks apart, in terms of Geometric Mean Titer ratio of SARS-CoV-2-specific neutralizing antibodies at two weeks after the second vaccination (i.e. Day 43) in adults aged 30 years and older. It will also evaluate the safety and tolerability of VLA2001 at two weeks after the second vaccination in adults aged 18 years and older.

    The trial will be conducted at approximately 25 sites in the U.K. Approximately 3,000 participants 30 years of age and older will be randomized in a 2:1 ratio to receive two intramuscular doses of either VLA2001 (n=2,000) or Vaxzevria (n=1,000) at the recommended dose level, 28 days apart, on Days 1 and 29. For immunogenicity analyses, samples from approximately 1,200 participants (600 per group) who have been tested sero-negative for SARS-CoV-2 at screening will be analyzed. Approximately 1,000 participants that are under 30 years of age will be placed in a non-randomized treatment group and receive VLA2001 28 days apart.

    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 Valneva SE

    Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. We take a highly specialized and targeted approach to vaccine development, beginning with the identification of deadly and debilitating infectious diseases that lack a prophylactic vaccine solution and for which there are limited therapeutic treatment options. We then apply our deep understanding of vaccine science, including our expertise across multiple vaccine modalities, as well as our established vaccine development capabilities, to develop prophylactic vaccines to address these diseases. We have leveraged our expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

     



    Valneva Investor and Media Contacts

    Laetitia Bachelot-Fontaine

    Director Investor Relations & Corporate Communications

    M +33 (0)6 4516 7099

    investors@valneva.com

            
     



     



    Dan Sharp

    Government & Public Affairs Manager

    T +44-(0)7436-244309

    communications@valneva.com
     



            
     



     

    Valneva 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 Approved by MHRA under reg. 174 and by the European Commission as conditional approval

    2 Valneva Reports Positive Phase 1/2 Data for Its Inactivated, Adjuvanted COVID-19 Vaccine Candidate, VLA2001

    3 https://www.worldometers.info/coronavirus/

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  32. Saint-Herblain (France), April 20, 2021Valneva SE, a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, today announced it is now focusing on bilateral discussions, on a country by country basis, to supply its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001, and is consequently deprioritizing the ongoing centralized discussions with the European Commission (EC).

    This follows the recent announcement on April 6, 2021 of positive initial results from the Phase 1/2 clinical trial of VLA20011.

    Valneva previously announced the advanced stage of its discussions, which started in the third quarter of 2020, with the EC on January…

    Saint-Herblain (France), April 20, 2021Valneva SE, a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, today announced it is now focusing on bilateral discussions, on a country by country basis, to supply its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001, and is consequently deprioritizing the ongoing centralized discussions with the European Commission (EC).

    This follows the recent announcement on April 6, 2021 of positive initial results from the Phase 1/2 clinical trial of VLA20011.

    Valneva previously announced the advanced stage of its discussions, which started in the third quarter of 2020, with the EC on January 12, 20212. In September 2020, Valneva announced a collaboration with the UK government to provide up to 190 million doses of VLA2001 through 20253, of which 100 million doses have already been ordered.

    Thomas Lingelbach, Chief Executive Officer of Valneva, said, "We've committed significant time and effort to try to meet the needs of the central EC procurement process. Despite our recent clinical data, we have not made meaningful progress and have not yet secured a supply agreement. We are therefore now focusing our efforts on those European Union member states, and interested parties outside the EU, who would like to include our inactivated approach within their vaccination strategy. We are convinced that VLA2001 has an important role to play in the future, including boosters or potential modifications to the vaccine to address variants".

    Valneva has the only inactivated vaccine candidate in clinical trials against COVID-19 in Europe and is preparing a pivotal, comparative immunogenicity Phase 3 clinical trial expected to commence by the end of April 2021 with the aim of making regulatory licensure submissions in the autumn of 2021.

    About the Novel Coronavirus SARS-CoV-2 and COVID-19 Disease

    SARS-CoV-2 is a new coronavirus identified in late 2019 and belongs to a family of enveloped RNA viruses that include MERS and SARS, both of which caused serious human infections of the respiratory system. The virus, which causes a disease named COVID-19, has never before been found in humans. Since this outbreak was first reported, the virus has caused millions of deaths globally4. It has been declared a pandemic by the World Health Organization (WHO).

    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 Valneva SE

    Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. We take a highly specialized and targeted approach to vaccine development, beginning with the identification of deadly and debilitating infectious diseases that lack a prophylactic vaccine solution and for which there are limited therapeutic treatment options. We then apply our deep understanding of vaccine science, including our expertise across multiple vaccine modalities, as well as our established vaccine development capabilities, to develop prophylactic vaccines to address these diseases. We have leveraged our expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

     



    Valneva Investor and Media Contacts

    Laetitia Bachelot-Fontaine

    Director Investor Relations & Corporate Communications

    M +33 (0)6 4516 7099

    investors@valneva.com

            
     



     



    Dan Sharp

    Government & Public Affairs Manager

    T +44-(0)7436-244309

    communications@valneva.com
     



            
     



     

    Valneva 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, timing and volume expectations with respect to the manufacture of our product candidates; the ability to market, commercialize and achieve market acceptance for product candidates, the ability to protect intellectual property and operate the business without infringing on the intellectual property rights of others, estimates for future performance and estimates regarding anticipated operating losses, future revenues, capital requirements and needs for additional financing. 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 Reports Positive Phase 1/2 Data for Its Inactivated, Adjuvanted COVID-19 Vaccine Candidate, VLA2001

    2 Valneva in Advanced Discussions with European Commission to Supply up to 60 Million Doses of Inactivated, Adjuvanted COVID-19 Vaccine Candidate

    3 Valneva Announces Major COVID-19 Vaccine Partnership with U.K. Government

    4 https://www.worldometers.info/coronavirus/

     

     

     

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  33. EMERYVILLE, Calif., April 19, 2021 /PRNewswire/ -- Dynavax Technologies Corporation (NASDAQ:DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, today announced that two HEPLISAV-B abstracts have been selected for oral presentation at the 2021 Annual Conference on Vaccinology Research (ACVR).

    "An Open-label, Single-Arm Study Evaluating the Immunogenicity and Safety of the Hepatitis B Vaccine HEPLISAV-B® in Adults Receiving Hemodialysis" reviews immunogenicity and safety data in adults receiving dialysis from the open-label, single-arm trial (HBV-24) evaluating a new 4-dose regimen of HEPLISAV-B in adults with end-stage renal disease (ESRD) who are undergoing hemodialysis and have not previously received a hepatitis B vaccine.

    "Post-licensure safety study of an adjuvanted hepatitis B vaccine" reviews final results from the post-marketing observational surveillance study (HBV-25) evaluating the occurrence of acute myocardial infarction (AMI) in more than 30,000 patients who received HEPLISAV-B® and more than 30,000 patients who received another hepatitis B vaccine. The study was conducted at Kaiser Permanente Southern California's Center for Vaccine Safety and Effectiveness.

    Abstract presentations will be available for on-demand viewing for registered attendees beginning April 26, 2021, through June 30, 2021. A conference virtual Oral Abstract Q&A Session is scheduled for Tuesday, April 27, 2021, from 3:00 – 4:00pm ET.

    About the Annual Conference on Vaccinology Research (ACVR)

    Sponsored by the National Foundation for Infectious Diseases (NFID) for more than 20 years, the Annual Conference for Vaccinology Research (ACVR) is a well-established forum for the exchange of the latest scientific and clinical research in vaccinology between healthcare professionals, trainees and young investigators, government officials, and representatives from industry and academia. The 2021 ACVR sponsored by NFID will be held virtually on April 26-27, 2021. Visit www.nfid.org/acvr for more information.

    About Hepatitis B

    Hepatitis B is a viral disease of the liver that can become chronic and lead to cirrhosis, liver cancer and death. The hepatitis B virus is 50 to 100 times more infectious than HIV,i and transmission is on the rise. There is no cure for hepatitis B, but effective vaccination can prevent the disease.

    In adults, hepatitis B is spread through contact with infected blood and through unprotected sex with an infected person. The U.S. Centers for Disease Control (CDC) recommends vaccination for those at high risk for infection due to their jobs, lifestyle, living situations and travel to certain areas.ii Because people with diabetes are particularly vulnerable to infection, the CDC recommends vaccination for adults age 19 to 59 with diabetes as soon as possible after their diagnosis, and for people age 60 and older with diabetes at their physician's discretion.iii Approximately 20 million U.S. adults have diabetes, and 1.5 million new cases of diabetes are diagnosed each year.iv

    About HEPLISAV-B

    HEPLISAV-B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with Dynavax's proprietary Toll-like Receptor (TLR) 9 agonist CpG 1018® adjuvant to enhance the immune response. Dynavax has worldwide commercial rights to HEPLISAV-B.

    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 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 its 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

    narndt@dynavax.com 

    510-665-7264

    Derek Cole, President

    Investor Relations Advisory Solutions

    derek.cole@IRadvisory.com

    i CDC. https://www.cdc.gov/hepatitis/hbv/bfaq.htm.

    ii CDC. https://www.cdc.gov/hepatitis/hbv/hbvfaq.htm.

    iii CDC. https://www.cdc.gov/diabetes/pubs/pdf/hepb_vaccination.pdf.

    iv CDC. https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-r

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/two-heplisav-b-abstracts-selected-for-oral-presentation-at-the-2021-annual-conference-on-vaccinology-research-acvr-301271856.html

    SOURCE Dynavax Technologies

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  34. EMERYVILLE, Calif., April 6, 2021 /PRNewswire/ -- Dynavax Technologies Corporation (NASDAQ:DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, today announced that Valneva SE reported positive initial results for Part A of the Phase 1/2 clinical trial of Valneva's inactivated COVID-19 vaccine candidate, VLA2001, using Dynavax's  CpG 1018™ adjuvant in 153 healthy adults aged 18 to 55 years. Based on these results, Valneva plans to commence a pivotal Phase 3 clinical trial by the end of April 2021, subject to regulatory approval.

    In their press release issued April 6th, 2021 (available here), Valneva reported that VLA2001 was generally safe and well tolerated across all dose groups tested and was highly immunogenic with a seroconversion rate for S-protein binding IgG antibodies of 100% in the high dose group. The IgG antibody response was highly correlated with neutralization titers in a micro-neutralization assay.  The geometric mean titer of neutralizing antibodies measured two weeks after completion of the two-dose schedule in this group was at or above levels for a panel of convalescent sera.  

    Ryan Spencer, Chief Executive Officer Dynavax, said, "We are excited to see the positive results Valneva has generated with their inactivated vaccine using Dynavax's CpG 1018 adjuvant. We believe the effect delivered by our CpG 1018 adjuvant combined with Valneva's existing manufacturing process for whole virus inactivated vaccines will result in an important option in the global fight against COVID-19. This platform has potential to allow rapid modifications to the vaccine as needed to address variants using Valneva's existing manufacturing process."

    Valneva plans to initiate a pivotal, comparative immunogenicity Phase 3 clinical trial with the high dose formulation by the end of April 2021. Other trials, including booster trials, involving antigen sparing doses will also be evaluated.

    About VLA2001

    VLA2001 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 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. The process includes inactivation with BPL to preserve the native structure of the S-protein. Valneva expects VLA2001 to conform with standard cold chain requirements (2 degrees to 8 degrees Celsius).

    About CpG 1018 Adjuvant

    CpG 1018 adjuvant is 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 Medicines Agency. 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 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 its 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 Forward-Looking Statements

    This press release contains "forward-looking" statements, including statements regarding the potential development (including the timing for a Phase 3 clinical trial and regulatory submission) and importance of a COVID-19 vaccine containing CpG 1018 adjuvant, the potential of the platform to address variants, and the evaluation of other trials.  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, dose selection, the results of clinical trials, whether and when the vaccine containing CpG 1018 adjuvant will be approved for use, whether and when purchases of CpG 1018 adjuvant will occur, and the ability to manufacture sufficient supply to meet the purchasing needs, 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.

    Dynavax Contacts:

    Nicole Arndt, Senior Manager, Investor Relations

    narndt@dynavax.com

    510-665-7264

    Derek Cole, President

    Investor Relations Advisory Solutions

    derek.cole@IRadvisory.com

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/positive-phase-12-results-for-valnevas-inactivated-covid-19-vaccine-candidate-using-dynavaxs-cpg-1018-adjuvant-301262647.html

    SOURCE Dynavax Technologies

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  35.  

    • VLA2001 was well tolerated with no safety concerns identified
       
    • In the high dose group :
       
      • IgG seroconversion rate of 100%
         
      • Neutralizing antibody titres at or above levels generally seen in convalescent sera.

    Saint-Herblain (France), April 6, 2021Valneva SE, a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, today announced positive data for Part A of the Phase 1/2 clinical trial of its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001. Based on this data, the Company plans to commence a Phase 3 clinical trial by the end of April 2021, subject to regulatory approval.

    In study VLA2001-201, three dose levels of VLA2001…



     

    • VLA2001 was well tolerated with no safety concerns identified

       
    • In the high dose group :

       
      • IgG seroconversion rate of 100%

         
      • Neutralizing antibody titres at or above levels generally seen in convalescent sera.

    Saint-Herblain (France), April 6, 2021Valneva SE, a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, today announced positive data for Part A of the Phase 1/2 clinical trial of its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001. Based on this data, the Company plans to commence a Phase 3 clinical trial by the end of April 2021, subject to regulatory approval.

    In study VLA2001-201, three dose levels of VLA2001 (low, medium, high), based on a schedule of two doses with vaccinations three weeks apart, were evaluated in 153 healthy adults aged 18 to 55 years.

    VLA2001 was generally safe and well tolerated across all dose groups tested, with no safety concerns identified by an independent Data Safety Monitoring Board. There were no statistically significant differences between dose groups and no differences between first and second vaccinations in terms of reactogenicity. The majority of Adverse Events (AEs) were mild or moderate and only two subjects reported severe solicited AEs (headache and fatigue). All solicited AEs were transient. Only 17.6% of unsolicited AEs up to day 36 were considered related to the vaccine and no severe unsolicited AEs were reported. No serious related AEs were reported.

    VLA2001 was highly immunogenic with more than 90% of all study participants developing significant levels of antibodies to the SARS-CoV-2 virus spike protein across all dose groups tested. Seroconversion Rates (SCR) for S-protein binding IgG antibodies were 89.8% in the medium dose and 100% in the high dose group. Two weeks after completion of the two dose schedule, Geometric Mean Fold Rise (GMFR) from baseline were 26 in the medium dose and 86 in the high dose group.

    Of note, the IgG antibody response was highly correlated with neutralization titres in a micro-neutralization assay (MNA50) (r=0.79, p<0.001).

    VLA2001 induced a dose dependent response with statistically significant higher Geometric Mean Titres (GMTs) for both IgG and neutralizing antibodies in the high dose group compared to the low and medium dose groups. In the high dose group, the GMT of neutralizing antibody titres measured two weeks after completion of the two-dose schedule was at or above levels for a panel of convalescent sera (GMT 530.4 (95% CI: 421.49, 667.52)).

    With a GMT ratio of vaccine vs. convalescent sera ≥ 1, vaccine efficacy has been reported above 80% for other vaccines1.

    VLA2001 induced broad T-cell responses across participants with antigen-specific IFN-gamma producing T-cells against the S-protein, M and N protein detected in 75.6 %, 35.6% and 48.9% of study participants, respectively.

    Thomas Lingelbach, Chief Executive Officer of Valneva, said: "We are extremely pleased with these results which take us a step closer to providing an inactivated vaccine to help the global fight against COVID-19. The world needs multiple vaccines as well as booster options. Given the potential advantages often associated with inactivated whole virus vaccines, we believe that VLA2001 has an important role to play. This includes potential modifications to the vaccine to address variants, using our existing manufacturing process. I want to thank everyone involved in the ongoing work. We could not have achieved this milestone without them."

    Health and Social Care Secretary, Matt Hancock said: "The U.K. government has funded these clinical trials and it is fantastic to see Valneva's vaccine produces a strong immune response. This vaccine will be made onshore in Livingston in Scotland, giving another boost to British life science, and if approved will play an important role in protecting our communities. I look forward to seeing the results of the upcoming phase 3 trial."

    Vaccines Minister Nadhim Zahawi said:  "These results are very promising and provide renewed hope that a vaccine using a whole inactivated virus might provide strong protection against variants. If the results from the phase 3 clinical trials are positive and the vaccine meets the robust standards of safety, quality and effectiveness of our medicines regulator, the MHRA, this will be another powerful weapon in our arsenal to beat this pandemic. The government has funded the clinical trials for this promising vaccine and, if approved, it will be manufactured in Scotland, boosting the UK's ability to become more self-sufficient in the future."

    Clive Dix, Chair of the Vaccines Taskforce said: "These are great results from Valneva, particularly around the antibody and cellular responses generated and low numbers of adverse events, as these indicate good levels of immune responses among the participants to date. The findings of 100% levels of immunogenicity against the viral spike protein in the high-dose group is also encouraging. Inactivated virus vaccines are proven technologies that are often able to induce wide-ranging immune responses, and these promising data indicate that VLA2001 may continue this trend. We are hopeful of seeing good results from the upcoming Phase 3 trials, and look forward to continuing working closely with Valneva on their vaccine."

    Based on the data assessed, the Company has decided to advance the high dose into the Phase 3 clinical trial. Other trials, including booster trials, involving antigen sparing doses will also be evaluated.

    The Company continues to work closely with the UK Government to review plans including potential variant vaccine development and supply as well as meeting the UK's booster campaign requirements acknowledging the ongoing vaccine roll out in the UK. As a result, Valneva now believes that the timeline for delivery of 60 million doses of vaccine to the UK Government will extend into the first quarter of 2022. Based on the Phase 1/2 data, the Company is also investigating antigen sparing options for booster strategies. Overall capacity and delivery schedule will be dependent on the UK's vaccine requirements and production related factors.

    Valneva plans to initiate a pivotal, comparative immunogenicity Phase 3 clinical trial by the end of April 2021 with the aim of making a regulatory licensure submission to the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom in the autumn 2021. Discussions with other regulatory bodies are ongoing.

    In parallel, Valneva has initiated the development of new variant based viral seed banks.

    About the Novel Coronavirus SARS-CoV-2 and COVID-19 Disease

    SARS-CoV-2 is a new coronavirus identified in late 2019 and belongs to a family of enveloped RNA viruses that include MERS and SARS, both of which caused serious human infections of the respiratory system. The virus, which causes a disease named COVID-19, has never before been found in humans. Since this outbreak was first reported, the virus has caused millions of deaths globally2. It has been declared a pandemic by the World Health Organization (WHO).

    About VLA2001-201

    VLA2001-201 is a randomized, dose-finding study to evaluate the safety, tolerability and immunogenicity of the inactivated, adjuvanted SARS-CoV-2 virus vaccine candidate VLA2001, against COVID-19 in healthy subjects. VLA2001-201 is the first-in-human Phase 1/2 study evaluating three dose levels of VLA2001 (low, medium, high) for safety, tolerability and immunogenicity in a two-dose schedule with intra muscular vaccinations three weeks apart. Overall, 153 healthy young adults aged 18 to 55 years have been recruited in the study. VLA2001-201 is being conducted in two parts: Part A (Day 1 to Day 36) and Part B (Day 37 to Day 208).

    This report is independent research paid for by the Department of Health and Social Care. The views expressed in this publication are those of the author(s) and not necessarily those of the Department of Health and Social Care.

    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 Valneva SE

    Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. We take a highly specialized and targeted approach to vaccine development, beginning with the identification of deadly and debilitating infectious diseases that lack a prophylactic vaccine solution and for which there are limited therapeutic treatment options. We then apply our deep understanding of vaccine science, including our expertise across multiple vaccine modalities, as well as our established vaccine development capabilities, to develop prophylactic vaccines to address these diseases. We have leveraged our expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

     



    Valneva Investor and Media Contacts

    Laetitia Bachelot-Fontaine

    Director Investor Relations & Corporate Communications

    M +33 (0)6 4516 7099

    investors@valneva.com



     



               
     



     





     



      

    Dan Sharp

    Government & Public Affairs Manager

    T +44-(0)7436-244309

    communications@valneva.com

             
     



     

    Valneva 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, timing and volume expectations with respect to the manufacture of our product candidates; the ability to market, commercialize and achieve market acceptance for product candidates, the ability to protect intellectual property and operate the business without infringing on the intellectual property rights of others, estimates for future performance and estimates regarding anticipated operating losses, future revenues, capital requirements and needs for additional financing. 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.


    1Earle et al. MedRxiv, March 2021, https://doi.org/10.1101/2021.03.17.20200246); Khoury et al. MedRxiv, March 2021, https://doi.org/10.1101/2021.03.09.21252641)

    2 https://www.worldometers.info/coronavirus/





     

     

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  36. EMERYVILLE, Calif., April 2, 2021 /PRNewswire/ -- Dynavax Technologies Corporation (NASDAQ:DVAX) today reported that it has granted nonstatutory stock options to purchase an aggregate of 142,000 shares of Dynavax common stock as inducements to six newly-hired employees in connection with commencement of employment with the Company.

    The stock options were granted on April 1, 2021 at an exercise price of $9.73 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 employment 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 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 Contacts:

    Nicole Arndt, Senior Manager, Investor Relations

    narndt@dynavax.com

    510-665-7264

    Derek Cole, President

    Investor Relations Advisory Solutions

    derek.cole@IRadvisory.com

     

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  37. CHENGDU, China and EMERYVILLE, Calif., March 24, 2021 /PRNewswire/ -- Clover Biopharmaceuticals (Clover), a global clinical-stage biotechnology company developing transformative biologics such as vaccines and therapeutics for the world's most debilitating diseases, and Dynavax Technologies Corporation ((Dynavax, NASDAQ:DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, today announced the first participants have been dosed in Clover's SPECTRA trial (Study Evaluating Protective-Efficacy and Safety of Clover's Trimeric Recombinant Protein-based and Adjuvanted COVID-19 Vaccine), a global Phase 2/3 clinical trial evaluating the efficacy, safety and immunogenicity of  Clover's protein-based S-Trimer COVID-19…

    CHENGDU, China and EMERYVILLE, Calif., March 24, 2021 /PRNewswire/ -- Clover Biopharmaceuticals (Clover), a global clinical-stage biotechnology company developing transformative biologics such as vaccines and therapeutics for the world's most debilitating diseases, and Dynavax Technologies Corporation ((Dynavax, NASDAQ:DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, today announced the first participants have been dosed in Clover's SPECTRA trial (Study Evaluating Protective-Efficacy and Safety of Clover's Trimeric Recombinant Protein-based and Adjuvanted COVID-19 Vaccine), a global Phase 2/3 clinical trial evaluating the efficacy, safety and immunogenicity of  Clover's protein-based S-Trimer COVID-19 vaccine candidate adjuvanted with Dynavax's CpG 1018 plus alum.

    The global Phase 2/3 trial is a double-blind, randomized, controlled study of the adjuvanted S-Trimer COVID-19 vaccine candidate in a two-dose regimen, given 21 days apart. The study is expected to enroll over 22,000 adult and elderly participants at multiple sites across Latin America, Asia, Europe and Africa. An independent external Data Safety Monitoring Board (DSMB) will provide safety oversight throughout the program by regular review of available efficacy and safety data. An interim analysis of the primary endpoint is expected in the middle of 2021, depending on trial enrollment and occurrence of COVID-19 cases in the study.

    Joshua Liang, Chief Executive Officer of Clover Biopharmaceuticals, said, "Dosing the first participants in SPECTRA marks another significant milestone in our journey to develop a COVID-19 vaccine. There is still a significant need in many global communities for COVID-19 vaccines and should the Phase 2/3 interim analysis be favorable, we will work closely with regulatory authorities worldwide to make our S-Trimer COVID-19 vaccine candidate available as soon as possible."

    Ryan Spencer, Chief Executive Officer of Dynavax, commented, "We are excited to see the first participants dosed in SPECTRA, providing an opportunity for Clover's protein subunit vaccine candidate adjuvanted with CpG 1018 to demonstrate safety and efficacy. Clover's adjuvanted vaccine candidate has the potential to be an important additional solution to address worldwide demand since it can be manufactured at large scale and stored at standard refrigeration temperature. We are proud to be collaborating with Clover on the development of this vaccine for COVID-19 and committed to supporting Clover in making the vaccine available globally."

    SPECTRA is fully funded by the Coalition for Epidemic Preparedness Innovations (CEPI). Through this collaboration, hundreds of millions of adjuvanted S-Trimer vaccine doses will potentially be made available for procurement and allocation through the COVAX Facility to protect the most at-risk populations in participating countries.

    Dr. Richard Hatchett, Chief Executive Officer of CEPI commented: "This is an important step forward in the development of Clover's promising vaccine candidate, which could give us a much-needed additional tool to help control the spread of COVID-19. If the vaccine is proven to be safe and effective, we hope to make hundreds of millions of doses globally accessible through COVAX."

    In December 2020, Clover reported positive clinical data from its Phase 1 trial demonstrating that its protein-based COVID-19 S-Trimer vaccine candidate in combination with Dynavax's CpG 1018 induces strong immune response, including neutralizing antibodies and cell-mediated immunity, as well as favorable safety and tolerability profiles in the adult and elderly participants. The vaccine candidate is expected to be stable long term under standard refrigeration conditions and has demonstrated stability at room temperature for at least two months, making it suitable for global distribution. 

    The Phase 1 data was shared in The Lancet in early 2021.

    About S-Trimer COVID-19 Vaccine Candidate

    Utilizing Clover's proprietary Trimer-Tag© technology, S-Trimer is a trimeric SARS-CoV-2 spike (S)-protein subunit vaccine candidate. Similar to other enveloped RNA viruses such as HIV, RSV and Influenza, SARS-CoV-2 is also an RNA virus that has a trimeric spike (S) protein on its viral envelope. The trimeric S protein of SARS-CoV-2 is responsible for binding to host cell surface receptor ACE2 and subsequent viral entry, making it the primary target antigen for vaccine development. S-Trimer resembles the native trimeric viral spike protein and is produced via a rapid mammalian cell-culture based expression system. S-Trimer is intended to be adjuvanted.

    About Trimer-Tag© Technology

    Trimer-Tag© is an innovative drug development platform which allows the production of novel, covalently-trimerized fusion proteins. Many major disease targets are trimerization-dependent such as the tumor necrosis factor (TNF) superfamily (involved in extrinsic apoptosis, immune co-stimulation and inflammation) as well as enveloped RNA virus antigens responsible for entry into host cells. Clover is using its Trimer-Tag© technology with global IP position to develop recombinant trimerized fusion proteins that are able to effectively target these previously undruggable pathways.

    About Clover Biopharmaceuticals

    Clover Biopharmaceuticals is a global clinical-stage biotechnology company developing transformative biologics as vaccines and therapeutics for the world's most debilitating diseases. By leveraging its proprietary Trimer-Tag© platform, Clover has developed a protein-based COVID-19 vaccine candidate. Clover expects to utilize its in-house cGMP biomanufacturing capabilities to potentially produce and broadly distribute hundreds of millions of COVID-19 vaccine doses annually to those who need it most around the globe. Clover's lead oncology asset, SCB-313, is in multiple ongoing Phase I clinical trials in Australia and China. Clover expects to advance multiple new pipeline products to the clinic and continues to discover, develop and deliver innovative and affordable medical solutions to improve the quality of life and wellbeing of patients around the world. Clover has corporate offices in Chengdu, Changxing, Shanghai and Beijing in China and expects to open a U.S. headquarters in Boston in the first half of 2021. Since 2020, Clover has raised more than USD $400 million and has built strong partnerships with internationally renowned healthcare organizations. For more information, please visit our website:  www.cloverbiopharma.com  and follow the company on LinkedIn.

    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.

    About CEPI

    CEPI is an innovative partnership between public, private, philanthropic, and civil organizations, launched at Davos in 2017, to develop vaccines to stop future epidemics. CEPI has moved with great urgency and in coordination with WHO in response to the emergence of COVID-19. CEPI has initiated 11 partnerships to develop vaccines against the novel coronavirus. The programmes are leveraging rapid response platforms already supported by CEPI as well as new partnerships.

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

    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. 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, 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 Contact:

    Cindy Min

    Vice President, Public Affairs

    cindy.min@cloverbiopharma.com

    Media Contact:

    Katelyn Caruso-Sharpe

    LifeSci Communications

    kcaruso-sharpe@lifescicomms.com

    Dynavax Contacts:

    Nicole Arndt, Senior Manager, Investor Relations

    narndt@dynavax.com

    510-665-7264

    Derek Cole, President

    Investor Relations Advisory Solutions

    derek.cole@IRadvisory.com

     

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    • Over 22,000 participants aged 18 years or older are expected to be enrolled in SPECTRA across Latin America, Asia, Europe and Africa
    • Interim analysis of the primary endpoint expected in the middle of 2021

    CHENGDU, China and EMERYVILLE, Calif., March 24, 2021 /PRNewswire/ -- Clover Biopharmaceuticals (Clover), a global clinical-stage biotechnology company developing transformative biologics such as vaccines and therapeutics for the world's most debilitating diseases, and Dynavax Technologies Corporation ((Dynavax, NASDAQ:DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, today announced the first participants have been dosed in Clover's SPECTRA trial (Study Evaluating Protective-Efficacy and Safety of…

    • Over 22,000 participants aged 18 years or older are expected to be enrolled in SPECTRA across Latin America, Asia, Europe and Africa
    • Interim analysis of the primary endpoint expected in the middle of 2021

    CHENGDU, China and EMERYVILLE, Calif., March 24, 2021 /PRNewswire/ -- Clover Biopharmaceuticals (Clover), a global clinical-stage biotechnology company developing transformative biologics such as vaccines and therapeutics for the world's most debilitating diseases, and Dynavax Technologies Corporation ((Dynavax, NASDAQ:DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, today announced the first participants have been dosed in Clover's SPECTRA trial (Study Evaluating Protective-Efficacy and Safety of Clover's Trimeric Recombinant Protein-based and Adjuvanted COVID-19 Vaccine), a global Phase 2/3 clinical trial evaluating the efficacy, safety and immunogenicity of  Clover's protein-based S-Trimer COVID-19 vaccine candidate adjuvanted with Dynavax's CpG 1018 plus alum.

    Logo (PRNewsfoto/Clover Biopharmaceuticals)

    The global Phase 2/3 trial is a double-blind, randomized, controlled study of the adjuvanted S-Trimer COVID-19 vaccine candidate in a two-dose regimen, given 21 days apart. The study is expected to enroll over 22,000 adult and elderly participants at multiple sites across Latin America, Asia, Europe and Africa. An independent external Data Safety Monitoring Board (DSMB) will provide safety oversight throughout the program by regular review of available efficacy and safety data. An interim analysis of the primary endpoint is expected in the middle of 2021, depending on trial enrollment and occurrence of COVID-19 cases in the study.

    Joshua Liang, Chief Executive Officer of Clover Biopharmaceuticals, said, "Dosing the first participants in SPECTRA marks another significant milestone in our journey to develop a COVID-19 vaccine. There is still a significant need in many global communities for COVID-19 vaccines and should the Phase 2/3 interim analysis be favorable, we will work closely with regulatory authorities worldwide to make our S-Trimer COVID-19 vaccine candidate available as soon as possible."

    Ryan Spencer, Chief Executive Officer of Dynavax, commented, "We are excited to see the first participants dosed in SPECTRA, providing an opportunity for Clover's protein subunit vaccine candidate adjuvanted with CpG 1018 to demonstrate safety and efficacy. Clover's adjuvanted vaccine candidate has the potential to be an important additional solution to address worldwide demand since it can be manufactured at large scale and stored at standard refrigeration temperature. We are proud to be collaborating with Clover on the development of this vaccine for COVID-19 and committed to supporting Clover in making the vaccine available globally."

    SPECTRA is fully funded by the Coalition for Epidemic Preparedness Innovations (CEPI). Through this collaboration, hundreds of millions of adjuvanted S-Trimer vaccine doses will potentially be made available for procurement and allocation through the COVAX Facility to protect the most at-risk populations in participating countries.

    Dr. Richard Hatchett, Chief Executive Officer of CEPI commented: "This is an important step forward in the development of Clover's promising vaccine candidate, which could give us a much-needed additional tool to help control the spread of COVID-19. If the vaccine is proven to be safe and effective, we hope to make hundreds of millions of doses globally accessible through COVAX."

    In December 2020, Clover reported positive clinical data from its Phase 1 trial demonstrating that its protein-based COVID-19 S-Trimer vaccine candidate in combination with Dynavax's CpG 1018 induces strong immune response, including neutralizing antibodies and cell-mediated immunity, as well as favorable safety and tolerability profiles in the adult and elderly participants. The vaccine candidate is expected to be stable long term under standard refrigeration conditions and has demonstrated stability at room temperature for at least two months, making it suitable for global distribution.  The Phase 1 data was shared in The Lancet in early 2021.

    About S-Trimer COVID-19 Vaccine Candidate

    Utilizing Clover's proprietary Trimer-Tag© technology, S-Trimer is a trimeric SARS-CoV-2 spike (S)-protein subunit vaccine candidate. Similar to other enveloped RNA viruses such as HIV, RSV and Influenza, SARS-CoV-2 is also an RNA virus that has a trimeric spike (S) protein on its viral envelope. The trimeric S protein of SARS-CoV-2 is responsible for binding to host cell surface receptor ACE2 and subsequent viral entry, making it the primary target antigen for vaccine development. S-Trimer resembles the native trimeric viral spike protein and is produced via a rapid mammalian cell-culture based expression system. S-Trimer is intended to be adjuvanted.

    About Trimer-Tag© Technology

    Trimer-Tag© is an innovative drug development platform which allows the production of novel, covalently-trimerized fusion proteins. Many major disease targets are trimerization-dependent such as the tumor necrosis factor (TNF) superfamily (involved in extrinsic apoptosis, immune co-stimulation and inflammation) as well as enveloped RNA virus antigens responsible for entry into host cells. Clover is using its Trimer-Tag© technology with global IP position to develop recombinant trimerized fusion proteins that are able to effectively target these previously undruggable pathways.

    About Clover Biopharmaceuticals

    Clover Biopharmaceuticals is a global clinical-stage biotechnology company developing transformative biologics as vaccines and therapeutics for the world's most debilitating diseases. By leveraging its proprietary Trimer-Tag© platform, Clover has developed a protein-based COVID-19 vaccine candidate. Clover expects to utilize its in-house cGMP biomanufacturing capabilities to potentially produce and broadly distribute hundreds of millions of COVID-19 vaccine doses annually to those who need it most around the globe. Clover's lead oncology asset, SCB-313, is in multiple ongoing Phase I clinical trials in Australia and China. Clover expects to advance multiple new pipeline products to the clinic and continues to discover, develop and deliver innovative and affordable medical solutions to improve the quality of life and wellbeing of patients around the world. Clover has corporate offices in Chengdu, Changxing, Shanghai and Beijing in China and expects to open a U.S. headquarters in Boston in the first half of 2021. Since 2020, Clover has raised more than USD $400 million and has built strong partnerships with internationally renowned healthcare organizations. For more information, please visit our website:  www.cloverbiopharma.com  and follow the company on LinkedIn.

    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.

    About CEPI

    CEPI is an innovative partnership between public, private, philanthropic, and civil organizations, launched at Davos in 2017, to develop vaccines to stop future epidemics. CEPI has moved with great urgency and in coordination with WHO in response to the emergence of COVID-19. CEPI has initiated 11 partnerships to develop vaccines against the novel coronavirus. The programmes are leveraging rapid response platforms already supported by CEPI as well as new partnerships.

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

    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. 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, 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 Contact:

    Cindy Min

    Vice President, Public Affairs

    cindy.min@cloverbiopharma.com

    Media Contact:

    Katelyn Caruso-Sharpe

    LifeSci Communications

    kcaruso-sharpe@lifescicomms.com

    Dynavax Contacts:

    Nicole Arndt, Senior Manager, Investor Relations

    narndt@dynavax.com

    510-665-7264


    Derek Cole, President

    Investor Relations Advisory Solutions

    derek.cole@IRadvisory.com

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/clover-biopharmaceuticals-and-dynavax-announce-first-participants-dosed-in-spectra-a-global-phase-23-clinical-trial-for-adjuvanted-s-trimer-covid-19-vaccine-candidate-301254587.html

    SOURCE Clover Biopharmaceuticals

    View Full Article Hide Full Article
  38. EMERYVILLE, Calif., March 1, 2021 /PRNewswire/ -- Dynavax Technologies Corporation (NASDAQ:DVAX), a biopharmaceutical company focused on developing and commercializing vaccines, today announced that Ryan Spencer, Chief Executive Officer, will present at the H.C. Wainwright Virtual 2021 Global Life Sciences Conference being held March 9-10, 2021.

    The on demand presentation will be available, beginning Tuesday, March 9, 2021 at 7:00 a.m. E.T. and may be accessed through the "Events & Presentations" page on the "Investors" section of the Company's website at http://investors.dynavax.com/events-presentations.

    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.

    Contacts:

    Nicole Arndt

    narndt@dynavax.com

    510-665-7264

    Derek Cole, President

    Investor Relations Advisory Solutions

    derek.cole@IRadvisory.com

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/dynavax-to-present-at-the-hc-wainwright-virtual-2021-global-life-sciences-conference-301237827.html

    SOURCE Dynavax Technologies

    View Full Article Hide Full Article
  39. EMERYVILLE, Calif., March 1, 2021 /PRNewswire/ -- Dynavax Technologies Corporation (NASDAQ:DVAX) today reported that in connection with the commencement of Ms. MacDonald's employment with the Company as Senior Vice President and Chief Financial Officer on March 1, 2021, the Company granted her a non-statutory stock option to purchase 350,000 shares of Dynavax common stock.  In addition, it also granted nonstatutory stock options to purchase an aggregate of 74,300 shares of Dynavax common stock as inducements to four newly-hired employees in connection with commencement of their employment with the Company.

    The stock options have 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 each employee's continued employment with Dynavax through the applicable vesting dates. The stock options were granted with an exercise price of $8.90 per share, which is equal to the closing price of Dynavax common stock on the date of grant, and were provided as a material inducement to each employee's employment in accordance with Nasdaq Listing Rule 5635(c)(4). The options 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. 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 Contacts:

    Nicole Arndt, Senior Manager, Investor Relations

    narndt@dynavax.com

    510-665-7264

    Derek Cole, President

    Investor Relations Advisory Solutions

    derek.cole@IRadvisory.com

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/dynavax-reports-inducement-grants-under-nasdaq-listing-rule-5635c4-301237824.html

    SOURCE Dynavax Technologies

    View Full Article Hide Full Article
  40. EMERYVILLE, Calif., Feb. 25, 2021 /PRNewswire/ -- Dynavax Technologies Corporation (NASDAQ:DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, today reported financial results for the fourth quarter and full year 2020.

    "2020 was an important year for Dynavax as we continue to build a leading vaccine company underpinned by growing recurring revenue from both HEPLISAV-B and CpG 1018," commented Ryan Spencer, Chief Executive Officer of Dynavax. "In addition to HEPLISAV-B, we continue to progress numerous collaborations to develop our proven vaccine adjuvant CpG 1018 across multiple indications, including COVID–19, pertussis, and universal flu."

    Mr. Spencer added, "Our COVID-19 collaborations have advanced significantly in recent months with multiple partners targeting emergency use authorization in the second half of 2021. The emerging portfolio of product opportunities with CpG 1018 has the potential to drive significant revenue growth in 2021 and beyond. Through the continued advancement of our multiple collaborations, CpG 1018 could be utilized in up to 500 million to 1.5 billion doses of vaccine annually starting in 2022, with additional capacity expansion available depending on global demand."

    HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted]

    • Full year 2020 net product revenue of $36.0 million compared to $34.6 million for full year 2019, a 4% year-over-year growth rate despite the substantial ongoing reduction in market utilization due to the pandemic and COVID-19 vaccine rollout.
    • Net product revenue for HEPLISAV-B during the fourth quarter 2020 was $11.5 million, up 8.5% year-over-year from $10.6 million for the fourth quarter of 2019.
    • Market share in accounts targeted by the field sales team increased to 26%, up from 20% market share in the fourth quarter of 2019.
    • Received Marketing Authorization in February 2021 from the European Commission following the positive opinion in December 2020 from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP).
    • Reported final immunogenicity data from a study in adults with end-stage renal disease (ESRD) undergoing hemodialysis. In this study of 119 patients, HEPLISAV-B demonstrated a high seroprotection rate of 89.3% at week 20 after 4 standard doses.

    CpG 1018 (Advanced Vaccine Adjuvant)

    • Dynavax is scheduled to supply CpG 1018 to produce up to 100 million doses of Valneva's SE adjuvanted COVID-19 vaccine in 2021, which would generate CpG 1018 revenue of up to $230 million in 2021, contingent on the continued success of Valneva's vaccine candidate.
    • First quarter 2021 CpG revenue is anticipated to be between $40 million and $60 million.
    • Clover Biopharmaceuticals is initiating a global Phase 2/3 efficacy trial with their protein sub–unit COVID-19 vaccine candidate adjuvanted with CpG 1018 with an interim analysis for vaccine efficacy expected in the middle of 2021.
    • Coalition for Epidemic Preparedness Innovations (CEPI) agreed to provide funding of up to $99 million for advanced manufacturing of CpG 1018 for use in COVID–19 vaccines developed by CEPI grantees to ensure product availability in 2021 upon emergency use authorization. 
    • Dynavax dosed the first participant in a Phase 1 clinical trial evaluating a tetanus, diphtheria, and acellular pertussis (Tdap) booster vaccine candidate adjuvanted with CpG 1018.

    Additional Corporate Updates

    • Appointed Kelly MacDonald as Senior Vice President and Chief Financial Officer
    • Dong Yu, Ph.D., joined as Senior Vice President of Vaccine Research

    2021 Milestones

    • Publication of data from the study of HEPLISAV-B in patients on hemodialysis anticipated in the first half
    • Multiple data readouts from our CpG 1018 collaboration partners throughout the year
    • Final report for HEPLISAV-B post-marketing study expected in the second quarter
    • Data from the ongoing Phase 1 study of an improved Tdap vaccine candidate adjuvanted with CpG 1018 anticipated in the fourth quarter
    • Launch HEPLISAV-B in the EU in the fourth quarter

    Financial Results

    Total Revenues and Product Revenue, Net. Total revenues for the fourth quarter of 2020 were $19.6 million, including $13.1 million of net product revenue. Total revenues for 2020 were $46.6 million compared to $35.2 million for 2019. HEPLISAV-B product revenue, net increased to $11.5 million in the fourth quarter of 2020 compared to $10.6 million in the same period in 2019. Full year product revenue, net for HEPLISAV-B in 2020 was $36.0 million compared to $34.6 million for the full year 2019. CpG 1018 product revenue, net was $1.6 million in the fourth quarter of 2020 compared to $0.0 million in the same period in 2019. Full year product revenue, net for CpG 1018 in 2020 was $3.3 million compared to $0.0 million for the full year 2019.

    Cost of Sales - Product. Cost of sales - product for the fourth quarter 2020 increased to $4.1 million, compared to $2.4 million for the fourth quarter of 2019. Full year 2020 cost of sales - product was $11.4 million compared to $10.2 million for the full year 2019. The increase was primarily due to higher unit costs for HEPLISAV-B as we produce and then sell inventory that reflects the full cost of manufacturing. For the six months ended December 31, 2020, cost of sales-product included $1.4 million of costs to produce CpG 1018 for our collaboration partners. The Company anticipates cost of sales - product to increase substantially in 2021 due to increased manufacturing of CpG 1018 under the supply agreement with Valneva.

    Research and Development Expenses. Research and development (R&D) expenses for the fourth quarter of 2020 decreased to $9.5 million, compared to $12.3 million for the fourth quarter of 2019. Full year 2020 R&D expenses were $28.6 million compared to $62.3 million for the full year 2019. The decrease in R&D expenses is due to personnel costs, facilities overhead cost allocations and non-cash stock-based compensation decreases due to lower R&D headcount resulting from our restructuring in May 2019 and the winding down of our immuno-oncology programs and an increase of additional CpG 1018 development costs at our third-party manufacturing facility to support increased CpG 1018 demand from our collaboration partners for use in their development and/or commercialization of COVID-19 vaccines.

    SG&A Expenses. Selling, general and administrative (SG&A) expenses for the fourth quarter of 2020 decreased to $17.8 million, compared to $20.3 million for the fourth quarter of 2019. Full year 2020 SG&A expenses were $79.3 million compared to $75.0 million for the full year 2019.

    Loss from Operations and Net Income Loss. Loss from operations for the fourth quarter of 2020 decreased to $11.9 million from $27.4 million in the fourth quarter of 2019. Full year 2020 loss from operations decreased to $68.4 million compared to $134.8 million for the full year 2019. Net loss for the fourth quarter of 2020 was $15.5 million compared to a net loss of $36.8 million for the fourth quarter of 2019. Basic and diluted net loss per share was $0.14 for the fourth quarter of 2020, compared to $0.44 per basic and diluted net loss per share in the fourth quarter of 2019. Full year 2020 net loss decreased to $75.2 million or $0.75 per basic and $0.78 per diluted share compared to $152.6 million or $2.16 per basic and diluted share for the full year 2019.  

    Cash Position. Cash, cash equivalents and marketable securities totaled $165.0 million at December 31, 2020.

    Conference Call and Webcast Information

    Dynavax will hold a conference call today 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 www.dynavax.com.  Alternatively, participants may dial (866) 420-4066 or (409) 217-8237 and refer to conference ID 8380559. A replay of the webcast will be available for 30 days following the live event.

    Please see Important Safety Information below.

    For more information about HEPLISAV-B, visit http://heplisavb.com.

    About Hepatitis B

    Hepatitis B is a viral disease of the liver that can become chronic and lead to cirrhosis, liver cancer and death. The hepatitis B virus is 50 to 100 times more infectious than HIV,i and transmission is on the rise. There is no cure for hepatitis B, but effective vaccination can prevent the disease.

    In adults, hepatitis B is spread through contact with infected blood and through unprotected sex with an infected person. The U.S. Centers for Disease Control (CDC) recommends vaccination for those at high risk for infection due to their jobs, lifestyle, living situations and travel to certain areas.ii Because people with diabetes are particularly vulnerable to infection, the CDC recommends vaccination for adults age 19 to 59 with diabetes as soon as possible after their diagnosis, and for people age 60 and older with diabetes at their physician's discretion.iii Approximately 20 million U.S. adults have diabetes, and 1.5 million new cases of diabetes are diagnosed each year.iv

    About HEPLISAV-B

    HEPLISAV-B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with Dynavax's proprietary Toll-like Receptor (TLR) 9 agonist CpG 1018 to enhance the immune response. Dynavax has worldwide commercial rights to HEPLISAV-B.

    Indication and Use

    HEPLISAV-B is indicated for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.

    Important Safety Information (ISI)

    Do not administer HEPLISAV-B to individuals with a history of severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV-B. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV-B. Hepatitis B has a long incubation period. HEPLISAV-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration. The most common patient reported adverse reactions reported within 7 days of vaccination were injection site pain (23% to 39%), fatigue (11% to 17%) and headache (8% to 17%).

    For full Prescribing Information for HEPLISAV-B, click here.

    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). 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. 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.

    Forward-Looking Statements

    This press release contains "forward-looking" statements, including statements regarding the potential for HEPLISAV-B to become the standard of care adult hepatitis B vaccine in the U.S., establishing CpG 1018 as a leading adjuvant, the development of vaccines containing CpG 1018 and potential future sales of CpG 1018, expected revenue for the first fiscal quarter of 2021, expected full-year revenue from Valneva, the launch of HEPLISAV-B in Europe, the timing of initiation and completion of  clinical studies and the publication of results, the timing of our collaborators seeking emergency use authorization of COVID-19 vaccines containing CpG 1018, our ability to scale manufacturing capacity, the expected demand for our products, our efforts to develop an improved pertussis vaccine, a vaccine for COVID-19, and a universal flu vaccine, entering into strategic relationships and expected results of such relationships, and sales potential under certain agreements.   Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including, the risk that HEPLISAV-B may not become the standard of care adult hepatitis B vaccine in the U.S., risks related to whether and when prescribers and other key decision-makers at potential purchasing entities will make the decision to switch to HEPLISAV-B, and the timing and quantity of actual purchases, risks related to the timing of completion and results of current clinical studies of HEPLISAV-B, risks related to the development and pre-clinical and clinical testing of vaccines containing CpG 1018, and whether use of CpG 1018 will prove to be beneficial in these vaccines, risks related to whether, when and the quantity of CpG 1018 actually purchased by vaccine companies, risks related to the use of contract manufacturers to supply CpG 1018 and financial commitments made to them, and risks related to the launch of HEPLISAV B in Europe, 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:

    Nicole Arndt, Senior Manager, Investor Relations

    narndt@dynavax.com

    510-665-7264

    Derek Cole, President

    Investor Relations Advisory Solutions

    derek.cole@IRadvisory.com

    i CDC. https://www.cdc.gov/hepatitis/hbv/bfaq.htm.

    ii CDC. https://www.cdc.gov/hepatitis/hbv/hbvfaq.htm.

    iii CDC. https://www.cdc.gov/diabetes/pubs/pdf/hepb_vaccination.pdf.

    iv CDC. https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-r





    DYNAVAX TECHNOLOGIES CORPORATION



    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS



    (In thousands, except per share amounts)



    (Unaudited)









    Three Months Ended





    Twelve Months Ended





    December 31,





    December 31,





    2020





    2019





    2020





    2019



    Revenues:































    Product revenues, net

    $

    13,112





    $

    10,558





    $

    39,307





    $

    34,644



    Other revenue



    6,438







    12







    7,244







    575



    Total revenues



    19,550







    10,570







    46,551







    35,219



































    Operating expenses:































    Cost of sales - product



    4,058







    2,407







    11,410







    10,172



    Cost of sales - amortization of intangible assets



    -







    2,323







    2,500







    9,217



    Research and development



    9,549







    12,269







    28,607







    62,331



    Selling, general and administrative



    17,838







    20,318







    79,256







    74,986



    Gain on sale of assets



    -







    -







    (6,851)







    -



    Restructuring



    -







    642







    -







    13,356



    Total operating expenses



    31,445







    37,959







    114,922







    170,062



































    Loss from operations



    (11,895)







    (27,389)







    (68,371)







    (134,843)



































    Other income (expense):































    Interest income



    70







    766







    1,260







    3,370



    Interest expense



    (4,805)







    (4,866)







    (19,062)







    (16,977)



    Sublease income



    1,927







    1,728







    7,706







    2,619



    Change in fair value of warrant liability



    (76)







    (7,266)







    4,124







    (7,500)



    Other



    (688)







    271







    (897)







    731



    Net loss

    $

    (15,467)





    $

    (36,756)





    $

    (75,240)





    $

    (152,600)



    Preferred stock deemed dividend



    -







    -







    -







    (3,267)



    Net loss allocable to common stockholders

    $

    (15,467)





    $

    (36,756)





    $

    (75,240)





    $

    (155,867)



    Basic net loss per share allocable to common stockholders

    $

    (0.14)





    $

    (0.44)





    $

    (0.75)





    $

    (2.16)



    Weighted average shares used to compute basic net loss per share allocable to common stockholders



    110,176







    83,868







    100,753







    72,024



    Diluted net loss per share allocable to common stockholders

    $