CpG 1018® adjuvant
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Dynavax to Report Third Quarter 2025 Financial Results and Host Conference Call on November 5, 2025
Prnewswire· 2025-10-22 20:01
Core Insights - Dynavax Technologies Corporation will report its third quarter 2025 financial results on November 5, 2025, after U.S. financial markets close [1] - A conference call and live audio webcast will be held on the same day at 4:30 p.m. ET/1:30 p.m. PT [1][2] Company Overview - Dynavax is a commercial-stage biopharmaceutical company focused on developing and commercializing innovative vaccines to combat infectious diseases [3] - The company has two commercial products: HEPLISAV-B® vaccine, approved in the U.S., EU, and UK for hepatitis B prevention in adults aged 18 and older, and CpG 1018® adjuvant, used in HEPLISAV-B and various adjuvanted COVID-19 vaccines [3]
Dynavax to Participate in the 2025 Wells Fargo Healthcare Conference
Prnewswire· 2025-08-27 20:05
Company Overview - Dynavax Technologies Corporation is a commercial-stage biopharmaceutical company focused on developing and commercializing innovative vaccines to combat infectious diseases [3] - The company has two commercial products: HEPLISAV-B® vaccine, approved in the U.S., EU, and UK for preventing hepatitis B virus infections in adults aged 18 and older, and CpG 1018® adjuvant, utilized in HEPLISAV-B and various adjuvanted COVID-19 vaccines [3] Upcoming Events - Dynavax will participate in a fireside chat at the 2025 Wells Fargo Healthcare Conference on September 3rd at 4:30 p.m. ET [1] - Presentations from the conference will be available via webcast on the "Events & Presentations" page of the company's website [2]
Dynavax Announces Positive Topline Phase 1/2 Results Supporting Potential Best-in-Class Shingles Vaccine Profile
Prnewswire· 2025-08-21 12:00
Core Insights - Dynavax Technologies Corporation announced positive topline results from Part 1 of its Phase 1/2 clinical trial for Z-1018, a novel shingles vaccine candidate, showing comparable immune responses to Shingrix in adults aged 50 to 69 years [1][4] Group 1: Clinical Trial Results - Z-1018 achieved a 100.0% humoral vaccine response rate compared to Shingrix's 96.9%, and an 89.7% cellular immune response rate versus Shingrix's 93.5%, resulting in a composite vaccine response rate of 89.7% for Z-1018 and 90.3% for Shingrix [2][8] - The trial demonstrated Z-1018's favorable safety profile, with lower rates of grade 2 and 3 post-injection reactions (PIRs) compared to Shingrix, specifically 12.5% for local PIRs and 27.5% for systemic PIRs for Z-1018 versus 52.6% and 63.2% for Shingrix, respectively [3][10] Group 2: Future Development Plans - Dynavax plans to advance Z-1018 into Part 2 of the Phase 1/2 trial targeting adults aged 70 and older, expected to start in the second half of 2025, using the 100 mcg dose of gE antigen with CpG 1018 and alum [1][7] - The objective of Part 2 is to generate clinical proof-of-concept against Shingrix in the older population, which is crucial for further development [4][7] Group 3: Market Potential - The company aims to disrupt the multi-billion-dollar shingles vaccine market, currently dominated by Shingrix, by developing a product with a potential best-in-class profile [4][5] - Z-1018 is designed to address the age-related decline in immune responses, providing a new option for protection against shingles, a disease affecting approximately 1 in 3 people in their lifetime [11][12]
Dynavax to Report Second Quarter 2025 Financial Results and Host Conference Call on August 7, 2025
Prnewswire· 2025-07-29 20:02
Core Viewpoint - Dynavax Technologies Corporation is set to report its second quarter 2025 financial results on August 7, 2025, after U.S. financial markets close, indicating ongoing operations and potential growth in the biopharmaceutical sector [1]. Company Overview - Dynavax is a commercial-stage biopharmaceutical company focused on developing and commercializing innovative vaccines to combat infectious diseases [3]. - The company has two commercial products: HEPLISAV-B® vaccine, approved in the U.S., EU, and UK for preventing hepatitis B virus infections in adults aged 18 and older, and CpG 1018® adjuvant, utilized in HEPLISAV-B and various adjuvanted COVID-19 vaccines [3]. Upcoming Events - A conference call and live audio webcast will be held on August 7, 2025, at 4:30 p.m. ET/1:30 p.m. PT, allowing investors to engage with the company's financial updates [1][2]. - Participants are encouraged to register for the call and join approximately 10 minutes early to ensure a smooth experience [2]. Investor Relations - Contact information for investor inquiries is provided, including Paul Cox and Nicole Arndt, with respective email addresses and phone numbers for further communication [4].
Dynavax Stockholders Elect All Dynavax Director Nominees at 2025 Annual Meeting
Prnewswire· 2025-06-11 15:01
Core Points - Dynavax Technologies Corporation announced the election of all four director nominees to its Board of Directors during the 2025 Annual Meeting of Stockholders [1] - Stockholders approved all other proposals recommended by the Board, including the phased declassification of the Board [2] - Dynavax is a commercial-stage biopharmaceutical company focused on developing and commercializing innovative vaccines, with two commercial products: HEPLISAV-B® and CpG 1018® adjuvant [4] Company Overview - Dynavax is engaged in the development and commercialization of vaccines aimed at protecting against infectious diseases [4] - The company’s HEPLISAV-B® vaccine is approved in the U.S., EU, and UK for preventing hepatitis B virus infections in adults aged 18 and older [4] - CpG 1018® adjuvant is utilized in HEPLISAV-B and various adjuvanted COVID-19 vaccines [4]
Dynavax Urges Stockholders to Support Its Director Nominees at June 11 Annual Meeting
Prnewswire· 2025-06-09 11:30
Core Viewpoint - Dynavax Technologies Corporation emphasizes the importance of re-electing its four director nominees to maintain strategic leadership and long-term stockholder value, contrasting this with the detrimental plans proposed by Deep Track [2][3][4]. Company Strategy and Performance - Since 2019, Dynavax has successfully repositioned its business, leading to significant stockholder value, with a total return of 203% over the last five years, outperforming vaccine peers (9% return) and the S&P Biotechnology Select Industry Index (-17% decline) [2][4]. - The company has generated over $950 million in revenue between 2020 and 2022, supported by a disciplined capital allocation plan, including over 85% execution of a $200 million share repurchase program authorized in November 2024 [4]. Board Composition and Qualifications - The current board, which includes nominees Brent MacGregor, Scott Myers, Lauren Silvernail, and Elaine Sun, possesses essential strategic leadership and expertise in vaccines, biotechnology, and finance, which are critical for the company's long-term strategy [3][5]. - The board has been reshaped with new independent directors, ensuring that six of the eight directors appointed since 2020 bring specialized skill sets aligned with Dynavax's strategic goals [5]. Opposition to Deep Track - Deep Track's candidates are criticized for lacking the necessary experience in corporate strategy and operations, with their proposed plan seen as a threat to Dynavax's long-term growth potential [2][3]. - Independent proxy advisory firms ISS and Egan-Jones have recommended stockholders support Dynavax's nominees, highlighting concerns over Deep Track's misleading materials and lack of a compelling case for change [4][5].
Dynavax Comments on Glass Lewis Recommendation
Prnewswire· 2025-06-04 20:59
Core Viewpoint - Dynavax Technologies Corporation is emphasizing the effectiveness of its current board and strategic direction, asserting that it has created significant long-term stockholder value, particularly through its focus on vaccine development and capital return strategies [1][2][3]. Company Strategy and Performance - Dynavax's strategic pivot in 2019 towards vaccines has led to substantial stockholder value creation, with a reported total return of 203% over the last five years, significantly outperforming vaccine peers (9%) and the S&P Biotechnology Select Industry Index (-17%) [2][3]. - The company has achieved market leadership with its HEPLISAV-B® vaccine, generating $268 million in net product revenue in 2024 and capturing a 44% market share in the U.S. adult hepatitis B vaccine market [2][3]. - In the first quarter of 2025, HEPLISAV-B® net product revenue reached $65 million, reflecting a 36% year-over-year increase, contributing to total revenue of $68.2 million, a 34% increase year-over-year [2][3]. Board Composition and Governance - The board has undergone significant refreshment, with six of the eight independent directors appointed since 2020, ensuring a balanced mix of experience and expertise in the healthcare sector [2][9]. - Dynavax's nominees for the board, including Brent MacGregor, Scott Myers, Lauren Silvernail, and Elaine Sun, are highlighted as possessing critical expertise necessary for guiding the company through pivotal developments [4][5]. Capital Return Strategy - As of May 5, 2025, Dynavax has executed over 85% of its $200 million share repurchase program, which represents 47% of its capital use, indicating a strong commitment to returning capital to stockholders [9].
Dynavax to Present at William Blair's 45th Annual Growth Stock Conference
Prnewswire· 2025-05-28 20:10
Company Overview - Dynavax Technologies Corporation is a commercial-stage biopharmaceutical company focused on developing and commercializing innovative vaccines to combat infectious diseases [3] - The company has two commercial products: HEPLISAV-B® vaccine, approved in the U.S., EU, and UK for hepatitis B prevention in adults aged 18 and older, and CpG 1018® adjuvant, utilized in HEPLISAV-B and various adjuvanted COVID-19 vaccines [3] Upcoming Events - Dynavax will present at William Blair's 45th Annual Growth Stock Conference on June 3rd at 2:40 p.m. CT [1] - The presentations will be available via webcast on the "Events & Presentations" page of the company's investor website [2]
Leading Independent Proxy Advisory Firm ISS Recommends Stockholders Vote "FOR" All Four of Dynavax's Highly Qualified Director Nominees
Prnewswire· 2025-05-23 17:44
Core Viewpoint - Institutional Shareholder Services (ISS) recommends Dynavax stockholders vote "FOR" all four of the Company's director nominees, indicating there is no compelling case for change in the current board or strategy [1][2]. Company Strategy and Board Composition - Dynavax's current strategy is recognized as the best path for long-term stockholder value creation, with a proactive board refreshment process in place [2][4]. - The director nominees possess significant expertise in strategic leadership, vaccine development, and biotechnology, which are essential for the Company's success [3][5]. Response to Dissident Campaign - Dynavax criticizes Deep Track's materials as misleading and lacking a solid case for change, emphasizing the board's commitment to long-term growth and value creation [4][6]. - The board has made ongoing refreshment efforts, with six of the nine directors appointed since 2020, demonstrating a commitment to evolving leadership [4][6]. Financial Performance and Market Position - Dynavax has generated over $950 million in revenue through its COVID-19 business development and has a strong position in the adult U.S. hepatitis B vaccine market with HEPLISAV-B [5][6]. - The Company has delivered a total return of 203% to stockholders over the last five years, indicating the effectiveness of its strategy [6]. Call to Action for Stockholders - Dynavax urges stockholders to vote "FOR" all four director nominees on the GOLD proxy card, emphasizing the importance of every vote [7].
Dynavax Files Investor Presentation Highlighting Superior Strategy and Board That is Delivering Strong Financial Results and Significant Long-Term Value
Prnewswire· 2025-05-12 11:30
Core Viewpoint - Dynavax Technologies Corporation emphasizes the importance of voting for its director nominees and criticizes Deep Track's plan as detrimental to stockholder value [2][3]. Group 1: Company Performance - Dynavax has achieved a total return of 203% for stockholders over the last five years, significantly outperforming vaccine peers (9% return) and the S&P Biotechnology Select Industry Index (-17% return) [4]. - The company reported $268 million in net product revenue from HEPLISAV-B® in 2024, capturing approximately 44% of the U.S. market share by year-end [4]. - In Q1 2025, Dynavax recorded net product revenue of $65 million from HEPLISAV-B®, marking a 36% year-over-year increase, with total revenue reaching $68.2 million, a 34% increase year-over-year [4]. - From 2020 to 2022, Dynavax generated over $950 million in net product revenue through its business development strategy during the pandemic [4]. Group 2: Board and Governance - The Dynavax Board of Directors unanimously recommends stockholders vote "FOR" all four director nominees, highlighting their qualifications and strategic leadership [3][4]. - The Board has implemented a proactive refreshment plan, with six of the eight independent directors appointed since 2020, enhancing accountability and oversight [4]. - Dynavax's capital allocation strategy includes a $200 million share repurchase program, of which over 85% has been executed, representing 47% of the company's capital use [4]. Group 3: Competitive Landscape - Deep Track's plan is criticized for being myopic, focusing solely on monetizing HEPLISAV-B® for immediate capital return, which could jeopardize Dynavax's long-term growth opportunities [4]. - Deep Track rejected reasonable settlement proposals, insisting on direct Board representation and a flawed strategy that would undermine Dynavax's expertise [4].