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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
EMERYVILLE, Calif., July 29, 2025 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial stage biopharmaceutical company developing and commercializing innovative vaccines, will report second quarter 2025 financial results on Thursday, August 7, 2025, after the U.S. financial markets close. Paul Cox [email protected] 510-665-0499 Nicole Arndt [email protected] 510-665-7264 SOURCE Dynavax Technologies To dial into the call, participants will need to register for the call using the call ...
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
Presentation Underscores Deep Track's Value Destructive Plan and Inferior Slate of Director Nominees Urges Stockholders to Vote "FOR" All Four Dynavax Director Nominees on the GOLD Proxy Card Today EMERYVILLE, Calif., May 12, 2025 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX) ("Dynavax" or the "Company"), a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, today announced that it has filed an investor presentation with the Securities and Exchang ...
Dynavax Issues Statement and Mails Letter to Stockholders Emphasizing Record Financial Results and Continued Momentum
Prnewswire· 2025-05-07 20:45
Core Viewpoint - Dynavax Technologies Corporation criticizes Deep Track Capital's investor presentation, asserting that it lacks understanding of the biotechnology sector and prioritizes short-term gains over long-term value creation [1][3]. Financial Performance - Dynavax reported total revenue of $68.2 million for Q1 2025, a 34% increase from $50.8 million in Q1 2024 [13]. - HEPLISAV-B® generated net product revenue of $65 million, marking a 36% increase compared to $47.8 million in Q1 2024 [13]. - The company expects to achieve full-year revenue guidance of $305 to $325 million [13]. - Adjusted EBITDA improved to negative $4 million from negative $7 million in Q1 2024, with expectations of at least $75 million in 2025 [13]. Strategic Direction - Dynavax emphasizes a balanced strategic plan that includes both internal and external growth opportunities while returning capital to stockholders [2][11]. - The company has executed over 85% of its $200 million share repurchase program, completing $172 million as of May 5, 2025 [13]. - Dynavax's market share for HEPLISAV-B® increased to approximately 43% from 41% in Q1 2024 [13]. Board and Governance - Dynavax urges stockholders to vote for its four director nominees, asserting that they possess superior qualifications compared to Deep Track's candidates [5][10]. - The current Board is described as highly qualified and refreshed, overseeing the company's successful strategic execution [4][11]. Growth Initiatives - Dynavax is advancing its differentiated vaccine pipeline, leveraging its proprietary CpG 1018 adjuvant [8][9]. - New pipeline programs are being initiated alongside ongoing shingles and plague vaccine programs [8].