Accessibility StatementSkip Navigation EMERYVILLE, Calif., Oct. 22, 2025 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial stage biopharmaceutical company developing and commercializing innovative vaccines, will report third quarter 2025 financial results on Wednesday, November 5, 2025, after the U.S. financial markets close. Dynavax will host a conference call and live audio webcast on Wednesday, November 5, 2025, at 4:30 p.m. ET/1:30 p.m. PT. The live audio webcast may be acces ...

Accessibility StatementSkip Navigation EMERYVILLE, Calif., Oct. 21, 2025 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, today presented positive topline data from Part 1 of its randomized, observer-blinded, active-controlled Phase 1/2 clinical trial of Z-1018, the Company's novel shingles vaccine candidate, in a late-breaker session at IDWeek 2025. Dynavax also today announced it has initiated ...

Live Chat on The Biotech Forum sees frequent discussion of specific covered call trades. To see what covered call trades I am currently executing along with a model portfolio of attractive biotech stocks, just initiate your free trial into The Biotech Forum by clicking HERE .In this column, I am going to highlight three of my favorite biotech stocks that are trading under $10.00 a share. First, I am going to put a few caveats in place. One of primary ones are these are stocksBret leads the investing group T ...

Financial Data and Key Metrics Changes - The company expects to generate over $300 million in revenue for FY 2025, with guidance between $315 million to $325 million, indicating a significant growth trajectory for its lead asset, HEPLISAV B [52][53]. Business Line Data and Key Metrics Changes - HEPLISAV B has seen increased market share due to its differentiated product profile, requiring only two doses compared to three doses for competitor vaccines, and achieving higher levels of seroprotection in Phase III trials [8][11]. - The retail segment is projected to grow significantly, potentially doubling in size by 2030, with the company currently holding nearly 60% market share in that space [10][11]. Market Data and Key Metrics Changes - The adult hepatitis B vaccine market is expanding, particularly after the ACIP recommended vaccination for all adults, creating a large addressable population [5][6]. - The company has successfully captured market share across key settings, including Integrated Delivery Networks (IDNs) and retail, with a focus on driving growth in these areas [12][15]. Company Strategy and Development Direction - The company aims to leverage its novel adjuvant technology to enhance vaccine efficacy and expand its pipeline, while maintaining a strong financial position to evaluate high-value business development opportunities [3][45]. - The strategy includes focusing on derisked assets and advancing products that have established biological efficacy, which sets the company apart from many other biotech firms [52][53]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ability to drive growth through HEPLISAV B and the emerging pipeline, emphasizing the importance of executing plans amidst a supportive public health environment for hepatitis B vaccination [22][23]. - The competitive landscape is viewed positively, with the company controlling the narrative in the market due to its focused approach on hepatitis B vaccines [25][27]. Other Important Information - The company is exploring additional opportunities in its pipeline, including a shingles vaccine and a plague vaccine in collaboration with the Department of Defense, which could provide further revenue streams [37][40]. - The company maintains a strong balance sheet and is open to returning capital to shareholders when appropriate, while also considering business development investments [45][48]. Q&A Session Summary Question: What is the company's long-term growth outlook? - The company anticipates significant revenue growth driven by HEPLISAV B and a robust pipeline, with expectations of over $300 million in revenue for FY 2025 [52][53]. Question: How does the company plan to capture market share in the retail segment? - The company projects that the retail segment will represent approximately 50% of the adult hepatitis B market by 2030, leveraging its strong product profile and commercial execution [10][11]. Question: What is the competitive environment like for the company? - The company believes it has a strong position in the market, controlling the narrative and focusing solely on its hepatitis B vaccine, which allows it to effectively compete against larger portfolios of competitors [25][27].

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]

Core Viewpoint - Dynavax Technologies (DVAX.US) shares rose approximately 7% following the announcement that its investigational shingles vaccine Z-1018 elicited an immune response comparable to GlaxoSmithKline's (GSK.US) Shingrix vaccine in Phase I/II trials [1] Group 1: Clinical Trial Results - The top-line data from the first part of the clinical trial indicated that Z-1018 achieved an overall vaccine response rate of 89.7%, while Shingrix had a response rate of 90.3% [1] - The study aimed to evaluate the effectiveness of Z-1018 compared to Shingrix in individuals aged 50 to 69 years [1] - Z-1018 demonstrated favorable tolerability and safety characteristics [1] Group 2: Adverse Reactions - Among participants receiving Z-1018, 12.5% experienced grade 2 or 3 local and systemic injection reactions, compared to 52.6% and 63.2% for Shingrix, respectively [1] Group 3: Future Plans - The second part of the Phase I/II trial will include adults aged 70 and older, with an expected launch in the second half of 2025 [1]

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]

Group 1 - Dynavax Technologies Corporation (NASDAQ: DVAX) reported second quarter results that exceeded expectations and provided a solid business update while slightly raising guidance [2] - Despite the positive results, DVAX's stock fell by over five percent during the week following the earnings report [2] - The company is viewed as a solid investment opportunity within the biotech sector, with a focus on high upside biotech stocks [2]

Core Insights - Dynavax Technologies reported quarterly earnings of $0.14 per share, exceeding the Zacks Consensus Estimate of $0.12 per share, and showing an increase from $0.08 per share a year ago, resulting in an earnings surprise of +16.67% [1] - The company achieved revenues of $95.44 million for the quarter ended June 2025, surpassing the Zacks Consensus Estimate by 8.99%, compared to $73.79 million in the same quarter last year [2] - Dynavax Technologies has outperformed consensus EPS estimates three times over the last four quarters and has topped consensus revenue estimates two times in the same period [2] Financial Performance - The company experienced a significant earnings surprise of -466.67% in the previous quarter, where it was expected to post earnings of $0.03 per share but instead reported a loss of $0.11 [1] - The current consensus EPS estimate for the upcoming quarter is $0.15, with expected revenues of $96.97 million, while the estimate for the current fiscal year is -$0.41 on revenues of $331.45 million [7] Market Position - Dynavax Technologies shares have declined approximately 12.4% since the beginning of the year, contrasting with the S&P 500's gain of 7.9% [3] - The Zacks Rank for Dynavax Technologies is currently 4 (Sell), indicating expectations of underperformance in the near future [6] Industry Context - The Medical - Biomedical and Genetics industry, to which Dynavax belongs, is currently ranked in the top 41% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]

Financial Data and Key Metrics Changes - Dynavax reported Q2 2025 net product revenue of $92 million, a 31% increase year over year, and total revenues of approximately $95 million, up 29% year over year [5][26] - HEPLISAV B gross margin was 85% for Q2 2025, an increase from 83% in Q2 2024 [27] - GAAP net income for Q2 2025 was $19 million compared to $11 million in Q2 2024, and non-GAAP adjusted EBITDA improved to $37 million from $20 million year over year [28][29] Business Line Data and Key Metrics Changes - HEPLISAV B's estimated market share in the U.S. adult hepatitis B vaccine market rose to 45% in Q2 2025 from 42% in the same period last year [6][12] - Total HEPLISAV B dose volume grew by approximately 13% year over year [12] - The company updated its full year 2025 Hepatitis B net product revenue guidance to $315 million to $325 million, raising the low end of the range [6][30] Market Data and Key Metrics Changes - The U.S. adult hepatitis B vaccine market is experiencing strong momentum due to increasing awareness and higher vaccination rates [11] - Retail segment performance showed a 35% increase in annual dose utilization, with expectations that retail will account for at least 50% of total hepatitis B doses by 2030 [15][18] - The ACIP universal recommendation has transformed the adult hepatitis B vaccine market, creating one of the largest addressable vaccination opportunities in the U.S. [12] Company Strategy and Development Direction - Dynavax aims to achieve at least 60% market share in the U.S. adult hepatitis B vaccine market by 2030, with expectations of double-digit annual growth in product net sales [6][19] - The company is advancing its vaccine pipeline, including a novel shingles program and programs in pandemic influenza and Lyme disease, leveraging its CpG 1018 adjuvant technology [7][21] - A disciplined capital allocation approach is being employed to support HEPLISAV B and advance internal pipeline programs while assessing attractive opportunities [9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong performance of HEPLISAV B and the overall market dynamics supporting continued growth [19][20] - The company remains focused on building a robust product portfolio and development pipeline, with a commitment to financial discipline [9][30] - Management highlighted the importance of retail partnerships and recent Medicare policy changes that enhance HEPLISAV B's growth potential [18] Other Important Information - The company completed a $200 million share repurchase program during Q2 2025, retiring over 16 million shares [29] - Cash, cash equivalents, and marketable securities at the end of Q2 2025 were $614 million, down from $714 million at the end of Q2 2024 [29] Q&A Session Summary Question: Inquiry about shingles readout and CD4 T cells - Management confirmed that they will focus on VRR as a composite endpoint at one month, with further assessments at six and twelve months [33][35] Question: HEPLISAV's performance and market share segments - Management clarified that there were no one-time issues affecting HEPLISAV's strong performance, attributing it to widespread adoption, particularly in retail [42][44] Question: Shift to retail and long-term guidance - Management explained that the shift to retail is driven by proactive outreach and aligns with trends seen in other adult vaccines, maintaining confidence in long-term guidance [48][50] Question: Plague program and DoD commitment - Management stated that they are fully aligned with the DoD on the plague program, with funding already awarded through the first half of 2027 [68][70] Question: Lyme disease enrollment and seasonal elements - Management indicated that seasonality will be considered in the clinical development plan for Lyme disease, focusing on safety and immunogenicity in upcoming studies [70]