Company: DVAX
Filing Date: 2025-11-05
Form Type: 10-Q
Source: 0001628280-25-049536
Chunk: 330

Company: DYNAVAX TECHNOLOGIES CORP
Filing Date: 2025-11-05
Form: 10-Q
Item: Part I, Item 8
Chunk 330
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 2021, 2022 and 2024, we recognized a net income of $26.9 million and a net loss of $50.5 million for the three and nine months ended September 30, 2025, respectively. As of September 30, 2025, we had an accumulated deficit of $953.7 million. 

With our investment in the launch and commercialization of HEPLISAV-B in the U.S. and advancing our clinical trials in different indications, we have in the past, and could in the future, incur operating losses. Our expenses have increased substantially as we maintain our HEPLISAV-B commercial infrastructure, including investments in internal infrastructure to support our investments in manufacturing and supply chain commitments to maintain commercial supply of HEPLISAV-B. Further, we expect to increase research and development costs as we invest in our pipeline. We are already advancing a multi-program clinical pipeline leveraging CpG 1018 adjuvant to develop improved vaccines in indications with unmet medical needs including a Phase 1/2 clinical trial for shingles and additional clinical and manufacturing activities, including a Phase 2 clinical trial initiated in the third quarter of 2025 for plague, in collaboration with and fully funded by the U.S. Department of Defense (“DoD”). We expect research and development costs to increase further if we add additional programs to our pipeline. If we are not able to successfully execute our development plans to 

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support advancement of our clinical pipeline on our expected timelines, we will not be able to generate the expected revenue streams from these programs, which would significantly harm our business prospects. 

Sales of CpG 1018 adjuvant generated significant revenue during the COVID-19 pandemic, but we do not currently expect such revenues to continue in the long term, and we did not recognize any CpG 1018 adjuvant revenue in 2024 or during the nine months ended September 30, 2025. The timing for uptake of our products in the U.S. and abroad may further affect costs or losses related to commercialization. Due to the numerous risks and uncertainties associated with developing and commercializing vaccine products or other products we may choose to offer in the future, we are unable to predict the extent of any future losses or when, if ever, we will become profitable on an annual recurring basis, or, that if we are able to reach consistent profitability that it will be sustainable for any period of time. 

Many of our competitors have greater financial resources and expertise than