Company: DVAX
Filing Date: 2025-08-07
Form Type: 10-Q
Source: 0001029142-25-000117
Chunk: 245

Company: DYNAVAX TECHNOLOGIES CORP
Filing Date: 2025-08-07
Form: 10-Q
Item: Part I, Item 1
Chunk 245
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 (the “CEPI-Bio E Assignment Agreement”). Under these agreements, CEPI forgave $47.4 million of outstanding Advance Payments (the “Bio E CEPI Advance Payments”) 

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and assumed our rights to collect from Bio E. We may receive additional payments of $5.5 million or $12.3 million from Bio E if specified milestones related to future collections from the Government of India are met by August 15, 2025. These amounts are not considered collectible unless the milestones are achieved. As of June 30, 2025, these future milestones have not been achieved 

Clinical and Preclinical Pipeline

We are advancing a pipeline of product candidates that leverage our CpG 1018 adjuvant, which has demonstrated its ability to enhance the immune response with a favorable tolerability profile in a wide range of clinical trials and real-world commercial use.

Shingles Vaccine Program:

Z-1018 is an investigational vaccine candidate being developed for the prevention of shingles in adults aged 50 years and older.

•We have completed enrollment in Part 1 of a Phase 1/2 clinical trial comparing Z-1018 to Shingrix® in 441 healthy adults aged 50 to 69, and anticipate reporting top-line immunogenicity and safety data in August 2025.

•We plan to advance the selected vaccine formulation and regimen from Part 1 into Part 2 of the Phase 1/2 study in adults over age 70 years to generate clinical proof-of-concept in this key population, with key endpoints including tolerability and immunogenicity comparisons to Shingrix, ahead of advancement into a pivotal trial.

Plague Vaccine Program:

We are developing a plague (rF1V) vaccine candidate adjuvanted with CpG 1018® in collaboration with, and fully funded by, the U.S. Department of Defense (DoD).

•In the fourth quarter of 2024, we and the DoD executed a new agreement for approximately $30 million through the first half of 2027 to support additional clinical and manufacturing activities, including a Phase 2 clinical trial we expected to initiate in the second half of 2025.

Pandemic Influenza Adjuvant Program:

We are evaluating CpG 1018 in an adjuvanted H5N1 influenza vaccine as a proof-of-concept for its potential use with pandemic influenza vaccines.

•We recently completed enrollment and dosing in Part 1 of a randomized, active