Company: DVAX
Filing Date: 2025-05-06
Form Type: 10-Q
Source: 0001029142-25-000071
Chunk: 249

Company: DYNAVAX TECHNOLOGIES CORP
Filing Date: 2025-05-06
Form: 10-Q
Item: Part I, Item 1
Chunk 249
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 these agreements, CEPI forgave $47.4 million of outstanding Advance Payments (the “Bio E CEPI Advance Payments”) and assumed our rights to collect from Bio E. We may receive additional payments of $5.5 million or $12.3 million from 

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Table of Contents

Bio E if specified milestones related to future collections from the Government of India are met by August 15, 2025; however, these amounts are not considered collectible unless the milestones are achieved.

Advance Clinical and Preclinical Pipeline Leveraging our Proven Adjuvant Technology

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 are currently conducting Part 1 of a Phase 1/2 clinical trial, a randomized, active-controlled, dose escalation, multicenter study, to evaluate the safety, tolerability, and immunogenicity of Z-1018 compared to Shingrix® in 441 healthy adults aged 50 to 69. 

•In the fourth quarter of 2024, we completed enrollment in Part 1, and we anticipate reporting top-line immunogenicity and safety data in the third quarter of 2025.

•We plan to advance the selected vaccine formulation and regimen from Part 1 into a 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 end points 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 expected to initiate in the third quarter of 2025.

Pandemic Influenza Adjuvant Program:

We are evaluating CpG 1018 in an adjuvanted H5