Company: DVAX
Filing Date: 2025-05-06
Form Type: 10-Q
Source: 0001029142-25-000071
Chunk: 296

Company: DYNAVAX TECHNOLOGIES CORP
Filing Date: 2025-05-06
Form: 10-Q
Item: Part I, Item 8
Chunk 296
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-current) and represents amounts due from Clover that we expect to become payable more than twelve months after March 31, 2025.

Advance Payments from CEPI of $60.3 million are recorded in CEPI accrual long-term in our condensed consolidated balance sheets as of March 31, 2025. We are only obligated to repay these Advance Payments to CEPI if, and to the extent, of our receipt from Clover of their payment for the corresponding CpG 1018 Materials. Advance Payments may be forgiven in accordance with the CEPI Agreement in the event we do not collect corresponding amounts from Clover. Pursuant to the terms of the Clover Supply Agreement, we intend to continue to pursue full collection of the $71.3 million due from Clover. Of this amount, $60.3 million will be payable to CEPI upon the occurrence of the applicable payment trigger events described above, whichever occurs first.

In April 2023, we entered into a third amendment to our supply agreement with Biological E. Limited (“Bio E”) and a related waiver and amendment to the CEPI Agreement (the “CEPI-Bio E Assignment Agreement”). Under 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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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