Company: DVAX
Filing Date: 2025-08-07
Form Type: 10-Q
Source: 0001029142-25-000117
Chunk: 295

Company: DYNAVAX TECHNOLOGIES CORP
Filing Date: 2025-08-07
Form: 10-Q
Item: Part I, Item 8
Chunk 295
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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-controlled Phase 1/2 study to evaluate the safety and immunogenicity of an investigational H5N1 influenza vaccine adjuvanted with CpG 1018 in 101 participants aged 18 to 49.

•We expect to use the Part 1 data to select the optimal formulations of CpG 1018 adjuvant to advance to Part 2 of the Phase 1/2 trial, with top-line immunogenicity and safety data expected in 2026.

Lyme Disease Vaccine Program:

We are developing an investigational multivalent protein subunit vaccine candidate adjuvanted with CpG 1018 for the prevention of Lyme disease, a bacterial infection that is the most common vector-borne illness in the Northern Hemisphere.

•There are currently no approved human vaccines for Lyme disease and current vaccine candidates in clinical development require a three-dose primary series and annual boosters. We believe our investigational Lyme disease vaccine adjuvanted with CpG 1018, which has a demonstrated ability to amplify immune response and improve durability of protection, has the potential for a differentiated and best-in-class vaccine profile. 

•Our Lyme disease vaccine candidate has progressed into Investigational New Drug (IND)-enabling studies, with plans to initiate clinical development in 2027.

HEPLISAV-B for Adults on Hemodialysis:

•We plan to conduct an observational retrospective cohort study to support our sBLA filing for a HEPLISAV-B® vaccine regimen for adults on hemodialysis. In the first quarter of 2025, we received feedback from the U.S. Food and Drug Administration (FDA) that our proposed patient 

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database may be acceptable for the observational retrospective cohort study, and we are engaging with the FDA to finalize the study protocol.

Convertible Notes

On March 13, 2025 (the "Settlement Date"), we entered into privately negotiated exchange and subscription agreements (the "Exchange Agreements") with certain holders of our outstanding 2.50% Convertible