Company: DVAX
Filing Date: 2025-02-20
Form Type: 10-K
Source: 0001029142-25-000049
Chunk: 6

Company: DYNAVAX TECHNOLOGIES CORP
Filing Date: 2025-02-20
Form: 10-K
Item: Item 1
Chunk 6
---
We are currently conducting a randomized, active-controlled, dose escalation, multicenter Phase 1/2 trial 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 the trial, and we anticipate reporting top line immunogenicity and safety data in the third quarter of 2025.

Plague vaccine candidate:

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").

•Based on the results from a randomized, active-controlled Phase 2 clinical trial of the two-dose plague vaccine adjuvanted with CpG 1018, we and the DoD executed a new agreement for approximately $30.0 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.

7

Table of Contents

HEPLISAV-B for Adults on Hemodialysis:

We are developing a four-dose HEPLISAV-B vaccine regimen for adults on hemodialysis.

•In the fourth quarter of 2024, we received feedback from the FDA regarding the potential to conduct an observational retrospective cohort study to support our sBLA filing for adults on hemodialysis.

Tdap vaccine program: 

•In November 2024, we announced that we have decided to discontinue development of our Tdap-1018 program based on results from a long-term Phase 1 extension study that did not demonstrate a differentiated profile that we believe would be successful commercially.

OUR STRATEGY

Our vision is to continue building a leading vaccines company dedicated to developing and commercializing innovative vaccines to help protect the world against infectious diseases. Our strategy is focused on our core priorities: drive growth in our HEPLISAV-B commercial vaccine, advance a differentiated vaccine pipeline, and identify strategic opportunities to accelerate growth. Key elements of our strategy include: 

•Increase our HEPLISAV-B vaccine market share to become the market leader in the future;

•Maximize total addressable HEPLISAV-B vaccine market based on the CDC's Advisory Committee on Immunization Practices ("ACIP") Universal Recommendation;

•Leverage HEPLISAV-B vaccine as a foundational commercial asset to support company growth and pipeline development