Company: DVAX
Filing Date: 2025-05-06
Form Type: 10-Q
Source: 0001029142-25-000071
Chunk: 298

Company: DYNAVAX TECHNOLOGIES CORP
Filing Date: 2025-05-06
Form: 10-Q
Item: Part I, Item 8
Chunk 298
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 trial.

Lyme Disease Vaccine Program:

We are developing an investigational multivalent protein subunit vaccine 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 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.

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HEPLISAV-B for Adults on Hemodialysis:

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

•We plan to conduct an observational retrospective cohort study to support its 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 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 Senior Notes due 2026 (the "2026 Notes") and one new investor. Pursuant to the Exchange Agreements, we issued $225.0 million aggregate principal amount of 2.00% Convertible Senior Notes due 2030 (the "2030 Notes"), consisting of (i) approximately $185.3 million issued in exchange for a corresponding principal amount of 2026 Notes, and (ii) approximately $39.7 million of 2030 Notes issued to existing holders and a new investor (the "Refinancing Transaction").

Following the completion of the Refinancing Transaction, the total principal balance of our outstanding convertible notes as of March 13, 2025, was $265.2 million, which comprised $225.0 million principal amount of the 2030 Notes and $40.2 million principal amount of the remaining 2026 Notes.

In connection with the Refinancing Transaction