Company: DVAX
Filing Date: 2025-11-05
Form Type: 10-Q
Source: 0001628280-25-049536
Chunk: 301

Company: DYNAVAX TECHNOLOGIES CORP
Filing Date: 2025-11-05
Form: 10-Q
Item: Part I, Item 8
Chunk 301
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axart’s oral pill COVID-19 vaccine candidate is currently in a Phase 2b clinical trial (the “COVID-19 Vaccine Candidate”) funded under an agreement between Vaxart and Advanced Technology International, the Rapid Response Partnership Vehicle’s Consortium Management Firm funded by BARDA (the U.S. Biomedical Advanced Research and Development Authority) as part of Project NextGen. See Note 14 – 

27

Subsequent Events, in the accompanying notes to the unaudited condensed consolidated financial statements included in Part I, Item 1, “Financial Statements (unaudited)” of this Quarterly Report on Form 10-Q.

HEPLISAV-B® Vaccine [Hepatitis B Vaccine (Recombinant), Adjuvanted] 

In Phase 3 trials, HEPLISAV-B demonstrated faster and higher rates of protection with two doses in one month compared to another currently approved hepatitis B vaccine, which requires three doses over six months, with a similar safety profile. HEPLISAV-B is the only two-dose hepatitis B vaccine for adults approved in the U.S., the EU and the UK.

We have worldwide commercial rights to HEPLISAV-B and we currently market it in the U.S. only. There are four other vaccines approved for the prevention of hepatitis B in the U.S.: Engerix-B and Twinrix® from GlaxoSmithKline plc, Recombivax-HB® from Merck & Co and PreHevbrio™ from VBI Vaccines Inc. In February 2021, we received Marketing Authorization of HEPLISAV-B from the European Commission for prevention of infection caused by all known subtypes of hepatitis B virus in adults aged 18 years and older. In March 2023, we received marketing authorization in the UK for HEPLISAV-B for the active immunization against hepatitis B virus infection caused by all known subtypes of hepatitis B virus in adults aged 18 years and older.

In May 2021, we entered into a commercialization agreement with Bavarian Nordic for the marketing and distribution of HEPLISAV-B in Germany, and in May 2022, we commenced commercial shipments of HEPLISAV-B in Germany. The agreement was not renewed upon its expiration in the second quarter of 2025. Under the terms of the agreement, Bavarian Nordic retains the right to distribute remaining inventory of HEPLISAV-B in Germany through April 30, 2026, after which commercialization rights will revert to Dynavax