Dynavax Exercises Option for $75 Million in Non-Dilutive Debt
"This non-dilutive financing, together with our
About Hepatitis B
Hepatitis B is a viral disease of the liver that can become chronic and lead to cirrhosis, liver cancer and death. The hepatitis B virus is 50 to 100 times more infectious than HIV,i and transmission is on the rise. In 2015, new cases of acute hepatitis B increased by more than 20 percent nationally.ii There is no cure for hepatitis B, but effective vaccination can prevent the disease.
In adults, hepatitis B is spread through contact with infected blood and through unprotected sex with an infected person. The CDC recommends vaccination for those at high risk for infection due to their jobs, lifestyle, living situations and travel to certain areas.iii Because people with diabetes are particularly vulnerable to infection, the CDC recommends vaccination for adults age 19 to 59 with diabetes as soon as possible after their diagnosis, and for people age 60 and older with diabetes at their physician's discretion.iv Approximately 20 million U.S. adults have diabetes, and 1.5 million new cases of diabetes are diagnosed each year.v
HEPLISAV-B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with Dynavax’s proprietary Toll-like Receptor (TLR) 9 agonist to enhance the immune response.
For more information about HEPLISAV-B, visit http://heplisavb.com/.
SD-101, the Company's lead clinical candidate, is a proprietary, second-generation Toll-like receptor 9 (TLR9) agonist CpG-C class oligodeoxynucleotide.
Dynavax is a fully-integrated biopharmaceutical company focused on leveraging the power of the body's innate and adaptive immune responses through Toll-like receptor (TLR) stimulation. Dynavax discovers and develops novel vaccines and immuno-oncology therapeutics. The Company launched its first commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], in
This press release contains forward-looking statements, including statements regarding our ability to successfully commercialize HEPLISAV-B, our anticipated level of sales and profitability from HEPLISAV-B operations, whether existing cash and the funds available under the term loan agreement will be sufficient to fund the continued launch of HEPLISAV-B and continued development of our pipeline, and the conduct of clinical trials of SD-101, including results from such trials. These statements are subject to a number of risks and uncertainties that could cause actual results to differ materially, including whether payers will provide timely reimbursement for HEPLISAV-B; whether prescribers and other key decision-makers will switch to HEPLISAV-B and consider HEPLISAV-B to be the standard of care, whether interim and final results of current and future clinical trials of product candidates including SD-101 will support the initiation or continuation of subsequent trials, and the costs of current and future clinical trials. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of
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Vice President, Investor Relations & Corporate Communications
i CDC. https://www.cdc.gov/hepatitis/hbv/bfaq.htm.
ii CDC. https://www.cdc.gov/hepatitis/statistics/2015surveillance/index.htm#tabs-5-8. Fig 3.2
iii CDC. https://www.cdc.gov/hepatitis/hbv/hbvfaq.htm.
iv CDC. https://www.cdc.gov/diabetes/pubs/pdf/hepb_vaccination.pdf.
v CDC. https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf.
Source: Dynavax Technologies Corporation