Dynavax Technologies Corporation (NASDAQ: DVAX) today announced
that it has exercised its option to draw down $75 million of
non-dilutive capital under its existing term loan agreement with
CRG Servicing LLC, a healthcare-focused investment firm.
"This non-dilutive financing, together with our
$145.5 million in cash and marketable securities at December 31,
2018, will be used for commercialization of our HEPLISAV-B adult
hepatitis B vaccine," said Michael Ostrach, chief financial officer
of Dynavax. " The proceeds will also help fund the completion of
our ongoing immuno-oncology studies. We are committed to being
thoughtful and diligent in determining the best path forward to
drive value for our shareholders in a capital-efficient manner and
ultimately provide better options for patients.”
Dynavax launched HEPLISAV-B in the U.S. in 2018
for the prevention of infection caused by all known subtypes of
hepatitis B virus in adults age 18 years and older. HEPLISAV-B is
the only two-dose hepatitis B vaccine, and it consistently protects
more than 90% of adult patients. HEPLISAV-B is poised to become the
standard of care hepatitis B adult vaccine and HEPLISAV-B
operations are expected to achieve profitability by the end of
2019.
Within immuno-oncology, Dynavax is focused on
the local induction of innate immunity, which will be instrumental
in the future treatment of cancer. The company’s lead TLR9
immuno-oncology compound, SD-101, has shown clinical activity as a
single agent and in combination with pembrolizumab in patients with
advanced melanoma and head and neck cancer, and has consistently
produced response rates that are higher than those reported for
anti-PD-1 therapy alone.
On March 12, 2019, Dynavax provided a notice of
borrowing to CRG Servicing for the $75 million tranche, with a
funding date of March 29, 2019. This second tranche is the
remaining portion of a $175 million term loan facility with CRG
Servicing, of which Dynavax drew down $100 million upon signing in
February 2018. The loans each have a maturity date of December 31,
2023, unless earlier prepaid. Final funding is subject to Dynavax’s
compliance with customary conditions.
Dynavax expects to use the proceeds for
marketing, sales and production activities for its HEPLISAV-B adult
hepatitis B vaccine and completion of its ongoing immuno-oncology
studies, as well as general working capital and general corporate
purposes.
About Hepatitis BHepatitis 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
About HEPLISAV-BHEPLISAV-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. Dynavax has worldwide
commercial rights to HEPLISAV-B.
For more information about HEPLISAV-B, visit
http://heplisavb.com/.
About SD-101SD-101, the
Company's lead clinical candidate, is a proprietary,
second-generation Toll-like receptor 9 (TLR9) agonist CpG-C class
oligodeoxynucleotide. Dynavax is evaluating this intratumoral TLR9
agonist in several clinical studies to assess its safety and
activity, including a Phase 1b/2 study in combination with
KEYTRUDA® (pembrolizumab), an anti-PD-1 therapy, in patients with
advanced melanoma and in patients with head and neck squamous cell
cancer in a clinical collaboration with Merck. Dynavax maintains
all commercial rights to SD-101.
About DynavaxDynavax 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 February 2018, following
U.S. FDA approval for prevention of infection caused by
all known subtypes of hepatitis B virus in adults age 18 years and
older. Dynavax's lead immunotherapy product, SD-101, is
an investigational cancer immunotherapeutic currently being
evaluated in Phase 1/2 studies and its second cancer
immunotherapeutic, DV281, is in Phase 1 development. For more
information, visit www.dynavax.com.
Forward-Looking Statements 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 Dynavax in general, see risks detailed in the "Risk
Factors" section of our most recent current periodic report filed
with the SEC. These statements represent our estimates and
assumptions only as of the date of this press release. We do not
undertake any obligation to update publicly any such
forward-looking statements, even if new information becomes
available. Information on Dynavax's website at www.dynavax.com is
not incorporated by reference in our current periodic reports with
the SEC.
KEYTRUDA is a registered trademark of Merck
Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Contact: Heather Rowe Vice
President, Investor Relations & Corporate
Communicationshrowe@dynavax.com 510-665-7269
____________________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 3.2iii 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.
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