|[February 04, 2014]
Arrowhead Reports Fiscal 2014 First Quarter Financial Results
PASADENA, Calif. --(Business Wire)--
Arrowhead Research Corporation (NASDAQ: ARWR), a biopharmaceutical
company developing targeted therapeutics, today announced financial
results for its fiscal 2014 first quarter ended December 31, 2013. The
company is hosting a conference call at 4:30 p.m. Eastern time to
discuss results. To participate, please dial 877-300-8521 (toll free
from the US), 855-669-9657 (toll free from Canada), or 412-317-6026 (for
international callers). Investors may also access a live audio webcast
of this conference call on the Company's website at http://www.arrowheadresearch.com/presentations.
A replay of the webcast will be available approximately one hour after
the conclusion of the call and will remain available for 90 days. An
audio replay will also be available approximately two hours after the
conclusion of the call and will be available for 30 days. The audio
replay can be accessed by dialing 877-870-5176 (toll free from the US
and Canada), or 858-384-5517 (for international callers), and entering
Event ID 10040388.
Fiscal 2014 First Quarter and Recent Company Highlights
Completed planned enrollment in a Phase 1 clinical trial of the
ARC-520 candidate against chronic hepatitis B infection in 36 healthy
Strengthened the balance sheet with an equity offering with $60
million in net proceeds;
Presented data at the AASLD Liver Meeting suggesting that in a
chimpanzee chronically infected with HBV, ARC-520 may have induced a
therapeutic immunological flare, which is thought to be part of a
cascade of events that after longer exposure may lead to functional
Submitted application to the Hong Kong Department of Health requesting
permission to begin a Phase 2a trial of ARC-520 in chronic hepatitis B
Presented unblinded Phase 1 data at HepDART 2013 indicating that
ARC-520 was generally safe and well tolerated at all six dose levels
studied, with no differences in adverse event frequency and severity
between treatment and placebo groups.
Selected Fiscal 2014 First Quarter Financial Results
Net loss attributable to Arrowhead for the quarter was $10.6 million, or
$0.28 per share based on 37.7 million weighted average shares
outstanding. This compares with a netloss attributable to Arrowhead of
$4.6 million, or $0.33 per share based on 14.1 million weighted average
shares outstanding, for the quarter ended December 31, 2012.
Total operating expenses for the quarter ended December 31, 2013 were
$7.1 million, compared to $5 million for the quarter ended December 31,
2012. Research and development related expenses were $4.5 million and
$1.7 million for general and administrative expenses.
Net cash used in operating activities for the quarter was $7 million,
compared with $3.8 million in the prior year period.
The company's cash and investments of cash were $85.5 million at
December 31, 2013, compared to $29.8 million at September 30, 2013. The
increase in the cash balance reflects $60 million from financings during
the quarter, plus cash inflow from exercise of warrants and stock
options of $2.8 million.
Common shares outstanding at December 31, 2013, were 39 million, and
49.7 million assuming conversion of preferred stock outstanding.
Approximately 350 million people worldwide are chronically infected with
the hepatitis B virus. Chronic HBV infection can lead to cirrhosis of
the liver and is responsible for 80% of primary liver cancers globally.
Arrowhead's RNAi-based candidate ARC-520 is designed to treat chronic
HBV infection by reducing the expression and release of new viral
particles and key viral proteins. The goal is to achieve a functional
cure, which is an immune clearant state characterized by hepatitis B
s-antigen negative serum with or without sero-conversion. The siRNAs in
ARC-520 intervene at the mRNA level, upstream of where nucleotide and
nucleoside analogues act. In transient and transgenic mouse models of
HBV infection, a single co-injection of Arrowhead's DPC delivery vehicle
with cholesterol-conjugated siRNA targeting HBV sequences resulted in
multi-log knockdown of HBV RNA, proteins and viral DNA with long
duration of effect. In a chimpanzee chronically infected with HBV and
high viremia and antigenemia, ARC-520 induced rapid reductions of 90-95%
in HBV DNA, e-antigen, and s-antigen, which did not return to baseline
until study day 43, 43, and 71, respectively. Data also suggested that a
therapeutic immunological flare occurred, which is thought to be part of
a cascade that under chronic therapy may lead to HBsAg seroconversion
and functional cure. Arrowhead has completed enrollment in a phase 1
single ascending dose study in normal volunteers, which the company
expects to follow with a phase 2a study in chronic HBV patients.
About Arrowhead Research Corporation
Arrowhead Research Corporation is a biopharmaceutical company developing
targeted RNAi therapeutics. The company is leveraging its proprietary
drug delivery technologies to develop targeted drugs based on the RNA
interference mechanism that efficiently silence disease-causing genes.
Arrowhead technologies also enable partners to create peptide-drug
conjugates that specifically home to cell types of interest while
sparing off-target tissues. Arrowhead's pipeline includes clinical
programs in chronic hepatitis B virus and partner-based programs in
obesity and oncology.
For more information please visit http://www.arrowheadresearch.com,
or follow us on Twitter (News - Alert) @ArrowRes.
To be added to the Company's email list to receive news directly, please
send an email to firstname.lastname@example.org.
Safe Harbor Statement under the Private Securities Litigation Reform
This news release contains forward-looking statements within the
meaning of the "safe harbor" provisions of the Private Securities
Litigation Reform Act of 1995. These statements are based upon our
current expectations and speak only as of the date hereof. Our actual
results may differ materially and adversely from those expressed in any
forward-looking statements as a result of various factors and
uncertainties, including our ability to finance our operations, the
future success of our scientific studies, our ability to successfully
develop drug candidates, the timing for starting and completing clinical
trials, rapid technological change in our markets, and the enforcement
of our intellectual property rights. Arrowhead Research Corporation's
most recent Annual Report on Form 10-K and subsequent Quarterly Reports
on Form 10-Q discuss some of the important risk factors that may affect
our business, results of operations and financial condition. We assume
no obligation to update or revise forward-looking statements to reflect
new events or circumstances.
[ InfoTech Spotlight's Homepage ]