Arrowhead Research Corporation (NASDAQ: ARWR), a biopharmaceutical
company developing targeted RNAi therapeutics, today announced financial
results for its fiscal 2013 fourth quarter and year ended September 30,
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 10038065.
Fiscal 2013 Fourth Quarter and Recent Company Highlights
Closed a $60 million financing from a syndicate of high-quality
biotech investors. This provided sufficient capital to fund
development into 2016;
Presented additional data at the AASLD Liver Meeting on the ARC-520
chimpanzee study indicating possible immune de-repression as hepatitis
B s-antigen levels were reduced;
Completed planned enrollment of a Phase 1 clinical trial of ARC-520 in
Submitted an application for a Certificate of Clinical Trial to the
Hong Kong Department of Health to begin a Phase 2a clinical trial of
ARC-520 in chronic HBV patients; and
Presented Phase 1 data at HepDART 2013 showing that ARC-520 was
generally safe and well-tolerated at all six dose levels studied.
Selected Fiscal 2013 Year End Financial Results
Total operating expenses for the year ended September 30, 2013 were
$24.9 million, compared to 21.2 million for the year ended September 30,
Net loss attributable to Arrowhead for the year ended September 30, 2013
was $31.1 million, or $1.30 per share based on 24 million weighted
average shares outstanding. This compares with a net loss attributable
to Arrowhead of $21.1 million, or $1.90 per share based on 11.1 million
weighted average shares outstanding, for the year ended September 30,
Net cash used in operating activities in fiscal 2013 was $19 million,
compared with $15.3 million in the prior year period. The increase in
operating expenses and cash used in operating activities of
approximately $3.5 million, as compared to the prior fiscal year,
reflects final pre-clinical requirements, including GMP manufacturing
and GLP toxicology, to enable our HBV candidate, ARC-520, to enter
clinical trials, as well as expenditures related to the phase 1 trial of
ARC-520 for which we completed planned enrollment in October 2013.
The company’s cash and investments of cash were $29.8 million at
September 30, 2013, compared to $3.4 million at September 30, 2012. The
increase in cash balance reflects $42.5 million in cash from financings
during fiscal 2013, plus cash inflow from warrant exercises of $2
million. Subsequent to September 30, 2013, an additional financing that
closed in October 2013 yielded $60 million in net proceeds.
During the fiscal year, cash outlays for research and development were
$13 million, and cash used for general and administrative purposes was
$6.6 million. Cash inflows during the fiscal year included $42.5 million
from the sale of equity securities, $2 million from warrant exercises,
$300,000 in revenue, and $1.4 million in proceeds related to the sale of
our former subsidiary, Unidym.
Common shares outstanding at September 30, 2013, were 32.5 million, and
37.9 million assuming conversion of preferred shares outstanding at
September 30, 2013. Taking into account the October financing and shares
issued through the exercise of warrants since the end of the fiscal
year, current common shares outstanding are 38.7 million, and 49.4
million assuming conversion of preferred shares 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 @ArrowRes.
To be added to the Company's email list to receive news directly, please
send an email to [email protected].
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.
Copyright Business Wire 2013