Full Press Release Details
Reports Fiscal 2014 Third Quarter Financial Results and Provides Update
Conference Call Today at 4:30 p.m. EDT
PASADENA, Calif.--(BUSINESS WIRE)--August 12, 2014--Arrowhead Research
Corporation (NASDAQ: ARWR), a biopharmaceutical company developing
targeted RNAi therapeutics, today announced financial results for its
fiscal 2014 third quarter ended June 30, 2014 and provided an update on
the Phase 2a study of ARC-520, its RNAi-based candidate for the
treatment of chronic hepatitis B infection. The company is hosting a
conference call at 4:30 p.m. EDT to discuss results. Conference call and
webcast details can be found below.
ARC-520 Phase 2a Study Update
Completed dosing of 1 mg/kg and 2 mg/kg dose cohorts
Initial blinded data suggest that the magnitude of HBsAg knockdown is
similar to non-human primate studies, including the chronically
infected chimpanzee reported on previously
Duration of knockdown appears to be substantially more sustained than
in non-human primates, with patients in the 2 mg/kg group still
demonstrating substantial knockdown after 8 weeks, which is the most
recent time point available
HBsAg levels appear to continue to decline in a number of patients at
the 8 week time point in the 2 mg/kg group
Based on initial review, dosing less frequent than once monthly will
be explored in Phase 2b
ARC-520 continues to be well tolerated, with no dropouts or serious
adverse events reported
The overall rate of AEs has been lower in the Phase 2a than in the
Phase 1 normal volunteer study and safety labs continue to show no
indication of end organ toxicity
Enrolled and dosed additional subjects at 3 mg/kg in the still open
normal volunteer study and the dose performed well, without detected
differences from safety and tolerability results at the other doses.
Overall AEs do not appear to be increasing in frequency or severity
Received IRB and DSMB approvals to proceed and began enrolling an
additional dose cohort at 3 mg/kg in the Phase 2a patient study
Fiscal 2014 Third Quarter and Recent Company Highlights
Nominated a second clinical candidate using our DPC delivery system,
ARC-AAT, for the treatment of a rare liver disease associated with
alpha-1 antitrypsin deficiency and hosted an analyst day to present
Signed an agreement with The Alpha-1 Project (TAP), the venture
philanthropy subsidiary of the Alpha-1 Foundation. Under the terms of
the agreement, TAP will partially fund the development of ARC-AAT. In
addition, TAP will make its scientific advisors available to
Arrowhead, assist with patient recruitment for clinical trials through
the Alpha-1 Foundation Patient Research Registry, and engage in other
collaborative efforts that support the development of ARC-AAT
Initiated the final steps required to file an IND or equivalent
application for ARC-AAT, including necessary toxicology studies
Expanded intellectual property protection with U.S. Patent Application
number 13/535,454 covering ARC-520's siRNA component, being recently
allowed by the U.S. Patent and Trademark Office
Presented data on advancements made to the DPC delivery system at
multiple scientific meetings
Arrowhead added to the broad-market Russell 3000 index and small-cap
Selected Fiscal 2014 Third Quarter Financial Results
Net loss attributable to Arrowhead for the quarter was $11.6 million, or
$0.22 per share based on 51.9 million weighted average shares
outstanding. This compares with a net loss attributable to Arrowhead of
$6.1 million, or $0.23 per share based on 26.1 million weighted average
shares outstanding, for the quarter ended June 30, 2013.
Total operating expenses for the quarter were $12.7 million, compared to
$6.4 million for the quarter ended June 30, 2013. Research and
development related expenses were $6.4 million and general and
administrative expenses were $1.6 during the quarter.
Net cash used in operating activities for the first nine months of
fiscal 2014 was $24.5 million, compared with $13.6 million in the prior
The company's cash and investments of cash were $188.5 million at June
30, 2014, compared to $29.8 million at September 30, 2013. The increase
in the cash balance reflects financings completed in October 2013 and
February 2014, plus cash inflow from exercise of warrants and stock
options of $12.4 million.
Common shares outstanding at June 30, 2014, were 52.9 million, and 58.5
million assuming conversion of preferred stock outstanding.
Conference Call and Webcast Details
To participate in the conference call, please dial 855-215-6159 (toll
free from the US) or 315-625-6887 (for international callers) and enter
Conference ID 82825377. Investors may also access a live audio webcast
of this conference call on the Company's website at http://ir.arrowheadresearch.com/events.cfm.
A replay of the webcast will be available approximately two hours 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 7 days. The audio
replay can be accessed by dialing 855-859-2056 (toll free from the US),
or 404-537-3406 (for international callers) and entering Conference ID
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 Dynamic
Polyconjugate (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. The company is
conducting a single dose Phase 2a study in chronic HBV patients, and
expects to follow with a multi-dose, multi-national Phase 2b program.
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 has developed ARC-AAT for the treatment of liver disease