- Conference Call and Webcast Today at 4:30
p.m. EDT
Arrowhead Research Corporation (NASDAQ: ARWR), a
biopharmaceutical company developing targeted RNAi therapeutics,
today announced financial results for its fiscal 2015 second
quarter ended March 31, 2015. The company is hosting a conference
call at 4:30 p.m. EDT to discuss results.
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 40592020. 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 40592020.
Fiscal 2015 Second Quarter and Recent Company
Highlights
- Started phase 1 study of ARC-AAT, the
company’s clinical candidate against liver disease associated with
alpha-1 antitrypsin deficiency
- Completed dosing of Part A of the
ARC-AAT phase 1 study in healthy volunteers, and transitioned the
study into Part B which will enroll patients with PiZZ genotype
alpha-1 antitrypsin deficiency
- Completed the acquisition of Novartis’
RNAi research and development portfolio, related licenses, and
assets
- Gained clearance from the U.S. Food and
Drug Administration to begin the Heparc-2004 multi-dose Phase 2b
study of ARC-520
- Filed with various regulatory
authorities in Europe and Asia to explore additional multi-dose
studies of ARC-520 outside of the U.S.
- Completed dosing in two additional dose
cohorts in the Heparc-2001, a single-dose phase 2a study of
ARC-520
- Expanded Heparc-2001 to include three
additional cohorts, which will be discussed on the call at 4:30
p.m. EDT
- Published data on a new construct of
the Dynamic Polyconjugate delivery system that appears to have
better stability and longer circulation times, which may enable
subcutaneous administration and potentially extra-hepatic
targeting
- Presented preclinical data on ARC-F12,
a potential new candidate targeting coagulation factor 12 for the
potential treatment of hereditary angioedema and thromboembolic
diseases
Selected Fiscal 2015 Second Quarter Financial Results
ARROWHEAD RESEARCH CORPORATION CONSOLIDATED
CONDENSED FINANCIAL INFORMATION (unaudited)
Three Months Ended March
31,
Six Months Ended March
31,
OPERATING
SUMMARY
2015 2014 2015 2014
REVENUE $ 43,750 $ 43,750
$ 214,500 $ 87,500 OPERATING
EXPENSES Research and development 11,640,794 5,216,446
29,387,524 8,349,460 Acquired in-process research and development
10,142,786 - 10,142,786 - Salaries and payroll-related costs
3,541,652 3,097,902 6,692,268 5,179,693 General and administrative
expenses 1,696,623 1,347,677 3,782,826 2,261,461 Stock-based
compensation 2,205,079 1,198,444 4,219,935 1,719,582 Depreciation
and amortization 449,559 395,779 739,598 799,184 TOTAL OPERATING
EXPENSES 29,676,493 11,256,248
54,964,937 18,309,380
OPERATING LOSS
(29,632,743 ) (11,212,498 )
(54,750,437 ) (18,221,880
) OTHER INCOME/(EXPENSE) 948,750
(2,770,202 ) 3,488,743
(6,446,551 ) NET LOSS $
(28,683,993 ) $ (13,982,700 )
$ (51,261,694 ) $
(24,668,431 ) EARNINGS PER SHARE (BASIC AND
DILUTED): $ (0.51 ) $ (0.31
) $ (0.93 ) $
(0.60 ) WEIGHTED AVERAGE SHARES OUTSTANDING
55,719,923 44,321,847
55,200,512 40,941,903
FINANCIAL
POSITION SUMMARY
March 31, December 31, 2015 2014
CASH AND CASH EQUIVALENTS 96,447,301
103,991,231 SHORT AND LONG-TERM INVESTMENTS
31,922,260 41,338,901 TOTAL CASH RESOURCES
(CASH, CASH EQUIVALENTS AND INVESTMENTS) 128,369,561
145,330,132 OTHER ASSETS 34,008,897
16,806,629 TOTAL ASSETS
162,378,458 162,136,761 TOTAL
LIABILITIES 18,182,104 16,427,090 TOTAL
STOCKHOLDERS' EQUITY 144,196,354
145,709,671 TOTAL LIABILITIES AND STOCKHOLDERS'
EQUITY 162,378,458 162,136,761
SHARES OUTSTANDING 59,435,862
54,715,714 PROFORMA SHARES OUTSTANDING (INCLUDING
CONVERSION OF PREFERRED SHARES) 62,106,852
58,702,920
About ARC-520
Arrowhead’s RNAi-based candidate ARC-520 is being investigated
in the treatment of chronic HBV infection. The small interfering
RNAs (siRNAs) in ARC-520 intervene at the mRNA level, upstream of
the reverse transcription process where current standard of care
nucleotide and nucleoside analogues act. Arrowhead is investigating
ARC-520 specifically, to determine if it can be used to achieve a
functional cure, which is an immune clearant state characterized by
hepatitis B s-antigen negative serum with or without
sero-conversion. Arrowhead has completed a Phase 1 single ascending
dose study in normal volunteers and the company is conducting
single dose Phase 2a studies and multiple dose Phase 2b studies in
chronic HBV patients. Approximately 350-400 million people
worldwide are chronically infected with the hepatitis B virus,
which can lead to cirrhosis of the liver and is responsible for 80%
of primary liver cancers globally.
About ARC-AAT
Arrowhead’s ARC-AAT is being investigated for the treatment of
liver disease associated with Alpha-1 Antitrypsin Deficiency
(AATD), a rare genetic disease that severely damages the liver and
lungs of affected individuals. ARC-AAT employs a novel unlocked
nucleobase analog (UNA) containing RNAi trigger molecule designed
for systemic delivery using the Dynamic Polyconjugate delivery
system. ARC-AAT is highly effective at knocking down the Alpha-1
antitrypsin (AAT) gene transcript and reducing the hepatic
production of the mutant AAT (Z-AAT) protein. Reduction of liver
production of the inflammatory Z-AAT protein, which is likely a
cause of progressive liver disease in AATD patients, is important
as it is expected to halt the progression of liver disease and
potentially allow fibrotic tissue repair. The Company is conducting
a single dose Phase 1 clinical study, with part A in healthy
volunteers and part B in AATD patients.
About Arrowhead Research Corporation
Arrowhead Research Corporation is a biopharmaceutical company
developing targeted RNAi therapeutics. The company is leveraging
its proprietary Dynamic Polyconjugate delivery platform to develop
targeted drugs based on the RNA interference mechanism that
efficiently silences disease-causing genes. Arrowhead’s pipeline
includes ARC-520 for chronic hepatitis B virus and ARC-AAT for
liver disease associated with Alpha-1 antitrypsin deficiency.
For more information please visit
http://www.arrowheadresearch.com, or follow us on Twitter
@ArrowRes. To be added to the Company's email list and receive news
directly, please visit
http://ir.arrowheadresearch.com/alerts.cfm.
Safe Harbor Statement under the Private Securities Litigation
Reform Act:
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.
Source: Arrowhead Research Corporation
Arrowhead Research CorporationVince Anzalone,
CFA626-304-3400ir@arrowres.comorInvestor Relations:The Trout
GroupTodd James646-378-2926ir@arrowres.comorMedia:Russo
PartnersMatt Middleman,
M.D.212-845-4272matt.middleman@russopartnersllc.com
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