Arrowhead Reports Fiscal 2015 Second Quarter Financial Results
– Conference Call and Webcast Today at 4:30 p.m. EDT
PASADENA, Calif.–(BUSINESS WIRE)–
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
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Started phase 1 study of ARC-AAT, the company’s clinical candidate
against liver disease associated with alpha-1 antitrypsin deficiency
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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
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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
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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
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ARROWHEAD RESEARCH CORPORATION |
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CONSOLIDATED CONDENSED FINANCIAL INFORMATION (unaudited) |
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Three Months Ended |
Six Months Ended |
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OPERATING SUMMARY |
2015 |
2014 |
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2015 |
2014 |
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REVENUE |
$ |
43,750 |
$ |
43,750 |
$ |
214,500 |
$ |
87,500 |
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OPERATING EXPENSES |
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Research and development |
11,640,794 |
5,216,446 |
29,387,524 |
8,349,460 |
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Acquired in-process research and development |
10,142,786 |
– |
10,142,786 |
– |
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Salaries and payroll-related costs |
3,541,652 |
3,097,902 |
6,692,268 |
5,179,693 |
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General and administrative expenses |
1,696,623 |
1,347,677 |
3,782,826 |
2,261,461 |
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Stock-based compensation |
2,205,079 |
1,198,444 |
4,219,935 |
1,719,582 |
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Depreciation and amortization |
449,559 |
395,779 |
739,598 |
799,184 |
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TOTAL OPERATING EXPENSES |
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29,676,493 |
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11,256,248 |
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54,964,937 |
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18,309,380 |
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OPERATING LOSS |
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(29,632,743 |
) |
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(11,212,498 |
) |
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(54,750,437 |
) |
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(18,221,880 |
) |
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OTHER INCOME/(EXPENSE) |
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948,750 |
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(2,770,202 |
) |
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3,488,743 |
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(6,446,551 |
) |
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NET LOSS |
$ |
(28,683,993 |
) |
$ |
(13,982,700 |
) |
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$ |
(51,261,694 |
) |
$ |
(24,668,431 |
) |
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EARNINGS PER SHARE (BASIC AND DILUTED): |
$ |
(0.51 |
) |
$ |
(0.31 |
) |
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$ |
(0.93 |
) |
$ |
(0.60 |
) |
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WEIGHTED AVERAGE SHARES OUTSTANDING |
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55,719,923 |
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44,321,847 |
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55,200,512 |
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40,941,903 |
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FINANCIAL POSITION SUMMARY |
March 31, |
December 31, |
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2015 |
2014 |
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CASH AND CASH EQUIVALENTS |
96,447,301 |
103,991,231 |
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SHORT AND LONG-TERM INVESTMENTS |
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31,922,260 |
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41,338,901 |
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TOTAL CASH RESOURCES (CASH, CASH EQUIVALENTS AND INVESTMENTS) |
128,369,561 |
145,330,132 |
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OTHER ASSETS |
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34,008,897 |
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16,806,629 |
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TOTAL ASSETS |
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162,378,458 |
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162,136,761 |
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TOTAL LIABILITIES |
18,182,104 |
16,427,090 |
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TOTAL STOCKHOLDERS’ EQUITY |
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144,196,354 |
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145,709,671 |
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TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
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162,378,458 |
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162,136,761 |
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SHARES OUTSTANDING |
59,435,862 |
54,715,714 |
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PROFORMA SHARES OUTSTANDING (INCLUDING CONVERSION OF PREFERRED SHARES) |
62,106,852 |
58,702,920 |
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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 Corporation
Vince Anzalone, CFA
626-304-3400
ir@arrowres.com
or
Investor
Relations:
The Trout Group
Todd James
646-378-2926
ir@arrowres.com
or
Media:
Russo
Partners
Matt Middleman, M.D.
212-845-4272
matt.middleman@russopartnersllc.com
Source: Arrowhead Research Corporation
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