– Conference Call Today at 4:30 p.m. EST
PASADENA, Calif.–(BUSINESS WIRE)–
Arrowhead Research Corporation (NASDAQ: ARWR), a biopharmaceutical
company developing targeted RNAi therapeutics, today announced financial
results for its fiscal 2014 fourth quarter and year ended September 30,
2014. The company is hosting a conference call at 4:30 p.m. EST 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 38229976. 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
38229976.
Fiscal 2014 Year End Company Highlights
Corporate Highlights
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Strengthened our balance sheet with equity financings totaling
approximately $172.6 million in net proceeds during fiscal 2014
-
Hired additional R&D staff in key areas, including manufacturing,
toxicology, chemistry, biology, quality assurance, regulatory and
clinical operations to support rapid development of ARC-520 and
additional clinical candidates
-
Upgraded NASDAQ listing to the Global Select Market
-
Joined the broad-market Russell 3000 Index and the small-cap Russell
2000 Index
Pipeline Highlights
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Nominated ARC-AAT as the Company’s next clinical candidate and held an
analyst day in June 2014 to present preclinical data
-
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
-
Completed planned enrollment of six initial dose cohorts (n=36) and
three additional cohorts (n=18) in a Phase 1 clinical trial indicating
ARC-520 was generally well-tolerated in all nine cohorts at ascending
dose levels of 0.01 – 4.0 mg/kg
-
Initiated a Phase 2a dose finding study of ARC-520 and completed
dosing of three initial dose cohorts (n=24) at 1.0, 2.0, and 3.0
mg/kg, with a 4.0 mg/kg cohort now underway
-
Presented preclinical data on ARC-520 at the 2013 AASLD Liver Meeting
demonstrating reduction of key HBV antigens and DNA, and evidence of
immune reactivation in a chimpanzee with chronic HBV infection
-
Presented interim data on the ongoing Phase 2a study of ARC-520 and
additional preclinical data on ARC-AAT at the 2014 AASLD Liver Meeting
Selected Fiscal 2014 Year End Financial Results
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ARROWHEAD RESEARCH CORPORATION |
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CONSOLIDATED CONDENSED FINANCIAL INFORMATION |
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Year Ended September 30, |
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OPERATING SUMMARY |
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2014 |
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2013 |
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REVENUE |
$ |
175,000 |
$ |
290,266 |
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OPERATING EXPENSES |
|||||||||
Research and development |
23,138,050 |
8,705,627 |
|||||||
Salaries and payroll-related costs |
12,829,355 |
6,667,669 |
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General and administrative expenses |
5,894,008 |
3,488,864 |
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Stock-based compensation |
5,696,173 |
1,536,271 |
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Depreciation and amortization |
1,345,655 |
1,751,412 |
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Impairment expense |
2,172,387 |
1,308,047 |
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Contingent consideration – fair value adjustments |
|
2,375,658 |
|
|
1,421,652 |
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TOTAL OPERATING EXPENSES |
|
53,451,286 |
|
|
24,879,542 |
|
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OPERATING LOSS |
|
(53,276,286 |
) |
|
(24,589,276 |
) |
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OTHER INCOME/(EXPENSE), LOSS FROM DISCONTINUED OPERATIONS, PROVISION FOR INCOME TAXES |
|
(5,449,126 |
) |
|
(7,114,157 |
) |
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NET LOSS |
$ |
(58,725,412 |
) |
$ |
(31,703,433 |
) |
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EARNINGS PER SHARE (BASIC AND DILUTED): |
$ |
(1.25 |
) |
$ |
(1.30 |
) |
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WEIGHTED AVERAGE SHARES OUTSTANDING |
|
46,933,030 |
|
|
24,002,224 |
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FINANCIAL POSITION SUMMARY |
September 30, |
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2014 |
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2013 |
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CASH AND CASH EQUIVALENTS |
132,510,610 |
19,114,444 |
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SHORT AND LONG-TERM INVESTMENTS |
|
44,741,378 |
|
|
10,732,414 |
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TOTAL CASH RESOURCES (CASH, CASH EQUIVALENTS AND INVESTMENTS) |
177,251,988 |
29,846,858 |
|||||||
OTHER ASSETS |
|
5,564,768 |
|
|
7,482,773 |
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TOTAL ASSETS |
|
182,816,756 |
|
|
37,329,631 |
|
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TOTAL LIABILITIES |
16,831,501 |
11,594,842 |
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TOTAL STOCKHOLDERS’ EQUITY |
|
165,985,255 |
|
|
25,734,789 |
|
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TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
182,816,756 |
|
|
37,329,631 |
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SHARES OUTSTANDING |
54,656,936 |
32,489,444 |
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PROFORMA SHARES OUTSTANDING (INCLUDING CONVERSION OF PREFERRED SHARES) |
58,644,142 |
37,899,280 |
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About ARC-520
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. Arrowhead has
completed enrollment in a Phase 1 single ascending dose study in normal
volunteers. The company is conducting a single dose Phase 2a study in
chronic HBV patients, and expects to follow with multi-dose,
multi-national Phase 2b studies. Approximately 350-400 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.
About ARC-AAT
Arrowhead has developed ARC-AAT 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 in
animal models. Reduction of liver production of the inflammatory Z-AAT
protein, which has been clearly defined as the 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 filed to initiate testing in humans in the fourth
quarter of 2014 and intends to begin the study shortly after receiving
approval.
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, ARC-AAT for liver disease associated with Alpha-1
antitrypsin deficiency, 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 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
Lauren Glaser
646-378-2972
ir@arrowres.com
or
Media:
Russo
Partners
Martina Schwarzkopf, Ph.D.
212-845-4292
martina.schwarzkopf@russopartnersllc.com
Source: Arrowhead Research Corporation
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