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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
Selected Fiscal 2014 Year End Financial Results
|CONSOLIDATED CONDENSED FINANCIAL INFORMATION|
|Research and development||23,138,050||8,705,627|
|Salaries and payroll-related costs||12,829,355||6,667,669|
|General and administrative expenses||5,894,008||3,488,864|
|Depreciation and amortization||1,345,655||1,751,412|
|Contingent consideration - fair value adjustments||2,375,658||1,421,652|
|TOTAL OPERATING EXPENSES||53,451,286||24,879,542|
|OTHER INCOME/(EXPENSE), LOSS FROM DISCONTINUED OPERATIONS, PROVISION FOR INCOME TAXES||(5,449,126||)||(7,114,157||)|
|EARNINGS PER SHARE (BASIC AND DILUTED):||$||(1.25||)||$||(1.30||)|
|WEIGHTED AVERAGE SHARES OUTSTANDING||46,933,030||24,002,224|
FINANCIAL POSITION SUMMARY
|CASH AND CASH EQUIVALENTS||132,510,610||19,114,444|
|SHORT AND LONG-TERM INVESTMENTS||44,741,378||10,732,414|
|TOTAL CASH RESOURCES (CASH, CASH EQUIVALENTS AND INVESTMENTS)||177,251,988||29,846,858|
|TOTAL STOCKHOLDERS' EQUITY||165,985,255||25,734,789|
|TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY||182,816,756||37,329,631|
|PROFORMA SHARES OUTSTANDING (INCLUDING CONVERSION OF PREFERRED SHARES)||58,644,142||37,899,280|
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.
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.
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.
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