Press Release Details
Arrowhead Reports Fiscal 2015 First Quarter Financial Results
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Fiscal 2015 First Quarter and Recent Company Highlights
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Expanded the management team with the appointment of
Susan Boynton as Vice President, Regulatory Affairs and Patrick O'Brien as General Counsel -
Presented initial data from the ongoing Phase 2a study of ARC-520, our
RNAi therapeutic candidate for the treatment of chronic hepatitis B
infection, in the late-breaking poster session at the 2014
American Association for the Study of Liver Diseases Meeting (AASLD) - Delivered a plenary presentation at AASLD with new preclinical efficacy data on ARC-AAT, our RNAi therapeutic candidate for the treatment of liver disease associated with Alpha-1 antitrypsin deficiency
- Filed an application for approval to begin a Phase 1 clinical trial of ARC-AAT
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Submitted an IND application to the
U.S. Food and Drug Administration to begin Phase 2b multiple dose studies - Completed dosing of 3 & 4 mg/kg cohorts in Phase 2a study of ARC-520
Selected Fiscal 2015 First Quarter Financial Results
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| CONSOLIDATED CONDENSED FINANCIAL INFORMATION | ||||
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Three Months Ended |
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OPERATING SUMMARY |
2014 |
2013 | ||
| REVENUE |
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| OPERATING EXPENSES | ||||
| Research and development | 17,744,312 | 3,133,014 | ||
| Salaries and payroll-related costs | 3,150,617 | 2,081,791 | ||
| General and administrative expenses | 2,086,202 | 913,784 | ||
| Stock-based compensation | 2,014,856 | 521,138 | ||
| Depreciation and amortization | 290,039 | 403,405 | ||
| TOTAL OPERATING EXPENSES | 25,286,026 | 7,053,132 | ||
| OPERATING LOSS | (25,115,276) | (7,009,382) | ||
| OTHER INCOME/(EXPENSE) | 2,539,994 |
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(3,676,350) | |
| NET LOSS |
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| EARNINGS PER SHARE (BASIC AND DILUTED): |
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| WEIGHTED AVERAGE SHARES OUTSTANDING | 54,692,392 | 37,741,743 | ||
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FINANCIAL POSITION SUMMARY |
2014 | 2014 | ||
| CASH AND CASH EQUIVALENTS | 103,991,231 | 132,510,610 | ||
| SHORT AND LONG-TERM INVESTMENTS | 41,338,901 | 44,741,378 | ||
| TOTAL CASH RESOURCES (CASH, CASH EQUIVALENTS AND INVESTMENTS) | 145,330,132 | 177,251,988 | ||
| OTHER ASSETS | 16,806,629 | 5,564,768 | ||
| TOTAL ASSETS | 162,136,761 | 182,816,756 | ||
| TOTAL LIABILITIES | 16,427,090 | 16,831,501 | ||
| TOTAL STOCKHOLDERS' EQUITY | 145,709,671 | 165,985,255 | ||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | 162,136,761 | 182,816,756 | ||
| SHARES OUTSTANDING | 54,715,714 | 54,656,936 | ||
| PROFORMA SHARES OUTSTANDING (INCLUDING CONVERSION OF PREFERRED SHARES) | 58,702,920 | 58,644,142 | ||
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 a single dose Phase 2a study 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 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. 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 with regulatory authorities in the fourth quarter of 2014 and intends to initiate clinical studies shortly after receiving permission to begin.
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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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