Press Release Details
Arrowhead Reports Fiscal 2015 Second Quarter Financial Results
- Conference Call and Webcast Today at
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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 andAsia 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
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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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| CONSOLIDATED CONDENSED FINANCIAL INFORMATION (unaudited) | ||||||||||||||||
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Three Months Ended |
Six Months Ended |
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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 | ||||||||||||
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FINANCIAL POSITION SUMMARY |
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| 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.
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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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