Arrowhead Reports Fiscal 2016 First Quarter Results
- Conference Call and Webcast Today at
Conference Call and Webcast Details
Investors may access a live audio webcast on the Company's website at http://ir.arrowheadresearch.com/events.cfm. For analysts that wish to participate in the conference call, please dial 855-215-6159 or 315-625-6887 and enter Conference ID 40876476.
A replay of the webcast will be available on the company's website 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 3 days. To access the audio replay, dial 404-537-3406 and enter Conference ID 40876476.
Fiscal 2016 First Quarter and Recent Company Highlights
ARC-520
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Presented data at the AASLD Liver Meeting 2015 including the following:
- ARC-520 led to robust, sustained anti-viral effects in chimpanzees with chronic HBV, and we also described an important new discovery that HBV DNA integrated into the host genome is likely an important source of HBV surface antigen (HBsAg) production
- In a Phase 2a clinical study, ARC-520 effectively reduced HBV viral antigens derived from cccDNA. HBsAg was reduced substantially with a maximum reduction of 1.9 logs (99%) and a mean maximum reduction of 1.5 logs (96.8%) in treatment naïve e-antigen (HBeAg)-positive patients
- Presented data at Hep DART 2015 showing that ARC-520 led to immune reactivation in 7 of 9 chimpanzees with chronic hepatitis B infection
- Began dosing in the Phase 2b MONARCH combination study
ARC-AAT
- Expanded Part A of the Phase 1 study to test additional dose levels in healthy volunteers and expanded Part B to add additional treatment sites for patients with alpha-1 antitrypsin deficiency
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Received Orphan Drug Designation by the
European Medicines Agency
Platform and Early Pipeline
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Presented data at the Annual Meeting of the
Oligonucleotide Therapeutics Society on the development of ARC-LPA against cardiovascular disease, which uses a new subcutaneous delivery construct that Arrowhead has developed
Selected Fiscal 2016 First Quarter Financial Results
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CONSOLIDATED CONDENSED FINANCIAL INFORMATION (unaudited) | ||||||||
Three Months Ended |
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OPERATING SUMMARY |
2015 | 2014 | ||||||
REVENUE | $ | 43,750 | $ | 170,750 | ||||
OPERATING EXPENSES | ||||||||
Research and development | 10,338,833 | 17,744,312 | ||||||
Salaries and payroll-related costs | 3,919,886 | 3,150,617 | ||||||
General and administrative expenses | 1,951,609 | 2,086,202 | ||||||
Stock-based compensation | 2,380,343 | 2,014,856 | ||||||
Depreciation and amortization | 794,349 | 290,039 | ||||||
TOTAL OPERATING EXPENSES | 19,385,020 | 25,286,026 | ||||||
OPERATING LOSS | (19,341,270 | ) | (25,115,276 | ) | ||||
OTHER INCOME/(EXPENSE), PROVISION FOR INCOME TAXES | 76,856 | 2,539,994 | ||||||
NET LOSS | $ | (19,264,414 | ) | $ | (22,575,282 | ) | ||
EARNINGS PER SHARE (BASIC AND DILUTED): | $ | (0.32 | ) | $ | (0.41 | ) | ||
WEIGHTED AVERAGE SHARES OUTSTANDING | 59,548,672 | 54,692,392 | ||||||
FINANCIAL POSITION SUMMARY |
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2015 | 2015 | |||||||
CASH AND CASH EQUIVALENTS | 62,165,088 | 81,214,354 | ||||||
SHORT-TERM INVESTMENTS | 14,431,498 | 17,539,902 | ||||||
TOTAL CASH RESOURCES (CASH, CASH EQUIVALENTS AND INVESTMENTS) | 76,596,586 | 98,754,256 | ||||||
OTHER ASSETS | 34,784,553 | 33,513,658 | ||||||
TOTAL ASSETS | 111,381,139 | 132,267,914 | ||||||
TOTAL LIABILITIES | 19,012,747 | 22,646,280 | ||||||
TOTAL STOCKHOLDERS' EQUITY | 92,368,392 | 109,621,634 | ||||||
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | 111,381,139 | 132,267,914 | ||||||
SHARES OUTSTANDING | 59,627,499 | 59,544,677 | ||||||
PROFORMA SHARES OUTSTANDING (INCLUDING CONVERSION OF PREFERRED SHARES) | 62,298,489 | 62,215,667 |
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. The mean estimated prevalence of AATD in the
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 seroconversion. 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. Arrowhead is currently conducting Phase 2b multiple dose and combination studies in chronic HBV patients. In clinical studies to date, the most common reported adverse events in all subjects completing treatment were upper respiratory infection and headache.
About
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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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