- 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 315-625-6887 and enter Conference ID 97375077.
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 97375077.
Fiscal 2015 Third Quarter and Recent Company Highlights
Platform and Early Pipeline
Selected Fiscal 2015 Third Quarter Financial Results
|CONSOLIDATED CONDENSED FINANCIAL INFORMATION (unaudited)|
Three Months Ended
Nine Months Ended
|Research and development||7,490,400||6,392,200||36,877,925||14,719,739|
|Acquired in-process research and development||-||-||10,142,786||-|
|Salaries and payroll-related costs||3,570,531||2,454,449||10,262,799||7,634,142|
|General and administrative expenses||1,829,393||1,582,465||5,612,219||3,865,845|
|Depreciation and amortization||741,058||276,054||1,480,656||1,075,238|
|TOTAL OPERATING EXPENSES||16,117,456||12,743,850||71,082,394||31,053,228|
|EARNINGS PER SHARE (BASIC AND DILUTED):||$||(0.27||)||$||(0.22||)||$||(1.19||)||$||(0.81||)|
|WEIGHTED AVERAGE SHARES OUTSTANDING||59,492,867||51,931,989||56,631,297||44,565,008|
FINANCIAL POSITION SUMMARY
|CASH AND CASH EQUIVALENTS||$||87,252,813||$||96,447,301|
|SHORT AND LONG-TERM INVESTMENTS||24,365,922||31,922,240|
|TOTAL CASH RESOURCES (CASH, CASH EQUIVALENTS, INVESTMENTS)||111,618,735||128,369,541|
|TOTAL STOCKHOLDERS' EQUITY||130,744,394||144,196,354|
|TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY||$||145,190,325||$||162,378,458|
|PROFORMA SHARES OUTSTANDING (INCLUDING CONVERSION OF PREFERRED SHARES)||62,169,352||62,106,852|
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.
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 U.S. is 1 per 3000-5000, or approximately 100,000 patients. AATD is also an important cause of pediatric liver disease with an estimated prevalence in children of approximately 20,000 patients, and 50-80% likely to manifest liver disease during childhood. It is a rare disease that appears to be frequently misdiagnosed or undiagnosed. ARC-AAT, which was granted orphan drug designation, 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 is believed to be 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. Arrowhead is conducting a single dose Phase 1 clinical study of ARC-AAT, with part A in healthy volunteers and part B in AATD patients.
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.
DYNAMIC POLYCONJUGATES is a trademark of
Matt Middleman, M.D.
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