Arrowhead Reports Fiscal 2016 First Quarter Results
– Conference Call and Webcast Today at 4:30 p.m. EST
PASADENA, Calif.–(BUSINESS WIRE)–
Arrowhead Research Corporation (NASDAQ: ARWR) today announced financial
results for its fiscal 2016 first quarter ended December 31, 2015. The
company is hosting a conference call at 4:30 p.m. EST to discuss results.
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:
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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
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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
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Presented data at Hep DART 2015 showing that ARC-520 led to immune
reactivation in 7 of 9 chimpanzees with chronic hepatitis B infection
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Began dosing in the Phase 2b MONARCH combination study
ARC-AAT
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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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ARROWHEAD RESEARCH CORPORATION |
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CONSOLIDATED CONDENSED FINANCIAL INFORMATION (unaudited) |
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Three Months Ended December 31, |
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OPERATING SUMMARY |
2015 |
2014 |
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REVENUE |
$ |
43,750 |
$ |
170,750 |
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OPERATING EXPENSES |
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Research and development |
10,338,833 |
17,744,312 |
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Salaries and payroll-related costs |
3,919,886 |
3,150,617 |
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General and administrative expenses |
1,951,609 |
2,086,202 |
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Stock-based compensation |
2,380,343 |
2,014,856 |
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Depreciation and amortization |
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794,349 |
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290,039 |
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TOTAL OPERATING EXPENSES |
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19,385,020 |
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25,286,026 |
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OPERATING LOSS |
(19,341,270 |
) |
(25,115,276 |
) |
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OTHER INCOME/(EXPENSE), PROVISION FOR INCOME TAXES |
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76,856 |
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2,539,994 |
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NET LOSS |
$ |
(19,264,414 |
) |
$ |
(22,575,282 |
) |
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EARNINGS PER SHARE (BASIC AND DILUTED): |
$ |
(0.32 |
) |
$ |
(0.41 |
) |
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WEIGHTED AVERAGE SHARES OUTSTANDING |
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59,548,672 |
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54,692,392 |
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FINANCIAL POSITION SUMMARY |
December 31, |
September 30, |
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2015 |
2015 |
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CASH AND CASH EQUIVALENTS |
62,165,088 |
81,214,354 |
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SHORT-TERM INVESTMENTS |
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14,431,498 |
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17,539,902 |
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TOTAL CASH RESOURCES (CASH, CASH EQUIVALENTS AND INVESTMENTS) |
76,596,586 |
98,754,256 |
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OTHER ASSETS |
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34,784,553 |
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33,513,658 |
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TOTAL ASSETS |
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111,381,139 |
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132,267,914 |
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TOTAL LIABILITIES |
19,012,747 |
22,646,280 |
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TOTAL STOCKHOLDERS’ EQUITY |
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92,368,392 |
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109,621,634 |
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TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
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111,381,139 |
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132,267,914 |
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SHARES OUTSTANDING |
59,627,499 |
59,544,677 |
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PROFORMA SHARES OUTSTANDING (INCLUDING CONVERSION OF PREFERRED SHARES) |
62,298,489 |
62,215,667 |
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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 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 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. ARC-AAT was granted orphan drug
designation in both the United States and in Europe, the latter being
held on Arrowhead’s behalf by a local EU representative Pharma Gateway
AB. Arrowhead is conducting a Phase 1 clinical study of ARC-AAT, with
part A in healthy volunteers and part B in AATD patients.
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 Arrowhead Research Corporation
Arrowhead Research Corporation is a biopharmaceutical company developing
targeted RNAi therapeutics. The company is leveraging its proprietary
Dynamic Polyconjugate™ delivery platform to develop targeted
drugs based on the RNA interference mechanism that efficiently silences
disease-causing genes. Arrowhead’s pipeline includes ARC-520 and ARC-521
for chronic hepatitis B virus, ARC-AAT for liver disease associated with
alpha-1 antitrypsin deficiency, ARC-F12 for hereditary angioedema and
thromboembolic diseases, and ARC-HIF2 for renal cell carcinoma.
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. Arrowhead Research Corporation’s
most recent Annual Report on Form 10-K and subsequent Quarterly Reports
on Form 10-Q discuss some of the important risk factors that may affect
our business, results of operations and financial condition. We assume
no obligation to update or revise forward-looking statements to reflect
new events or circumstances.
DYNAMIC POLYCONJUGATES is a trademark of Arrowhead Research
Corporation.
Source: Arrowhead Research Corporation
View source version on businesswire.com: http://www.businesswire.com/news/home/20160209006596/en/
Arrowhead Research Corporation
Vince Anzalone, CFA
626-304-3400
ir@arrowres.com
or
Investor
Relations:
The Trout Group
Chad Rubin
646-378-2947
ir@arrowres.com
or
Media:
Russo
Partners
Matt Middleman, M.D.
212-845-4272
matt.middleman@russopartnersllc.com
Source: Arrowhead Research Corporation
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