Arrowhead Reports Fiscal 2015 Third Quarter Financial Results

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Arrowhead Reports Fiscal 2015 Third...

– Conference Call and Webcast Today at 4:30 p.m. EDT

PASADENA, Calif.–(BUSINESS WIRE)–

Arrowhead Research Corporation (NASDAQ: ARWR) today announced financial

results for its fiscal 2015 third quarter ended June 30, 2015. The

company is hosting a conference call at 4:30 p.m. EDT 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 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

ARC-520

  • Received regulatory permission to initiate three multiple-dose Phase

    2b studies in the United States (Heparc-2004) and in Germany and Hong

    Kong (Heparc-2002 and 2003)

  • Completed dosing of four cohorts in a single-dose Phase 2a study

    (Heparc-2001) and expanded the study to include three additional

    cohorts

  • Completed dosing in a non-clinical study in chronically infected

    chimpanzees that spanned more than a year

  • Highlights of the Phase 2a and chimpanzee studies to be presented at

    an analyst day planned for September 24, 2015

ARC-AAT

  • Met the dosing target for Part A of the ARC-AAT Phase 1 study in

    healthy volunteers, and transitioned the study into Part B which is

    designed to enroll patients with PiZZ genotype alpha-1 antitrypsin

    deficiency

  • Began dosing Part B of the Phase 1 study at one site in Australia

  • Gained regulatory clearance to expand Part B of the Phase 1 study to

    allow additional sites in the United Kingdom and New Zealand

  • Gained Orphan Drug Designation from the United States Food and Drug

    Administration

Platform and Early Pipeline

  • Published data on advances being made in a subcutaneously administered

    formulation of the Dynamic Polyconjugate (DPC) delivery system

  • 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 Third Quarter Financial Results

ARROWHEAD RESEARCH CORPORATION

CONSOLIDATED CONDENSED FINANCIAL INFORMATION (unaudited)

 

 

 

 

Three Months Ended June 30,

Nine Months Ended June 30,

OPERATING SUMMARY

 

2015

 

 

2014

 

 

2015

 

 

2014

 

 

REVENUE

$

123,750

$

43,750

$

338,250

$

$131,250

OPERATING EXPENSES

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

Stock-based compensation

2,486,074

2,038,682

6,706,009

3,758,264

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

OPERATING LOSS

 

(15,993,706

)

 

(12,700,100

)

 

(70,744,144

)

 

(30,921,978

)

OTHER INCOME/(EXPENSE)

 

57,653

 

 

1,073,649

 

 

3,546,398

 

 

(5,372,902

)

NET LOSS

$

(15,936,053

)

$

(11,626,451

)

$

(67,197,746

)

$

(36,294,880

)

 

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

June 30,

March 31,

 

2015

 

 

2015

 

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

OTHER ASSETS

 

33,571,590

 

 

34,008,917

 

TOTAL ASSETS

$

145,190,325

 

$

162,378,458

 

TOTAL LIABILITIES

$

14,445,931

$

18,182,104

TOTAL STOCKHOLDERS’ EQUITY

 

130,744,394

 

 

144,196,354

 

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

$

145,190,325

 

$

162,378,458

 

 

SHARES OUTSTANDING

59,498,362

59,435,862

PROFORMA SHARES OUTSTANDING (INCLUDING CONVERSION OF PREFERRED

SHARES)

62,169,352

62,106,852

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. 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.

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 for chronic

hepatitis B virus and ARC-AAT for liver disease associated with Alpha-1

antitrypsin deficiency.

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

Arrowhead Research Corporation
Vince Anzalone, CFA
626-304-3400
ir@arrowres.com
or
Investor

Relations:
The Trout Group
Todd James
646-378-2926
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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