Arrowhead Reports Fiscal 2015 Year End Results

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Arrowhead Reports Fiscal 2015 Year...

– 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 2015 fourth quarter and year ended September 30,

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 99535530.

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 99535530.

Fiscal 2015 Fourth Quarter and Recent Company Highlights

ARC-520

  • Presented data at AASLD Liver Meeting 2014 showing statistically

    significant reduction in HBsAg through day 43 after a single injection

    (p &#60 0.05) in human clinical trials

  • Submitted an Investigational New Drug (IND) application to the U.S.

    Food and Drug Administration and submitted additional clinical trial

    authorization applications with regulatory authorities in various

    jurisdictions in Europe, Asia, and Australia/New Zealand for ARC-520

  • Initiated dosing in Heparc-2004, a multiple-dose Phase 2b clinical

    study of ARC-520 in the U.S.

  • Initiated multiple-dose Heparc-2002 and Heparc-2003 Phase 2b studies

    of ARC-520 in Europe and Asia

  • Hosted an analyst day to discuss top-line findings from the

    Heparc-2001 Phase 2a clinical study of ARC-520 and findings from a

    study of 9 chimpanzees that have been treated monthly with ARC-520 for

    between 6 and 11 months. Key messages included the following:

    • Arrowhead’s proprietary DPC™ platform can effectively and

      consistently knock down target genes in humans

    • ARC-520 achieved significant HBV s-Antigen (HBsAg) reductions in

      humans, particularly in treatment naïve, HBeAg-positive patients

    • Arrowhead identified a large target HBV population for ARC-520 and

      described a new paradigm for the HBV lifecycle

    • ARC-520 induced deep HBsAg reduction in chronically HBV infected

      chimpanzees

    • ARC-520 was well tolerated, no serious or severe adverse events

      were reported in these studies

    • Arrowhead expanded its HBV portfolio by nominating ARC-521, an

      additional clinical candidate that is complementary to ARC-520

  • 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. HBV surface antigen (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

ARC-AAT

  • Presented data at AASLD Liver Meeting 2014

    • Repeat dosing of ARC-AAT in primates showed reduction of

      approximately 90% of serum alpha-1 antitrypsin (AAT) with long

      duration of effect suggesting that monthly or less frequent dosing

      may be sufficient for sustained suppression of hepatic AAT

      production

    • ARC-AAT abstract highlighted in the AASLD President’s Press

      Conference as a promising new treatment

  • Filed for regulatory approval to begin a Phase 1 clinical trial of

    ARC-AAT for the treatment of liver disease associated with alpha-1

    antitrypsin deficiency

  • Initiated dosing in a Phase 1 clinical trial of ARC-AAT

  • Completed dosing of Part A of the ARC-AAT phase 1 study in healthy

    volunteers, and transitioned the study into Part B in patients with

    PiZZ genotype alpha-1 antitrypsin deficiency

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

    Administration

  • Expanded Part B of the Phase 1 study of ARC-AAT to include additional

    treatment sites in Europe, Australia, and New Zealand

Platform and Early Pipeline

  • Acquired Novartis Institutes for BioMedical Research, Inc (“Novartis”)

    entire RNAi research and development portfolio and associated assets,

    including:

    • Multiple patent families covering RNAi-trigger design rules and

      modifications that fall outside of key patents controlled by

      competitors, which the Company believes provides freedom to

      operate for any target and indication

    • Novel intracellular targeting ligands that enhance the activity of

      RNAi-triggers by targeting the RNA-induced silencing complex

      (RISC) more effectively and improving stability once RISC is loaded

    • An assignment of Novartis’ license from Alnylam Pharmaceuticals,

      Inc. (“Alnylam”) granting Arrowhead access to Alnylam intellectual

      property, excluding delivery, for 30 gene targets chosen by

      Novartis

    • A pipeline of three candidates initiated by Novartis for which

      Novartis has developed varying amounts of preclinical data

  • Published new data in the Journal of Controlled Release, 209

    (2015) 57-66, on a subcutaneously administered formulation of its DPC™

    delivery system

  • Presented data at the TIDES Conference on the development of ARC-F12,

    an RNAi therapeutic for factor 12 mediated hereditary angioedema and

    thromboembolic diseases

  • Nominated ARC-HIF2 against clear cell renal cell carcinoma as

    Arrowhead’s first therapeutic candidate delivered using a new DPC™

    designed to target tissues outside of the liver

  • 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 2015 Year End Financial Results

 

ARROWHEAD RESEARCH CORPORATION

CONSOLIDATED CONDENSED FINANCIAL INFORMATION

 

 

Year Ended September 30,

OPERATING SUMMARY

2015

2014

 

REVENUE

$

382,000

$

175,000

OPERATING EXPENSES

Research and development

47,267,361

23,138,050

Acquired in-process research and development

10,142,786

–

Salaries and payroll-related costs

16,554,008

12,829,355

General and administrative expenses

7,931,184

5,894,008

Stock-based compensation

10,232,897

5,696,173

Depreciation and amortization

2,336,207

1,345,655

Impairment expense

–

2,172,387

Contingent consideration – fair value adjustments

 

1,891,533

 

2,375,658

TOTAL OPERATING EXPENSES

 

96,355,976

 

53,451,286

OPERATING LOSS

(95,973,976

)

(53,276,286

)

OTHER INCOME/(EXPENSE), LOSS FROM DISCONTINUED OPERATIONS,

PROVISION FOR INCOME TAXES

 

4,033,094

 

(5,449,126

)

NET LOSS

$

(91,940,882

)

$

(58,725,412

)

 

EARNINGS PER SHARE (BASIC AND DILUTED):

$

(1.60

)

$

(1.25

)

WEIGHTED AVERAGE SHARES OUTSTANDING

 

57,358,442

 

46,933,030

 

FINANCIAL POSITION SUMMARY

September 30,

2015

2014

CASH AND CASH EQUIVALENTS

81,214,354

132,510,610

SHORT AND LONG-TERM INVESTMENTS

 

17,539,902

 

44,741,378

TOTAL CASH RESOURCES (CASH, CASH EQUIVALENTS AND INVESTMENTS)

98,754,256

177,251,988

OTHER ASSETS

 

33,513,658

 

5,564,768

TOTAL ASSETS

 

132,267,914

 

182,816,756

TOTAL LIABILITIES

22,646,280

16,831,501

TOTAL STOCKHOLDERS’ EQUITY

 

109,621,634

 

165,985,255

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

 

132,267,914

 

182,816,756

 

SHARES OUTSTANDING

59,544,677

54,656,936

PROFORMA SHARES OUTSTANDING (INCLUDING CONVERSION OF PREFERRED

SHARES)

62,215,667

58,644,142

 

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 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 is

conducting Phase 2b multiple dose and combination 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 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

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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