Form 8-K ARROWHEAD PHARMACEUTICAL For: May 08

May 8, 2018 4:10 PM

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): May 8, 2018

 

Arrowhead Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

 

 

 

 

Delaware

 

001-38042

 

46-0408024

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

225 South Lake Avenue, Suite 1050, Pasadena, CA 91101

(Address of principal executive offices) (Zip Code)

Registrant’s telephone number, including area code (626) 304-3400

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)

Pre-commencement communications pursuant to Rule 13e-4 (c) under the Exchange Act (17 CFR 240.13e-4(c)

 

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 

 

 



Item 2.02 Results of Operations and Financial Condition

On May 8, 2018, Arrowhead Pharmaceuticals, Inc. announced and commented on its fiscal 2018 second quarter financial results for the period ended March 31, 2018. A copy of the press release is furnished herewith as Exhibit 99.1.

 

In accordance with General Instruction B.2 of Form 8-K, the information in this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing to this Current Report on Form 8-K.

 

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

 

 

 

 

Exhibit No.

  

Description

 

 

99.1

  

Press Release, dated May, 8, 2018.

 

 

 



SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

Date: May 8, 2018

 

 

 

 

ARROWHEAD PHARMACEUTICALS, INC.

 

 

By:

 

/s/ Kenneth Myszkowski

 

 

Kenneth Myszkowski

 

 

Chief Financial Officer

 

 

Exhibit 99.1

PRESS RELEASE

May 8, 2018

 

 

 

 

Arrowhead Pharmaceuticals Reports Fiscal 2018 Second Quarter Results

 

-

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

PASADENA, Calif., May 8, 2018 — Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced financial results for its fiscal 2018 second quarter ended March 31, 2018. 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.arrowheadpharma.com/events.cfm. For analysts that wish to participate in the conference call, please dial 855-215-6159 or 315-625-6887 and provide Conference ID 2895628.

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 855-859-2056 or 404-537-3406 and provide Conference ID 2895628.

Selected Fiscal 2018 Second Quarter and Recent Events

 

Strengthened the balance sheet with an equity financing yielding gross proceeds of $60.4 million

 

Received orphan drug designation from the United States Food and Drug Administration (FDA) for ARO-AAT, Arrowhead's second-generation investigational medicine for the treatment of a rare genetic liver disease associated with alpha-1 antitrypsin deficiency


 

Initiated dosing in AROAAT1001 (NCT03362242), a Phase 1 single- and multiple-ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and effect of ARO-AAT on serum alpha-1 antitrypsin levels in healthy adult volunteers

 

Initiated dosing in AROHBV1001 (NCT03365947), a Phase 1/2 study to evaluate the safety, tolerability, and pharmacokinetic effects of single-ascending doses (SAD) of ARO-HBV in healthy adult volunteers, and to evaluate the safety, tolerability, and pharmacodynamic effects of multiple-ascending doses (MAD) of ARO-HBV in patients with chronic HBV

 

Presented clinical data on ARC-520, the company’s prior generation investigational medicine for the treatment of chronic hepatitis B infection, at The International Liver Congress™ 2018 (ILC), the annual meeting of the European Association for the Study of the Liver (EASL), including the following key results:

 

o

Multiple doses of ARC-520 resulted in s-antigen reductions in all patients by as much as 5.3 Log10

 

o

Where measurable, multi-log reductions were also seen in e-antigen, core-related antigen, DNA and HBV RNA

 

o

One e-antigen negative patient, while remaining on entecavir, serocleared for all measurable viral markers including s-antigen, core-related antigen, HBV RNA, and HBV DNA. We believe this will represent a functional cure

 

o

2 out of 3 e-antigen positive and 2 out of 5 e-antigen negative patients, or half of the patients in the study, achieved productive and sustained host responses.  These were characterized by mild ALT elevations coinciding with continued reductions in various viral markers which persisted after ARC-520 therapy was removed

 

o

Two patients that experienced sustained host responses but had not yet serocleared, appear poised to potentially seroclear if the trends in the decrease of viral markers continues

 

Presented preclinical data on both ARO-AAT and ARO-HBV at EASL

 

Made continued progress on the emerging pipeline of RNAi therapeutics developed using the Targeted RNAi Molecule (TRiMTM) platform including:

 

o

The cardiometabolic pipeline, which includes ARO-APOC3, targeting apolipoprotein C-III (ApoC3), and ARO-ANG3, targeting angiopoietin-like protein 3 (ANGPTL3)


 

o

The pulmonary pipeline, which includes ARO-ENaC, formerly called ARO-Lung1, which is an inhaled RNAi therapeutic targeting the epithelial sodium channel alpha subunit (aENaC) for the treatment of cystic fibrosis

 

o

ARO-HIF2 for the treatment of clear cell renal cell carcinoma

Selected Fiscal 2018 Second Quarter Financial Results

ARROWHEAD PHARMACEUTICALS, INC.

CONSOLIDATED CONDENSED FINANCIAL INFORMATION (unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

March 31,

 

 

Six Months Ended

March 31,

 

 

OPERATING SUMMARY

2018

 

 

2017

 

 

2018

 

 

2017

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

REVENUE

$

650,125

 

 

$

8,985,930

 

 

$

4,159,946

 

 

$

13,351,426

 

 

OPERATING EXPENSES

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

12,002,354

 

 

 

11,438,216

 

 

 

24,921,972

 

 

 

26,226,466

 

 

General and administrative expenses

 

3,681,830

 

 

 

3,677,356

 

 

 

8,085,381

 

 

 

8,156,491

 

 

TOTAL OPERATING EXPENSES

 

15,684,184

 

 

 

15,115,572

 

 

 

33,007,353

 

 

 

34,382,957

 

 

OPERATING LOSS

 

(15,034,059

)

 

 

(6,129,642

)

 

 

(28,847,407

)

 

 

(21,031,531

)

 

OTHER INCOME/(EXPENSE), PROVISION FOR INCOME TAXES

 

149,748

 

 

 

87,085

 

 

 

764,218

 

 

 

2,902,864

 

 

NET LOSS

$

(14,884,311

)

 

$

(6,042,557

)

 

$

(28,083,189

)

 

$

(18,128,667

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NET LOSS PER SHARE (BASIC AND DILUTED):

$

(0.18

)

 

$

(0.08

)

 

$

(0.35

)

 

$

(0.25

)

 

WEIGHTED AVERAGE SHARES OUTSTANDING

 

84,083,937

 

 

 

74,629,855

 

 

 

79,406,838

 

 

 

73,019,726

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

FINANCIAL POSITION SUMMARY

March 31,

 

 

September 30,

 

 

 

 

 

 

 

 

 

 

 

2018

 

 

2017

 

 

 

 

 

 

 

 

 

 

CASH AND CASH EQUIVALENTS

$

69,805,117

 

 

$

24,838,567

 

 

 

 

 

 

 

 

 

 

SHORT-TERM INVESTMENTS

 

21,736,820

 

 

 

40,769,539

 

 

 

 

 

 

 

 

 

 

TOTAL CASH RESOURCES (CASH AND INVESTMENTS)

 

91,541,937

 

 

 

65,608,106

 

 

 

 

 

 

 

 

 

 

OTHER ASSETS

 

35,456,978

 

 

 

38,414,174

 

 

 

 

 

 

 

 

 

 

TOTAL ASSETS

 

126,998,915

 

 

 

104,022,280

 

 

 

 

 

 

 

 

 

 

TOTAL LIABILITIES

 

13,283,833

 

 

 

23,155,118

 

 

 

 

 

 

 

 

 

 

TOTAL STOCKHOLDERS' EQUITY

 

113,715,082

 

 

 

80,867,162

 

 

 

 

 

 

 

 

 

 

TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY

$

126,998,915

 

 

$

104,022,280

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SHARES  OUTSTANDING

 

87,570,398

 

 

 

74,785,426

 

 

 

 

 

 

 

 

 

 



About Arrowhead Pharmaceuticals

Arrowhead Pharmaceuticals develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.

For more information, please visit www.arrowheadpharma.com, or follow us on Twitter @ArrowheadPharma. To be added to the Company's email list and receive news directly, please visit http://ir.arrowheadpharma.com/email-alerts.

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 the safety and efficacy of our product candidates, the duration and impact of regulatory delays in our clinical programs, 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. Our 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.

 

Contacts:

Arrowhead Pharmaceuticals, Inc.

Vince Anzalone, CFA

626-304-3400

ir@arrowheadpharma.com

 

Investors and Media:

LifeSci Advisors, LLC

Brian Ritchie
212-915-2578

britchie@lifesciadvisors.com

www.lifesciadvisors.com

 

Source: Arrowhead Pharmaceuticals, Inc.

 

 

 

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