-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, D9/Kbv166PwiUbpcMfkRXXySNEiIjNPlRVNpAPkfCroRQQe162lbm5GthortHH9a Rh/IAw8JNipL0jj4upN9cA== 0001104659-07-009198.txt : 20070209 0001104659-07-009198.hdr.sgml : 20070209 20070209152142 ACCESSION NUMBER: 0001104659-07-009198 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20070208 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20070209 DATE AS OF CHANGE: 20070209 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ARQULE INC CENTRAL INDEX KEY: 0001019695 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 043221586 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-21429 FILM NUMBER: 07597620 BUSINESS ADDRESS: STREET 1: 19 PRESIDENTIAL WAY CITY: WOBURN STATE: MA ZIP: 01801 BUSINESS PHONE: 781-994-0300 MAIL ADDRESS: STREET 1: 19 PRESIDENTIAL WAY CITY: WOBURN STATE: MA ZIP: 01801 8-K 1 a07-4081_18k.htm 8-K

 

 

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): February 8, 2007

ARQULE, INC.

(Exact Name of Issuer as Specified in Charter)

Delaware

 

000-21429

 

04-3221586

(State or other jurisdiction

 

(Commission File Number)

 

(I.R.S. Employer

of incorporation)

 

 

 

Identification No.)

 

19 Presidential Way

Woburn, MA

(Address of principal executive offices)

01801

(Zip code)

(781) 994-0300

(Registrant’s telephone number, including area code)

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 (see General Instruction A.2. below):

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

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

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

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

 

 




Section 2 —  Financial Information

Item 2.02 Results of Operations and Financial Condition.

On February 8, 2007, ArQule, Inc. (the “Registrant”) issued a press release announcing its financial results for the fiscal year ended December 31, 2006.  The press release is furnished as Exhibit 99.1 hereto and incorporated herein by reference.

SECTION 9 — FINANCIAL STATEMENTS AND EXHIBITS

 

Item 9.01.  Financial Statements and Exhibits.

(d)  Exhibits.

99.1                           Text of press release announcing results of operations dated February 8, 2007.

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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 hereunto duly authorized.

 

 

 

ARQULE, INC.

 

 

 

 

(Registrant)

 

 

 

 

 

 

 

 

 

/s/ Peter S. Lawrence

 

 

 

 

Peter S. Lawrence

 

 

 

 

Executive Vice President, Chief Business

Officer, General Counsel and Secretary

February 9, 2007

 

 

 

 

 

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EX-99.1 2 a07-4081_1ex99d1.htm EX-99.1

Exhibit 99.1

 

 

 

Contact:

 

 

VP, Investor Relations/

 

 

William B. Boni

 

 

 Corp. Communications

 

 

(781) 994-0300

 

 

www.ArQule.com

 

FOR IMMEDIATE RELEASE:

ARQULE REPORTS FISCAL 2006 YEAR END AND
FOURTH QUARTER RESULTS

 

Conference call scheduled today at 9:00 a.m. eastern time

Woburn, MA, February 8, 2007 — ArQule, Inc. (NASDAQ: ARQL) today announced its financial results for the year and for the fourth quarter ended December 31, 2006.

The Company reported a net loss of $31,440,000 or $0.88 per share, for the year ended December 31, 2006, compared with a net loss of $7,520,000, or $0.22 per share, for the year ended December 31, 2005.  For the quarter ended December 31, 2006, the Company reported a net loss of $12,830,000, or $0.36 per share, compared to a net loss of $2,733,000, or $0.08 per share, for the quarter ended December 31, 2005.

These results reflect discontinued operations related to the Company’s termination of its chemistry services operations on May 22, 2006.  As previously announced, ArQule ceased these operations upon the conclusion of its agreement with Pfizer in May 2006.  All line items discussed below, including prior period amounts, also exclude the results of these discontinued operations.

At December 31, 2006, the Company had a total of approximately $95,832,000 in cash and marketable securities.

Operational Review

“Clinical progress was achieved on a timely and rapid basis during 2006, enabling us to meet our operational goals for the year,” said Dr. Stephen A. Hill, president and chief executive of ArQule.

“One of the most exciting developments during the year was the emergence of ARQ 197, a proprietary small-molecule inhibitor of the c-Met receptor tyrosine kinase with which we initiated a Phase 1, dose escalation trial in early 2006,” said Dr. Hill.  “We presented promising interim data from this trial at the November EORTC-NCI-AACR conference. We have now completed dose escalation, and pending the development of a continuous dosing regimen and completion of a biomarker study, we expect to initiate Phase 2 testing with ARQ 197 in the second quarter of 2007.  Patients are currently being enrolled into a continuous dosing regimen at 240 milligrams daily as part of the Phase 1 trial.

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“In our Activated Checkpoint Therapy® (ACT) program, we presented data from Phase 1 monotherapy and combination therapy trials with ARQ 501 in a number of peer-reviewed forums throughout the year,” said Dr. Hill.  “Combined, these data demonstrated clinical tolerability, favorable pharmacokinetics and promising signs of anti-tumor activity.  Based on these findings, we selected dose levels of 450 milligrams per meter squared (mg/m2) for Phase 2 monotherapy trials in leiomyosarcoma and head and neck cancer, and 400 mg/m2 for the Phase 2 combination therapy trial with gemcitabine. I am pleased to report that we have completed patient recruitment in all of these trials

“Toward the end of the year, we also initiated Phase 1 clinical testing with ARQ 171, a second generation ACT compound that, like ARQ 501, activates DNA damage response/checkpoint pathways regulated by the E2F-1 regulatory protein,” said Dr. Hill.  “We are pursuing the development of these compounds under an alliance with Hoffmann-La Roche (Roche), which has an option to license compounds from our E2F program based on a Phase 2 clinical data package with ARQ 501 and Phase 1 data with ARQ 171.

“Our Phase 2 program with ARQ 501 is expected to reach completion in 2007, and we anticipate reporting data from these trials in appropriate peer-reviewed forums beginning mid-year,” said Dr. Hill.  “We also plan to fully recruit our Phase 1 trial with ARQ 171 by the end of the year, depending upon the identification of a recommended Phase 2 dose.  The first two cohorts in this trial have been dosed successfully at 24 mg/m2 and 48 mg/m2, and we anticipate dosing the third cohort at 96 mg/m2 imminently.

“In May 2006, we formally concluded our chemistry services business and our agreement with Pfizer to focus operationally on developing our oncology portfolio,” said Dr. Hill.  “We strongly believe that our clinical-stage programs represent highly innovative approaches to treating cancer and considerable shareholder value going forward.  We look to add to that value by advancing our clinical-stage products, by moving internally defined product candidates toward the clinic and by exploring business development opportunities that will help expand and accelerate the development of our pipeline.”

Revenues and Expenses

Revenues for the year ended December 31, 2006 were $6,626,000 compared with revenues of $6,628,000 for the year ended December 31, 2005.  For the quarter ended December 31, 2006, revenues were $1,670,000 compared with revenues of $1,672,000 for the quarter ended December 31, 2005.  Revenues for both years related primarily to financial support from Roche for the Company’s ongoing development of products in its E2F cancer therapy program.

Fiscal 2006 research and development expenses were $47,428,000 compared to $24,646,000 for fiscal 2005.  Fourth quarter 2006 research and development expenses were $12,421,000 compared to $6,481,000 for the fourth quarter of 2005.  Increased research and development expenses during 2006 consisted primarily of costs related to the Phase 1 clinical trial with ARQ 197, Phase 1 and Phase 2 trials with ARQ 501 and the Phase 1 clinical trial with ARQ 171.

5




 

General and administrative expenses for fiscal 2006 were $11,560,000 compared to $8,688,000 for fiscal 2005.  In the fourth quarter of 2006, these expenses were $3,224,000, compared with $1,892,000 in the fourth quarter of 2005.  The increased expenses in fiscal 2006 were due primarily to the recognition of stock-based compensation expense as required by Statement of Financial Accounting Standards No. 123(R) and to facility costs previously absorbed by our chemical services operations that were discontinued in 2006.

2007 Financial Guidance

For 2007, ArQule expects revenues to range between $6.5 and $7.0 million, primarily related to the ongoing partnership with Roche.  Net use of cash is expected to range between $59 and $64 million.  Net loss is expected to range between $60 and $65 million, and net loss per share to range between $1.68 and $1.82 for the year.  ArQule expects to end 2007 with between $32 and $37 million in cash and marketable securities.

Conference Call and Webcast

ArQule will hold a conference call at 9:00 a.m. eastern time today, February 8, 2007.  Dr. Stephen A. Hill, president and chief executive officer, and Richard H. Woodrich, acting chief financial officer, will lead the call.

Date:

 

Thursday, February 8, 2007

 

Time:

 

9:00 a.m., eastern time

 

Conference Call Numbers

 

 

 

Domestic:

 

800.510.9834

 

International:

 

617.614.3669

 

Participant Passcode :

 

ArQule

 

Webcast:

 

www.arqule.com

 

A replay of the conference call will be available for five days and can be accessed by dialing toll-free 888.286.8010, and outside the U.S. 617.801.6888.  The access code is 18107940.

About ArQule

ArQule, Inc. is a biotechnology company engaged in the research and development of next-generation, small-molecule cancer therapeutics.  The Company’s targeted, broad-spectrum products and research programs are designed to affect key biological processes that are central to cancer. ArQule’s lead clinical-stage products have been generated from two scientific platforms: Cancer Survival Protein modulation and Activated Checkpoint Therapy® (ACT).  The Cancer Survival Protein modulation platform has generated a clinical-stage product designed to inhibit a molecule known as c-Met, which plays multiple roles in cancer cell growth, survival, invasion, angiogenesis and metastasis.  The ACT platform is designed to kill cancer cells selectively while sparing normal cells through direct activation

6




 

of DNA damage response/checkpoint pathways. The Company’s lead ACT program, based on the E2F-1 pathway, is partnered with Roche. For more information, please visit www.arqule.com.

This press release contains forward-looking statements regarding the Company’s operating performance, such as projections about its future results of operations or its financial condition, as well as the progress of its clinical trials, including the Phase 1 trial with ARQ 171, Phase 1 and 2 trials with ARQ 197 and Phase 2 trials with ARQ 501.  These statements are based on the Company’s current beliefs and expectations, and are subject to risks and uncertainties that could cause actual results to differ materially.  Positive information about early stage clinical trial results does not ensure that later stage or larger scale clinical trials will be successful. For example, ARQ 171, ARQ 501 and ARQ 197 may not demonstrate promising therapeutic effect; in addition, they may not demonstrate an appropriate safety profile in current or later stage or larger scale clinical trials as a result of known or as yet unanticipated side effects. The results achieved in later stage trials may not be sufficient to meet applicable regulatory standards. Problems or delays may arise during clinical trials or in the course of developing, testing or manufacturing these compounds that could lead the Company or its partner to discontinue development.  Even if later stage clinical trials are successful, the risk exists that unexpected concerns may arise from analysis of data or from additional data or that obstacles may arise or issues be identified in connection with review of clinical data with regulatory authorities or that regulatory authorities may disagree with the Company’s view of the data or require additional data or information or additional studies.  In addition, the planned timing of initiation and completion of clinical trials for ARQ 171, ARQ 501 and ARQ 197 are subject to the ability of the Company to enroll patients, enter into agreements with clinical trial sites and investigators, and other technical hurdles and issues that may not be resolved.  Drug development involves a high degree of risk. Only a small number of research and development programs result in the commercialization of a product.   Furthermore, ArQule may not have the financial or human resources to successfully pursue drug discovery in the future. For more detailed information on the risks and uncertainties associated with the Company’s drug development and other activities see the Company’s periodic reports filed with the Securities and Exchange Commission. The Company does not undertake any obligation to publicly update any forward-looking statements.

7




 

ArQule, Inc.

Condensed Statement of Operations

(In Thousands, Except Per Share Amounts)

 

 

 

Three Months Ended

 

Twelve Months Ended

 

 

 

December 31

 

December 31

 

 

 

(Unaudited)

 

(Unaudited)

 

 

 

2006

 

2005

 

2006

 

2005

 

 

 

 

 

 

 

 

 

 

 

Research and development revenue

 

$

1,670

 

$

1,672

 

$

6,626

 

$

6,628

 

 

 

 

 

 

 

 

 

 

 

Costs and expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

12,421

 

6,481

 

47,428

 

24,646

 

General and administrative

 

3,224

 

1,892

 

11,560

 

8,688

 

Total costs and expenses

 

15,645

 

8,373

 

58,988

 

33,334

 

 

 

 

 

 

 

 

 

 

 

Loss from continuing operations

 

(13,975

)

(6,701

)

(52,362

)

(26,706

)

 

 

 

 

 

 

 

 

 

 

Net investment income

 

1,207

 

1,184

 

5,139

 

3,331

 

Loss on investment

 

 

 

 

(250

)

 

 

 

 

 

 

 

 

 

 

Net loss from continuing operations

 

(12,768

)

(5,517

)

(47,223

)

(23,625

)

 

 

 

 

 

 

 

 

 

 

Income (loss) from discontinued operations

 

(62

)

2,784

 

15,783

 

16,105

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(12,830

)

$

(2,733

)

$

(31,440

)

$

(7,520

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted income (loss) per share (A):

 

 

 

 

 

 

 

 

 

Net loss from continuing operations

 

$

(0.36

)

$

(0.16

)

$

(1.33

)

$

(0.68

)

Income (loss) from discontinued operations

 

 

0.08

 

0.45

 

0.46

 

 

 

$

(0.36

)

$

(0.08

)

$

(0.88

)

$

(0.22

)

 

 

 

 

 

 

 

 

 

 

Weighted average common shares outstanding - basic and diluted

 

35,760

 

35,264

 

35,539

 

34,619

 

 


(A)         Basic and diluted net loss per share amounts were equal in all periods presented.

 

 

 

December 31,

 

December 31,

 

Balance sheet data (in thousands):

 

2006

 

2005

 

 

 

 

 

 

 

Cash, cash equivalents and marketable securities

 

$

95,832

 

$

140,643

 

Working capital

 

80,557

 

105,646

 

Total assets

 

104,820

 

156,684

 

Stockholders’ equity

 

79,954

 

105,458

 

 

 

 

# # #

8



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