Printer Friendly
The Free Library
14,716,216 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

ARIAD Reports Third Quarter 2004 Results.


CAMBRIDGE, Mass. -- ARIAD ARIAD Allison Research Index of Art and Design  Pharmaceuticals, Inc. (Nasdaq: ARIA) today announced consolidated financial results for the quarter ended September 30, 2004 and provided an overview of the clinical development of AP23573.

"In the third quarter, we continued to move forward in implementing our comprehensive clinical development plan for AP23573 in multiple forms of cancer - initiating our first solid tumor Phase 2 trial - while diligently managing our financial resources," said Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. "We are on course to achieve this year's ambitious clinical objectives, while operating within our guidance concerning cash used in operations for 2004. Most importantly Adv. 1. most importantly - above and beyond all other consideration; "above all, you must be independent"
above all, most especially
, we remain focused on continuing to build our business around AP23573 and our cancer pipeline."

Financial Highlights

For the three months ended September 30, 2004, the Company reported a net loss of $9.4 million, or $0.18 per share, compared to a net loss of $4.4 million, or $0.11 per share, for the same period in 2003. For the nine months ended September 30, 2004, the Company reported a net loss of $24.9 million, or $0.49 per share, compared to a net loss of $14.0 million, or $0.38 per share, for the same period in 2003. The increase in net loss is due primarily to the expansion of the Company's clinical trials for its lead product candidate AP23573 and supporting manufacturing and other development costs.

The Company ended the quarter with $87.4 million in cash, cash equivalents and marketable securities Marketable Securities

Very liquid securities that can be converted into cash quickly at a reasonable price.

Notes:
Marketable securities are very liquid as they tend to have maturities less than one year, and the rate at which these securities can be bought or sold has
. This compares to cash, cash equivalents and marketable securities of $66.7 million at December 31, 2003. For the nine months ended September 30, 2004, the Company reported net cash used in operations of $18.9 million.

AP23573 Update

The Company presented updated results from two nearly completed Phase 1 clinical trials phase 1 clinical trial Phase 1 study. See Phase study.  with AP23573 - as a single agent - at the 2004 EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics. Both trials showed documented tumor regression in patients with advanced cancers - most of whom had progressive disease upon entering the trial and had failed alternative treatments. Reported findings included:
--  Of the combined 49 evaluable patients in the two trials, 49%
        (24 of 49) demonstrated anti-tumor activity due to AP23573,
        specifically:

        --  Four partial responses (defined by RECIST);

        --  Five minor responses; and

        --  Fifteen with disease stabilization.

    --  Anti-tumor responses were demonstrated in nine different
        refractory and/or relapsed cancers, including:

        --  Sarcoma (five of five evaluable patients),

        --  Kidney cancer (seven of seven),

        --  Non-small cell lung cancer (two of three), and

        --  Lymphoma (one of one)

        --  Bladder (one of one).


AP23573 has been generally well tolerated by patients in both trials, with mild or moderate, readily reversible adverse events. The dose-limiting toxicity was severe oral mucositis, an inflammatory irritation of the mucous membranes Mucous membranes
The inner tissue that covers or lines body cavities or canals open to the outside, such as nose and mouth. These membranes secrete mucus and absorb water and salts.

Mentioned in: Leprosy, Pulmonary Fibrosis, Topical Anesthesia
 of the mouth and a common finding in cancer patients on various types of treatments.

To date, two multicenter Phase 2 trials of AP23573 as a single agent have been initiated in patients with relapsed or refractory cancers refractory cancer Oncology Cancer that is unresponsive to treatment. See Radioinsensitive. , both with the primary objective of assessing response rates in well-defined cancers. The first trial is in patients with hematologic hematological, hematologic

pertaining to or emanating from blood cells.


hematological tests
total and differential white cell counts, hematocrit estimation, erythrocyte count.
 cancers, including disease-specific categories of lymphomas and leukemias in which current therapeutic options are limited or only palliative palliative /pal·li·a·tive/ (pal´e-a?tiv) affording relief; also, a drug that so acts.

pal·li·a·tive
adj.
Relieving or soothing the symptoms of a disease or disorder without effecting a cure.
. This study is designed to enroll up to 200 patients. The second trial is in patients with soft-tissue and bone sarcomas Sarcomas Definition

A sarcoma is a bone tumor that contains cancer (malignant) cells. A benign bone tumor is an abnormal growth of noncancerous cells.
Description

A primary bone tumor originates in or near a bone.
 characterized by tumor type. This study is designed to enroll up to 175 patients. Additional Phase 2 trials are planned to start over the coming year. A Phase 1b trial of AP23573 has also been initiated in patients with relapsed or refractory glioblastoma multiforme glioblastoma mul·ti·for·me
n.
A virulent brain cancer that is usually fatal.
.

The small-molecule drug, AP23573, starves cancer cells cells once believed to be peculiar to cancers, but now know to be epithelial cells differing in no respect from those found elsewhere in the body, and distinguished only by peculiarity of location and grouping.

See also: Cancer
 and shrinks tumors by inhibiting the critical cell-signaling protein, mTOR, which regulates the response of tumor cells to nutrients and growth factors, and controls tumor blood supply and angiogenesis angiogenesis /an·gio·gen·e·sis/ (-jen´e-sis) vasculogenesis; development of blood vessels either in the embryo or in the form of neovascularization or revascularization.

an·gi·o·gen·e·sis
n.
 through effects on Vascular Endothelial endothelial /en·do·the·li·al/ (-the´le-al) pertaining to or made up of endothelium.
Endothelial
A layer of cells that lines the inside of certain body cavities, for example, blood vessels.
 Grown Factor (VEGF VEGF vascular endothelial growth factor. ).

Business Strategy

The Company is committed to building a bio-oncology franchise. Its initial focus is the clinical development of lead product candidate, AP23573. The Company's development strategy addresses unmet medical needs in the treatment of relapsed and/or refractory cancers. Multiple parallel clinical trials - planned or already initiated - are designed to obtain critical data as expeditiously ex·pe·di·tious  
adj.
Acting or done with speed and efficiency. See Synonyms at fast1.



ex
 as possible to enable the Company to select registration indication(s) by the end of 2005. The Company's goals are to market and sell its oncology products in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area.  and to seek commercialization partners for these products outside the U.S. after obtaining definitive clinical data in key indications.

"Based on the promising early clinical benefits seen with AP23573, we are committed to a development plan that may allow us to bring this potential new treatment option to cancer patients in need as quickly as possible," added Dr. Berger.

Upcoming Events

ARIAD's chairman and chief executive officer will be presenting updated overviews of the Company progress and plans at three investor conferences - all to be webcast - during the fourth quarter:

--CIBC World Markets 15th Annual Healthcare Conference at the Plaza Hotel The Plaza Hotel in New York City is a landmark 19-story luxury hotel with a height of 250 feet (76 m) and length of 400 feet that (122 m) occupies the west side of Grand Army Plaza, from which it derives its name, and extends along Central Park South in Manhattan.  in New York New York, state, United States
New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of
, New York, November 8 - 10, 2004;

--Lehman Brothers 2004 Small Cap Conference at the Phoenician Hotel in Scottsdale, Arizona Scottsdale (O'odham Vaṣai S-vaṣonĭ) is a city in Maricopa County, Arizona, United States, adjacent to Phoenix. Scottsdale has become internationally recognized as a premier and posh tourist destination, while maintaining its own identity and culture as " , November 17 - 19, 2004; and

--Lazard First Annual Life Sciences Conference at the Mandarin Oriental Hotel in New York, New York, November 30 - December 1, 2004.

About ARIAD

ARIAD is engaged in the discovery and development of breakthrough medicines to treat cancer by regulating cell signaling Cell signaling is part of a complex system of communication that governs basic cellular activities and coordinates cell actions. The ability of cells to perceive and correctly respond to their microenvironment is the basis of development, tissue repair, and immunity as well as  with small molecules. The Company is developing a comprehensive approach to patients with cancer that addresses the greatest medical need - aggressive and advanced-stage cancers for which current treatments are inadequate. ARIAD also has an exclusive license to pioneering technology and patents related to certain NF-(kappa Kappa

Used in regression analysis, Kappa represents the ratio of the dollar price change in the price of an option to a 1% change in the expected price volatility.

Notes:
Remember, the price of the option increases simultaneously with the volatility.
)B treatment methods, and the discovery and development of drugs to regulate NF-(kappa)B cell-signaling activity, which may be useful in treating certain diseases. Additional information about ARIAD can be found on the web at http://www.ariad.com.

Some of the matters discussed herein are "forward-looking statements forward-looking statement

A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections.
" within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995. Such statements are identified by the use of words such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe," and other words and terms of similar meaning in connection with any discussion of future operating or financial performance. Such statements are based on management's current expectations and are subject to certain factors, risks and uncertainties that may cause actual results, outcome of events, timing and performance to differ materially from those expressed or implied by such forward-looking statements. These risks include, but are not limited to, risks and uncertainties regarding the Company's ability to accurately estimate the actual research and development expenses and other costs associated with the preclinical and clinical development of our product candidates, the adequacy of our capital resources and the availability of additional funding, risks and uncertainties regarding the Company's ability to successfully conduct preclinical and clinical studies of its product candidates, risks and uncertainties that clinical trial results at any phase of development may be adverse or, as with the trials described in this release, may not be predictive of future result or lead to regulatory approval of any of the Company's product candidates, and risks and uncertainties relating to relating to relate prepconcernant

relating to relate prepbezüglich +gen, mit Bezug auf +acc 
 regulatory oversight, intellectual property claims, the timing, scope, cost and outcome of legal proceedings All actions that are authorized or sanctioned by law and instituted in a court or a tribunal for the acquisition of rights or the enforcement of remedies. , future capital needs, key employees, dependence on the Company's collaborators and manufacturers, markets, economic conditions, products, services, prices, reimbursement rates, competition and other risks detailed in the Company's public filings with the Securities and Exchange Commission, including ARIAD's Annual Report on Form 10-K Form 10-K

A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information.


Form 10-K

See 10-K.
 for the fiscal year ended December 31, 2003. The information contained in this document is believed to be current as of the date of original issue. The Company does not intend to update any of the forward-looking statements after the date of this document to conform these statements to actual results or to changes in the Company's expectations, except as required by law.
ARIAD PHARMACEUTICALS, INC. AND SUBSIDIARIES
            CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

In thousands, except
 share and            Three Months Ended       Nine Months Ended
 per share data           September 30,           September 30,
                   ----------------------   ----------------------
                        2004         2003        2004         2003
                   ---------   ----------   ---------   ----------
                        (Unaudited)              (Unaudited)

Total license
 revenue          $      185  $       190  $      563  $       469
                   ---------   ----------   ---------   ----------

Operating expenses:
   Research and
    development        7,401        3,292      18,836       11,039
   General and
    administrative     2,386        1,292       7,169        3,414
                   ---------   ----------   ---------   ----------
       Total
        operating
        expenses       9,787        4,584      26,005       14,453
                   ---------   ----------   ---------   ----------

Other income
 (expense), net          223           (5)        583          (31)
                   ---------   ----------   ---------   ----------
Net loss          $   (9,379) $    (4,399) $  (24,859) $   (14,015)
                   =========   ==========   =========   ==========
Net loss per
 common share
(basic and
 diluted)         $     (.18) $      (.11) $     (.49) $      (.38)
                   =========   ==========   =========   ==========

Weighted average
 number of shares of
 common stock
 outstanding (basic
 and diluted)     52,544,234   38,992,031  50,840,247   36,885,579


           CONDENSED CONSOLIDATED BALANCE SHEET INFORMATION

In thousands                               September 30,  December 31,
                                                   2004          2003
                                           ------------   -----------
                                            (Unaudited)

Cash, cash equivalents and marketable
 securities                                    $ 87,432      $ 66,740
Total assets                                   $ 96,799      $ 74,284
Total liabilities                              $ 19,188      $ 14,958
Stockholders' equity                           $ 77,611      $ 59,326
COPYRIGHT 2004 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2004, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Publication:Business Wire
Geographic Code:1USA
Date:Nov 8, 2004
Words:1493
Previous Article:GlobalAutoIndustry.com Alert: ``More Than 100 Senior Automotive Executives to Gather in Dearborn at Economist Conferences' First U.S. Automotive...
Next Article:Florida Association of Mortgage Brokers -FAMB- Daytona Beach Chapter Welcomes State Rep. Pat Patterson, R-Dist. 26.
Topics:



Related Articles
ARIAD Reports Third Quarter 1998 Financial Results.
Ariad Reports 43% Reduction in Third Quarter Operating Loss and Updates Recent Progress in Development Programs.
ARIAD Reports 2001 Third Quarter Results; Oncology Product Portfolio and Research Highlighted.
ARIAD Reports Third Quarter 2002 Results.
ARIAD Reports Third Quarter 2003 Results; Clinical and Commercial Development Plans Highlighted.
Ariad Reports Fourth Quarter and Year-End 2003 Results; Highlights AP23573 Product Development Progress and Plans.
ARIAD Reports First Quarter 2004 Results; Presentation of AP23573 Phase 1 Results and Clinical Trial Plans Imminent.
ARIAD to Webcast Conference Call on First Quarter 2005 Financial Results.
ARIAD Reports Third Quarter 2005 Results; Further Strengthening of Senior Management Team Positions ARIAD to Achieve Future Milestones.
ARIAD Reports Third Quarter 2006 Results.

Terms of use | Copyright © 2009 Farlex, Inc. | Feedback | For webmasters | Submit articles