ARIAD Reports Second Quarter 2004 Results; Update on Status of Clinical and Preclinical Programs.CAMBRIDGE, Mass. -- ARIAD ARIAD Allison Research Index of Art and Design Pharmaceuticals, Inc. (Nasdaq: ARIA) today announced results for the second quarter of 2004 and updated the status of its clinical and preclinical programs. Financial Highlights For the three months ended June 30, 2004, the Company reported a net loss of $9.2 million, or $0.18 per share, compared to a net loss of $4.3 million, or $0.12 per share, for the same period in 2003. The Company ended the quarter with $94.8 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 six months ended June 30, 2004, the Company reported net cash used in operations of $12.8 million. "We are moving ahead aggressively with the global clinical development of our lead oncology product, AP23573, and the further development of our pipeline of preclinical programs. Our highest priority is progressing AP23573 as quickly as possible to registration trials in clinical indications in which there is great unmet medical need," said Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. Update on AP23573 Clinical Program In June, the Company announced details of its comprehensive global clinical development plan for its lead oncology product candidate, AP23573, and initiated enrollment of patients in a multicenter Phase 2 study of this product candidate as a single agent in hematologic hematological, hematologic pertaining to or emanating from blood cells. hematological tests total and differential white cell counts, hematocrit estimation, erythrocyte count. cancers (i.e., leukemias and lymphomas) in which current therapeutic options are limited or only palliative. Concurrently, the Company initiated enrollment of patients with glioblastoma multiforme glioblastoma mul·ti·for·me n. A virulent brain cancer that is usually fatal. in a multicenter Phase 1b clinical trial to identify the optimal dosing of AP23573 to achieve maximal activity within brain tumors. The AP23573 development plan also calls for the initiation of additional Phase 2 trials of the drug as a single agent in patients with specific advanced, relapsed and/or metastatic Metastatic The term used to describe a secondary cancer, or one that has spread from one area of the body to another. Mentioned in: Coagulation Disorders metastatic pertaining to or of the nature of a metastasis. solid tumors (e.g., brain, breast, endometrial endometrial /en·do·me·tri·al/ (en?do-me´tre-il) pertaining to the endometrium. endometrial, n relating to the end-ometrium or cavity of the uterus. and prostate cancers, as well as 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. ) 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 Europe. In parallel, additional Phase 1b studies are planned in selected cancers aimed at further evaluating the anti-tumor activity, safety and pharmacokinetics of AP23573, both as a single agent and in combination with chemotherapeutic agents This is a list of specific pharmacologic agents that are known to be of use in the treatment of cancer, otherwise known as chemotherapeutic agents. This list is organized by "type" of agent, though the subsections are not necessarily definitive and are subject to revision. and other molecularly targeted drugs. A near-term objective of the AP23573 development plan is to obtain sufficient clinical data to support expedited or "fast-track" regulatory review of AP23573, both in the United States and Europe, in specific clinical indications to be determined over the next year. The initial Phase 1 clinical data presented at the recent American Society of Clinical Oncology American Society of Clinical Oncology, or ASCO, is an organization that represents all clinical oncologists. Every year, ASCO holds a large symposium where physicians and researchers meet to convey and discuss research and ideas. annual meeting supported the optimism about the clinical potential of AP23573. Sustained anti-tumor activity of AP23573 as a single agent was observed in 50% of the evaluable patients in a broad spectrum of cancers in the daily dosing trial - the dosing regimen that generally will be used in subsequent trials. These Phase 1 results were especially striking since all patients had untreatable Un`treat´a`ble a. 1. Incapable of being treated; not practicable. advanced tumors, and many patients received very low doses of drug (due to the dose-escalation design of the trials, which were aimed primarily at evaluating the safety of the drug). Further follow up of these patients is ongoing, as is enrollment of additional patients at the higher doses. 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. ). Update on Preclinical Programs In parallel with the Company's AP23573 clinical program, it is also proceeding with both of its preclinical cancer programs - its oncogenic oncogenic /on·co·gen·ic/ (-jen´ik) giving rise to tumors or causing tumor formation; said especially of tumor-inducing viruses. on·co·gen·ic or on·cog·e·nous adj. kinase inhibitor program based on AP23464 and its bone-targeted mTOR inhibitor program based on AP23841. As part of the oncogenic kinase inhibitor program, extensive preclinical studies preclinical studies, n.pl a term used to describe research done before a clinical study. May be laboratory or epidemiologic research. have been conducted on AP23464 along with backup compounds, providing insights into their biologic, metabolic and pharmacologic profiles. Recently obtained results of animal studies in this program have led the Company to focus its development efforts on two classes of chemically related back-up compounds of AP23464 in order to initiate clinical trials with a product candidate that has a more optimal and competitive metabolic profile. Accordingly, the Company is not currently providing updated guidance on the IND filing date. Dr. Berger added, "We remain strongly committed to our oncogenic kinase inhibitor program which represents a compelling medical and commercial opportunity. Our scientific team and network of academic collaborators understand the cancer targets and inhibitors in this program extremely well. We are actively pursuing a rapid path to selection of the optimal compound for clinical development." Upcoming Events Updated clinical data on the Phase 1 trials of AP23573 will be presented at EORTC-NCI-AACR Conference on Molecular Targets and Cancer Therapeutics, Geneva Geneva, canton and city, Switzerland Geneva (jənē`və), Fr. Genève, canton (1990 pop. 373,019), 109 sq mi (282 sq km), SW Switzerland, surrounding the southwest tip of the Lake of Geneva. , Switzerland (September 28 - October 1, 2004). More information about this medical conference is available at the meeting's website (http://www.aacr.org/4400m.asp). In addition, ARIAD's chairman and chief executive officer will be presenting updated overviews of the Company progress and plans at six investor conferences - all to be webcast - during the next several months: --Adams Harkness 24th Summer Seminar at the Marriot Long Wharf Long Wharf may refer to:
Boston is the capital and most populous city of Massachusetts.[3] The largest city in New England, Boston is considered the unofficial economic and cultural center of the entire New on August 3, 2004. --UBS 2004 Global Life Sciences Conference at the Grand Hyatt 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 on September 27-30, 2004. --JPMorgan Third Annual Small Cap Conference at the Four Seasons in Boston, Massachusetts on October 25-26, 2004. --Rodman and Renshaw Sixth Annual Healthcare Conference at the Waldorf-Astoria in New York, New York on October 26-28, 2004. --Lehman Brothers 2004 Small Cap Conference at the Phoenician 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 " on November 17-19, 2004. --Lazard First Annual Life Sciences Conference at the Mandarin Oriental in New York, New York on November 30 - December 1, 2004. Details concerning audio webcasts of these presentations, together with more specific dates and times, will be provided in separate press releases for each conference. 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)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" 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 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 prep → concernant relating to relate prep → bezüglich +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, Three Months Six Months
except share Ended Ended
and per share June 30, June 30,
data -------------------- --------------------
2004 2003 2004 2003
--------- --------- --------- ---------
(Unaudited) (Unaudited)
Total license
revenue $ 188 $ 153 $ 378 $ 279
----------- ----------- ----------- -----------
Operating
expenses:
Research and
development 7,102 3,206 11,435 7,747
General and
administrative 2,565 1,237 4,783 2,122
----------- ----------- ----------- -----------
Total operating
expenses 9,667 4,443 16,218 9,869
----------- ----------- ----------- -----------
Other income
(expense), net 234 (14) 360 (26)
----------- ----------- ----------- -----------
Net loss $ (9,245) $ (4,304) $ (15,480) $ (9,616)
----------- ----------- ----------- -----------
----------- ----------- ----------- -----------
Net loss per
common share
(basic and
diluted) $ (.18) $ (.12) $ (.31) $ (.27)
----------- ----------- ----------- -----------
----------- ----------- ----------- -----------
Weighted average
number of shares of
common stock
outstanding
(basic and
diluted) 52,416,929 36,769,778 49,978,892 35,814,896
CONDENSED CONSOLIDATED BALANCE SHEET INFORMATION
June 30, Dec. 31,
In thousands 2004 2003
---------------------
(Unaudited)
Cash, cash equivalents and marketable securities $ 94,815 $66,740
Total assets $102,582 $74,284
Total liabilities $ 16,200 $14,958
Stockholders' equity $ 86,382 $59,326
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