ARIAD Reports Second Quarter 2003 Results; Progress in Development of Oncology Product Candidates Updated.Business Editors/Health/Medical Writers BIOWIRE2K CAMBRIDGE, Mass.--(BUSINESS WIRE)--Aug. 1, 2003 ARIAD ARIAD Allison Research Index of Art and Design Pharmaceuticals, Inc. (Nasdaq: ARIA) today announced results for the second quarter of 2003. Financial Highlights For the three months ended June 30, 2003, the Company reported a net loss of $4.3 million, or $0.12 per share, compared to a net loss of $7.0 million, or $0.22 per share, for the same period in 2002. This decrease in net loss is due primarily to lower R&D expenses resulting from the Company's focus on development of its small-molecule product candidates for cancer. In May 2003, the Company raised $10 million through the sale of 4 million shares of its common stock in a direct equity placement to two institutional investors Institutional Investor A non-bank person or organization that trades securities in large enough share quantities or dollar amounts that they qualify for preferential treatment and lower commissions. . As a result, the Company ended the second quarter of 2003 with $26.6 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 , compared with cash and cash equivalents of $26.9 million at December 31, 2002. The year-to-date results are consistent with the Company's anticipated cash burn rate for the year 2003 of approximately $18 million. "At mid-year, we are on target to meet all of our major financial and product development goals for 2003," said Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. Product Development Highlights Three important oncology meetings - the 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. , the International Cancer Conference, and the American Association for Cancer Research Wikipedia is not the place for advertisement or self-advertising. The American Association for Cancer Research (AACR) is an organization based in Philadelphia, Pennsylvania, that focuses on all aspects of cancer research including basic, clinical and translational - provided ideal opportunities for the Company to report recent progress in developing its three lead cancer product candidates. AP23573 - the Company's lead candidate in phase 1 clinical trials phase 1 clinical trial Phase 1 study. See Phase study. - was shown to be highly effective in animal models of human solid tumors: treatment initiated in early-stage tumor growth induced persistent tumor regression of up to 90%, and treatment at a later more-aggressive stage still produced significant reductions in the rate of growth of all six tumor types studied (i.e., brain, prostate, breast, pancreas, lung, and colon cancers colon cancer, cancer of any part of the colon (often called the large intestine). Colon cancer is the second most common cancer diagnosed in the United States. ). The research presented also supports the use of AP23573 in multi-drug regimens that can be tailored to treat specific cancers. Enrollment in phase 1 studies of AP23573 in cancer patients with recurrent, advanced, or refractory disease was initiated in May at major cancer centers in the U.S. and is progressing on schedule. The cancers being studied include multiple solid tumors and blood malignancies. AP23841 - in pre-IND development - was shown to directly block and potently inhibit both tumor growth and bone destruction - the two processes that need to be controlled to treat the grave clinical consequences of cancer that has spread to bone from primary tumor primary tumor A neoplasm which, in clinical parlance, is regarded as malignant, arising in one site and capable of giving rise to metastatic or secondary tumors. See Metastasis. Cf Tumor of unknown origin. sites. AP23841 is also intended to treat primary bone cancers, such as osteogenic sarcomas osteogenic sarcoma n. See osteosarcoma. . AP23573 and AP23841 both inhibit the activity of a protein known as mTOR, leading to shrinking of tumors by a novel mode of action - cancer-cell starvation (metabolic arrest) through inhibition of nutrient uptake to tumor cells, as well as inhibition of growth factor stimulation. AP23464 - also in pre-IND development - was shown to be over 10-fold more potent than imatinib (Gleevec(TM)), the leading product for chronic myeloid leukemia myeloid leukemia n. See myelogenous leukemia. (CML 1. CML - A query language. ["Towards a Knowledge Description Language", A. Borgida et al, in On Knowledge Base Management Systems, J. Mylopoulos et al eds, Springer 1986]. 2. CML - Concurrent ML. ), in blocking the activity of the key cancer-causing protein responsible for Gleevec's efficacy. Furthermore, unlike Gleevec, AP23464 is designed to block additional leukemia leukemia (l  kē`mēə), cancerous disorder of the blood-forming tissues (bone marrow, lymphatics, liver, spleen) characterized by excessive production of immature or mature therapeutic targets that become increasingly important in
patients who no longer respond to Gleevec - 75% of advanced-stage CML
patients treated for two years. AP23464 is also intended to block the
spread of cancer by inhibiting a protein that plays a key role in
orchestrating the molecular changes in 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 that enable them to escape from primary tumors and travel to distant sites. ARIAD is engaged in the discovery and development of breakthrough medicines that regulate 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 the treatment of cancer and is primarily focused on a series of product candidates for targeted oncology indications. ARIAD also has an exclusive license to pioneering technology and patents related to the discovery, development and use of drugs that regulate 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 cell-signaling activity, which has been implicated im·pli·cate tr.v. im·pli·cat·ed, im·pli·cat·ing, im·pli·cates 1. To involve or connect intimately or incriminatingly: evidence that implicates others in the plot. 2. in many major diseases. Additional information about ARIAD can be found on the web at http://www.ariad.com. Gleevec is a trademark of Novartis AG Novartis AG Swiss pharmaceutical company. It was formed through the 1996 merger of two Swiss firms: Ciba (see Ciba-Geigy) and Sandoz, a chemical company with interests in pharmaceuticals, nutrition, and agriculture. . 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 and include statements regarding the Company's anticipated cash burn rate for 2003, the Company's belief that it is on target to meet all major financial and product development goals for 2003, and the potential efficacy of the Company's product candidates. 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 conduct preclinical and clinical studies of its product candidates and the results of such studies, 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, 2002. 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 per share data
Three Months Ended Six Months Ended
June 30, June 30,
2003 2002 2003 2002
(Unaudited) (Unaudited)
Total license
revenue $ 153 $ 13 $ 279 $ 13
Operating expenses:
Research and
development 3,206 6,028 7,747 11,127
General and
administrative 1,237 1,655 2,122 2,839
Total operating
expenses 4,443 7,683 9,869 13,966
Other income
(expense), net (14) 627 (26) 743
Net loss $ (4,304) $ (7,043) $ (9,616) $ (13,210)
Net loss per
common share
(basic and
diluted) $ (.12) $ (.22) $ (.27) $ (.41)
Weighted average
number of shares
of common stock
outstanding
(basic and
diluted) 36,769,778 32,452,353 35,814,896 32,385,139
CONDENSED CONSOLIDATED BALANCE SHEET INFORMATION
June 30, December 31,
In thousands 2003 2002
(Unaudited)
Cash, cash equivalents and marketable
securities $ 26,622 $ 26,850
Total assets $ 34,421 $ 35,104
Working capital $ 22,703 $ 21,172
Total liabilities $ 12,685 $ 13,252
Stockholders' equity $ 21,736 $ 21,852
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