ILEX Oncology Announces Third Quarter Results; Company Remains on Schedule with Development of Lead Compound, CAMPATH.SAN ANTONIO--(BUSINESS WIRE)--Nov. 11, 1998--ILEX(tm) Oncology oncology /on·col·o·gy/ (ong-kol´ah-je) the sum of knowledge regarding tumors; the study of tumors. on·col·o·gy n. Inc. (Nasdaq:ILXO) today reported operating highlights and financial results for the third quarter and nine months ended Sept. 30, 1998. Among highlights of the period were:
-- Fast Track designation was granted by the Food and Drug
Administration for CAMPATH(R), the Company's lead drug candidate,
currently in pivotal trials for the treatment of patients with
chronic lymphocytic leukemia (CLL).
-- ILEX strengthened its product development portfolio with the
addition of a new compound, SR-45023A, that appears to
selectively target cancer cells, inducing their death through
apoptosis.
-- Revenues from the Company's contract research services business
increased 82% over the same quarter last year.
Total revenue for the quarter increased 27% to $3.6 million, compared with $2.8 million in the third quarter of 1997. This includes $2.2 million in revenue from the Company's Services business, up 82% from $1.2 million in the same period a year ago. Research and development spending was down 9% from the same period a year ago, with about half of the investment during the 1998 third quarter directed toward CAMPATH Campath® Oncology A humanized monoclonal antibody to leukocyte antigen CD52, used to manage CLL refractory to standard therapies; it is expressed on lymphocytes and monocytes, but not hematopoietic stem cells (R). Total net loss for the quarter was $4.5 million, or a $0.35 loss per share, compared to a loss of $3.9 million, or a loss of $0.31 per share, in third quarter 1997. The increased loss relates primarily to higher general and administrative expenses stemming from overall company growth. ILEX Ilex a bush bearing berries containing saponins; cause vomiting, diarrhea. Called also holly. ended the quarter with approximately $27 million in cash and cash equivalents. "Our development plans for CAMPATH(R) remain on track, and we plan to file a Biologics License Application in mid-1999," said Richard Love, ILEX President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . He noted that the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. recently approved a request to designate des·ig·nate tr.v. des·ig·nat·ed, des·ig·nat·ing, des·ig·nates 1. To indicate or specify; point out. 2. To give a name or title to; characterize. 3. CAMPATH(R) as a Fast Track development program. Under the FDA Modernization modernization Transformation of a society from a rural and agrarian condition to a secular, urban, and industrial one. It is closely linked with industrialization. As societies modernize, the individual becomes increasingly important, gradually replacing the family, Act of 1997, designation as a Fast Track product for a new drug or biological product means that the agency will take appropriate actions to expedite ex·pe·dite tr.v. ex·pe·dit·ed, ex·pe·dit·ing, ex·pe·dites 1. To speed up the progress of; accelerate. 2. the development and review of the application for marketing approval. ILEX is developing CAMPATH(R) in a 50/50 joint venture with LeukoSite Inc. The compound is in pivotal trials in the U.S. and Europe for the treatment of patients with chronic lymphocytic leukemia chronic lymphocytic leukemia n. Abbr. CLL Lymphocytic leukemia occurring mainly in older adults, characterized by slow onset and gradual progression of symptoms. who have previously received alkylating agents al·kyl·at·ing agent n. Any of various highly reactive chemical compounds that bond with various nucleophilic groups in nucleic acids and proteins and cause mutagenic, carcinogenic, or cytotoxic effects. and are refractory refractory Material that is not deformed or damaged by high temperatures, used to make crucibles, incinerators, insulation, and furnaces, particularly metallurgical furnaces. to fludarabine treatment. While the Company has not released any interim data from the pivotal trial, preliminary unaudited results were reported at the Hematologic Malignancies hematologic malignancy Hematologic cancer Hematology Any CA of blood-forming tissues, BM, or lymph nodes–eg, leukemia and lymphoma conference in Chicago in October by Dr. Kanti Rai of Long Island Jewish Medical Center Long Island Jewish Medical Center (LIJMC) shares the title of clinical and academic hub of the North Shore-Long Island Jewish Health System. It is an 827-bed voluntary, non-profit tertiary care teaching hospital serving the greater metropolitan New York area. , one of the approximately 20 trial sites. According to according to prep. 1. As stated or indicated by; on the authority of: according to historians. 2. In keeping with: according to instructions. 3. the report, objective responses, as defined by the National Cancer Institute, were observed in seven of the ten patients treated. "These data cannot be construed as an indication of the ultimate outcome of the pivotal trial as they are very preliminary and come from just one site in this multi-center study. However, we are certainly encouraged by the early reports of efficacy, which is in keeping with the published results of prior trials," Love said. During the quarter, ILEX's Products business further diversified diversified (di·verˑ·s its portfolio of compounds to treat and prevent cancer through a joint development agreement with Symphar S.A. of 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, for SR-45023A, a bisphosphonate ester that stimulates a newly identified nuclear receptor In the field of molecular biology, nuclear receptors are a class of proteins found within the interior of cells that are responsible for sensing the presence of hormones and certain other molecules. (FXR FXR Fixer FXR Flash X-Ray FXR WinFax Pro Filename Extension Fax Received FXR Harley-Davidson Super Glide motorcycle model ), appearing to selectively induce in·duce v. 1. To bring about or stimulate the occurrence of something, such as labor. 2. To initiate or increase the production of an enzyme or other protein at the level of genetic transcription. 3. apoptosis apoptosis or programmed cell death Mechanism that allows cells to self-destruct when stimulated by the appropriate trigger. It may be initiated when a cell is no longer needed, when a cell becomes a threat to the organism's health, or for other reasons. in malignant malignant /ma·lig·nant/ (-nant) 1. tending to become worse and end in death. 2. having the properties of anaplasia, invasiveness, and metastasis; said of tumors. cells. A Phase I study of the drug in advanced metastatic cancer Metastatic cancer A cancer that has spread to an organ or tissue from a primary cancer located elsewhere in the body. Mentioned in: Liver Cancer metastatic cancer is under way. ILEX believes SR-45023A may have potential use in a wide spectrum of combination chemotherapies as well as in chemoprevention che·mo·pre·ven·tion n. The use of chemical agents, drugs, or food supplements to prevent disease. chemoprevention . In other product-related developments, ILEX has discontinued dis·con·tin·ue v. dis·con·tin·ued, dis·con·tin·u·ing, dis·con·tin·ues v.tr. 1. To stop doing or providing (something); end or abandon: the development of mitoguazone and of piritrexim for the treatment of advanced bladder cancer bladder cancer Malignant tumour of the bladder. The most significant risk factor associated with bladder cancer is smoking. Exposure to chemicals called arylamines, which are used in the leather, rubber, printing, and textiles industries, is another risk factor. . Expenditure reductions in these programs contributed to the decline in R&D spending for the quarter. "To date, clinical trials of these compounds have failed to show sufficient efficacy to warrant their continued development, although we will continue testing piritrexim for the treatment of malignant fibrous histiocytoma malignant fibrous histiocytoma n. A deeply situated tumor, especially on the extremities of adults, frequently recurring after surgery and metastasizing to the lungs. ," said Love. Continuing, Love said, "As part of our business strategy, we are keenly aware of the need to devote corporate resources to our most promising compounds. With that in mind, we are constantly evaluating our portfolio to identify those compounds with the best prospects for therapeutic and commercial success and to commit resources accordingly. With CAMPATH(R) as our lead compound and the addition of other novel technologies at earlier stages of development, we believe our drug development portfolio has never been stronger or more diversified." In the company's other business segment, ILEX Oncology Services, revenues increased 82% to $2.2 million in the third quarter from $1.2 million in the same period a year ago. Expenses in the Services segment totaled $2.4 million during the quarter, up from $1.5 million in the third quarter of 1997. Commenting on the segment's performance, Richard J. Marcel Marcel the fast ebbing of time impels him to devote his life to recording it. [Fr. Lit.: Proust Remembrance of Things Past] See : Time , Chief Operating Officer Chief Operating Officer (COO) The officer of a firm responsible for day-to-day management, usually the president or an executive vice-president. of ILEX Oncology Services Inc., said, "While third quarter revenue was up 82% year-over-year, it did not reach our projected levels due to a client's cancellation of one project and sponsor-initiated delays of several other projects into the first quarter of 1999. We continue to develop Services as a viable business, both as an income generator from external clients and as the cost-effective developer of the ILEX Products portfolio." For the first nine months of 1998, revenue from both the Products and Services segments totaled $10.6 million, a 28% increase from the $8.3 million recorded in the same period of 1997. This includes $7.1 million in revenue from the Services business, up 87% from $3.8 million during the same period a year ago. The company's net loss for the first nine months of 1998 was $15.9 million, or a loss of $1.28 per share, compared to a net loss of $5.7 million, or $0.47 per share, in the same period last year. The higher loss reflects a $1 million decrease in product development revenue from corporate partners, a $6.8 million increase in research and development spending on the Company's products portfolio (including a one-time, non-cash licensing fee of $3.4 million for the acquisition of THP-dox in first quarter 1998), and a $2.1 million increase in general and administrative expenses stemming from overall company growth. "We expect to augment aug·ment v. aug·ment·ed, aug·ment·ing, aug·ments v.tr. 1. To make (something already developed or well under way) greater, as in size, extent, or quantity: our current cash balance with a mix of corporate partnering deals and other financing to meet the cash requirements of 1999 and beyond," Love said. ILEX Oncology Inc. is a drug development company focused on the development and marketing approval of drugs for the treatment and prevention of cancer. ILEX provides pharmaceutical and biotechnology companies Top 100 Biotechnology Companies The following is a list of the top 100 biotechnology companies ranked by revenue. The first nine companies qualify for the list of the top 50 pharmaceutical companies. with compounds for their pipeline through its Products subsidiary, as well as drug development and manufacturing services on a contract basis through its Services subsidiary. ILEX's close association with cancer research and treatment institutions allows access to both the opinion leaders and patients necessary for the development of oncology drugs. Certain statements contained herein are "forward-looking" statements (as such term is defined in 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). Because such statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such 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. . Factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, risks in technology and product development, failure to successfully complete clinical trials, failure to receive market clearance from regulatory agencies regulatory agency Independent government commission charged by the legislature with setting and enforcing standards for specific industries in the private sector. The concept was invented by the U.S. , competitive risks and those risks and uncertainties discussed in filings made by ILEX Oncology Inc. with the Securities and Exchange Commission. The company disclaims any obligation to update these forward-looking statements. This release and other information about ILEX Oncology Inc. can be found on the World Wide Web at http://www.ilexoncology.com -0-
ILEX ONCOLOGY INC.
CONSOLIDATED CONDENSED BALANCE SHEETS
(In Thousands)
September 30,
December 31, 1998
1997 (unaudited)
-------------- ---------------
ASSETS
Cash, cash equivalents
and marketable securities $ 42,646 $ 27,004
Accounts receivable, net 3,405 4,219
Prepaid expenses and other
current assets 720 652
Inventory -- 500
Investment in and advances to
joint ventures and affiliates 1,134 3,217
Intangible asset, net of
amortization 4,847 7,059
Property and equipment, net of
accumulated depreciation 2,559 3,983
-------------- ---------------
Total assets $ 55,311 $ 46,634
============== ===============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities $ 3,802 $ 4,492
Long-term Liabilities 433 409
Stockholders' Equity 51,076 41,733
-------------- ---------------
Total liabilities and
stockholders' equity $ 55,311 $ 46,634
============== ===============
ILEX ONCOLOGY INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(In Thousands, Except Per Share Amounts)
Three Months
ended
September 30,
1997 1998
----------------------
REVENUE:
Product development $ 1,622 $ 1,400
Contract research services, net 1,212 2,190
------- -------
Total revenue 2,834 3,590
------- -------
OPERATING EXPENSES:
Research and development costs 2,394 3,051
Direct costs of research services 1,493 2,422
General and administrative 1,313 1,885
Licensing fees -- --
------- -------
Total operating expenses 5,200 7,358
------- -------
OPERATING LOSS (2,366) (3,768)
------- -------
OTHER INCOME (EXPENSE):
Equity in income (losses) of:
Research and development partnerships (2,067) (1,031)
Contract research affiliate (83) (150)
Interest income 657 438
Gain on sale of securities -- 49
------- -------
NET LOSS $(3,859) $(4,462)
======= =======
BASIC AND DILUTED NET LOSS PER SHARE $ (.31) $ (.35)
======= =======
WEIGHTED AVERAGE SHARES USED IN
COMPUTING BASIC AND DILUTED LOSS
PER SHARE OF COMMON STOCK 12,503 12,640
======= =======
ILEX ONCOLOGY INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(In Thousands, Except Per Share Amounts)
Nine Months
ended
September 30,
1997 1998
----------------------
REVENUE:
Product development $ 4,456 $ 3,490
Contract research services, net 3,830 7,113
------- --------
Total revenue 8,286 10,603
------- --------
OPERATING EXPENSES:
Research and development costs 6,308 8,961
Direct costs of research services 3,662 7,036
General and administrative 2,980 5,071
Licensing fees -- 3,443
------- --------
Total operating expenses 12,950 24,511
------- --------
OPERATING LOSS (4,664) (13,908)
------- --------
OTHER INCOME (EXPENSE):
Equity in income (losses) of:
Research and development partnerships (2,613) (3,390)
Contract research affiliate (83) (71)
Interest income 1,708 1,453
Gain on sale of securities -- 49
------- --------
NET LOSS $(5,652) $(15,867)
======= ========
BASIC AND DILUTED NET LOSS PER SHARE $ (.47) $ (1.28)
======= ========
WEIGHTED AVERAGE SHARES USED IN
COMPUTING BASIC AND DILUTED LOSS
PER SHARE OF COMMON STOCK 11,971 12,423
======= ========
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