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Keryx Reports First Quarter 2001 Financial Results BOSTON and JERUSALEM, May 15, 2001 - Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX; AIM: KRX) today released financial results for the first quarter ended March 31, 2001. Keryx's core KinAce™ drug discovery technology provides a direct pathway from kinase sequence data to potential drug candidates. The Company is also developing KRX-101 (sulodexide), an in-licensed product that is in late-stage clinical development for the treatment of diabetic nephropathy. The net loss for the three months ended March 31, 2001 was $2,388,363, or $0.12 per share, compared to a net loss of $2,466,841, or $0.30 per share, for the three months ended March 31, 2000. This decrease was primarily attributable to non-cash compensation expenses related to stock options grants of $401,038 and $1,343,040 for the quarters ended March 31, 2001 and 2000, respectively. Net of non-cash compensation, net loss increased by $863,524 due primarily to increased manufacturing costs associated with the build up of clinical study supplies for KRX-101, and secondarily to increases in professional fees, expenditures on expansion of existing research and development activities, and general and administrative activities. At March 31, 2001, Keryx had cash, cash equivalents, interest receivable and investments of $47.3 million, compared with $48.9 million at December 31, 2000. "The first quarter of 2001 has proven successful for Keryx. The granting of the first of several fundamental patents we are seeking to obtain related to our core KinAce™ platform has moved us towards the fulfillment of our 2001 corporate goals," said Morris Laster, M.D., Chief Executive Officer and Chairman of Keryx Biopharmaceuticals, Inc. The patent focuses on one of the most important classes of kinases-serine threonine kinases (STKs)-and is based on the discovery that short sequences (six to ten amino acids in length) derived from a specific region of STK sequences can be used to selectively modulate kinase activity. The regions are distinct for each kinase, providing a basis for the discovery of highly specific modulators. "In the first quarter we also achieved positive results with the refinement of our first KinAce compound, KRX-123, for the treatment of hormone resistant prostate cancer (HRPC), which is expected to enter a Phase I/II clinical trial later this year," continued Dr. Laster. "Additionally, we began building adequate supplies of KRX-101 for our Phase III clinical trial in diabetic nephropathy which, subject to FDA approval of our trial protocol, is expected to begin in 2001." Keryx, with a staff of 42 people and a network of prestigious research collaborators and consultants, plans to continue to advance KinAce programs in the therapeutic areas of oncology, immunology, metabolic disorders, and tissue remodeling, as well as in the area of functional genomics. The Company also plans to continue developing KRX-101, for the treatment of diabetic nephropathy. Keryx believes that the product has long-term potential for other diseases and intends to expand the future clinical development of the compound as appropriate. About Keryx Biopharmaceuticals, Inc. Keryx Biopharmaceuticals is building a pipeline of drug candidates that target protein kinases by applying its proprietary bioinformatics technology to genomics data. Kinases, which play a key role in the way cells communicate, are implicated in a wide range of diseases. Using its KinAce™ drug discovery platform technology, the Company has established therapeutic programs in oncology, immunology, metabolic, and other disease areas. The Company's most advanced drug candidate, KRX-123, is part of the oncology program, and is scheduled to enter clinical trials for advanced prostate cancer in 2001. The Company is also developing a late stage, in-licensed product, KRX-101 (sulodexide), for the treatment of diabetic nephropathy. Conditional upon the Food and Drug Administration's (FDA's) response to the clinical protocol to be filed, the Company expects to commence Phase III trials in 2001. Keryx is traded on NASDAQ (KERX) and the London AIM (KRX). Web site address: www.keryxbiopharm.com Statements contained or referenced in this news release that are not historical facts may be forward-looking statements, as the term is defined in the Private Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terminology 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. Our actual results and the timing of certain events may differ significantly from the results discussed in forward-looking statements. Factors that might cause or contribute to such a discrepancy include, but are not limited to, the risks outlined in our Registration Statement on Form S-1 filed with the Securities and Exchange Commission. The forward-looking statements contained in this filing or in our Registration Statement on Form S-1 include, among other things, statements relating to our drug development and regulatory strategy, growth strategy, use of proceeds, projected capital expenditures, research and development expenditures, other costs and expenses, revenue, profitability, and liquidity and capital resources.
Keryx Biopharmaceuticals, Inc. Ron
Bentsur
Keryx Biopharmaceuticals, Inc
Selected Financial Data
Statement of Operations:
Three Months Ended March 31,
2001 2000
OPERATING EXPENSES:
Research and
development $2,031,306 $1,400,879
General and
administrative 1,166,502 1,093,513
LOSS FROM OPERATIONS(3,147,808) (2,494,392)
OTHER INCOME(EXPENSE):
Financing income
(expenses) 869,535 54,672
Taxes on income (110,090) (27,121)
NET LOSS $(2,388,363) $(2,466,841)
NET LOSS PER COMMON
Basic and diluted $(0.12) $(0.30)
SHARES USED IN COMPUTING
NET LOSS PER COMMON SHARE
Basic and diluted 19,594,448 8,108,306
Balance Sheet:
March 31, 2001 December 31, 2000
Cash and cash equivalents $47,318,518 $48,899,874
Total assets 48,902,282 50,264,356
Accumulated deficit (26,301,155) (23,912,792)
Stockholders' equity 46,892,513 48,866,648
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