ALTH Allos Therapeutics, Inc. (MM)

Allos Therapeutics Reports Second Quarter 2004 Financial Results WESTMINSTER, Colo., Aug. 3 /PRNewswire-FirstCall/ -- Allos Therapeutics, Inc. (NASDAQ:ALTH) today reported financial results for the second quarter of 2004. For the three months ended June 30, 2004, the Company reported a net loss of $7.2 million, or $0.23 per share. This compares to a net loss of $11.8 million, or $0.45 per share, for the second quarter of 2003. For the six months ended June 30, 2004, the Company reported a net loss of $12.3 million, or $0.40 per share, compared to a net loss of $18.9 million, or $0.73 per share, for the same period last year. Cash, cash equivalents and investments in marketable securities as of June 30, 2004 were $34.1 million, including $550,000 in restricted cash. Second quarter highlights: * The FDA's Oncologic Drug Advisory Committee did not recommend approval of EFAPROXYN(TM) (efaproxiral), formerly known as RSR13, as an adjunct to radiation therapy for the treatment of patients with brain metastases originating from breast cancer. * The Company received an approvable letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for EFAPROXYN(TM) for the treatment of patients with brain metastases originating from breast cancer. In the letter, the FDA indicated that before the NDA may be approved, it will be necessary for the Company to complete its ongoing Phase 3 ENRICH trial and submit the results as an NDA amendment for the FDA's review. * The Company filed a Marketing Authorization Application with the European Medicines Agency for approval to market EFAPROXYN(TM) as an adjunct to whole brain radiation therapy for the treatment of patients with brain metastases originating from breast cancer. * The Company presented results from its previously completed Phase 3 trial of EFAPROXYN(TM) for the treatment of patients with brain metastases in three poster sessions at the 40th annual meeting of the American Society of Clinical Oncology. * The Company initiated discussions with various Contract Research Organizations to expand the Company's Phase 3 ENRICH trial into Europe and South America. Conference Call Allos Therapeutics will host a conference call to review the Company's second quarter 2004 results today at 4:30 p.m. EDT on Tuesday, August 3, 2004. The dial in number for U.S. residents to participate is 800-310-1961. International callers should dial 1-719-457-2692. Conference Call Replay An audio replay of the conference call will be available from 7:30 p.m. EDT on Tuesday, August 3, 2004 until 12:59 a.m. EDT on August 10, 2004. To access the replay, please dial 1-888-203-1112 (U.S./Canada); international +1-719-457-0820; the pass code number is 133938. Webcast Allos Therapeutics will hold a live web cast of the conference call. The webcast will be available from the homepage and investor relation's section of the Company's web site at http://www.allos.com/ and will be archived for 30 days. About Allos Therapeutics, Inc. Allos Therapeutics, Inc. is a biopharmaceutical company focused on developing and commercializing innovative drugs for improving cancer treatments. The Company's lead clinical candidate EFAPROXYN(TM) (efaproxiral), formerly know as RSR13, is a synthetic small molecule that has the potential to sensitize hypoxic (oxygen deprived) tumor tissues and enhance the efficacy of standard radiation therapy. In addition, Allos is developing PDX (pralatrexate), a novel small molecule cytoxic injectable antifolate (DHFR inhibitor) intended to treat non-small cell lung cancer, mesothelioma and non-Hodgkin's lymphoma. For more information, please visit the Company's web site at: http://www.allos.com/. Safe Harbor Statement This announcement contains forward-looking statements that involve risks and uncertainties. Future events may differ materially from those discussed herein due to a number of factors, including, but not limited to risks and uncertainties detailed from time to time in the Company's SEC filings, including its Annual Report on Form 10-K, as amended, for the year ended December 31, 2003. All forward-looking statements are based on information currently available to the company on the date hereof, and the Company assumes no responsibility to update such statements. ALLOS THERAPEUTICS, INC. CONDENSED STATEMENTS OF OPERATIONS (in thousands - except share and per share information) (unaudited) Three-months ended Six-months ended June 30, June 30, 2004 2003 2004 2003 Operating expenses: Research and development $3,446 $5,081 $5,435 $8,487 Clinical manufacturing 1,374 3,866 2,156 5,946 Marketing, general and administrative 2,442 2,523 4,955 4,542 Restructuring costs -- 578 -- 578 Total operating expenses 7,262 12,048 12,546 19,553 Loss from operations (7,262) (12,048) (12,546) (19,553) Interest and other income, net 111 277 249 649 Net loss $(7,151) $(11,771) $(12,297) $(18,904) Basic and diluted net loss per share $(0.23) $(0.45) $(0.40) $(0.73) Weighted average common shares: basic and diluted 31,139,289 25,888,500 31,124,616 25,884,381 ALLOS THERAPEUTICS, INC. CONDENSED BALANCE SHEETS (in thousands) (unaudited) June 30, 2004 December 31, 2003 ASSETS Cash, cash equivalents and investments in marketable securities $34,148 $45,597 Other assets 1,341 1,121 Equipment and leasehold improvements, net 1,207 1,456 Total assets $36,696 $48,174 Liabilities and Stockholders' Equity Liabilities $ 3,325 $2,763 Stockholders' equity 33,371 45,411 Total liabilities and stockholders' equity $36,696 $48,174 DATASOURCE: Allos Therapeutics, Inc. CONTACT: Jennifer Neiman, Corporate Communications Manager of Allos Therapeutics, Inc., +1-720-540-5227, ; or Fern Lazar of Lazar Partners Limited, +1-212-867-1762, , for Allos Therapeutics, Inc. Web site: http://www.allos.com/

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