ALTH Allos Therapeutics, Inc. (MM)

WESTMINSTER, Colo., Aug. 8 /PRNewswire-FirstCall/ -- Allos Therapeutics, Inc. (NASDAQ:ALTH) today reported financial results for the second quarter of 2005. For the three months ended June 30, 2005, the Company reported a net loss of $5.6 million, or $0.13 per share. This compares to a net loss of $7.2 million, or $0.23 per share, for the second quarter of 2004. For the six months ended June 30, 2005, the Company reported a net loss of $10.7 million, or $0.29 per share, compared to a net loss of $12.3 million, or $0.40 per share, for the same period last year. Cash, cash equivalents, and investments in marketable securities as of June 30, 2005 were $62.6 million. Product Portfolio Update: EFAPROXYN(TM) (efaproxiral): * ENRICH, the Company's Phase 3 study of the radiation sensitizer EFAPROXYN in patients with brain metastases originating from breast cancer, continues to progress in line with expectations. To date, 100 out of 125 planned investigative sites have opened for enrollment. The Company expects to complete patient enrollment in this trial during the second half of 2006 and report preliminary results approximately six months thereafter. * In June 2005, the Company entered into a long-term manufacturing agreement with Hovione for the supply of EFAPROXYN bulk drug substance, efaproxiral sodium. Under the agreement, Hovione is committed to manufacture and supply Allos with sufficient quantities of efaproxiral sodium to support Allos' anticipated requirements for both the pre-and post-commercialization phases of production. * Results from the Company's Phase 2 trial of EFAPROXYN in patients with Stage IIIA/IIIB NSCLC were accepted for publication in the August 20th edition of the Journal of Clinical Oncology. * The Marketing Authorization Application (MAA) for EFAPROXYN, filed in June 2004, remains under review by the European Medicines Agency (EMEA). In June 2005, the Company received the EMEA's Day 180 List of Outstanding Issues, to which the Company must respond by September 14, 2005. PDX (pralatrexate): * During the quarter, researchers at Memorial Sloan Kettering completed enrollment of a Phase 1 trial of PDX in combination with docetaxel in patients with advanced cancer who failed prior chemotherapy. RH1: * Enrollment in a Phase 1 dose escalation study of RH1 in patients with advanced solid tumors continues to progress in line with expectations. The Company currently expects to complete enrollment in this trial in the second half of 2005. Financial Highlights: In May 2005, the Company announced stockholder approval of the issuance of shares of the Company's common stock upon exchange of shares of the Company's Series A Exchangeable Preferred Stock sold to Warburg Pincus Private Equity VIII, L.P. (Warburg) and certain other investors in a financing transaction in March 2005. As a result of such approval, the Company issued a total of 23,524,430 shares of common stock upon exchange of 2,352,443 shares of Series A Exchangeable Preferred Stock. After giving effect to the share exchange, the Company now has approximately 55.0 million shares of common stock outstanding, of which Warburg owns approximately 22.6 million shares, or 41%. Conference Call The Company will host a conference call to review its second quarter results on Monday, August 8, 2005, at 4:30 PM ET. The dial in number for U.S. residents to participate is 877-407-8031. International callers should dial 201-689-8031. Participants should reference the Allos Therapeutics conference call. Conference Call Replay An audio replay of the conference call will be available from 5:30 PM ET on Monday, August 8, 2005, until 11:59 PM ET on Thursday, August 18, 2005. To access the replay, please dial 877-660-6853 (domestic) or 201-612-7415 (international); Replay pass codes (both required for playback): account # 286; conference ID # 161942. Webcast Allos Therapeutics will hold a live web cast of the conference call. The webcast will be available from the homepage and the investors/media 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. (NASDAQ:ALTH) is a biopharmaceutical company focused on developing and commercializing innovative small molecule therapeutics for the treatment of cancer. Our lead product candidate, EFAPROXYN(TM) (efaproxiral), is a synthetic small molecule designed to sensitize hypoxic, or oxygen-deprived, tumor tissue during radiation therapy. EFAPROXYN is currently being evaluated as an adjunct to whole brain radiation therapy in a pivotal Phase 3 trial in women with brain metastases originating from breast cancer. Our other product candidates are: PDX (pralatrexate), a small molecule chemotherapeutic agent (DHFR inhibitor) currently under investigation as both a single agent and in combination therapy regimens in patients with non-small cell lung cancer and Non-Hodgkin's lymphoma; and RH1, a small molecule chemotherapeutic agent bioactivated by the enzyme DT-diaphorase currently under evaluation in patients with advanced solid tumors. For more information, please visit the Company's web site at: http://www.allos.com/. Safe Harbor Statement This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements concerning our projected timelines for completion of enrollment and announcement of the results of our clinical trials, the potential safety and efficacy of EFAPROXYN, and other statements which are other than statements of historical facts. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "expects," "intends," "plans," anticipates," "believes," "estimates," "predicts," "projects," "potential," "continue," and other similar terminology or the negative of these terms, but their absence does not mean that a particular statement is not forward-looking. Such forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those anticipated by the forward-looking statements. These risks and uncertainties include, among others: that we may experience difficulties or delays in our clinical trials, whether caused by adverse events, investigative site initiation rates, patient enrollment rates, regulatory issues or other factors; and that clinical trials may not demonstrate the safety and efficacy of our product candidates in their target indications. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K for the year ended December 31, 2004, and in the Company's other periodic reports and filings with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this presentation, except as required by law. 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 2005 2004 2005 Operating expenses: Research and development $3,447 $2,621 $5,435 $4,969 Clinical manufacturing 1,374 268 2,156 628 Marketing, general and administrative 2,441 2,615 4,955 4,807 Restructuring costs -- -- -- 380 Total operating expenses 7,262 5,504 12,546 10,784 Loss from operations (7,262) (5,504) (12,546) (10,784) Interest and other income, net 111 507 249 716 Net loss $(7,151) $(4,997) $(12,297) $ (10,068) Dividend related to beneficial conversion feature of preferred stock -- (623) -- (623) Net loss attributable to common stockholders (7,151) (5,620) (12,297) (10,691) Basic and diluted net loss per share $(0.23) $(0.13) $(0.40) $(0.29) Weighted average common shares: basic and diluted 31,139,289 42,683,395 31,124,616 36,961,378 ALLOS THERAPEUTICS, INC. CONDENSED BALANCE SHEETS (in thousands) (unaudited) December 31, 2004 June 30, 2005 ASSETS Cash, cash equivalents and investments in marketable securities $23,849 $62,571 Other assets 1,344 1,953 Equipment and leasehold improvements, net 980 830 Total assets $26,173 $65,354 Liabilities and Stockholders' Equity Liabilities $2,310 $ 2,061 Stockholders' equity 23,863 63,293 Total liabilities and stockholders' equity $26,173 $65,354 DATASOURCE: Allos Therapeutics, Inc. CONTACT: Jennifer Neiman, Manager, Corporate Communications of Allos Therapeutics, Inc., +1-720-540-5227, Web site: http://www.allos.com/

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