SAN MATEO, Calif., March 28, 2011 (GLOBE NEWSWIRE) -- Talon Therapeutics, Inc. (OTCBB:TLON) today reported financial results for the fourth quarter and full year ended December 31, 2010, and provided a corporate update. "2010 was a year of significant accomplishments for Talon clinically and financially," stated Steven R. Deitcher, M.D., President and Chief Executive Officer of Talon Therapeutics. "For 2011, we will continue our focus on submitting a New Drug Application for accelerated approval of Marqibo." 2010 Corporate Highlights
- Completed and presented data for a Phase 2 pivotal study of Marqibo(R) for the treatment of Philadelphia chromosome negative (Ph-) adult acute lymphoblastic leukemia (ALL) in second or greater relapse or that has progressed following two or more prior lines of anti-leukemia therapy, referred to as the rALLy study.
- Completed the Phase 1 program for Menadione Topical Lotion for the treatment of dose-limiting skin rash associated with taking epidermal growth factor receptor (EGFR) inhibitors for anti-cancer treatment.
- Completed a financing with Warburg Pincus and Deerfield Management for up to $100 million, of which $40 million was received in June 2010.
- Strengthened intellectual property coverage with new patents issued for Menadione Topical Lotion and Marqibo.
Total operating expenses for the three months ended December 31, 2010, were $6.5 million, compared with $5.4 million for the three months ended December 31, 2009. Research and development expenses were $5.2 million for the three months ended December 31, 2010, compared with $4.0 million for the three months ended December 31, 2009. General and administrative expenses were $1.3 million for the three months ended December 31, 2010, compared with $1.4 million for the three months ended December 31, 2009.As of December 31, 2010, the Company had cash, cash equivalents and available-for-sale securities of $22.6 million. Cash used in operations was $5.1 million for the three months ended December 31, 2010. The per share results for all periods have been adjusted to reflect the impact of the Company's 1-for-4 reverse stock split that occurred at the close of business on September 10, 2010. Twelve Months Ended December 31, 2010 Financial Results For the twelve months ended December 31, 2010, the Company reported a net loss of $26.0 million and deemed dividends on preferred stock of $32.3 million, which when combined, resulted in a net loss applicable to common stockholders of $58.3 million, or $2.81 per share. The deemed dividends on preferred stock contributed $1.56 per share to the total net loss applicable to common stockholders for the twelve months ended December 31, 2010. This compares with a net loss of $24.1 million, or a loss per share of $2.27, for the twelve months ended December 31, 2009. There were no deemed dividends on preferred stock for the twelve months ended December 31, 2009. Total operating expenses for the twelve months ended December 31, 2010, were $25.8 million, compared with $19.6 million for the twelve months ended December 31, 2009. Research and development expenses were $20.2 million for the twelve months ended December 31, 2010, compared with $14.7 million for the twelve months ended December 31, 2009. General and administrative expenses were $5.6 million for the twelve months ended December 31, 2010, compared with $4.9 million for the twelve months ended December 31, 2009.
Cash used in operations was $25.7 million for the twelve months ended December 31, 2010.The per share results for all periods have been adjusted to reflect the impact of the Company's 1-for-4 reverse stock split that occurred at the close of business on September 10, 2010. About Marqibo (vincristine sulfate liposomes injection) Marqibo is a novel, targeted Optisome™ encapsulated formulation product candidate of the FDA-approved anticancer drug vincristine. Talon is primarily developing Marqibo for the treatment of Ph- adult ALL. Vincristine, a microtubule inhibitor, is FDA-approved for ALL and is widely used as a single agent and in combination regimens for treatment for hematologic malignancies such as lymphomas and leukemias. Talon's encapsulation formulation is designed to provide prolonged circulation of the drug in the blood and accumulation at the tumor site. These characteristics are intended to increase the dose of vincristine delivered in a safe and effective manner. Based on the data from the rALLy study, in the first half of 2011 Talon plans to submit to the FDA a New Drug Application seeking accelerated approval of Marqibo in Ph- adult ALL, in second or greater relapse or that has progressed following two or more prior lines of anti-leukemia therapy. Talon has received orphan drug and fast track designations for Marqibo for the treatment of adult ALL from the U.S. Food and Drug Administration. Marqibo has also received orphan drug designation in adult ALL from the European Medicines Evaluation Agency. About Talon Therapeutics Talon Therapeutics, Inc. is a biopharmaceutical company dedicated to seizing upon medical opportunities, efficiently and expertly leading product candidates through clinical development, and transferring value to patients, patient care providers, shareholders, corporate partners, and employees. In addition to Marqibo and Menadione Topical Lotion, the Company has additional pipeline opportunities some of which, like Marqibo, improve delivery and enhance the therapeutic benefits of well characterized, proven chemotherapies and enable high potency dosing without increased toxicity.
Additional information on Talon Therapeutics can be found at www.talontx.com.The Talon Therapeutics, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=3290 Forward-Looking Statement This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are often, but not always, made through the use of words or phrases such as "anticipates," "expects," "plans," "believes," "intends," and similar words or phrases. These forward-looking statements include without limitation, statements regarding the timing of planned regulatory filings relating to Marqibo, Talon's ability to obtain accelerated approval of Marqibo for the treatment of Ph- adult ALL, and the potential of Marqibo to replace existing therapies. Such statements involve risks and uncertainties that could cause Talon's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties, which could cause actual outcomes and results to differ materially from these statements. Among other things, there can be no assurances that any of Talon's clinical and regulatory development efforts relating to Marqibo will be successful; that even if an NDA for Marqibo is accepted by the FDA, that it will be approved; that the data of the clinical trials of Marqibo will be sufficient to support approval by the FDA of an NDA for Marqibo; that the results of the clinical trials of Marqibo will support Talon's claims or beliefs concerning Marqibo's safety and effectiveness; and that Talon will be able to secure the additional capital necessary to fund its product development programs, including Marqibo, to completion, Talon's reliance on third-party researchers to develop its product candidates, and its lack of experience in developing and commercializing pharmaceutical products. Additional risks are described in the company's Annual Report on Form 10-K for the year ended December 31, 2010. Talon assumes no obligation to update these statements, except as required by law.
|TALON THERAPEUTICS, INC.|
|December 31, 2010||December 31, 2009|
|Cash and cash equivalents||$ 4,573,254||$ 9,570,453|
|Available-for-sale, equity securities||74,000||68,000|
|Available-for-sale, debt securities||17,993,745||—|
|Prepaid expenses and other current assets||253,901||114,067|
|Total current assets||22,894,900||9,752,520|
|Property and equipment, net||97,231||252,455|
|Debt issuance costs||904,909||1,193,594|
|Total assets||$ 24,022,040||$ 11,323,569|
|LIABILITIES AND STOCKHOLDERS' DEFICIT|
|Accounts payable and accrued liabilities||$ 6,051,982||$ 4,027,075|
|Other short-term liabilities||1,787||43,586|
|Total current liabilities||6,053,769||4,070,661|
|Notes payable, net of discount||23,340,144||22,597,050|
|Other long-term liabilities||4,753||6,540|
|Investors' right to purchase future shares of Series A-1 and A-2 preferred stock||5,131,000||—|
|Warrant liabilities, non-current||712,965||2,145,511|
|Total long term liabilities||29,188,862||24,749,101|
|Commitments and contingencies:|
|Redeemable convertible preferred stock; $100 par value:|
|10 million shares authorized, 0.4 million and 0 shares issued and outstanding at December 31, 2010 and December 31, 2009, respectively; aggregate liquidation value of $42.4 million and $0 at December 31, 2010 and December 31, 2009, respectively||30,643,219||—|
|Common stock; $0.001 par value:|
|350 million and 200 million shares authorized, 21.2 million and 19.9 million shares issued and outstanding at December 31, 2010 and December 31, 2009, respectively||21,234||19,912|
|Additional paid-in capital||119,241,956||117,632,111|
|Accumulated other comprehensive loss||(15,841)||(24,000)|
|Total stockholders' deficit||(41,863,810)||(17,496,193)|
|Total liabilities, redeemable convertible preferred stock and stockholders' deficit||$ 24,022,040||$ 11,323,569|
|TALON THERAPEUTICS, INC.|
|STATEMENTS OF OPERATIONS|
|Three Months Ended December 31,||Years Ended December 31,|
|General and administrative||$ 1,270,891||$ 1,402,795||$ 5,570,820||$ 4,907,690|
|Research and development||5,228,110||3,990,944||20,194,878||14,692,417|
|Total operating expenses||6,499,001||5,393,729||25,765,698||19,600,097|
|Loss from operations||(6,499,001)||(5,393,729)||(25,765,698)||(19,600,097)|
|Other income (expense):|
|Other expense, net||—||—||(3,512)||(4,908)|
|Change in fair value of warrant liabilities||(20,690)||1,345,554||(55,509)||(1,103,666)|
|Change in fair value of investors' right to purchase future shares of Series A-1 and A-2 preferred stock||1,108,000||—||3,539,000||—|
|Total other income (expense)||229,434||399,113||(221,245)||(4,538,532)|
|Net loss||$ (6,269,567)||$ (4,994,616)||$ (25,986,943)||$ (24,138,629)|
|Deemed dividends attributable to preferred stock||(941,814)||—||(32,308,787)||—|
|Net loss applicable to common stockholders||(7,211,382)||(4,994,616)||(58,295,730)||(24,138,629)|
|Net loss per share, basic and diluted||$ (0.34)||$ (0.28)||$ (2.81)||$ (2.27)|
|Weighted average shares used in computing net loss per share, basic and diluted||21,234,307||18,098,807||20,737,470||10,637,854|
CONTACT: Talon Therapeutics, Inc. Investor & Media Contacts: Investor Relations Team (650) 588-6641 email@example.com