SAN MATEO, Calif., Aug. 15, 2011 (GLOBE NEWSWIRE) -- Talon Therapeutics, Inc., (OTCBB:TLON), today reported financial results for the three and six months ended June 30, 2011.
"Submitting our new drug application for Marqibo® was a momentous event for Talon. It was the culmination of exceptional dedication on the part of our employees and illustrates what a small company can accomplish with single-minded focus. For the next few months the Company will be focused on preparing for a possible ODAC meeting and pre-approval inspections of Talon and our manufacturing suppliers," stated Steven R. Deitcher, M.D. President, Chief Executive Officer and Board Member of Talon Therapeutics.
Recent Corporate Highlights:
- Submission of the NDA for Marqibo seeking accelerated approval in adult Ph- ALL, in second or greater relapse or that has progressed following two or more prior lines of anti-leukemia therapy.
- Submission of a Special Protocol Assessment proposal for the Phase 3 confirmatory study for Marqibo in newly diagnosed, treatment-naïve elderly ALL patients (front-line setting).
- Initiation of a Phase 3 Study of Marqibo in elderly patients with newly diagnosed aggressive Non-Hodgkin's Lymphoma to be conducted by the German High-Grade Non-Hodgkin's Lymphoma Study Group.
- Enrollment of the first patient in a Phase 1 trial of Marqibo in children and adolescents with relapsed or refractory cancer being conducted by the Pediatric Branch of the National Cancer Institute.
Three Months Ended June 30, 2011 Financial Results
For the three months ended June 30, 2011, Talon reported a net loss of $6.0 million and deemed dividends attributable to preferred stock of $1.0 million, which when combined, resulted in a net loss applicable to common stockholders of $7.0 million, or $0.33 per share. The deemed dividends attributable to preferred stock contributed $0.05 per share to the total net loss applicable to common stockholders for the three months ended June 30, 2011. This compared with a net loss of $6.3 million and deemed dividends attributable to preferred stock of $9.3 million, which when combined, resulted in a net loss applicable to common stockholders of $15.6 million, or $0.76 per share, for the three months ended June 30, 2010.
Total operating expenses for the three months ended June 30, 2011 were $4.8 million, compared with $4.6 million for the three months ended June 30, 2010. Research and development expenses were $3.5 million for the three months ended June 30, 2011, compared with $2.7 million for the same period in 2010. The increase of $0.8 million reflects increased activity in preparation for Talon's Marqibo NDA submission. General and administrative expenses were $1.3 million for the three months ended June 30, 2011, compared with $1.9 million for the same period in 2010.
As of June 30, 2011, the Company had cash, cash equivalents and available-for-sale securities of $10.5 million. Cash used in operations was $6.0 million for the three months ended June 30, 2011.
Six Months Ended June 30, 2011 Financial Results
For the six months ended June 30, 2011, Talon reported a net loss of $16.5 million and deemed dividends attributable to preferred stock of $1.9 million, which when combined, resulted in a net loss applicable to common stockholders of $18.4 million, or $0.86 per share. The deemed dividends attributable to preferred stock contributed $0.09 per share to the total net loss applicable to common stockholders for the six months ended June 30, 2011. This compared with a net loss of $11.8 million and deemed dividends attributable to preferred stock of $9.3 million, which when combined, resulted in a net loss applicable to common stockholders of $21.1 million, or $1.04 per share, for the six months ended June 30, 2010.
Total operating expenses for the six months ended June 30, 2011 were $11.4 million, compared with $9.0 million for the same period in 2010. Research and development expenses were $8.7 million for the six months ended June 30, 2011, compared with $6.0 million for the same period in 2010. The increase of $2.7 million reflects increased activity in preparation for Talon's Marqibo NDA submission. General and administrative expenses were $2.8 million for the six months ended June 30, 2011, compared with $3.0 million for the same period in 2010.
Cash used in operations was $12.3 million for the six months ended June 30, 2011.
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 July 2011, Talon submitted 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 previously 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 developing and commercializing new, differentiated cancer therapies designed to improve and enable current standards of care. Talon is developing its lead product candidate, Marqibo, primarily for the treatment of ALL and lymphomas. The Company has additional pipeline opportunities some of which, like Marqibo, are designed to 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 Talon's ability to obtain accelerated approval of Marqibo for the treatment of adult Ph- adult ALL, and the potential of Marqibo to replace existing therapies, and the timing, progress and anticipated results of the clinical development of Marqibo and Talon's other product candidates. 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 for filing by the FDA, 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 and its Quarterly Report on Form 10-Q for the quarter ended June 30, 2011. Talon assumes no obligation to update these statements, except as required by law.
| TALON THERAPEUTICS, INC. | ||
| CONDENSED BALANCE SHEETS | ||
| (In thousands, except par values) | ||
|
June 30, 2011 |
December 31, 2010 |
|
| ASSETS | (Unaudited) | |
| Current assets: | ||
| Cash and cash equivalents | $ 10,514 | $ 4,573 |
| Available-for-sale securities | 28 | 18,068 |
| Prepaid expenses and other current assets | 80 | 254 |
| Total current assets | 10,622 | 22,895 |
| Property and equipment, net | 100 | 97 |
| Restricted cash | -- | 125 |
| Other long-term assets | 32 | -- |
| Debt issuance costs | 827 | 905 |
| Total assets | $ 11,581 | $ 24,022 |
| LIABILITIES AND STOCKHOLDERS' DEFICIT | ||
| Current liabilities: | ||
| Accounts payable, accrued liabilities and other short-term liabilities | $ 5,608 | $ 6,054 |
| Total current liabilities | 5,608 | 6,054 |
| Notes payable, net of discount | 23,685 | 23,340 |
| Other long-term liabilities | 4 | 5 |
| Investors' rights to purchase additional shares of Series A-1 and A-2 preferred stock | 7,530 | 5,131 |
| Warrant liabilities | 1,257 | 713 |
| Commitments and contingencies: | ||
| Redeemable convertible preferred stock; $100 par value: | ||
| 10 million shares authorized, 0.4 million shares issued and outstanding at June 30, 2011 and December 31, 2010; aggregate liquidation value of $44.3 million and $42.4 million at June 30, 2011 and December 31, 2010, respectively | 30,643 | 30,643 |
| Stockholders' deficit: | ||
| Common stock; $0.001 par value: | ||
| 350 million shares authorized, 21.7 million and 21.2 million shares issued and outstanding at June 30, 2011 and December 31, 2010, respectively | 22 | 21 |
| Additional paid-in capital | 120,397 | 119,242 |
| Accumulated other comprehensive income (loss) | 12 | (16) |
| Accumulated deficit | (177,577) | (161,111) |
| Total stockholders' deficit | (57,146) | (41,864) |
| Total liabilities, redeemable convertible preferred stock and stockholders' deficit | $ 11,581 | $ 24,022 |
| TALON THERAPEUTICS, INC. | ||||
| CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||
| (In thousands, except per share data) | ||||
| (Unaudited) | ||||
|
Three Months Ended June 30, |
Six Months Ended June 30, |
|||
| 2011 | 2010 | 2011 | 2010 | |
| Operating expenses: | ||||
| General and administrative | $ 1,277 | $ 1,876 | $ 2,757 | $ 3,047 |
| Research and development | 3,533 | 2,705 | 8,677 | 5,964 |
| Total operating expenses | 4,810 | 4,581 | 11,434 | 9,011 |
| Loss from operations | (4,810) | (4,581) | (11,434) | (9,011) |
| Other income (expense): | ||||
| Interest expense | (887) | (941) | (1,768) | (2,025) |
| Other income, net | 2 | -- | 7 | 1 |
| Change in fair value of warrant liabilities | (338) | (424) | (796) | (384) |
| Impairment of available-for-sale securities | -- | -- | (76) | -- |
| Change in fair value of rights to purchase additional shares of Series A-1 and A-2 Preferred Stock | (17) | (378) | (2,399) | (378) |
| Total other expense | (1,240) | (1,743) | (5,032) | (2,786) |
| Net loss | $ (6,050) | $ (6,324) | $ (16,466) | $ (11,797) |
| Dividends attributable to preferred shares | (972) | (9,307) | (1,913) | (9,307) |
| Net loss applicable to Common Stock | (7,022) | (15,631) | (18,379) | (21,104) |
| Net loss per share, basic and diluted | $ (0.33) | $ (0.76) | $ (0.86) | $ (1.04) |
| Weighted average shares used in computing net loss per share, basic and diluted | 21,423 | 20,517 | 21,334 | 20,233 |
| Comprehensive loss: | ||||
| Net loss | $ (6,050) | $ (6,324) | $ (16,466) | $ (11,797) |
| Unrealized holdings gains (losses) arising during the period | 12 | -- | (48) | 8 |
| Less: reclassification adjustment for other-than-temporary impairment included in net loss | -- | -- | 76 | -- |
| Comprehensive loss | $ (6,038) | $ (6,324) | $ (16,438) | $ (11,789) |