SAN MATEO, Calif., May 15, 2012 (GLOBE NEWSWIRE) -- Talon Therapeutics, Inc., (OTCBB:TLON), today reported financial results for the three months ended March 31, 2012.
"In the first quarter, the Oncologic Drugs Advisory Committee (ODAC) affirmed evidence from clinical studies that support the use of Marqibo® for a very rare patient population with a grave prognosis and no existing standard of treatment. As we approach our new PDUFA date of August 12, 2012, we will continue to work collaboratively with the Food and Drug Administration on the Marqibo review process, including on-going label negotiations. We remain committed, energized, and focused on our goal of FDA approval of Marqibo," stated Steven R. Deitcher, M.D. President, Chief Executive Officer and Board Member of Talon Therapeutics.
Recent Corporate Highlights:
- Positive vote (7 to 4 with 2 abstentions) from the ODAC affirming evidence from clinical studies that support a favorable benefit/risk assessment for use of Marqibo in the treatment of advanced relapsed adult acute lymphoblastic leukemia (ALL).
- Appointment of Howard Pien to Talon's Board of Directors.
Three Months Ended March 31, 2012 Financial Results
For the three months ended March 31, 2012, Talon reported a net loss of $30.5 million and deemed dividends attributable to preferred stock of $5.6 million, which when combined, resulted in a net loss applicable to common stockholders of $36.1 million, or $1.66 per share. This compares to a net loss of $10.4 million and deemed dividends of $0.9 million, which when combined, resulted in a net loss of $11.3 million, or $0.53 per share, for the three months ended March 31, 2011. The change in fair value of certain investors' rights to purchase shares of preferred stock contributed to $24.7 million, or $1.13 per share, of the total net loss applicable to common stockholders for the three months ended March 31, 2012. The deemed dividends attributable to preferred stock contributed to $5.6 million, or $0.26 per share, of the total net loss applicable to common stockholders for the three months ended March 31, 2012.
Total operating expenses for the three months ended March 31, 2012 were $4.4 million, compared with $6.6 million for the three months ended March 31, 2011. Research and development expenses were $2.7 million for the three months ended March 31, 2012, compared with $5.1 million for the corresponding period in the preceding year. The decrease of $2.4 million reflects decreased activity following the submission of the Marqibo NDA, offset by expenses related to the March 2012 ODAC meeting. General and administrative expenses were $1.7 million for the three months ended March 31, 2012, compared with $1.5 million for the corresponding period in the preceding year.
As of March 31, 2012, the Company had cash and cash equivalents of $6.9 million. Cash used in operations was $4.4 million for the three months ended March 31, 2012.
About Marqibo(R) (vincristine sulfate liposome 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 Philadelphia negative (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.
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. In 2012, Talon submitted, and the FDA accepted for filing, a new drug application (NDA) seeking accelerated approval of Marqibo for the treatment of Ph- adult ALL in second or greater relapse or that has progressed following two or more lines of anti-leukemia therapy. The NDA has a current FDA action date goal of August 12, 2012 under the Prescription Drug User Fee Act.
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 potential of Marqibo to replace existing therapies, the timing of Talon's ongoing and planned clinical trials, and Talon's ability to obtain approval of its Marqibo NDA. 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. Such risks and uncertainties include: that there can be no assurances that any of Talon's clinical and regulatory development efforts relating to Marqibo will be successful; that Talon's NDA for Marqibo will be approved; that the data of the clinical trials of Marqibo will be sufficient to support approval by the FDA of the 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; 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 Quarterly Report on Form 10-Q for the quarter ended March 31, 2012. Talon assumes no obligation to update these statements, except as required by law.
| TALON THERAPEUTICS, INC. | ||
| CONDENSED BALANCE SHEETS | ||
| (In thousands) | ||
| (Unaudited) | ||
|
March 31, 2012 |
December 31, 2011 |
|
| ASSETS | ||
| Current assets: | ||
| Cash and cash equivalents | $ 6,850 | $ 1,029 |
| Prepaid expenses and other current assets | 173 | 635 |
| Total current assets | 7,023 | 1,664 |
| Property and equipment, net | 60 | 72 |
| Debt issuance costs | 687 | 751 |
| Total assets | $ 7,770 | $ 2,487 |
| LIABILITIES AND STOCKHOLDERS' DEFICIT | ||
| Current liabilities: | ||
| Accounts payable and accrued liabilities | $ 3,077 | $ 4,557 |
| Other short-term liabilities | 2 | 2 |
| Total current liabilities | 3,079 | 4,559 |
| Notes payable, net of discount | 24,230 | 24,033 |
| Other long-term liabilities | 2 | 2 |
| Investors' right to purchase future shares of Series A-1 and A-2 preferred stock | — | 1,772 |
| Investors' right to purchase future shares of Series A-3 preferred stock | 33,971 | — |
| Warrant liabilities | 957 | 502 |
| Total long term liabilities | 59,160 | 26,309 |
| Total liabilities | 62,239 | 30,868 |
| Redeemable convertible preferred stock; $0.001 par value: | ||
| 10 million shares authorized, 0.5 and 0.4 million issued and outstanding as of March 31, 2012 and December 31, 2011, respectively; aggregate liquidation value of $59.3 million and $46.4 million at March 31, 2012 and December 31, 2011, respectively | 34,661 | 30,643 |
| Stockholders' deficit: | ||
| Common stock; $0.001 par value: | ||
| 600 million shares authorized, 21.9 and 21.8 million shares issued and outstanding at March 31, 2012 and December 31, 2011 | 22 | 22 |
| Additional paid-in capital | 121,272 | 120,887 |
| Accumulated deficit | (210,424) | (179,933) |
| Total stockholders' deficit | (89,130) | (59,024) |
| Total liabilities, redeemable convertible preferred stock and stockholders' deficit | $ 7,770 | $ 2,487 |
| TALON THERAPEUTICS, INC. | ||
| CONDENSED STATEMENTS OF OPERATIONS | ||
| (In thousands, except per share data) | ||
| (Unaudited) | ||
|
Three Months Ended |
||
| March 31, | ||
| 2012 | 2011 | |
| Operating expenses: | ||
| General and administrative | $ 1,685 | $ 1,480 |
| Research and development | 2,742 | 5,144 |
| Total operating expenses | 4,427 | 6,624 |
| Loss from operations | (4,427) | (6,624) |
| Other expense: | ||
| Interest expense | (938) | (881) |
| Other income (expense) | — | (70) |
| Change in fair value of warrant liabilities | (455) | (458) |
| Change in fair value of investors' right to purchase future shares of Series A-1 and A-2 preferred stock | (1,007) | (2,382) |
| Change in fair value of investors' right to purchase future shares of Series A-3 preferred stock | (23,664) | — |
| Total other expense | (26,064) | (3,791) |
| Net loss | $ (30,491) | $ (10,415) |
| Deemed dividends attributable to preferred stock in connection with the embedded beneficial conversion features | (4,352) | — |
| Deemed dividends attributable to preferred stock in connection with accretion | (1,262) | (941) |
| Net loss applicable to common stock | (36,105) | (11,356) |
| Net loss per share applicable to common stock, basic and diluted | $ (1.66) | $ (0.53) |
| Weighted average shares used in computing net loss per share, basic and diluted | 21,788 | 21,243 |