Threshold recognized revenue of
The net loss for the first quarter of 2012 was
For the quarter ended
Clinical Development Update
The Company is evaluating TH-302, the Company's hypoxia-targeted drug, in various solid tumors and hematologic malignancies. The Company has several ongoing clinical trials of TH-302, including the most advanced "406 trial", a pivotal Phase 3, randomized, controlled trial in combination with doxorubicin in patients with metastatic or locally advanced unresectable soft tissue sarcoma. The "407 trial" is a Phase 1 monotherapy trial in patients with advanced leukemias. The "408 trial" is a Phase 1/2 trial exploring TH-302 monotherapy and in combination with bortezomib in patients with multiple myeloma. The "410 trial" is a Phase 1/2 trial in combination with sunitinib in patients with renal cell carcinoma, gastrointestinal stromal tumors or pancreatic neuroendocrine tumors. To date, across all clinical trials, TH-302 has been administered to more than 600 patients with cancer.
Key accomplishments during the quarter were as follows:
The Company currently anticipates the following key clinical milestones for TH-302:
TH-302 is a hypoxia-targeted drug that was designed to be activated under extreme hypoxic conditions, a hallmark of many cancer indications. Areas of low oxygen levels (hypoxia) within tissues are common in many solid tumors due to insufficient blood vessel growth. Similarly, the bone marrow of patients with hematological malignancies has also been shown, in some cases, to be extremely hypoxic.
TH-302 has been investigated in over 600 patients in Phase 1/2 clinical trials in a broad spectrum of tumor types, both as a monotherapy and in combination with chemotherapy treatments and other targeted cancer drugs. Threshold has several additional ongoing clinical trials, the most advanced of which is a Phase 3 pivotal study evaluating TH-302 in combination with doxorubicin versus doxorubicin alone in patients with soft tissue sarcoma. In
Threshold is a biotechnology company focused on the discovery and development of drugs targeting tumor hypoxia, the low oxygen condition found in microenvironments of most solid tumors as well as the bone marrows of some hematologic malignancies. This approach offers broad potential to treat a variety of cancers. By selectively targeting tumor cells, Threshold is building a pipeline of drugs that hold promise to be more effective and less toxic to healthy tissues than conventional anticancer drugs. For additional information, please visit www.thresholdpharm.com.
Except for statements of historical fact, the statements in this press release are forward-looking statements, including statements regarding Threshold's product candidates, anticipated milestones, clinical trials and anticipated results and announcements, potential therapeutic uses and benefits of TH-302 and financial results, estimates, projections and requirements, including anticipated and potential payments from Merck KGaA. These statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, but are not limited to, Threshold's ability to enroll or complete its anticipated clinical trials, the time and expense required to conduct such clinical trials and analyze data, issues arising in the regulatory or manufacturing process and the results of such clinical trials (including product safety issues and efficacy results). Further information regarding these and other risks is included under the heading "Risk Factors" in Threshold's Quarterly Report on Form 10-Q, which has been filed with the
THRESHOLD PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except per share amounts) (Unaudited) Three Months Ended March 31, ------------------- 2012 2011 --------- --------- Revenue $ 252 $ - Operating expenses Research and development 5,687 6,097 General and administrative 1,708 1,297 --------- --------- Total Operating Expenses 7,395 7,394 Loss from operations (7,143) (7,394) Interest income (expense), net 1 3 Other Income (expense), net (1) (108,391) (939) --------- --------- Net Loss (115,533) (8,330) ========= ========= Net loss per common share-basic and diluted $ (2.30)$ (0.23) ========= ========= Weighted-average shares used in computing basic and diluted net loss per common share 50,326 36,445 ========= ========= (1) Non-cash expense related to the change in fair value of the Company's outstandingand exercised warrants, classified as other income (expense). THRESHOLD PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) March 31, December 31, 2012 2011 ------------- ------------- (unaudited) (1) Assets Cash, cash equivalents and marketable securities $ 49,731 $ 20,290 Collaboration Receivable 37,540 - Prepaid expenses and other current assets 767 254 Property and equipment, net 617 543 Other assets 1,059 1,349 ------------- ------------- Total assets $ 89,714 $ 22,436 ============= ============= Liabilities and stockholders' equity Total current liabilities (2) $ 15,214 $ 8,591 Deferred Revenue 50,060 - Long-term liabilities (3) 101,887 9,362 Stockholders' equity (77,447) 4,483 ------------- ------------- Total liabilities and stockholders' equity $ 89,714 $ 22,436 ============= ============= (1) Derived from audited financial statements (2) Amount includes current portion of deferred revenue of
$7.2Mas of March 31, 2012(3) Includes as of March 31, 2012and December 31, 2011, $101.6 millionand $9.2 millionof warrant liability, respectively.
Joel A. Fernandes Threshold Pharmaceuticals, Inc.650-474-8273 Email Contact
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