updated 5/12/2011 4:17:54 PM ET 2011-05-12T20:17:54

REDWOOD CITY, Calif., May 12, 2011 (GLOBE NEWSWIRE) -- Threshold Pharmaceuticals, Inc. (Nasdaq:THLD), today reported financial results for the first quarter ended March 31, 2011.

The net loss for the first quarter of 2011 was $8.3 million compared to $6.0 million for the first quarter of 2010. Research and development expenses were $6.1 million for the first quarter of 2011 compared to $4.5 million for the first quarter of 2010. The increase in research and development expenses primarily reflects an increase in clinical trial expenses related to TH-302. General and administrative expenses were $1.3 million for the first quarter of 2011 versus $1.3 million for the first quarter of 2010. Non-cash stock compensation expense for the Company was $0.2 million for the first quarter of 2011 versus $40,000 for the first quarter of 2010. The increase in stock-based compensation expense is due to the amortization of more options. Other income (expense) for the first quarter of 2011 was non-cash expense of $0.9 million compared to non-cash expense of $0.2 million in the first quarter of 2010. This increase in non-cash expense in the first quarter of 2011 compared to first quarter 2010 is due to the changes in the fair value of the Company's outstanding warrants to purchase 16.6 million shares of common stock, which are classified as a liability.

For the quarter ended March 31, 2011, the Company's operating cash requirements were $6.0 million. As of March 31, 2011, Threshold had $38.4 million in cash, cash equivalents and marketable securities. The Company currently expects 2011 operating cash requirements to be in the range of $27.0 million to $29.0 million. The Company also expects existing cash, cash equivalents and marketable securities to be sufficient to fund the Company's projected operating requirements into the third quarter of 2012.

2011 Key Milestones

The Company currently anticipates the following key clinical milestones in 2011:

  • Report top line results from the Phase 1 clinical trial in advanced leukemias in the second half of 2011,
  • Report top line efficacy analysis results from the randomized Phase 2 trial in pancreatic cancer at the end of 2011, and
  • Initiate a pivotal Phase 3 clinical trial of TH-302 plus doxorubicin compared to doxorubicin alone in patients with metastatic or locally advanced unresectable soft tissue sarcoma in the middle of 2011.

About Threshold Pharmaceuticals

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. This approach offers broad potential to treat most solid tumors. 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 the website ( www.thresholdpharm.com ).

Forward-Looking Statements

Except for statements of historical fact, the statements in this press release are forward-looking statements, including statements regarding Threshold's product candidates and approach to developing new product candidates, clinical trials and anticipated results and announcements, potential therapeutic uses and benefits of TH-302 and financial results, estimates, projections and requirements, including the need for additional cash. 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)r. 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 Securities Exchange Commission on May 12, 2011 and is available from the SEC's website ( www.sec.gov ) and on our website ( www.thresholdpharm.com ) under the heading "Investors." We undertake no duty to update any forward-looking statement made in this news release.

(A Development Stage Enterprise)
(in thousands, except per share amounts)
  Three Months Ended
  March 31,
  2011 2010
Revenue  $ —   $ — 
Operating expenses    
Research and development  6,097  4,467
General and administrative  1,297  1,289
Total Operating Expenses  7,394  5,756
Loss from operations  (7,394)  (5,756)
Interest and other income  3  20
Interest and other expense  (939)  (223)
Net Loss  (8,330)  (5,959)
Net loss per common share-basic and diluted  $ (0.23)  $ (0.18)
Weighted-average shares used in computing basic and diluted net loss per common share  36,445  33,603
(A Development Stage Enterprise)
(in thousands)
  March 31,  December 31,
  2011 2010
  (unaudited)  (1) 
Cash, cash equivalents and marketable securities  $ 38,366  $ 14,699
Prepaid expenses and other current assets  943  944
Property and equipment, net  199  271
Other assets  290  290
Total assets  $ 39,798  $ 16,204
Liabilities and stockholders' equity    
Total current liabilities  $ 4,632  $ 3,514
Long-term liabilities (2)  14,684  7,747
Stockholders' equity  20,482  4,943
Total liabilities and stockholders' equity  $ 39,798  $ 16,204
(1) Derived from audited financial statements
(2) Includes as of March 31, 2011 and December 31, 2010, $14.5 million and $7.5 million of warrant liability, respectively, as a result of the Company's adoption on January 1, 2009 of guidance now codified under ASC Topic 815, "Derivatives and Hedging"
CONTACT: Denise Powell
         Sr. Director, Corporate Communications
         Threshold Pharmaceuticals, Inc.

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