updated 3/24/2011 8:46:10 AM ET 2011-03-24T12:46:10

REDWOOD CITY, Calif., March 24, 2011 (GLOBE NEWSWIRE) -- Threshold Pharmaceuticals, Inc. (Nasdaq:THLD), today reported financial results for the fourth quarter and the year ended December 31, 2010.

The net loss for 2010 was $18.7 million compared to a net loss of $23.6 million in 2009. Total research and development expenses for 2010 increased to $18.9 million from $15.8 million in 2009. The increase in research and development expenses primarily reflects an increase in clinical trial expenses related to TH-302, the Company's hypoxia activated prodrug (HAP) including initiating a Phase 2 controlled clinical trial in patients with advanced pancreatic cancer. General and administrative expenses were $5.0 million for 2010 compared to $5.5 million in 2009. This decrease was primarily due to lower employee stock-based compensation partially offset by higher payroll and facilities expenses. Total non-cash stock compensation expense was $0.8 million for 2010 compared to $2.2 million for 2009. The decrease in stock-based compensation expense is due to the amortization of options with lower valuations. Other income (expense) for 2010 was non-cash income of $5.2 million compared to non-cash expense of $2.3 million in 2009. This non-cash income was due to a decline in the fair value of the Company's outstanding warrants to purchase 10.9 million shares of common stock, which are classified as a liability.

The Company's net loss for the fourth quarter of 2010 was $6.6 million compared to $4.7 million for the fourth quarter of 2009. Research and development expenses were $4.7 million for the fourth quarter of 2010 compared to $4.1 million for the fourth quarter of 2009. The increase in research and development expenses primarily reflects an increase in clinical trial expenses related to TH-302. General and administrative expenses were $1.4 million for the fourth quarters of 2010 and 2009. Non-cash stock compensation expense was $0.3 million for the fourth quarter of 2010 compared to $0.6 million for the fourth quarter of 2009. The decrease in stock-based compensation expense is due to the amortization of options with lower valuations. Other income (expense) for the fourth quarter of 2010 was non-cash expense of $0.4 million compared to non-cash income of $0.7 million in the fourth quarter of 2009. This non-cash income and expense in the fourth quarter of 2010 and 2009, respectively, is due to the changes in the fair value of the Company's outstanding warrants to purchase 10.9 million shares of common stock, which are classified as a liability.

For the year ended December 31, 2010, the Company's cash requirements were $22.6 million. As of December 31, 2010, Threshold had $14.7 million in cash, cash equivalents and marketable securities. On March 16, 2011, the Company announced that it had completed a registered direct offering of Threshold common stock and warrants. Aggregate proceeds from the offering were $30.1 million and net proceeds are expected to be approximately $27.8 million. The Company now expects existing cash, cash equivalents and marketable securities, including net proceeds from the offering, to last approximately into the third quarter of 2012. Threshold currently expects that total operating expenses for 2011 will be between $27 and $29 million.

Clinical Development Summary

The Company is evaluating TH-302, the Company's hypoxia-activated prodrug, in various solid tumors and in hematologic malignancies as well. The Company has three clinical trials of TH-302 that are currently open to enrollment. The most advanced is the "404 trial", a Phase 2, controlled trial in combination with gemcitabine in patients with advanced pancreatic cancer. The "403 trial" is a Phase 1/2 trial of TH-302 in combination with doxorubicin in patients with advanced soft tissue sarcoma. The "407 trial" is a Phase 1, open label trial of TH-302 as monotherapy in patients with advanced leukemias. To date, across all clinical trials, TH-302 has been administered to more than 400 cancer patients.

Key accomplishments during the past twelve months were as follows:

  • Commenced two new clinical trials, the "407 trial" and the "404 trial"
  • Reached agreement with the FDA on a Special Protocol Assessment (SPA) for a Phase 3 randomized trial of TH-302 in patients with soft tissue sarcoma
  • Presented TH-302 clinical data at select medical conferences including, for example, ASCO (American Society of Clinical Oncology), CTOS (Annual Connective Tissue Oncology Society) and ESMO (European Society for Medical Oncology)
  • Collected approximately half a million dollars in grants under the Qualifying Therapeutic Discovery Project ("QTDP") program to advance the development of clinical programs for TH-302, and
  • Completed a registered direct offering for the sale of its common stock and warrants with gross proceeds of approximately $30.1 million.

The Company anticipates the following clinical milestones:

  • 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, pre-clinical testing of TH-302, 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 attract and retain employees, commence, 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) as well as the Company's ability to close its recently announced securities purchase agreement. Further information regarding these and other risks is included under the heading "Risk Factors" in Threshold's Annual Report on Form 10-K, which has been filed with the Securities Exchange Commission on March 24, 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.

THRESHOLD PHARMACEUTICALS, INC.
(A Development Stage Enterprise)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(Unaudited)
 
  Three Months Ended Year Ended
  December 31, December 31,
  2010 2009 2010 2009
         
Revenue  $ --   $ --   $ --   $ -- 
         
Operating expenses        
Research and development  4,743  4,125  18,937  15,844
General and administrative  1,380  1,365  4,971  5,480
Total Operating Expenses  6,123  5,490  23,908  21,324
         
Loss from operations  (6,123)  (5,490)  (23,908)  (21,324)
         
Interest income (expense), net  7  24  60  (13)
Other income (expense), net  (438)  733  5,166  (2,311)
Net Loss  $ (6,554)  $ (4,733)  $ (18,682)  $ (23,648)
         
Net loss per common share, basic & diluted  $ (0.19)  $ (0.15)  $ (0.56)  $ (1.21)
Weighted average number of shares used in per common share calculations: basic and diluted  33,702  32,566 33,654 19,594
 
 
THRESHOLD PHARMACEUTICALS, INC.
(A Development Stage Enterprise)
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
 
  December 31,  December 31, 
  2010 2009 (1)
  (unaudited)  
Assets    
     
Cash, cash equivalents and marketable securities  $ 14,699  $ 37,315
Prepaid expenses and other current assets (2)  944  10,342
Property and equipment, net  271  505
Other assets  290  523
Total assets  $ 16,204  $ 48,685
     
Liabilities and stockholders' equity    
     
Total current liabilities (2)  $ 3,514  $ 12,874
Long-term liabilities (3)  7,747  13,154
Stockholders' equity  4,943  22,657
Total liabilities and stockholders' equity  $ 16,204  $ 48,685
 
(1) Derived from audited financial statements
(2) Includes as of December 31, 2009, $10 million of settlement costs to be paid to the plaintiffs of an outstanding class action lawsuit by the Company's insurers. During the second quarter of 2010 the settlement was approved by the Court and the $10.0 million was paid by the Company's insurers.
(3) Includes as of December 31, 2010 and December 31, 2009, $7.5 million and $12.7 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.
         650-474-8206
         dpowell@thresholdpharm.com

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