Threshold Pharmaceuticals Reports Third Quarter 2011 Financial and Operational Results

 

SOUTH SAN FRANCISCO, CA--(Marketwire - Nov 3, 2011) - Threshold Pharmaceuticals, Inc. (NASDAQ: THLD) today reported financial results for the third quarter ended September 30, 2011. The net loss for the third quarter and nine months ended September 30, 2011 was $4.1 million and $20.4 million, respectively. As of September 30, 2011, Threshold had $25.3 million in cash, cash equivalents and marketable securities, with no debt outstanding.

The net loss for the third quarter of 2011 was $4.1 million compared to $5.9 million for the third quarter of 2010. Included in the net loss for the third quarter of 2011 was non-cash income of $3.7 million compared to non-cash income of $0.1 million in the third quarter of 2010. The non-cash income related to the changes in fair value of the Company's outstanding warrants and was classified as other income (expense). Research and development expenses were $6.5 million for the third quarter of 2011 compared to $4.8 million for the third 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 third quarter of 2011 versus $1.3 million for the third quarter of 2010. Non-cash stock compensation expense for the Company was $0.3 million for the third quarter of 2011 versus $0.3 million for the third quarter of 2010.

For the nine months ended September 30, 2011, the net loss was $20.4 million, compared to $12.1 million for the nine months ended September 30, 2010. Included in the net loss, for the nine months ended June 30, 2011 was non-cash income of $1.5 million compared to non-cash income of $5.6 million for the nine months ended September 30, 2010. The non-cash income related to the changes in fair value of the Company's outstanding warrants and was classified as other income (expense). Research and development expenses were $17.6 million for the nine months ended September 30, 2011 compared to $14.2 million for the nine months ended September 30, 2010, and increased primarily due to clinical trial expenses related to TH-302. General and administrative expenses increased to $4.3 million for the nine months ended September 30, 2011 from $3.6 million for the nine months ended September 30, 2010, primarily due to an increase in consulting, facilities and personnel related expenses. Total non-cash stock compensation expense for the Company was $0.7 million for the nine months ended September 30, 2011 versus $0.5 million for the nine months ended September 30, 2010. This increase was primarily due to the amortization of an increased number of options.

For the nine months ended September 30, 2011, the Company's operating cash requirements were $19.7 million. The Company currently expects 2011 operating cash requirements to be in the range of $28.0 million to $30.0 million. As of September 30, 2011, Threshold had $25.3 million in cash, cash equivalents and marketable securities and 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.

Key Milestones
The Company currently anticipates the following key clinical milestones:

  • Report top line results from the Phase 1 clinical trial in advanced leukemias by the end of 2011,
  • Report top line efficacy analysis results from the randomized Phase 2 trial in pancreatic cancer around the end of 2011, and
  • Provide an update on the interim analysis from the 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 around the end of 2012.

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 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, we are 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 our 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, 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 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). 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 November 3, 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 Nine Months Ended
September 30, September 30,
2011 2010 2011 2010
Revenue $ - $ - $ - $ -
Operating expenses
Research and development 6,481 4,773 17,646 14,194
General and administrative 1,308 1,297 4,290 3,591
Total Operating Expenses 7,789 6,070 21,936 17,785
Loss from operations (7,789 ) (6,070 ) (21,936 ) (17,785 )
Interest income (expense), net 6 14 21 53
Other income (expense) 3,658 148 1,537 5,604
Net Loss $ (4,125 ) $ (5,908 ) $ (20,378 ) $ (12,128 )
Net loss per common share - basic and diluted $ (0.08 ) $ (0.18 ) $ (0.45 ) $ (0.36 )
Weighted-average shares used in computing basic and diluted net loss per common share
49,052

33,672

44,812

33,638

THRESHOLD PHARMACEUTICALS, INC.
(A Development Stage Enterprise)
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
September 30, December 31,
2011 2010
(unaudited) (1)
Assets
Cash, cash equivalents and marketable securities $ 25,287 $ 14,699
Prepaid expenses and other current assets 830 944
Property and equipment, net 409 271
Other assets 349 290
Total assets $ 26,875 $ 16,204
Liabilities and stockholders' equity
Total current liabilities $ 5,387 $ 3,514
Long-term liabilities (2) 12,034 7,747
Stockholders' equity 9,454 4,943
Total liabilities and stockholders' equity $ 26,875 $ 16,204
(1) Derived from audited financial statements
(2) Includes as of September 30, 2011 and December 31, 2010, $12.0 million and $7.5 million of warrant liability, respectively


Contact:
Joel A. Fernandes
Threshold Pharmaceuticals, Inc.
650.474.8273
ir@thresholdpharm.com