REDWOOD CITY, Calif., Nov. 6, 2008 (GLOBE NEWSWIRE) -- Threshold Pharmaceuticals, Inc. (Nasdaq:THLD) today reported financial results for the third quarter ended September 30, 2008. The net loss for the third quarter of 2008 was $4.6 million compared to $6.6 million for the third quarter of 2007.
Research and development expenses were $3.7 million for the third quarter of 2008 versus $4.9 million for the third quarter of 2007. The decrease in research and development expenses primarily reflects a decrease in clinical development expenses related to glufosfamide and, to a lesser extent, lower staffing and facilities expenses due to lower headcount. These decreases in expenses were partially offset by higher clinical development expenses related to TH-302. General and administrative expenses were $1.3 million for the third quarter of 2008 versus $2.4 million for the third quarter of 2007. This decrease was primarily due to lower staffing and facilities expenses related to staff reductions in 2007 and, to a lesser extent, lower consulting expenses. Threshold recognized revenue of $0.4 million for each of the quarters ended September 30, 2008 and 2007, related primarily to a pre-existing development agreement with MediBIC Co., Ltd. Total non-cash stock compensation expense for the Company was $0.7 million for the third quarter of 2008 versus $1.5 million for the third quarter of 2007, primarily due to lower stock-based compensation expense as a result of staff reductions in November 2007.
For the nine months ended September 30, 2008, the net loss was $13.5 million, compared to $23.3 million in 2007. Research and development expenses were $9.9 million in the 2008 period compared to $18.2 million in 2007, and declined as a result of the decrease in expenses for glufosfamide clinical trials, and a decrease in staffing and facilities expense. General and administrative expenses decreased to $5.1 million in the first nine months of 2008 from $7.5 million in 2007, primarily due to lower staffing and facilities expenses related to staff reductions in November 2007. Threshold recognized revenue of $1.1 million for each of the nine months ended September 30, 2008 and 2007, related to a pre-existing development agreement. Total non-cash stock compensation expense for the Company was $2.6 million for the first nine months of 2008 versus $4.5 million for the first nine months of 2007.
On September 2, 2008, the Company announced that a private placement of Threshold common stock and warrants had been completed. Net proceeds from the financing were $16.8 million. As of September 30, 2008, Threshold had $26.5 million in cash, cash equivalents and marketable securities. The Company expects cash, cash equivalents and marketable securities to last through the fourth quarter of 2009.
Clinical Trial Update
The Company's clinical development program expanded during the quarter. In addition to the ongoing Phase 1 clinical trial of TH-302 as a monotherapy in patients with advanced solid tumors, the Company commenced two additional clinical trials of TH-302 in combination with chemotherapy in patients with advanced solid tumors during the quarter.
The first is a Phase 1/2 clinical trial evaluating the activity of TH-302 against multiple tumor types in combination with established chemotherapeutic agents. The clinical trial includes three separate treatment arms to each examine TH-302 in combination with one of the following chemotherapeutic agents: gemcitabine, docetaxel or pemetrexed. Approximately 54 patients with advanced solid tumors are planned to enroll in the Phase 1/2, open-label, dose-escalation portion of the clinical trial. Once the maximum tolerated dose (MTD) has been reached, the Phase 2 portion of the trial will enroll an additional 12 patients at the MTD within each treatment arm as follows: gemcitabine in advanced pancreatic cancer patients, docetaxel in patients with androgen-independent prostrate cancer or non-small cell lung cancer, and pemetrexed in patients with non-small cell lung cancer.
The second is a Phase 1/2 clinical trial of TH-302 in combination with doxorubicin in patients with advanced soft tissue sarcoma. Approximately 36 patients with metastatic and/or advanced unresectable soft tissue sarcoma are planned to enroll in the clinical trial. The dose escalation phase of the trial will enroll up to 24 patients. The primary objective of the dose escalation component of the study is to establish the MTD and dose limiting toxicities of TH-302 in combination with doxorubicin. Once the MTD has been reached, the Phase 2 portion of the trial will enroll an additional 12 patients at the MTD.
About Threshold Pharmaceuticals, Inc.
Threshold is a biotechnology company focused on the discovery and development of therapeutics for the potential treatment of cancer. By selectively targeting abnormally-proliferating tumor cells, the Company's drug candidates are designed to be potentially more effective and less toxic to healthy tissues than conventional treatments. 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 and approach to developing new product candidates, clinical trials and anticipated results, potential therapeutic uses and benefits of our product candidates and financial results, estimates, projections and requirements. 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). Further information regarding these and other risks is included under the heading "Risk Factors" in Threshold's Quarterly Report on Form 10-Q, which was filed with the Securities Exchange Commission on November 6, 2008 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,
------------------ -----------------
2008 2007 2008 2007
------- ------- ------- -------
Revenue $ 362 $ 359 $ 1,080 $ 1,077
Operating expenses
Research and development 3,672 4,896 9,873 18,230
General and administrative 1,344 2,407 5,067 7,517
------- ------- -------- --------
Total Operating Expenses 5,016 7,303 14,940 25,747
------- ------- -------- --------
Loss from operations (4,654) (6,944) (13,860) (24,670)
Interest and other income 109 415 414 1,524
Interest expense (13) (30) (52) (110)
------- ------- -------- --------
Net Loss $(4,558) $(6,559) $(13,498) $(23,256)
======= ======= ======== ========
Net loss per common share,
basic & diluted (1) $ (0.49) $ (1.06) $ (1.86) $ (3.77)
======= ======= ======== ========
Weighted average number of
shares used in per common
share calculations: basic and
diluted (1) 9,392 6,180 7,276 6,165
======= ======= ======== ========
(1) Weighted-average shares used in calculating net loss per basic and
diluted common share have been retrospectively restated to reflect the
one-for-six reverse stock split effective August 20, 2008
THRESHOLD PHARMACEUTICALS, INC.
(A Development Stage Enterprise)
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
September 30, December 31,
2008 2007
-------- --------
(unaudited) (1)
Assets
Cash, cash equivalents and
marketable securities $ 26,549 $ 22,693
Prepaid expenses and other current assets 527 516
Property and equipment, net 1,398 2,097
Other assets 508 508
-------- --------
Total assets $ 28,982 $ 25,814
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Liabilities and stockholders' equity
Total current liabilities $ 2,938 $ 5,325
Long-term liabilities (2) 560 902
Stockholders' equity 25,484 19,587
-------- --------
Total liabilities and stockholders' equity $ 28,982 $ 25,814
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(1) Derived from audited financial statements
(2) Includes as of December 31, 2007 $0.3 million
of long-term debt under the Company's loan
and security agreement