REDWOOD CITY, Calif., May 9 /PRNewswire-FirstCall/ -- Threshold Pharmaceuticals, Inc. , today reported financial results for the first quarter ended March 31, 2007 and announced the filing of an investigational new drug application (IND), for TH-302, the Company’s hypoxia- activated prodrug, for a potential clinical trial in advanced solid tumors.
The net loss for the first quarter of 2007 was $9.1 million compared to $13.8 million for the first quarter of 2006. Research and development expenses were $7.3 million for the first quarter of 2007 versus $11.4 million for the first quarter of 2006. The decrease in research and development expenses primarily reflects the discontinuation of the Company’s multi-center clinical trials of TH-070 for the treatment of benign prostatic hyperplasia (BPH) in July 2006, partially offset by increased expenses for the Phase 3 glufosfamide clinical trial, the results of which were reported in February 2007, expenses related to the initiation of the additional Phase 2 glufosfamide clinical trials and preclinical expenses for the Company’s TH-302 hypoxia-activated prodrug program. General and administrative expenses were $2.6 million for the first quarter of 2007 versus $3.8 million for the first quarter of 2006. This decrease was primarily due to lower employee-related and consulting expenses in 2007. Threshold recognized revenue of $0.4 million for each of the quarters ended March 31, 2007 and 2006, related to a pre-existing development agreement with MediBIC Co., Ltd. Total non-cash stock compensation expense for the Company was $1.4 million for the first quarter of 2007 versus $3.0 million for the first quarter of 2006, primarily due to cancellations of option grants in 2006 resulting from staff reductions.
As of March 31, 2007, Threshold had $42.2 million in cash and investments.
Pending review of the IND by the Food and Drug Administration (FDA) the Company plans to start a Phase 1 clinical trial during the third quarter this year to evaluate the safety of TH-302 in patients with advanced solid tumors. Approximately 50 patients are planned to enroll in the Phase 1, open-label, dose-escalation clinical trial at various sites in the United States.
The Company recently announced the initiation of Phase 2 clinical trials of glufosfamide in each of the following indications: soft tissue sarcoma, recurrent sensitive small cell lung cancer and platinum-resistant ovarian cancer. In addition, the Company has an ongoing Phase 2 clinical trial of glufosfamide in combination with gemcitabine for first-line treatment of advanced pancreatic cancer and a Phase 1 clinical trial of 2-Deoxyglucose (2DG) for treatment of solid tumors.
“Starting three additional clinical trials in as many months and filing an IND for TH-302 is quite an accomplishment and I am proud of the teams at Threshold that made these events happen,” said Barry Selick, Threshold’s chief executive officer. “Ovarian cancer, small-cell lung cancer and soft tissue sarcoma remain major unmet medical needs and I remain hopeful that glufosfamide may provide a new treatment option for these patients.”
2007 Guidance and Key Milestones
The Company currently expects 2007 cash requirements to be in the range of $30 to $35 million. The Company continues to expect its existing cash and marketable securities to last at least through the middle of 2008.
The Company currently anticipates the following clinical milestones in 2007:
-- Report results from a Phase 2 clinical trial of glufosfamide for first-line treatment of advanced pancreatic cancer in the third quarter; -- Report top-line results from a Phase 1 clinical trial of 2DG for treatment of solid tumors in the third quarter; -- Commence a Phase 1 clinical trial for TH-302 in the third quarter; and -- Complete enrollment in the ovarian cancer, small-cell lung cancer and soft tissue sarcoma Phase 2 trials.
About Threshold Pharmaceuticals
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 (http://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, clinical trial progress and 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 Annual Report on Form 10-K, which was filed with the Securities Exchange Commission on March 15, 2007 and is available from the SEC’s website (http://www.sec.gov) and on our website (http://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 March 31, 2007 2006 Revenue $359 $359 Operating expenses Research and development 7,342 11,438 General and administrative 2,648 3,813 Total Operating Expenses 9,990 15,251 Loss from operations (9,631) (14,892) Interest and other income 611 1,072 Interest expense (39) (6) Net Loss (9,059) $(13,826) Net loss per common share-basic and diluted $(0.25) $(0.38) Weighted-average shares used in computing basic and diluted loss per common share 36,860 35,949 THRESHOLD PHARMACEUTICALS, INC. (A Development Stage Enterprise) CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except per share amounts) (Unaudited) Three Months Ended March 31, 2007 2006 Revenue $359 $359 Operating expenses Research and development 7,342 11,438 General and administrative 2,648 3,813 Total Operating Expenses 9,990 15,251 Loss from operations (9,631) (14,892) Interest and other income 611 1,072 Interest expense (39) (6) Net Loss (9,059) $(13,826) Net loss per basic and diluted loss per common share $(0.25) $(0.38) Weighted-average shares used in computing basic and diluted loss per common share 36,860 35,949 THRESHOLD PHARMACEUTICALS, INC. (A Development Stage Enterprise) CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) March 31, December 31, 2007 2006 (unaudited) (1) Assets Cash, cash equivalents and marketable securities $42,214 $52,810 Prepaid expenses and other current assets 996 547 Property and equipment, net 2,926 3,169 Other assets 508 508 Total assets $46,644 $57,034 Liabilities and stockholders’ equity Total current liabilities $7,421 $9,659 Long-term liabilities (2) (3) 2,586 3,137 Stockholders’ equity 36,637 44,238 Total liabilities and stockholders’ equity $46,644 $57,034 (1) Derived from audited financial statements (2) Includes as of March 31, 2007 and December 31, 2006 $1.0 million and $1.2 million, respectively, of long-term debt under the Company’s loan and security agreement (3) Includes as of March 31, 2007 and December 31, 2006 $1.1 million and $1.4 million, respectively, of deferred revenue related to the development agreement with MediBIC Co. Ltd. Contact: Denise T. Powell Sr. Director, Corporate Communications Threshold Pharmaceuticals, Inc. 650-474-8206 dpowell@thresholdpharm.com
Threshold Pharmaceuticals, Inc.
CONTACT: Denise T. Powell, Sr. Director, Corporate Communications,Threshold Pharmaceuticals, Inc., +1-650-474-8206, ordpowell@thresholdpharm.com
Web site: http://www.thresholdpharm.com//
