Threshold Pharmaceuticals Reports Fourth Quarter And Year End 2010 Financial Results
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.
- 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
| 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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