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Threshold recognized revenue of
The net income for the second quarter of 2012 was
For the six months ended
Clinical Development Update
The Company is evaluating TH-302, the Company's hypoxia-targeted drug, in patients with various solid tumors and hematologic malignancies. The Company has several ongoing clinical trials of TH-302, including the most advanced "406 trial," a pivotal Phase 3, randomized controlled trial in combination with doxorubicin in patients with metastatic or locally advanced unresectable soft tissue sarcoma. The "404 trial" is a randomized Phase 2 trial investigating two dose levels of TH-302 in combination with gemcitabine versus gemcitabine alone in patients with advanced pancreatic adenocarcinoma. The "407 trial" is a Phase 1 monotherapy trial in patients with advanced leukemias. The "408 trial" is a Phase 1/2 trial exploring TH-302 monotherapy and in combination with bortezomib in patients with multiple myeloma. The "410 trial" is a Phase 1/2 trial in combination with sunitinib in patients
with renal cell carcinoma, gastrointestinal stromal tumors or pancreatic neuroendocrine tumors. To date, across all clinical trials, TH-302 has been administered to more than 600 patients with cancer.
Key accomplishments during the quarter were as follows:
Key Milestones
The Company currently anticipates the following key clinical milestones for TH-302:
About TH-302
TH-302 is a hypoxia-targeted drug candidate that was designed to be activated under extreme hypoxic conditions, a hallmark of many cancer indications. Areas of low oxygen levels (hypoxia) within tissues are common in many solid tumors due to insufficient blood vessel growth. Similarly, the bone marrow of patients with hematological malignancies has also been shown, in some cases, to be extremely hypoxic.
TH-302 has been investigated in over 600 patients in Phase 1/2 clinical trials in a broad spectrum of tumor types, both as a monotherapy and in combination with chemotherapy treatments and other targeted cancer drugs. Threshold has several additional ongoing clinical trials, the most advanced of which is a Phase 3 pivotal study evaluating TH-302 in combination with doxorubicin versus doxorubicin alone in patients with soft tissue sarcoma. In
About
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, 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 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 anticipated and potential payments from Merck KGaA. 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
THRESHOLD PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(Unaudited)
Three Months Ended Six Months Ended
June 30, June 30,
------------------ ------------------
2012 2011 2012 2011
-------- -------- -------- --------
Revenue $ 1,797 $ - $ 2,049 $ -
Operating expenses
Research and development 2,897 5,068 8,584 11,165
General and administrative 1,780 1,685 3,488 2,982
-------- -------- -------- --------
Total Operating Expenses 4,677 6,753 12,072 14,147
-------- -------- -------- --------
Loss from operations (2,880) (6,753) (10,023) (14,147)
Interest income (expense), net 29 12 30 15
Other income (expense) (1) 19,852 (1,182) (88,539) (2,121)
-------- -------- -------- --------
Net Income (loss) $ 17,001 $ (7,923) $(98,532) $(16,253)
======== ======== ======== ========
Net income (loss) per common share
Basic $ 0.31 $ (0.16) $ (1.88) $ (0.38)
======== ======== ======== ========
Diluted $ (0.04) $ (0.16) $ (1.88) $ (0.38)
======== ======== ======== ========
Weighted-average shares used in per
common
share calculation:
Basic 54,549 48,805 52,435 42,659
======== ======== ======== ========
Diluted 63,494 48,805 52,435 42,659
======== ======== ======== ========
(1) Noncash income (expense) related to change in the fair value of the
Company's outstanding and exercised warrants, classified as other income
(expense).
THRESHOLD PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
June 30, December 31,
2012 2011
------------ ------------
(unaudited) (1)
Assets
Cash, cash equivalents and marketable
securities $ 66,535 $ 20,290
Collaboration Receivable 16,412 -
Prepaid expenses and other current assets 1,652 254
Property and equipment, net 684 543
Other assets 1,059 1,349
------------ ------------
Total assets $ 86,342 $ 22,436
============ ============
Liabilities and stockholders' equity
Total current liabilities (2) $ 13,421 $ 8,591
Deferred Revenue 48,263 -
Long-term liabilities (3) 76,032 9,362
Stockholders' equity (net capital deficiency) (51,374) 4,483
------------ ------------
Total liabilities and stockholders' equity $ 86,342 $ 22,436
============ ============
(1) Derived from audited financial statements
(2) Amount includes current portion of deferred revenue of $7.2M as of June
30, 2012
(3) Includes as of June 30, 2012 and December 31, 2011 , $75.8 million and
$9.2 million of warrant liability, respectively.
Contact:Joel A. Fernandes Threshold Pharmaceuticals, Inc. Email Contact
Source:
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