REDWOOD CITY, Calif., Nov. 5, 2009 (GLOBE NEWSWIRE) -- Threshold Pharmaceuticals, Inc. (Nasdaq:THLD) today reported financial results for the third quarter ended September 30, 2009.
The net loss for the third quarter of 2009 was $6.2 million compared to $4.6 million for the third quarter of 2008.
Research and development expenses were $4.0 million for the third quarter of 2009 versus $3.7 million for the third quarter of 2008. The increase in research and development expenses primarily reflects an increase in clinical trial expenses related to TH-302, the Company's hypoxia activated prodrug (HAP) in clinical trials for the treatment of solid tumors. General and administrative expenses were $1.2 million for the third quarter of 2009 versus $1.3 million for the third quarter of 2008. This decrease was primarily due to lower consulting expenses and employee-related and facilities expenses. Threshold recognized no revenue in the quarter ended September 30, 2009, compared to $0.4 million for the quarter ended September 30, 2008, related to amortization of an up-front payment from a pre-existing development agreement with MediBIC Co., Ltd. Revenue was fully recognized under this agreement as of the end of the fourth quarter of 2008. Total non-cash stock compensation expense for the Company was $0.5 million for the third quarter of 2009 versus $0.7 million for the third quarter of 2008. The decrease in stock-based compensation expense is due to the amortization of fewer options with lower valuations. Interest and other expense for the third quarter of 2009 was $1.0 million versus $13,000 for the third quarter of 2008. This increase was due to a $1.0 million non-cash charge related to the revaluation of the Company's 3.6 million outstanding common stock warrants as a result of its adoption of new guidance now codified under ASC Topic 815, "Derivatives and Hedging" in the first quarter of 2009.
For the nine months ended September 30, 2009, the Company's net loss was $18.9 million, compared to $13.5 million in 2008. Research and development expenses were $11.7 million in the 2009 period compared to $9.9 million in 2008, and increased primarily as a result of clinical trial expenses related to TH-302. General and administrative expenses decreased to $4.1 million in the first nine months of 2009 from $5.1 million in 2008, primarily due to lower employee-related and facilities expenses and, to a lesser extent, consulting expenses. Threshold recognized no revenue for the nine months ended September 30, 2009, compared to $1.1 million for the nine months ended September 30, 2008, related to the pre-existing MediBIC agreement. As previously mentioned, revenue was fully recognized under this agreement as of the end of the fourth quarter of 2008. Total non-cash stock compensation expense for the Company was $1.6 million for the first nine months of 2009 versus $2.6 million for the first nine months of 2008. This decrease was primarily due to the amortization of fewer options with lower valuations. Interest and other expense for the nine months ended September 30, 2009 was $3.2 million versus $0.1 million for the nine months ended September 30, 2008. This increase was due to a $3.0 million non-cash charge related to the revaluation of the Company's 3.6 million outstanding common stock warrants as a result of its adoption of new guidance now codified under ASC Topic 815.
For the nine months ended September 30, 2009, the Company's cash requirements were $13.8 million. As of September 30, 2009, Threshold had $8.5 million in cash, cash equivalents and marketable securities. On October 6, 2009, the Company announced that a private placement of Threshold common stock and warrants had been completed. Aggregate gross proceeds from the financing were approximately $35 million and net proceeds are expected to be approximately $33.1 million. The Company currently expects existing cash, cash equivalents and marketable securities, including net proceeds from the recently completed financing, to last through the second quarter of 2011.
Clinical Development Update
The Company recently presented clinical trial results at two medical conferences: The 15th Congress of the European CanCer Organisation (ECCO) and 34th Congress of the European Society for Medical Oncology (ESMO) Conference and The Perspectives in Melanoma XIII Conference. In the ECCO/ESMO presentation, 45 patients in the dose-escalation phase had been assessed for response. Of the 45 patients assessed, 12 patients (27%) had a RECIST (Response Evaluation Criteria In Solid Tumors) criteria partial response, 22 patients (49%) achieved stable disease and 11 patients (24%) had progressive disease. The partial responses included both confirmed and unconfirmed partial responses. In general, hematologic toxicity was higher than might be expected if chemotherapy was administered by itself, but was generally well tolerated. Some of the dose limiting toxicities reported with each of the combination chemotherapies were hematologic. Skin and mucosal toxicities were TH-302 dose dependent with a trend for increased frequency and greater severity at higher doses. The addition of TH-302 to standard chemotherapies did not appear to enhance toxicities in other body systems.
In the presentation at the Melanoma Conference, 8 of the 9 metastatic melanoma patients receiving TH-302 alone were assessed for response. Six of 8 (75%) evaluable melanoma patients had stable disease or better, including 3 (38%) patients with a partial response (one confirmed, one un-confirmed who discontinued treatment after their first tumor assessment due to seizures related to brain metastases, one on study yet to receive a second tumor assessment) as measured by RECIST. Four of the 8 patients continued to receive TH-302 after receiving TH-302 for 2.6 to 6.2 months. TH-302 was well tolerated and there were no new unexpected serious adverse events. Hematologic toxicity was not dose-limiting. Skin and mucosal toxicities were common, but were generally grade 1 or grade 2. Additional patients are being enrolled to better define the extent of the tumor response activity.
The Company expects to complete enrollment in the combination therapy trials around the end of 2009. The Company also expects to present top-line results from the monotherapy and combination therapy clinical trials in the first quarter of 2010. Depending on the results from the ongoing clinical trials, the Company expects to initiate at least one controlled trial with TH-302 in the first half of 2010.
The Company also announced the successful resolution of an outstanding class action lawsuit that was originally filed against the Company in 2007. The lawsuit was related to clinical trials of Lonidamine that were completed in 2006. On October 30, 2009, the parties entered into a stipulation agreement to resolve the lawsuit. The settlement provides for payment to the plaintiff class solely by the Company's insurers. The settlement is subject to preliminary and, following notice to class members, final approval by the Court. There can be no assurance at this time that the settlement process will result in final approval. The Company has denied all allegations of wrongdoing.
Last month, the Company also announced the execution of a licensing agreement granting Eleison Pharmaceuticals exclusive worldwide rights to glufosfamide, the Company's drug candidate that was evaluated in multiple cancer clinical trials. Eleison will be responsible for the development, manufacturing and marketing of glufosfamide, with Eleison and Threshold equally sharing any financial upside as a result of successful development and commercial efforts that may take place.
About Threshold Pharmaceuticals, Inc.
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. This approach offers broad potential to treat most solid tumors. 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 the 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 5, 2009 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,
------------------ ------------------
2009 2008 2009 2008
-------- -------- -------- --------
Revenue $ -- $ 362 $ -- $ 1,080
Operating expenses
Research and development 3,973 3,672 11,719 9,873
General and administrative 1,235 1,344 4,115 5,067
-------- -------- -------- --------
Total Operating Expenses 5,208 5,016 15,834 14,940
-------- -------- -------- --------
Loss from operations (5,208) (4,654) (15,834) (13,860)
Interest and other income 12 109 73 414
Interest expense (957) (13) (3,154) (52)
-------- -------- -------- --------
Net Loss $ (6,153) $ (4,558) $(18,915) $(13,498)
======== ======== ======== ========
Net loss per common share,
basic & diluted $ (0.40) $ (0.49) $ (1.24) $ (1.86)
======== ======== ======== ========
Weighted average number of
shares used in per common
share calculations: basic
and diluted 15,227 9,392 15,223 7,276
======== ======== ======== ========
THRESHOLD PHARMACEUTICALS, INC.
(A Development Stage Enterprise)
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
Sept. 30, Dec. 31,
2009 2008
-------- --------
(unaudited) (1)
Assets
Cash, cash equivalents and
marketable securities $ 8,489 $ 22,337
Prepaid expenses and other current assets (2) 11,135 518
Property and equipment, net 647 1,168
Other assets 609 508
-------- --------
Total assets $ 20,880 $ 24,531
======== ========
Liabilities and stockholders' equity
Total current liabilities (2) $ 13,230 $ 2,563
Long-term liabilities (3) 4,081 554
Stockholders' equity 3,569 21,414
-------- --------
Total liabilities and stockholders' equity $ 20,880 $ 24,531
======== ========
(1) Derived from audited financial statements
(2) Includes as of September 30, 2009, $10 million of settlement
costs to be paid to the plaintiffs of an outstanding class action
lawsuit by the Company's insurers.
(3) Includes as of September 30, 2009, $3.6 million of warrant
liability as a result of the Company's adoption on January 1,
2009 of new guidance now codified under ASC Topic 815,
"Derivatives and Hedging"