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Business
3 Months Ended
Mar. 31, 2012
Business

1. Business

 

Overview

 

ZIOPHARM Oncology, Inc. (“ZIOPHARM” or the “Company”) is a biopharmaceutical company that seeks to acquire, develop and commercialize, on its own or with other commercial partners, products for the treatment of important unmet medical needs in cancer.

 

The Company’s operations to date have consisted primarily of raising capital and conducting research and development.  Accordingly, the Company is considered to be in the development stage at March 31, 2012. The Company's fiscal year ends on December 31.

 

The Company has operated at a loss since its inception in 2003 and has minimal revenues. The Company anticipates that losses will continue for the foreseeable future. At March 31, 2012, the Company’s accumulated deficit was approximately $212.1 million. The Company currently believes that it has sufficient capital to fund development and commercialization activities into the second half of 2013. The Company’s ability to continue operations after its current cash resources are exhausted depends on its ability to obtain additional financing or to achieve profitable operations, as to which no assurances can be given. Cash requirements may vary materially from those now planned because of changes in the Company’s focus and direction of its research and development programs, competitive and technical advances, patent developments, regulatory changes or other developments. Additional financing will be required to continue operations after the Company exhausts its current cash resources and to continue its long-term plans for clinical trials and new product development. There can be no assurance that any such financing can be realized by the Company, or if realized, what the terms thereof may be, or that any amount that the Company is able to raise will be adequate to support the Company’s working capital requirements until it achieves profitable operations.

 

Basis of Presentation

 

The accompanying unaudited interim financial statements have been prepared in accordance with the instructions to Form 10-Q pursuant to the rules and regulations of the Securities and Exchange Commission. Certain information and note disclosures required by generally accepted accounting principles in the United States have been condensed or omitted pursuant to such rules and regulations.

 

It is management’s opinion that the accompanying unaudited interim financial statements reflect all adjustments (which are normal and recurring) that are necessary for a fair statement of the results for the interim periods. The unaudited interim financial statements should be read in conjunction with the audited financial statements and the notes thereto for the year ended December 31, 2011 included in the Company’s Form 10-K for such fiscal year.

 

The year-end balance sheet data was derived from the audited financial statements but does not include all disclosures required by generally accepted accounting principles in the United States.

 

The results disclosed in the Statements of Operations for the three months ended March 31, 2012 are not necessarily indicative of the results to be expected for the full fiscal year.

 

Use of Estimates

 

The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Although the Company regularly assesses these estimates, actual results could differ from those estimates. Changes in estimates are recorded in the period in which they become known.

 

 

 

The Company’s most significant estimates and judgments used in the preparation of our financial statements are:

 

· Clinical trial expenses;

 

· Fair value measurements for stock based compensation and warrants; and

 

· Income taxes.

 

Subsequent Events

 

The Company evaluated all events and transactions that occurred after the balance sheet date through the date of this filing.  Except as disclosed below, the Company did not have any other material subsequent events that impacted its financial statements or disclosures.

 

Subsequent to March 31, 2012, the Company signed a lease agreement for additional space in the Boston office. In accordance with this lease, the Company will incur an additional obligation of approximately $493 thousand through August 2016. The Company also signed a lease agreement for additional space in the New York office. In accordance with this lease, the Company will incur an additional obligation of approximately $383 thousand through October 2018. The Company also signed a clinical research organization agreement with Pharmaceutical Research Associates, Inc. to conduct a Phase 3 trial in small cell lung cancer. The agreement includes future milestone payments of $18.1 million, the timing of which are dependent upon factors that are beyond the Company’s control, including the ability to recruit patients, the outcome of future clinical trials and any requirements imposed on clinical trials by regulatory agencies.