publication in a scientific journal and public announcement. This series of processes is under way. It is anticipated that public announcement will follow these processes.
We are continuing to negotiate and enter into agreements with warrant and option holders to extend earlier suspensions, enter into additional new suspensions, and/or determine compensation for suspensions, to assist us in maintaining reasonable capacity for additional financings if needed prior to the next shareholders’ meeting. Going forward, we may enter into further agreements, as appropriate, at least until the next shareholders’ meeting, with our investors and/or officers and directors.
Critical Accounting Policies and Estimates
Our discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of these financial statements requires us to make estimates and judgments that affect our reported amounts of assets, liabilities, revenues and expenses.
On an ongoing basis, we evaluate our estimates and judgments, including those related to accrued expenses and stock-based compensation. We based our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the reported amounts of revenues and expenses that are not readily apparent from other sources. Actual results may differ from these estimates.
Our critical accounting policies and significant estimates are detailed in our Annual Report on Form 10-K for the year ended December 31, 2019 and Note 12 Leases to the condensed consolidated financial statements in this accompanying Form 10-Q. Other than the changes related to the accounting for goodwill and intangible assets, our critical accounting policies and significant estimates have not changed substantially from those previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2019. Our critical accounting policy for goodwill and intangible asset is detailed in Note 3.
Revision of Previously Issued Unaudited Financial Statements
We have revised certain previously reported non-material financial information for the three and nine months ended September 30, 2019 in this Item 2, Management’s Discussion and Analysis of Financial Condition and Results of Operations, including but not limited to information within the Results of Operations section.
See Note 13, Revision to Prior Period Financial Statements, in Item 1, Financial Statements, for additional information related to the revision, including descriptions of the misstatements and the non-material impact on our unaudited condensed consolidated financial statements.
Results of Operations
Operating costs:
Operating costs and expenses consist primarily of research and development expenses, including clinical trial expenses, which increase when we are actively participating in clinical trials and especially when we are completing a large international trial, and undertaking substantial one-time expenses such as for final site visits, query resolutions, statistical work for the Statistical Analysis Plan, preparations for data analyses and other activities related to completion and assessment of the trial. The operating costs also include administrative expenses associated with trials, and increase as such operating activities grow.
In addition to clinical trial related costs, our operating costs may include ongoing work relating to our DCVax products, including R&D, product characterization, and related matters. Going forward, we are also incurring large amounts of costs to carry out and complete statistical analyses, process validation work, final data collection and validation, and other work associated with the processes for locking, unblinding and analyzing the trial results. We are also incurring substantial expenses to develop our Sawston, U.K. facility, prepare for regulatory inspection and certification of the facility and prepare for manufacturing validation and scale-up.