We are filing certain information for the purpose of updating the description of our business contained in our other filings with the Securities and Exchange Commission. A copy of this additional disclosure is attached as Exhibit 99.1 to this report and incorporated herein by reference.
Item 9.01 | Financial Statements and Exhibits. |
(d)Exhibits.
Forward-Looking Statements
This report, including Exhibit 99.1, contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements relate to future events or to our future financial performance and involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. Forward-looking statements include, but are not limited to statements about:
| • | | our plans to research, develop and commercialize our drug candidates, including the timing of our ongoing clinical trials of repotrectinib,TPX-0022 andTPX-0046 and ourIND-enabling studies and IND submission forTPX-0131; |
| • | | the success, cost and timing of our product development activities and clinical trials, including whether the Phase 2 portion ofTRIDENT-1 will support the approval of repotrectinib in ROS1+ advancednon-small-cell lung cancer (NSCLC) and NTRK+ advanced solid tumors; |
| • | | the impact of theCOVID-19 pandemic on our business, operations and financial condition; |
| • | | our ability to obtain and maintain regulatory approval for repotrectinib or any of our other current or future drug candidates, and any related restrictions, limitations, and/or warnings in the label of an approved drug candidate; |
| • | | our expectations regarding the size of target patient populations for our drug candidates, if approved for commercial use, and any additional drug candidates we may develop; |
| • | | our ability to obtain funding for our operations; |
| • | | the commercialization of our drug candidates, if approved; |
| • | | our ability to attract collaborators with development, regulatory and commercialization expertise; |
| • | | our expectations regarding our ability to obtain, maintain, enforce and defend our intellectual property protection for our drug candidates; |
| • | | future agreements with third parties in connection with the commercialization of repotrectinib, or any of our other current or future drug candidates; |
| • | | the size and growth potential of the markets for our drug candidates, and our ability to serve those markets; |
| • | | the rate and degree of market acceptance of our drug candidates, as well as third-party payor coverage and reimbursement for our drug candidates; |
| • | | regulatory and legal developments in the United States and foreign countries; |
| • | | the performance of our third-party suppliers and manufacturers; |
| • | | the success of competing therapies that are or may become available; |
| • | | our ability to attract and retain key scientific or management personnel; and |
| • | | the accuracy of our estimates regarding expenses, capital requirements and needs for additional financing. |
In some cases, you can identify these statements by terms such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” or the negative of those terms, and similar expressions that convey uncertainty of future events or outcomes. These forward-looking statements reflect our management’s beliefs and views with respect to future events and are based