Item 7.01. | Regulation FD Disclosure. |
Starting on October 9, 2018, representatives of Tocagen Inc. (the “Company” or “Tocagen”) will be presenting to and conducting meetings with investors, analysts and others. During these presentations and meetings, the Company will present the slides attached as Exhibit 99.1 to this Current Report on Form8-K, which updated slides include certain additional information related to the statistical analysis plan for the Phase 3 clinical trial of Toca 5 and are incorporated herein by reference.
The information in this Item 7.01 of this Current Report on Form8-K, including Exhibit 99.1, is being furnished pursuant to Item 7.01 and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and it shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or under the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing to this item of this report.
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By filing this Current Report on Form8-K and furnishing this information, the Company makes no admission as to the materiality of any information in this report. The information contained in this report is intended to be considered in the context of the Company’s filings with the Securities and Exchange Commission (“SEC”) and other public announcements that the Company makes, by press release or otherwise, from time to time. The Company undertakes no duty or obligation to publicly update or revise the information contained in this report, although it may do so from time to time as its management believes is appropriate. Any such updating may be made through the filing of other reports or documents with the SEC, through press releases or through other public disclosure.
Tocagen cautions you that statements included in this report that are not a description of historical facts are forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “indicates,” “will,” “should,” “intends,” “potential,” “suggests,” “assuming,” “designed” and similar expressions are intended to identifyforward-looking statements. These statements are based on Tocagen’s current beliefs and expectations. These forward-looking statements include statements regarding: the success, cost, timing and potential indications of Tocagen’s product development activities and clinical trials, including ongoing clinical trials of Toca 511 & Toca FC; Tocagen’s ability to obtain and maintain regulatory approval of product candidates, including Toca 511 & Toca FC, in any of the indications for which it plans to develop them, and any related restrictions, limitations, and/or warnings in the label of an approved product candidate; Tocagen’s ability to obtain funding for its operations, including funding necessary to complete the clinical trials of any of its product candidates, including Toca 511 & Toca FC; Tocagen’s plans to research, develop and commercialize its product candidates, including Toca 511 & Toca FC; Tocagen’s ability to attract and retain collaborators with development, regulatory and commercialization expertise; and regulatory developments in the United States and foreign countries.
Actual results may differ materially from those expressed or implied in this presentation due to the risk and uncertainties inherent in the Tocagen business, including, without limitation, risks described in Tocagen’s filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Tocagen undertakes no obligation to revise or update this report to reflect events or circumstances after the date hereof. Further information regarding these and other risks is included under the heading “Risk Factors” in Tocagen’s Quarterly Report on Form10-Q filed with the SEC on August 9, 2018 and its other reports, which are available from the SEC’s