| Item 7.01 | Regulation FD Disclosure. |
On August 25, 2020, Sanofi Pasteur Inc. (“Sanofi”) will present information at the Third ISV COVID-19 Vaccines Virtual Congress hosted by the International Society of Vaccines (the “Virtual Congress”) regarding, among other things, its collaboration with Translate Bio, Inc. (the “Company”), to develop an mRNA vaccine for SARS-CoV-2 (severe acute respiratory syndrome 2), which causes the coronavirus disease referred to as COVID-19. A copy of the portion of Sanofi’s slide presentation to be presented at the Virtual Congress pertaining to the collaboration with the Company is attached to this Current Report on Form 8-K as Exhibit 99.1 and is incorporated by reference into this Item 7.01. The slides, to the extent applicable to the Company, describe preclinical data of the mRNA vaccine candidate at three dose levels in a non-human primate model, including binding antibody levels, neutralizing antibody titers and helper T-cell response. These data demonstrate that two immunizations of the mRNA vaccine induced high neutralizing titers that are comparable to the upper range of those observed in infected humans. Additionally, the mRNA vaccine induced Th1-biased T-cell responses.
The information in this Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing.
Forward-Looking Statements
This Current Report on Form 8-K, including the document filed as Exhibit 99.1 hereto, contains forward-looking statements about the Company within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, those regarding the expected timing to begin clinical studies of a COVID-19 vaccine candidate under the collaboration between Sanofi and the Company, and expectations regarding manufacturing capacity and manufacturing approaches for such vaccine. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “hope,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from current expectations and beliefs, including, but not limited to: risks and uncertainties related to the development of a COVID-19 vaccine; uncertainties related to general and industry-specific market conditions; the current and potential future impacts of the ongoing COVID-19 pandemic on the Company’s business, financial condition, operations and liquidity; the Company’s ability to advance the
