Item 8.01 Other Events.
On March 26, 2020, Translate Bio, Inc. (the "Company") issued a press release to
announce that due to the COVID-19 pandemic response, the Company anticipated
interruptions in enrollment, dosing and follow-up in the ongoing Phase 1/2
clinical trial for MRT5005 in patients with cystic fibrosis, and that the
Company would provide an update when it had additional insight into enrollment
and dosing metrics given the uncertain and dynamic nature of the situation.
Enrollment and dosing in the clinical trial have been paused as a consequence of
the response to the COVID-19 pandemic. As previously disclosed, the Company
plans to provide updated timing on the expected interim data readout of the
additional single-ascending dose ("SAD") group and the multiple-ascending dose
("MAD") portion of the clinical trial at a later date.
Cautionary Note Regarding Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements 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
Company's expectations on when it will report interim data from the additional
SAD group and the MAD portion of the Phase 1/2 clinical trial of MRT5005; and
the Company's plans, strategies and prospects for its business, including its
lead development programs. The words "anticipate," "believe," "continue,"
"could," "estimate," "expect," "forward," "intend," "may," "plan," "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: the Company's ability to resume
enrollment and dosing in its Phase 1/2 clinical trial of MRT5005 and timing
thereof; the Company's ability to advance the development of its platform and
programs under the timelines it projects, demonstrate the requisite safety and
efficacy of its product candidates and replicate in clinical trials any positive
findings from preclinical studies; the content and timing of decisions made by
the U.S. Food and Drug Administration, other regulatory authorities and
investigational review boards at clinical trial sites, including decisions as it
relates to ongoing and planned clinical trials; the Company's ability to obtain,
maintain and enforce necessary patent and other intellectual property
protection; the availability of significant cash required to fund operations;
competitive factors; the COVID-19 pandemic; general economic and market
conditions and other important risk factors set forth under the caption "Risk
Factors" in the Company's Annual Report on Form 10-K for the fiscal year ended
December 31, 2019 filed with the Securities and Exchange Commission on March 12,
2020 and in any other subsequent filings made by the Company. Any
forward-looking statements contained in this Current Report on Form 8-K speak
only as of the date hereof, and the Company specifically disclaims any
obligation to update any forward-looking statement, whether as a result of new
information, future events or otherwise.
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