Current Report Filing (8-k)
January 13 2020 - 6:51AM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT
REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): January 13, 2020
Translate Bio, Inc.
(Exact name of registrant as specified in its charter)
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Delaware
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001-38550
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61-1807780
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(State or other jurisdiction
of incorporation)
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(Commission
File Number)
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(IRS Employer
Identification No.)
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29 Hartwell Avenue
Lexington, Massachusetts
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02421
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(Address of principal executive offices)
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(Zip Code)
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Registrants telephone number, including area code: (617)
945-7361
Not applicable
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of
the registrant under any of the following provisions (see General Instruction A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17
CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading
Symbol(s)
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Name of exchange
on which registered
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Common Stock, $0.001 par value
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TBIO
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Nasdaq Global Select Market
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of
1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an
emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange
Act. ☒
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 Companys estimated cash, cash equivalents and short-term investments as of December 31, 2019; the
Companys belief that its cash, cash equivalents and short-term investments as of December 31, 2019 will enable it to fund its operating expenses and capital expenditure requirements into the second quarter of 2021; and the Companys
plans to report data in the third quarter of 2020 from the Phase 1/2 clinical trial of MRT5005. The words anticipate, believe, continue, could, estimate, expect,
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 Companys 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 as it relates to ongoing and planned clinical trials; the Companys ability to obtain, maintain and enforce necessary patent and other intellectual property protection; the availability of significant cash required to fund operations;
competitive factors; general economic and market conditions and other important risk factors discussed in the Risk Factors section in the Companys Quarterly Report on Form 10-Q for the
quarterly period ended September 30, 2019 filed with the Securities and Exchange Commission (SEC) on November 6, 2019, and in any other subsequent filings made by the Company with the SEC. Any forward-looking statements contained in
this Current Report on Form 8-K speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statement, whether as a result of new information, future
events or otherwise.
Item 2.02 Results of Operations and Financial Condition.
The information provided in Item 8.01 of this Current Report on Form 8-K regarding the
Companys estimated cash, cash equivalents and short-term investments as of December 31, 2019 and its ability to fund its operating expenses and capital expenditure requirements is incorporated by reference into this Item 2.02.
Item 7.01 Regulation FD Disclosure.
Translate Bio, Inc. (the Company) from time to time presents or distributes to the investment community, at various industry and
other conferences, slide presentations to provide updates and summaries of its business. A copy of the Companys current corporate slide presentation 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 Company undertakes no obligation to update, supplement or amend the materials attached hereto as
Exhibit 99.1.
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.
Item 8.01 Other Events.
On
January 13, 2020, the Company disclosed certain preliminary information related to the Companys estimated cash, cash equivalents and short-term investments as of December 31, 2019 and its ability to fund its operating expenses and
capital expenditure requirements. Although the Company has not yet completed its financial statements for the fourth quarter and fiscal year ended December 31, 2019, it expects to report cash, cash equivalents and short-term investments of
$188.7 million as of December 31, 2019, and the Company believes that its cash, cash equivalents and short-investments as of December 31, 2019 will enable the Company to fund its operating expenses and capital expenditure requirements
into the second quarter of 2021.
The Companys estimates of its cash, cash equivalents and short-term investments as of
December 31, 2019 and its ability to fund its operating expenses and capital expenditure requirements are preliminary and unaudited, represent management estimates as of the date of this Current Report on Form
8-K and are subject to completion of the Companys financial closing procedures. The Companys independent registered public accounting firm has not conducted an audit or review of, and does not
express an opinion or any other form of assurance with respect to, the estimated cash, cash equivalents and short-term investments and its ability to fund its operating expenses and capital expenditure requirements.
On January 13, 2020, the Company also disclosed that it expects to report data in the third quarter of 2020 from the additional 20 mg
single-ascending dose group and the multiple-ascending dose portion of the ongoing Phase 1/2 clinical trial which is evaluating the safety and tolerability of single and multiple ascending doses of MRT5005.
Item 9.01 Financial Statements and Exhibits.
(d)
Exhibits
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned
hereunto duly authorized.
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TRANSLATE BIO, INC.
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Date: January 13, 2020
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By:
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/s/ Paul Burgess
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Paul Burgess
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Chief Operating Officer, Chief Legal Officer and Secretary
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