Current Report Filing (8-k)
April 29 2021 - 4:43PM
Edgar (US Regulatory)
0001035354
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2021-04-29
2021-04-29
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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): April 29, 2021
Eloxx Pharmaceuticals, Inc.
(Exact name of registrant as specified
in its charter)
Delaware
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001-31326
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84-1368850
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(State or other jurisdiction
of incorporation)
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(Commission
File Number)
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(I.R.S. Employer
Identification No.)
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950 Winter Street
Waltham, MA
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02451
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(Address of principal executive offices)
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(Zip Code)
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(Registrant’s telephone number,
including area code): (781) 577-5300
(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:
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¨
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Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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¨
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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¨
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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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¨
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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:
Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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Common Stock, $0.01 par value per share
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ELOX
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The Nasdaq Global 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. ¨
Cautionary Statement Regarding Forward-Looking Statements
This
Current Report on Form 8-K contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking
statements can be identified by the words "expects," "anticipates," "believes," "intends," "estimates,"
"plans," "will," "outlook" and similar expressions. Forward-looking statements are based on management's
current plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake no obligation to update
any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements
involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results
or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors,
including: the Company’s ability to execute and effect its restructuring program; the development of the Company’s read-through
technology; the approval of the Company’s patent applications; the Company’s ability to successfully defend its intellectual
property or obtain necessary licenses at a cost acceptable to the Company, if at all; the successful implementation of the Company’s
research and development programs and collaborations; the Company’s ability to obtain applicable regulatory approvals for its current
and future product candidates; the acceptance by the market of the Company’s products should they receive regulatory approval; the
timing and success of the Company’s preliminary studies, preclinical research, clinical trials, and related regulatory filings;
the ability of the Company to consummate additional financings as needed; the impact of global health concerns, such as the COVID-19
global pandemic, on our ability to continue our clinical and preclinical programs and otherwise operate our business effectively; the
successful integration of acquired companies, such as Zikani Therapeutics; as well as those discussed in more detail in our Annual Report
on Form 10-K and our other reports filed with the Securities and Exchange Commission.
On April
29, 2021, Eloxx Pharmaceuticals, Inc. (the “Company”) issued a press release indicating that the Company added a new
study arm in its Phase 2 clinical trial program for ELX-02 in cystic fibrosis. The Phase 2 clinical program now includes a fifth treatment
arm to evaluate safety of ELX-02 in combination with Kalydeco (ivacaftor), an FDA-approved CFTR (CF transmembrane conductance regulator)
potentiator for the treatment of cystic fibrosis in patients who have at least one mutation in their CF gene amenable to ivacaftor. A
copy of the Company’s press release is being furnished as Exhibit 99.1 to this Form 8-K and is incorporated herein by reference.
Item 9.01.
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Financial Statements and Exhibits.
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(d) Exhibits.
SIGNATURE
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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ELOXX PHARMACEUTICALS, INC.
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Date: April 29, 2021
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By:
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/s/ Neil S. Belloff
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Name:
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Neil S. Belloff
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Title:
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Chief Operating Officer, General Counsel
and Corporate Secretary
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