AND EXCHANGE COMMISSION
to Section 13 OR 15(d) of the Securities Exchange Act of 1934
of Report (Date of earliest event reported): July 16, 2020
name of registrant as specified in its charter)
or other jurisdiction
of principal executive offices and zip code)
telephone number, including area code: (781) 357-3300
name or former address, if changed since last report.)
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:
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)|
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)|
pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))|
pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))|
registered pursuant to Section 12(b) of the Act: None.
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).
growth company ☐
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.
Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements
of Certain Officers.
July 16, 2020, the four current members of the Board of Directors (the “Board”) of GI Dynamics, Inc. (the “Company”)
advised the Company of their intention to resign as members of the Board and corresponding Board committees after the Company
is removed from the Official List of the Australian Securities Exchange. Such resignations are not the result of any dispute or
disagreement with the Company or the Board on any matter relating to the operations, policies or practices of the Company.
to resigning, the members of the Board will appoint at least one new member to serve on the Board. The Company will provide further
disclosure regarding the exact timing of each director’s departure as such information becomes available.
copy of the Company’s press releases, dated July 20, 2020, announcing these changes are filed herewith as Exhibit 99.1 and
is incorporated herein by reference.
Current Report on Form 8-K and the press release attached as Exhibit 99.1 may contain forward-looking statements. These statements
are based on management’s current estimates and expectations of future events as of the date of the Current Report on Form
8-K and the press release, as applicable. Furthermore, the estimates are subject to several risks and uncertainties that could
cause actual results to differ materially and adversely from those indicated in or implied by such forward-looking statements.
risks and uncertainties include, but are not limited to, risks associated with the Company’s ability to negotiate and consummate
a proposed equity financing, the Company’s ability to continue to operate as a going concern; the ability of the Company,
its critical vendors, and key regulatory agencies to resume operational capabilities subsequent to the removal of COVID-19 pandemic
restrictions; the Company’s ability to conduct the planned pivotal trial of EndoBarrier in the United States (“STEP-1”);
the Company’s ability to execute STEP-1 under the FDA’s Investigational Device Exemption; the Company’s ability
to enlist clinical trial sites and enroll patients in accordance with STEP-1; the risk that the FDA stops STEP-1 early as a result
of the occurrence of certain safety events or does not approve an expansion of STEP-1; the Company’s ability to enroll patients
in accordance with I-STEP; the Company’s ability to secure a CE Mark; obtaining and maintaining regulatory approvals required
to market and sell the Company’s products; the possibility that future clinical trials will not be successful or confirm
earlier results; the timing and costs of clinical trials; the timing of regulatory submissions; the timing, receipt and maintenance
of regulatory approvals; the timing and amount of other expenses; the timing and extent of third-party reimbursement; intellectual-property
risk; risks related to excess inventory; risks related to assumptions regarding the size of the available market; the benefits
of the Company’s products; product pricing; timing of product launches; future financial results; and other factors, including
those described in the Company’s filings with the U.S. Securities and Exchange Commission.
these uncertainties, one should not place undue reliance on these forward-looking statements. The Company does not assume any
obligation to publicly update or revise any forward-looking statements, whether as a result of new information or future events
or otherwise, unless it is required to do so by law.
Financial Statements and Exhibits.
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.
||GI DYNAMICS, INC.|
|Dated: July 20, 2020
||Chief Financial Officer|