Item 8.01 Other Events.

On June 4, 2020 (June 5, 2020 Australian Eastern Standard Time), the Company issued a press release announcing it has postponed the Company’s Special Meeting of Stockholders (the “Special Meeting”) previously scheduled for June 7, 2020, at 6:00 p.m., United States Eastern Daylight Time (“EDT”), which is June 8, 2020, at 8:00 a.m., Australian Eastern Standard Time (“AEST”). As stated in the press release, the Special Meeting has been postponed to June 16, 2020 at 6:00 p.m., EDT, which is June 17, 2020 at 8:00 a.m., AEST, and will continue to be held virtually due to COVID-19 via the online platform at The record date of April 21, 2020 has not changed.

The full text of the press release is attached to this Current Report on Form 8-K as Exhibit 99.1 and is incorporated by reference herein.

Forward-Looking Statements

This 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.

These risks and uncertainties include, but are not limited to, risks associated with 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 continue to operate as a going concern; the Company’s ability to raise sufficient additional funds to continue operations, including the successful closing of an equity or debt financing, as further discussed in the press release, the related bridge loan and a delisting from the Australian Securities Exchange, and 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; the Company’s ability to maintain compliance with its obligations under its existing convertible note and warrant agreements executed with Crystal Amber Fund Limited (“Crystal Amber”), including its obligations to make payments on the Senior Secured Convertible Promissory Note that is due on June 15, 2020 and its ability to restructure the terms of such note with Crystal Amber if the Company is unable to raise sufficient funds to enable it to fully repay such convertible note when due; 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.

Given 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.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

99.1 Press Release of GI Dynamics, Inc. dated June 5, 2020 (Australian Eastern Standard Time)

EX-99.1 2 ea122703ex99-1_gidynamics.htm PRESS RELEASE OF GI DYNAMICS,…
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