HART NYLI Healthy Hearts ETF

Litigation Update

On January 25, 2022, Biostage, Inc. (the “Company”, “we,” “our,” and “us”) issued a press release announcing that the Court hearing the Company’s dispute with its product liability insurance carrier as to the defense of a wrongful death complaint that was filed against the Company and other defendants in 2017. As further described in the release, the Court issued a Preliminary Injunction Order requiring such carrier to continue paying for the defense of the underlying litigation. Although the coverage dispute remains pending between the parties and there can be no assurance that we will ultimately prevail in such coverage litigation, the Court held that the insurance carrier will mostly likely lose its claim seeking to terminate the payment of the defense, and therefore, it must continue to pay the defense until the coverage dispute is resolved. The Court also awarded the Company its attorneys’ fees and costs arising from the carrier’s breach of the duty to defend. The Company will continue to vigorously defend against carrier’s denial of coverage and related matters, as well as continue to vigorously defend against the claims in the underlying case.

The full text of the press release is attached as Exhibit 99.1 hereto and incorporated by reference into this Item 8.01.

Webinar

On January 25, 2022, the Company also issued a press release announcing that it will be hosting two webinars to allow investors to meet its new Interim CEO, David Green. During the webinars Mr. Green will review the Company’s plans for its approved clinical trial, raising capital and uplisting to NASDAQ.

The full text of the press release, including a link to register for the webinars, is attached as Exhibit 99.2 hereto and incorporated by reference into this Item 8.01.

Forward-Looking Statements 

This Current Report on Form 8-k includes statements that are "forward-looking" and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These "forward-looking" statements include, but are not limited to, statements relating to the litigation matters described above, our defense of such matters and the impact of such matters, including on our financial condition and operations. These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this Form 8-k, including, among other things, factors described under the heading "Item 1A. Risk Factors" in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2020 or described in the Company's other public filings. The forward-looking statements in this Form 8-k speak only as of the date of this Form 8-k. The Company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions or circumstances on which any such statement is based.