Biostage Inc (NASDAQ:BSTG), or the Company, issued a press release announcing a regulatory update following its planned pre-Investigational New Drug, or IND, meeting with the U.S. Food and Drug Administration, or FDA, for the advancement of its lead product candidate, Cellspan™ Esophageal Implant, into human clinical studies. The regulatory update included that the Company now expects to file its IND application with the FDA by the end of the second quarter of 2017 based on its election to extend the duration of its ongoing GLP animal studies following the feedback provided by the FDA. The Company’s meeting with the FDA and related feedback are discussed in more detail in the press release.

The press release is furnished as Exhibit 99.1 and investors should read the press release in its entirety, including the cautionary statement regarding forward looking statements therein. The forward looking statement above filed in this Form 8-k, as well as those furnished in the Exhibit 99.1 as noted below, involve known and unknown risks, uncertainties and other factors that may cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.