Exhibit 99.1

 

Biostage Reports Second Quarter 2019 Financial Results

 

-        Preparing to file first IND in September 2019

 

 

Holliston, MA – August 13, 2019 –

Biostage, Inc. (OTCQB: BSTG) (“Biostage” or the “Company”), a biotechnology company developing bioengineered organ implants to treat life-threatening conditions of the esophagus, bronchus and trachea, today announced its financial results for the three and six months ended June 30, 2019.

 

Similar to its first quarter, Biostage focused its main efforts in the second quarter on finalizing the groundwork for its planned September 2019 Investigational New Drug (IND) filing with the U.S. Food and Drug Administration (FDA). This milestone, subject to FDA approval, will mark Biostage’s transition to a clinical stage company and allow it to begin clinical trials of its groundbreaking Cellspan™ Esophageal Implant (CEI) product candidate.

 

Biostage has been working to meticulously prepare for these clinical trials during 2019, striving to get all the moving parts in place and up to the FDA’s rigorous quality and manufacturing standards.

 

Biostage CEO Jim McGorry commented that he is pleased with the Biostage team’s steady pace in fulfilling the FDA’s many requirements.

 

“We had a low-profile second quarter this past spring, but we’ve made great headway towards our imminent goal to file our first IND with the FDA in September. We believe our Cellspan implant has the potential to change lives, so after all the time and effort invested in this project, it’s a wonderful thing to see our clinical stage coming over the horizon. We still have a lot of due diligence and final details to work through, but the Biostage team along with our regulatory partners and consultants have been focused on reaching our goal.”

 

McGorry also explained that Biostage continues to bring in private placement funding at a premium to its share price in order to fund the Company.

 


The following information was filed by Biostage, Inc. (BSTG) on Tuesday, August 13, 2019 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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