Small-Cap Investor Forum

[MissionIR]

Biostage (BSTG) CEO Updates Shareholders

In a letter from Jim McGorry, CEO of Biostage, Inc. (NASDAQ: BSTG), shareholders were updated on the company’s valuation and the outlook for the second half of 2016. Biostage is a Massachusetts-based developer of bioengineered organ implants for treating life-threatening diseases of the esophagus, bronchus, and trachea, including cancer.

McGorry explained that Biostage has made “tremendous progress” in developing the company’s breakthrough Cellframe™ technology for creating Cellspan™ organ implants using a patient’s own stem cells and a proprietary biocompatible scaffold. As a result, the company is now able to transition, over the remainder of 2016, toward the start of human clinical trials, the first step of which is the filing of an investigational new drug application (IND) with the U.S. Food and Drug Administration. McGorry explained how the company took the appropriate time to ensure its product’s safety and efficacy, while remaining on schedule for the planned filing by the end of 2016.

Biostage announced in May successful results from their large-animal studies of the Cellspan Esophageal Implant, conducted in conjunction with the Mayo Clinic. McGorry explained how the data obtained will form the basis for the company’s FDA application, seeking orphan designation for the product, and how Biostage is currently working on getting the results published in a peer-reviewed scientific journal, which will “greatly support and validate” the company’s progress. He added that anticipated progress over the second half of the year is expected to present “potential value inflection moments for shareholders.”

McGorry explained that Biostage’s recent $5 million at-the-market offering was an important step in solidifying the company’s cash position and addressing any market concerns in this area. He concluded, “We now have the capital to get us through a number of milestones in 2016 including the filing of an IND, and we expect to move into human clinical trials in 2017,” adding, “we believe the company’s momentum, liquidity and value should substantially increase,” and that “by this time next year our esophageal implant will be in a human clinical trial”. Biostage plans to follow this first esophageal product candidate with additional products to address life-threatening conditions of the bronchus and trachea.

For more on Biostage, visit www.biostage.com