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
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