August 15, 2018

Biostage eyes FDA application in 2019

Photo | Courtesy
Biostage CEO Jim McGorry.

Despite just $5.8 million in cash to its name, Holliston organ bioengineering firm Biostage is eyeing a 2019 U.S. Food and Drug Administration application for its esophagus-regenerating device.

With no product on the market, the company reported no revenue in the second quarter, but was able to significantly reduce its expense. As a result, the company's net loss of $2.1 million was a decrease of 71 percent compared to the same period last year.

For the year, the company is losing $3.6 million, a 105-percent decrease from the first six months of 2017.

The company made progress in raising capital and launching studies in preparation for a regulatory filing.

Preclinical studies for pediatric use was launched in conjunction with Connecticut Children's Medical Center after a study in large animals showed the company's Cellframe technology can help regenerate a patient's' throat organs.

The company closed on $4.5 million from two private placements from Chinese investors and added two Chinese executives to its leadership to help Biostage break into the Chinese market, where rates of esophageal cancer are high.

Wei Zhang, a Chinese health policy expert, was added to the company's board of directors, and Hong Yu was named president of the company.

CEO Jim McGorry in a statement highlighted the progress made during the quarter, but added the company still has a long way to go.

"There's still a lot of ground to cover to reach our goal of filing an (investigational new drug application) in 2019, but based on our second quarter activities and our current pace of progress I feel steadfast in my confidence of our company's trajectory," McGorry said.

The company still looks to rebound and eyes profitability after being delisted from Nasdaq last year, seeing a private investment fall through and having to lay off most of its workforce.

After several private investments largely from Chinese investors since then, the company was able to ramp up its workforce once more.

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