EXHIBIT 99.1

 

 

 

Biostage Reports 2019 Financial Results

 

·FDA Removes clinical hold on Cellspan™ Esophageal Implant (CEI) study

 

Holliston, MA – March 27, 2020 –

Biostage, Inc. (OTCQB: BSTG) (“Biostage” or the “Company”), a biotechnology company developing next-generation esophageal implants, today announced its financial results for the three and twelve months ended December 31, 2019.

 

Conference Call

 

Due to the impact of COVID-19, the Company will not hold a conference call at this time. The Company anticipates that it will hold a future conference call to discuss its clinical and business plans based on the U.S. Food and Drug Administration (FDA) removing the clinical hold on its Cellspan™ Esophageal Implant (CEI) study.

 

Operating Highlights

 

On October 30, 2019 Biostage announced the submission of its Investigational New Drug (IND) application to the FDA for the Company’s lead product candidate, the CEI, to treat patients with end-stage esophageal disease, absent of cancer, in adults that require a segmental surgical resection to repair the diseased tissue.

 

On March 24, 2020 the Company received a notification from the FDA which notified the Company that the clinical hold on its CEI study was removed and the Company may proceed with its study for its CEI. This FDA approval enables us to start our transition to a clinical-stage biotechnology company, and start clinical planning, including engaging with a clinical research organization and site readiness in advance of starting the clinical trial for our CEI product candidate.

 

Summary of Financial Results

 

For the three months ended December 31, 2019, the Company reported a net loss of $1.6 million, ($0.21 per share), compared to a net loss of $1.8 million, ($0.32 per share), for the three months ended December 31, 2018. The $0.2 million year-over-year decrease in net loss was due primarily to a $0.3 million decrease in research and development costs and a $0.1 decrease in general and administrative expenses, offset in part by a $0.2 million decrease in grant income for qualified expenditures from our SBIR grant.

 

For the year ended December 31, 2019, the Company reported a net loss of $8.3 million, ($1.21 per share), compared to a net loss of $7.5 million, ($1.69 per share), for the year ended December 31, 2018. The $0.8 million year-over-year increase in net loss was due primarily to a $0.9 million increase in research and development costs and a $0.1 million increase in general and administrative expenses, offset in part by a $0.1 million net decrease in expense from change in the fair value of warrants. In addition, the Company recognized grant income for qualified expenditures from the SBIR grant of $473,000 for the year ended December 31, 2019 compared to $401,000 for the year ended December 31, 2018.

 


The following information was filed by Biostage, Inc. (BSTG) on Friday, March 27, 2020 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-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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