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Biostage Reports 2016 Financial Results and Provides Business Update
• 2016 marked by establishing a strong foundation on operational, clinical and regulatory fronts in anticipation of a transformational year ahead
• Growing body of proof-of-concept preclinical data from ongoing studies continue to show clear pattern of regeneration
• Company remains on track to file IND with FDA for esophageal implant program in Q3 2017
• Company remains on track to commence first-in-human study for esophageal implant in Q4 2017
• Management to host business update conference call and webcast today at 9 AM ET
Holliston, MA, March 9, 2017 – Biostage, Inc. (Nasdaq: BSTG), ("Biostage" or the "Company"), a biotechnology company developing bioengineered organ implants to treat cancers and other lifethreatening conditions of the esophagus, bronchus and trachea, today announced financial results for the quarter and year ended December 31, 2016.
The Company also provided an update to its corporate and clinical progress and reviewed its expected near-term milestones. As previously announced, Biostage management will host a business update conference call and live webcast, with accompanying presentation slides, for investors, analysts and other interested parties today at 9 AM ET (details below).
Recent Corporate, Development and Regulatory Highlights
• Closed an $8.0 million public offering;
• Received Orphan Drug Designation (ODD) for Cellspan™ Esophageal Implant from U.S. Food and Drug Administration (FDA);
• Submitted peer-reviewed manuscript for publication with Mayo Clinic on esophageal regeneration data;
• Advanced collaborative preclinical studies with Connecticut Children’s Medical Center for pediatric esophageal atresia;
• Additional preclinical studies with Mayo Clinic on esophagus and bronchus program;
• Built foundation requirements for ongoing Good Laboratory Practice (GLP) preclinical studies of esophageal implant in support of FDA requirements for IND filing; and
• Continued improvements on internal quality, regulatory and clinical infrastructure in preparation of advancement into human clinical studies this year.
The following information was filed by Biostage, Inc. (BSTG) on Friday, March 10, 2017 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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