HOLLISTON, Mass., May 22, 2017 /PRNewswire/ -- Biostage Inc.,
(Nasdaq: BSTG), ("Biostage" or the "Company"), a biotechnology
company developing bioengineered organ implants to treat cancers
and other life-threatening conditions of the esophagus, bronchus
and trachea, announced today that, as anticipated, on May 18, 2017, the Company received a letter from
the Listing Qualifications Staff (the "Staff") of The NASDAQ Stock
Market LLC ("Nasdaq") indicating that the Company's failure to
regain compliance with the minimum $1.00 bid price requirement by May 17, 2017, and its non-compliance with the
$2.5 million stockholders' equity
requirement as of the quarter ended March
31, 2017, could serve as a basis for delisting the Company's
common stock from The Nasdaq Capital Market unless the Company
timely requests a hearing before the Nasdaq Hearings Panel (the
"Panel").
The Company plans to timely request a hearing before the Panel,
which request will stay any delisting action by the Staff at least
pending the issuance of the Panel's decision following the hearing
and the expiration of any extension period that may be granted by
the Panel. At the hearing, Biostage will present its plan to
evidence compliance with the bid price and stockholders' equity
requirements and request an extension of time within which to do
so. The Panel has the discretion to grant the Company an extension
through no later than November 14,
2017. The Company's common stock will continue to trade on
Nasdaq under the symbol "BSTG" at least pending the ultimate
conclusion of the hearing process. Biostage intends to provide a
further update when additional relevant information becomes
available.
About Biostage
Biostage is a biotechnology company developing bioengineered
organ implants based on the Company's new Cellframe™
technology which combines a proprietary biocompatible scaffold with
a patient's own stem cells to create Cellspan organ implants.
Cellspan implants are being developed to treat life-threatening
conditions of the esophagus, bronchus or trachea with the hope of
dramatically improving the treatment paradigm for patients. Based
on its preclinical data, Biostage has selected life-threatening
conditions of the esophagus as the initial clinical application of
its technology.
Cellspan implants are currently being advanced and tested in
collaborative preclinical studies. Preclinical, large-animal safety
studies, conducted in compliance with the FDA Good Laboratory
Practice ("GLP") regulations, for the Company's Cellspan Esophageal
Implant product candidate are ongoing, in support of Biostage's
goal of filing an Investigational New Drug application ("IND") with
the U.S. FDA in the third quarter of 2017. Upon IND approval, the
Company plans to initiate its first-in-human clinical trials for
its esophageal implant product candidate by the end of 2017.
For more information, please visit www.biostage.com and connect
with the Company on Twitter and LinkedIn.
Forward-Looking Statements:
Some of the statements in this press release are
"forward-looking" and are made pursuant to the safe harbor
provision of the Private Securities Litigation Reform Act of 1995.
Actual results and the timing of events could differ materially
from those anticipated in such forward-looking statements as a
result of risks and uncertainties including the timing and outcome
of any NASDAQ decision with respect to our requests; our inability
to take other actions to regain compliance with the NASDAQ minimum
closing bid price requirement and stockholders' equity requirement;
our inability to maintain compliance with other NASDAQ Capital
Market listing requirements; our inability to comply with the
covenants in our credit facilities or to obtain additional debt or
equity financing. Additional "forward-looking" statements in this
press release include, but are not limited to, statements relating
to the development expectations and regulatory approval of any of
our products, including those utilizing our Cellframe technology,
by the U.S. Food and Drug Administration, the European Medicines
Agency or otherwise, which expectations or approvals may not be
achieved or obtained on a timely basis or at all; or success with
respect to any collaborations, clinical trials and other
development and commercialization efforts of our products,
including those utilizing our Cellframe technology, which such
success may not be achieved or obtained on a timely basis or at
all. These statements involve risks and uncertainties that may
cause results to differ materially from the statements set forth in
this press release, including, among other things, our ability to
obtain and maintain regulatory approval for our products; plus
other factors described under the heading "Item 1A. Risk Factors"
in our Annual Report on Form 10-K for the fiscal year ended
December 31, 2016 or described in our
other public filings. Our results may also be affected by factors
of which we are not currently aware. The forward-looking statements
in this press release speak only as of the date of this press
release. Biostage expressly disclaims any obligation or undertaking
to release publicly any updates or revisions to such statements to
reflect any change in its expectations with regard thereto or any
changes in the events, conditions or circumstances on which any
such statement is based.
Investor Relations
Contacts:
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Tom
McNaughton
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Jenene
Thomas
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Chief Financial
Officer
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Jenene Thomas
Communications LLC
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774-233-7321
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(908)
938-1475
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tmcnaughton@biostage.com
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jtc@jenenethomascommunications.com
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Media
Contacts:
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David Schull or
Maggie Beller
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Russo Partners
LLC
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212-845-4271 or
646-942-5631
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Email:
Maggie.beller@russopartnersllc.com
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SOURCE Biostage, Inc.