HOLLISTON, Mass., Nov. 22, 2016 /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, today announced that it has received a continued
listing deficiency notice from The NASDAQ Stock Market LLC because
its share price has not met the $1.00
minimum closing bid price requirement for 30 consecutive business
days [Nasdaq Listing Rule 5450(a)(1)]. This notice has no immediate
effect on the Company's Nasdaq listing or the trading of its common
stock.
Nasdaq has provided Biostage with a 180-day compliance period,
until May 17, 2017, in which to
regain compliance with the minimum bid price requirement [Nasdaq
Listing Rule 5500(a)(2)]. If at any time during the compliance
period, the closing bid price of Biostage's common stock is at
least $1.00 per share for at least
ten consecutive business days, Nasdaq will provide the Company a
written confirmation of compliance and the matter will be
closed.
Should Biostage not regain compliance with the bid price
requirement by May 17, 2017, it may
be eligible for an additional 180-day compliance period if it meets
the market value of publicly held shares requirement for continued
listing, all other initial inclusion requirements for the Capital
Market, except for the bid price requirement, and provides written
notice that it intends to regain compliance with the bid price
requirement during the second 180-day compliance period.
Biostage's CEO, Jim McGorry,
commented, "We are very confident in Biostage's ability to regain
compliance with Nasdaq's minimum bid price requirement. We
strongly believe we have a number of catalytic milestones in the
near-term that have the potential to drive value for
Biostage."
"We are focused on solving our short-term financing needs and
our goal is to pursue a financing strategy that is in the best
interest of the future of Biostage and all of our
shareholders. We have never been more invigorated by the
potential of Biostage, specifically with the line of sight we have
on bringing our first product candidate towards a human clinical
study," Mr. McGorry added.
About Biostage
Biostage Inc. (Nasdaq: BSTG), is a
biotechnology company developing bioengineered organ implants based
on the company's new CellframeTM technology which
combines a proprietary biocompatible scaffold with a patient's own
stem cells to create CellspanTM 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 pre-clinical studies. Pre-clinical, large-animal
safety studies, conducted in compliance with the FDA Good
Laboratory Practice (GLP) regulations, for the Company's Cellspan
Esophageal Implant product candidate have begun, in support of
Biostage's goal of filing an Investigational New Drug (IND)
application with the U.S. FDA by the end of the second quarter of
2017. The IND will seek approval to initiate clinical trials for
its esophageal implant product candidate in humans.
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. These "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, 2015 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
|
Jenene
Thomas
|
Chief Financial
Officer
|
Jenene Thomas
Communications LLC
|
774-233-7321
|
908-938-1475
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tmcnaughton@biostage.com
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jtc@jenenethomascommunications.com
|
|
|
Media
Contact:
|
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David
Schull
|
|
Russo
Partners
|
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212-845-4271
|
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David.schull@russopartnersllc.com
|
|
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SOURCE Biostage, Inc.