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Company Receives Notice of NASDAQ Listing Deficiency
ST. PAUL, Minn.(BUSINESS WIRE)
EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices using
neuroblocking technology to treat obesity and other gastrointestinal
disorders, today reported financial results for the three and nine
months ended September 30, 2009.
For the three months ended September 30, 2009, the Company reported a
net loss of $12.0 million, or $0.40 per share, including non-cash
expense of $3.8 million related to the revaluation of warrant liability,
research and development expenses of $4.6 million, and general and
administrative expenses of $2.7 million. For the nine months ended
September 30, 2009, the Company reported a net loss of $29.0 million, or
$1.06 per share. Operating expenses were primarily associated with the
cost of supporting the Company's clinical trials and the development of
VBLOC vagal blocking therapy delivered through the Company's Maestro
System. On September 30, 2009, the Company's cash, cash equivalents and
short-term investments totaled $27.1 million, which does not reflect the
proceeds of its October 2, 2009 agreement with an institutional investor
to raise $4.9 million in a registered direct offering of its common
stock.
We expect to complete our evaluation of the one year data from the
EMPOWER trial during the fourth quarter. This process will help us
determine the Company's plans for VBLOC Therapy,? said President and CEO
Mark B. Knudson, Ph.D. "We remain fully committed to the support of the
patients and health care professionals involved in our ongoing clinical
studies."
Our cash position gives us operating flexibility well into 2010,?
stated Gregory S. Lea, Senior Vice President and Chief Financial Officer
of EnteroMedics. We are focused on effectively managing our expenses
while we finalize our next steps with the Maestro System.?
NASDAQ Notice of Deficiency
EnteroMedics also announced today that on October 19, 2009 it received a
Nasdaq Staff Deficiency Letter indicating that, for ten consecutive
business days, the Company's common stock did not maintain the minimum
Market Value of Listed Securities (MVLS) of $50,000,000 as required by
Listing Rule 5450(b)(2)(A). The Company has been provided 90 calendar
days, or until January 19, 2010, to regain listing compliance, which can
be achieved if the Company's MVLS closes at $50,000,000 or more for a
minimum of ten consecutive business days during this time. The
Company will continue to be listed on the NASDAQ Global Market during
this period.
In the event the Company does not regain compliance prior to expiration
of the 90 days, it will receive written notification that its securities
are subject to delisting. The Company may, at that time, appeal the
Staff's determination to a Hearings Panel. Such an appeal, if granted,
would stay delisting until a Panel ruling. Alternatively, the Company
may choose to apply for transfer to the Nasdaq Capital Market, provided
it satisfies the requirements for continued listing on that market.
There can be no assurance that the Company will be able to reestablish
or maintain compliance with listing criteria on either Nasdaq market or
that an appeal, if taken, would be successful.
About EnteroMedics Inc.
EnteroMedics is a development stage medical device company focused on
the design and development of devices that use neuroblocking technology
to treat obesity and other gastrointestinal disorders. EnteroMedics'
proprietary neuroblocking technology, VBLOC vagal blocking therapy, is
designed to intermittently block the vagus nerves using high-frequency,
low-energy, electrical impulses. EnteroMedics is currently recruiting
patients outside of the United States for a feasibility study examining
VBLOC Therapy's effects on blood glucose levels in diabetic patients.
For more information, visit www.enteromedics.com.
Forward-Looking Safe Harbor Statement:
This press release contains forward-looking statements about
EnteroMedics Inc. Our actual results could differ materially from those
discussed due to known and unknown risks, uncertainties and other
factors including our limited history of operations, our losses since
inception and for the foreseeable future; our lack of regulatory
approval for our Maestro System for the treatment of obesity; our
preliminary findings from our EMPOWER? pivotal trial; our ability to
commercialize our Maestro System; our dependence on third parties to
initiate and perform our clinical trials; the need to obtain regulatory
approval for any modifications to our Maestro System; physician adoption
of our Maestro System and VBLOC vagal blocking therapy; our ability to
obtain third party coding, coverage or payment levels; ongoing
regulatory compliance; our dependence on third party manufacturers and
suppliers; the successful development of our sales and marketing
capabilities; our ability to raise additional capital when needed; our
ability to attract and retain management and other personnel and to
manage our growth effectively; potential product liability claims;
potential healthcare fraud and abuse claims; potential healthcare
legislative reform and our ability to obtain and maintain intellectual
property protection for our technology and products. These and
additional risks and uncertainties are described more fully in the
Company's filings with the Securities and Exchange Commission,
particularly those factors identified as "risk factors" in the Company's
Form 10-K dated March 12, 2009. We are providing this information as of
the date of this press release and do not undertake any obligation to
update any forward-looking statements contained in this document as a
result of new information, future events or otherwise.
Caution-Investigational device. Limited by U.S. Federal law to
investigational use.
The implantation procedure and usage of the Maestro System carry some
risks, such as the risk generally associated with laparoscopic
procedures and those related to treatment as described in the EMPOWER
clinical trial informed consent.
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ENTEROMEDICS INC.
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(A Development Stage Company)
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Condensed Consolidated Statements of Operations (unaudited)
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(in thousands, except per share data)
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Three Months Ended
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Nine Months Ended
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September 30,
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September 30,
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2009
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2008
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2009
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2008
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Operating expenses:
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Research and development
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$
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4,564
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$
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8,193
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$
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12,420
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$
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23,287
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Selling, general and administrative
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2,702
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1,869
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6,777
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6,516
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Total operating expenses
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7,266
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10,062
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19,197
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29,803
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Loss from operations
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(7,266
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)
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(10,062
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)
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(19,197
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)
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(29,803
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)
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Other income (expense), net
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(4,742
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)
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(138
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)
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(9,842
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)
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(249
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Net loss
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$
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(12,008
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)
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$
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(10,200
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)
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$
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(29,039
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)
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$
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(30,052
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)
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Net loss per share - basic and diluted
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$
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(0.40
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$
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(0.61
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)
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$
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(1.06
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)
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$
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(1.79
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)
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Shares used to compute basic and diluted net loss per share
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30,064
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16,854
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27,445
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16,821
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ENTEROMEDICS INC.
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(A Development Stage Company)
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Condensed Consolidated Balance Sheets (unaudited)
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(in thousands)
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September 30,
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December 31,
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2009
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2008
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ASSETS
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Cash, cash equivalents and short-term investments
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$
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27,052
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$
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26,295
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Prepaid expenses and other current assets
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341
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499
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Property and equipment, net
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1,054
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1,264
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Other assets
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192
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221
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Total assets
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$
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28,639
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$
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28,279
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LIABILITIES AND STOCKHOLDERS' EQUITY
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Liabilities:
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Accounts payable
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$
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210
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$
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163
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Debt
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16,999
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13,670
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Other liabilities
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8,075
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3,040
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Total liabilities
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25,284
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16,874
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Stockholders' equity
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3,354
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11,405
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Total liabilities and stockholders equity
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$
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28,639
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$
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28,279
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EnteroMedics Inc. Greg S. Lea, 651-789-2860 ir@enteromedics.com
Source: EnteroMedics Inc.
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