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Galectin Therapeutics Reports First Quarter 2012 Financial Results
NEWTON, Mass. --(Business Wire)--
Galectin Therapeutics Inc. (NASDAQ: GALT), the leading developer of
therapeutics that target galectin proteins to treat fibrosis and cancer,
today reported its financial results for first quarter, ended March 31,
2012. These results are included in the Company's Quarterly Report on
Form 10-Q, which has been filed with the SEC (News - Alert).
"Galectin made important progress in its clinical programs as well as
its operations in the first quarter. Notably, the preclinical
development of Galectin's lead candidate for the treatment of fibrosis,
GR-MD-02, continues on track and we expect to file an investigational
new drug application with the US FDA by year end," said Peter G. Traber,
M.D., Chief Executive Officer, President and Chief Medical Officer,
Galectin Therapeutics. "Accordingly, we plan to initiate a Phase 1
clinical trial of GR-MD-02 in patients with NASH and fibrosis in early
2013 to assess safety and preliminary evidence of efficacy in humans
with Phase 2 studies potentially beginning by the end of next year with
expected top-line results by the end of 2014. The novel mechanism of
GR-MD-02, in combination with compelling preclinical data, gives us
great hope that this compound may ultimately meet the needs of these
patients with this deadly disease that has no currently approved
therapeutic options."
Traber continued, "As previously disclosed, the Company has refocused
its pipeline of galectin inhibitors in cancer to reflect the highest
likelihood of creating value in the near-term and is now developing
GM-CT-01 in melanoma. This development strategy is based on compelling
data demonstrating that GM-CT-01 can protect a patient's immune system
from the "Galectin Effect"; whereby tumors secrete galectin proteins
that block the body's efforts to fight tumors. We are collaborating with
the Ludwig Institute, where the Galectin Effect was discovered, for a
Phase 2 clinical evaluation of GM-CT-01 which is currently underway. We
feel that melanoma is an ideal indication because it is an
immunologically responsive tumor and there are newly approved therapies
that we suspect will be synergistic with GM- CT-01."
"Our Colombian partner, PROCAPS, S.A., continues to attempt to gain
approval of GM-CT-01 in Colombia. The Colombian effort originated after
the Company was encouraged by a key oncologist at Colombia's National
Cancer Institute, the government and a regional pharmaceutical company
to seek approval for GM-CT-01 as an adjuvant to 5-FU, because the data
that showed it may increase the efficacy of 5-FU and reduce its side
effects. The time to receive a definitive answer regarding Colombian
approval has clearly taken longer than we were originally led to
believe. At this point, our corporate strategy for increasing the value
of the Company is not dependent on approval in Colombia. We have not
taken into account projections for revenues, so if this should be
successful, it will all be upside. We currently take a guarded view of
the prospects for an approval and hope to report more by the end of the
second quarter."
"Finally, Galectin Therapeutics recently completed a fund raising and
listing of our common stock on The NASDAQ Capital Market. Importantly,
the proceeds from this offering are expected to provide us with the
financial resources to fund our promising development programs through
the end of 2013, including the initiation of Phase 2 trials of GR-MD-02.
The listing on NADSDAQ should provide increased liquidity and access to
Galectin stock," concluded Traber.
On March 28, 2012, the Company completed an underwritten public offering
in which it sold 2,666,722 shares of common stock and related warrants
for 1,333,361 shares of common stock for $12.0 million (net cash
proceeds of $10.4 million). On March 23, 2012, the Company effected a
one-for-six reverse split of its common stock and began trading on The
NASDAQ Capital Market under the symbol GALT. At March 31, 2012, the
Company had $15.3 million of non-restricted cash and cash equivalents
available to fund future operations. The Company believes that with the
funds on hand at March 31, 2012, there is sufficient cash to fund core
operations and planned research and development through 2013.
For the first quarter of 2012, the Company reported a net loss
applicable to common stock of $2.2 million, or ($0.17) per share, basic
and diluted, compared with a net loss of $2.7 million, or ($0.24) per
share for the same period in 2011. Included in the losses was $0.3
million in non-cash dividend and accretion expenses related to the
preferred stock for both the 2012 and 2011 periods and a $0.4 million
non-cash expense related to the change in fair value of warrant
liabilities in 2011.
Research and development expense for the first quarter of 2012 was $0.9
million, compared with $0.7 million for the same period in 2011. The
increase is due primarily to greater pre-clinical activity in our
fibrosis program and our clinical program related to our GM and GR
compounds offset by decreased stock-based compensation.
General and administrative expense for the first quarter of 2012 was
$1.1 million, compared with $1.3 million for the same period in 2011.
The decrease is due primarily to lower payroll costs, decreased business
development costs related to our marketing efforts in South America and
decreased legal and accounting costs, offset by increased stock-based
compensation.
About Galectin Therapeutics
Galectin Therapeutics (NASDAQ: GALT) is developing promising
carbohydrate-based therapies for the treatment of fibrotic liver disease
and cancer based on the Company's unique understanding of galectin
proteins, key mediators of biologic function. We are leveraging
extensive scientific and development expertise as well as established
relationships with external sources to achieve cost effective and
efficient development. We are pursuing a clear development pathway to
clinical enhancement and commercialization for our lead compounds in
liver fibrosis and cancer. Additional information is available at www.galectintherapeutics.com.
Forward Looking Statements
This press release contains, in addition to historical information,
forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995. These statements relate to future events
or future financial performance, and use words such as "may,"
"estimate," "could," "expect" and others. They are based on our current
expectations and are subject to factors and uncertainties which could
cause actual results to differ materially from those described in the
statements. Factors that could cause our actual performance to differ
materially from those discussed in the forward-looking statements
include, among others: incurrence of operating losses since our
inception, uncertainty as to adequate financing of our operations,
extensive and costly regulatory oversight that could restrict or prevent
product commercialization, inability to achieve commercial product
acceptance, inability to protect our intellectual property, dependence
on strategic partnerships, product competition, and others stated in
risk factors contained in our SEC filings. We cannot assure that we have
identified all risks or that others may emerge which we do not
anticipate. You should not place undue reliance on forward-looking
statements. Although subsequent events may cause our views to change, we
disclaim any obligation to update forward-looking statements.
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Condensed Consolidated Statements of Operations
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Three Months Ended March 31,
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2012
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2011
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(in thousands, except per share data) (unaudited)
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Operating expenses:
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Research and development
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$
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901
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$
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744
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General and administrative
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1,052
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1,269
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Total operating expenses
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1,953
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1,289
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Total operating loss
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(1,953
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)
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(1,289
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)
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Other income and (expense):
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Interest income
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3
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5
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Change in fair value of warrant liabilities
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-
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(384
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)
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Total other income (expense)
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3
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(379
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)
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Net loss
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$
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(1,950
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)
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$
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(2,392
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)
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Preferred stock dividends and accretion costs
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(254
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)
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(330
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Net loss applicable to common stock
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$
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(2,204
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)
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$
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(2,722
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Basic and diluted net loss per share
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$
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(0.17
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)
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$
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(0.24
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Shares used in computing basic and diluted net loss per share
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13,010
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11,156
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Condensed Consolidated Balance Sheet Data
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March 31, 2012
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December 31, 2011
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(in thousands, unaudited)
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Cash and cash equivalents
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$
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15,314
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$
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6,397
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Total assets
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15,538
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6,612
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Accounts payable and accrued expenses
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1,935
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2,015
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Deferred revenue
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200
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200
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Total liabilities
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2,135
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2,215
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Total stockholders' equity (deficit)
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$
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6,824
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$
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(2,125)
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