GlycoMimetics, Inc. (NASDAQ: GLYC) today reported financial results for
the third quarter ended September 30, 2015. As of September 30, 2015,
GlycoMimetics had cash and cash equivalents of $53.8 million, which
includes a $20.0 million milestone payment from Pfizer in August upon
its initiation of a Phase 3 clinical trial for rivipansel.
The company’s research and development expenses decreased slightly to
$5.0 million for the quarter ended September 30, 2015 as compared to
$5.1 million for the third quarter of 2014. The decrease was primarily
attributable to a decrease in spending related to manufacturing and
process development for the Phase 1/2 clinical trial of GMI-1271, offset
by an increase in the related clinical costs associated with site
initiations and patient enrollment for the Phase 1/2 clinical trial.
GlycoMimetics is studying the safety, pharmacokinetics and efficacy
of GMI-1271, when used in combination with chemotherapy in patients with
acute myeloid leukemia (AML), in the ongoing Phase 1/2 clinical
trial. The first patient in the trial was enrolled in May 2015. In
addition, the preclinical development of GMI-1359, the company’s next
drug candidate, resulted in increased expenses in manufacturing and for
the toxicology studies required to support a potential investigational
new drug (IND) application.
The company’s general and administrative expenses increased to $2.1
million for the quarter ended September 30, 2015 as compared to $1.6
million for the third quarter of 2014. The increase was primarily
attributable to additional professional fees, including patent costs,
market research studies, insurance and other costs associated with
supporting public company operations, as well as increased stock-based
compensation expense.
“We have made recent achievements across our clinical pipeline,” said
Rachel King, CEO of GlycoMimetics. “Enrollment for the rivipansel Phase
3 clinical trial is underway and our partner Pfizer has also initiated
dosing in a Phase 1 trial of a subcutaneous formulation of rivipansel.
We have completed enrollment for our Phase 1 trial of GMI-1271 in
healthy volunteers, and are enrolling patients in our Phase 1/ 2 trial
in AML. Additionally, three posters and one oral presentation of new
data for both GMI-1271, a novel and proprietary E-selectin antagonist,
and GMI-1359, an antagonist of E-selectin and CXCR4 in advanced
preclinical studies, have been selected for presentation at the annual
ASH meeting in December. These accomplishments position us for multiple
news opportunities in 2016 and support our focus on programs that may
potentially transform the treatment both of sickle cell disease and AML.”
About GlycoMimetics, Inc.
GlycoMimetics is a clinical stage biotechnology company focused on the
discovery and development of novel glycomimetic drugs to address unmet
medical needs resulting from diseases in which carbohydrate biology
plays a key role. GlycoMimetics entered into an exclusive license
agreement with Pfizer for rivipansel in October 2011. Under the license
agreement, Pfizer is responsible for the clinical development,
regulatory approval and potential commercialization of rivipansel.
GlycoMimetics’s wholly-owned drug candidate (GMI-1271) for AML and other
blood disorders is also in clinical trials. Glycomimetics are molecules
that mimic the structure of carbohydrates involved in
important biological processes. Using its expertise in carbohydrate
chemistry and knowledge of carbohydrate biology, GlycoMimetics is
developing a pipeline of glycomimetic drug candidates that inhibit
disease-related functions of carbohydrates, such as the roles they play
in inflammation, cancer and infection. Learn more at www.glycomimetics.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements regarding the
clinical development of the company’s drug candidates and the
presentation of data. Actual results may differ materially from those in
these forward-looking statements. For a further description of the risks
associated with these statements, as well as other risks facing
GlycoMimetics, please see the risk factors described in the company’s
annual report on Form 10-K that was filed with the U.S. Securities and
Exchange Commission (SEC) on March 16, 2015, and other filings the
company makes with the SEC from time to time. Forward-looking statements
speak only as of the date of this release, and GlycoMimetics undertakes
no obligation to update or revise these statements, except as may be
required by law.
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GlycoMimetics, Inc.
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Condensed Statements of Operations
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(In thousands, except share and per share data)
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Three months ended September 30,
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Nine months ended September 30,
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(Unaudited)
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(Unaudited)
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2015
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2014
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2015
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2014
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Revenue
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$
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-
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$
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-
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$
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20,035
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$
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15,027
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Costs and Expenses:
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Research and development
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5,038
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5,051
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18,089
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14,290
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General and administrative
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2,133
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1,648
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5,844
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4,479
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Total costs and expenses
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7,171
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6,699
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23,933
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18,769
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Loss from operations
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(7,171
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(6,699
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(3,898
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(3,742
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)
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Other income
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3
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5
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10
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14
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Loss and comprehensive loss before income taxes
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(7,168
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(6,694
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(3,888
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(3,728
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Income tax benefit
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-
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(77
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-
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-
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Net loss and net comprehensive loss
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$
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(7,168
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$
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(6,617
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$
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(3,888
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$
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(3,728
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Net loss per share – basic
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$
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(0.38
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$
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(0.35
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$
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(0.20
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$
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(0.20
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Net loss per share – diluted
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$
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(0.38
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$
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(0.35
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$
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(0.20
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$
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(0.20
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Weighted average shares – basic
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19,025,623
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18,893,834
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18,999,705
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18,311,358
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Weighted average shares – diluted
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19,025,623
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18,893,834
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18,999,705
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18,311,358
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GlycoMimetics, Inc.
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Balance Sheet Data
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(In thousands)
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September 30,
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December 31,
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2015
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2014
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(Unaudited)
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Cash and cash equivalents
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$
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53,760
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$
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55,199
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Working capital
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47,628
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49,655
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Total assets
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55,742
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57,264
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Total liabilities
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6,850
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6,461
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Total stockholders' equity
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48,705
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50,803
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View source version on businesswire.com: http://www.businesswire.com/news/home/20151112005840/en/
Copyright Business Wire 2015