[March 01, 2017] |
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GlycoMimetics Reports Fourth Quarter and Year-End 2016 Results
GlycoMimetics, Inc. (NASDAQ: GLYC) today reported progress on its
clinical development programs and its financial results for the fourth
quarter and year ended December 31, 2016.
"In 2016, GlycoMimetics made significant progress across its clinical
pipeline, perhaps most significantly in the maturing data from our study
of GMI-1271, an E-selectin antagonist, in acute myeloid leukemia (AML).
Starting early in the year, continuing mid-year at the European
Hematology Association (EHA), and finally, in December at the 58th
Annual American Society of Hematology (ASH) Annual Meeting, we presented
results from the Phase 2 portions of this study, in both newly diagnosed
and relapsed/refractory patients. The ongoing trial is expected to
complete enrollment in the first half of this year. Importantly the data
to date suggest a very real potential for bringing a differentiated
commercial product to this vastly underserved market.
Beyond this program, we initiated two new trials in 2016, a Phase 1
clinical trial of GMI-1271 in multiple myeloma (MM), and a Phase 1
clinical trial of our next drug candidate GMI-1359, a dual antagonist of
both E-selectin and CXCR4, in healthy volunteers. These accomplishments
position us for significant news flow in 2017. In addition, the Phase 3
trial of rivipansel being conducted by Pfizer continues to enroll sickle
cell patients with the goal of completion of enrollment in the second
half of 2018," said Rachel King, GlycoMimetics' Chief Executive Officer.
Key Operational Highlights for the Fourth Quarter of 2016:
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At the ASH Annual Meeting in San Diego held in December 2016,
GlycoMimetics presented results from its Phase 1/2 clinical trial of
GMI-1271, in which high rates of remission and favorable tolerability
were observed among AML patients in both arms of the trial. In the
Phase 1/2 clinical trial, clinicians are studying the use of GMI-1271
along with chemotherapy. For a total of 33 study participants with
relapsed or refractory disease in one arm of the trial, the complete
response (CR) rate was 45 percent. For 11 newly diagnosed study
participants 60 or more years of age in the second arm of the trial,
the CR rate was 73 percent. All study participants evaluated as of the
ASH meeting who had responded had complete remissions; there were no
patients observed who responded with incomplete count recoveries. In
addition, in elderly, newly diagnosed patients evaluated as of the
date of the ASH meeting, the 60-day mortality rate was zero for those
receiving intensive induction chemotherapy plus GMI-1271.
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GlycoMimetics continues to recruit and dose patients in the Phase 2
portion of its clinical study evaluating GMI-1271 in AML in both newly
diagnosed and relapsed/refractory patients at eight active sites in
the United States, Ireland and Australia. GMI-1271 has received fast
track designation from the US Food & Drug Administration (FDA) for the
treatment of AML, and GlycoMimetics plans to continue to engage with
the FDA to discuss clinical and manufacturing planning as the program
progresses.
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GlycoMimetics continues enrollment in a Phase 1 clinical trial of
GMI-1271 for MM, which enrolled the first patient in September 2016.
The multi-center, open-label dose escalation trial, which has begun in
Ireland, is designed to measure the efficacy, safety and
pharmacokinetics of GMI-1271 in combination with chemotherapy among
patients who have been diagnosed with MM and have not responded well
to standard chemotherapy.
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GlycoMimetics completed dosing in a Phase 1 clinical trial of GMI-1359
in healthy volunteers. GMI-1359 is a small molecule drug candidate
that simultaneously inhibits both E-selectin and CXCR4. In this
first-in-human trial, volunteer participants received a single
injection of GMI-1359 and were evaluated for safety, tolerability,
pharmacokinetics and pharmacodynamics over 16 days. The randomized,
double-blind escalating dose study was conducted at a single site in
the United States.
Fourth Quarter 2016 Financial Results:
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Cash position: As of December 31, 2016, GlycoMimetics had cash and
cash equivalents of $40.0 million as compared to $46.8 million as of
December 31, 2015.
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Revenue: The company's revenue for the year ended December 31, 2016
was not material. The revenue recorded in the year ended December 31,
2015 was due to a $20.0 million non-refundable milestone payment from
Pfizer triggered upon the dosing of the first patient in the Phase 3
clinical trial of rivipansel. There were no milestone or royalty
payments from Pfizer during the year ended December 31, 2016.
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R&D Expenses: The company's research and development expenses
decreased to $6.1 million for the quarter ended December 31, 2016 as
compared to $7.0 million for the fourth quarter of 2015. Research and
development expenses similarly decreased by $1.8 million to $23.3
million for the year ended December 31, 2016, from $25.1 million in
the year ended December 31, 2015. During the year ended December 31,
2016, there was an increase in the costs associated with the clinical
development for GMI-1271 and GMI-1359, offset by a year-over-year
decrease in expenses related to manufacturing and process development
for GMI-1271.
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G&A Expenses: The company's general and administrative expenses
increased to $2.3 million for the quarter ended December 31, 2016 as
compared to $2.0 million for the fourth quarter of 2015. General and
administrative expenses for the year ended December 31, 2016 increased
to $8.7 million as compared to $7.8 million in the prior year. These
increases were primarily due to increased labor-related costs and
stock-based compensation expense.
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Shares Outstanding: Shares outstanding as of December 31, 2016 were
23,250,023.
About GMI-1271
GMI-1271 is designed to block E-selectin (an adhesion molecule on cells
in the bone marrow) from binding with blood cancer cells as a targeted
approach to disrupting well-established mechanisms of leukemic cell
resistance within the bone marrow microenvironment. Preclinical research
points to the drug's potential role in moving cancerous cells out of the
protective environment of the bone marrow where they hide and escape the
effects of chemotherapy. In preclinical studies using animal models of
AML, the results of which were presented at ASH meetings, GMI-1271 was
also associated with a reduction of chemotherapy-induced neutropenia and
chemotherapy-induced mucositis.
About GlycoMimetics, Inc.
GlycoMimetics is a clinical-stage biotechnology company focused on
cancer and sickle cell disease. GlycoMimetics' most advanced drug
candidate, rivipansel, a pan-selectin antagonist, is being developed for
the treatment of vaso-occlusive crisis in sickle cell disease and is
being evaluated in a Phase 3 clinical trial being conducted by its
strategic collaborator, Pfizer. GlycoMimetics' wholly-owned drug
candidate, GMI-1271, an E-selectin antagonist, is being evaluated in an
ongoing Phase 1/2 clinical trial as a potential treatment for AML and in
a Phase 1 clinical trial as a potential treatment for MM. GlycoMimetics
has also recently completed dosing in a clinical trial with a third drug
candidate, GMI-1359, a combined CXCR4 and E-selectin antagonist.
GlycoMimetics is located in Rockville, MD in the BioHealth Capital
Region. 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 clinical 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 (News - Alert)) on March 1, 2017, and other
filings GlycoMimetics 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 December 31,
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Year ended December 31,
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2016
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2015
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2016
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2015
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(Unaudited)
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Revenue
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$
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-
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$
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35
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$
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18
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$
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20,071
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Costs and expenses:
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Research and development expense
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6,060
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6,961
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23,282
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25,050
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General and administrative expense
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2,298
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1,962
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8,650
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7,805
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Total costs and expenses
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8,358
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8,923
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31,932
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32,855
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Loss from operations
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(8,358
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(8,888
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(31,914
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(12,784
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Other income
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29
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6
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104
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15
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Net loss and net comprehensive loss
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$
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(8,329
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$
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(8,882
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$
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(31,810
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$
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(12,769
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Net loss per common share - basic and diluted
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$
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(0.36
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$
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(0.47
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$
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(1.50
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$
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(0.67
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Weighted average common shares - basic and diluted
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23,110,862
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19,043,234
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21,256,312
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19,010,587
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GlycoMimetics, Inc.
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Balance Sheet Data
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(In thousands)
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December 31,
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December 31,
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2016
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2015
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Cash and cash equivalents
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$
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40,042
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$
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46,803
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Working capital
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34,187
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39,497
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Total assets
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42,388
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48,462
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Total liabilities
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7,087
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7,991
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Total stockholders' equity
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35,301
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40,472
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View source version on businesswire.com: http://www.businesswire.com/news/home/20170301005309/en/
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