GlycoMimetics Reports Program Updates and First Quarter 2017 Results
May 08 2017 - 9:00AM
Business Wire
- Completed enrollment in the first of
two patient cohorts in the Phase 1/2 acute myeloid leukemia (AML)
trial of GMI-1271
- Presented preclinical data for GMI-1271
and GMI-1359 in multiple myeloma at AACR Annual Meeting 2017
- Company management will host a
conference call on Thursday, May 18, 2017 at 8:30
a.m. Eastern time to provide an update on development
programs
GlycoMimetics, Inc. (NASDAQ: GLYC) today reported progress on
its clinical development programs and its financial results for the
first quarter ended March 31, 2017.
“In the first quarter of 2017, GlycoMimetics delivered on its
plan to provide updates on both data and the status of its ongoing
pipeline programs. The acceptance of our clinical and preclinical
abstracts for presentation at key oncology congresses, including
AACR and more recently, ASCO, reinforces our enthusiasm for the
GMI-1271 and GMI-1359 programs, and demonstrates to the scientific
and physician communities the relevance of our work to address
unmet medical needs in a novel way. As we look forward to the
remainder of 2017, our plan is to build on this progress with
further data updates: at the Annual ASCO meeting in Chicago
followed by the European Hematology Association meeting, both
before the end of the second quarter in June. Additionally, we can
report that the Phase 3 program to evaluate rivipansel for
vaso-occlusive sickle cell crisis, according to our partner Pfizer,
remains on track for completion in the second half of 2018, ” said
Rachel King, GlycoMimetics’ Chief Executive Officer.
Company management will host a conference call on Thursday,
May 18, 2017 at 8:30 a.m. Eastern time to provide a
clinical data update from the abstracts for the upcoming ASCO
conference. A question and answer session with the GlycoMimetics
team will follow the company’s remarks. The call can be accessed by
dialing (844) 413-7154 (U.S. and Canada) or (216)
562-0466 (international) and entering passcode 4110139. To access
the live audio webcast, or the subsequent archived recording, visit
the “Investors - Events & Presentations” section of the
GlycoMimetics website at www.glycomimetics.com. The webcast will be
recorded and available for replay on the GlycoMimetics website for
30 days following the call.
Key Operational Highlights for the First Quarter of
2017:
- The first of two patient cohorts in the
Phase 2 portion of the AML trial of GMI-1271 has completed
enrollment. This cohort is comprised of 25 patients 60 years of age
or older with newly diagnosed AML. The study is designed to
evaluate the potential of GMI-1271, GlycoMimetics’ E-selectin
antagonist drug candidate, in combination with chemotherapy, as a
treatment for patients with both newly diagnosed and
relapsed/refractory AML. Enrollment in the study's second cohort is
expected to complete in the middle of this year. The two arms
combined will enroll a total of about 90 patients.
- Pre-clinical research supporting the
potential of two of its drug candidates, GMI-1271 and GMI-1359,
against multiple myeloma was shared via an oral presentation at the
American Association for Cancer Research (AACR) Annual Meeting
2017. Combination therapy of
carfilzomib with GMI-1271 or GMI-1359 prolonged survival of mice
with multiple myeloma over treatment with carfilzomib alone.
- The company announced that it will
provide an update on clinical data from its Phase 1/2 study of
GMI-1271 in AML at the 2017 American Society for Clinical Oncology
in Chicago. GMI-1271 is an antagonist of E-selectin, for which
prior clinical data has shown an emerging and differentiated
potential efficacy and safety profile.
First Quarter 2017 Financial Results:
- Cash position: As of March 31, 2017,
GlycoMimetics had cash and cash equivalents of $34.6 million as
compared to $40.0 million as of December 31, 2016. Subsequent to
March 31, 2017, the Company has raised an additional $3.8 million
in net proceeds under the at-the-market facility.
- R&D Expenses: The Company’s
research and development expenses increased to $5.9 million for the
quarter ended March 31, 2017 as compared to $5.5 million for the
first quarter of 2016. The increase was due to on-going costs
associated with the clinical trials for GMI-1271 in AML and MM,
partially offset by a decrease in expenses related to manufacturing
and process development for GMI-1271.
- G&A Expenses: The company’s general
and administrative expenses remained at $2.1 million for both the
quarters ended March 31, 2017 and 2016.
- Shares Outstanding: Shares outstanding
as of March 31, 2017 were 23,855,934.
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 GMI-1359
GMI-1359 is designed to simultaneously inhibit both E-selectin
and CXCR4. E-selectin and CXCR4 are both adhesion molecules that
keep cancer cells in the bone marrow. Preclinical studies indicate
that targeting both E-selectin and CXCR4 with a single compound
could improve efficacy in the treatment of cancers that involve the
bone marrow such as AML and MM.
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 1/2 clinical trial as a
potential treatment for MM. GlycoMimetics has also recently
completed dosing in a Phase 1 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,
including the expected timing of enrollment in and completion of
clinical trials and the presentation of clinical data at scientific
conferences. 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 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.
GlycoMimetics, Inc. Condensed
Statements of Operations (In thousands, except share and per share
data) Three months ended March 31, 2017
2016 (Unaudited) Revenue $ - $ -
Cost and expenses: Research and development expense 5,879 5,519
General and administrative expense 2,092 2,056
Total costs and expenses 7,971 7,575
Loss from operations (7,971 ) (7,575 ) Other
income 39 20 Net loss and
comprehensive loss $ (7,932 ) $ (7,555 ) Net loss per
share - basic and diluted $ (0.34 ) $ (0.40 ) Weighted average
shares - basic and diluted 23,480,432 19,071,838
GlycoMimetics, Inc. Balance Sheet Data (In thousands)
March 31, December 31, 2017 2016
(unaudited) Cash and cash equivalents $ 34,591 $ 40,042
Working capital 30,754 34,187 Total assets 37,174
42,388 Total liabilities 5,288 7,087 Stockholders'
equity 31,886 35,301
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version on businesswire.com: http://www.businesswire.com/news/home/20170508005623/en/
GlycoMimeticsInvestor Contact:Shari Annes,
650-888-0902sannes@annesassociates.comorMedia Contact:Jamie
Lacey-Moreira, 410-299-3310jamielacey@presscommpr.com
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