- Ongoing discussions with U.S. Food and
Drug Administration (FDA) regarding regulatory path for GMI-1271,
including planned Phase 3 trial initiation in mid-2018
- Pro forma cash balance of $132.1
million as of September 30
- Two abstracts accepted as oral
presentations at the 2017 American Society of Hematology (ASH)
meeting in December
- Phase 3 clinical trial of rivipansel on
track for completion in second half of 2018
GlycoMimetics, Inc. (NASDAQ: GLYC) today reported progress on
its clinical development programs and its financial results for the
third quarter and nine months ended September 30, 2017.
The Company will host a conference call and webcast to provide a
corporate update and report its third-quarter 2017 financial
results today at 8:30 a.m. ET. The dial-in number for the
conference call is (844) 413-7154 for domestic participants and
(216) 562-0466 for international participants with participant code
8794188. A webcast replay will be available via the “Investors” tab
on the GlycoMimetics website for 30 days following the call. A
dial-in phone replay will be available for 24 hours after the close
of the call by dialing (855) 859-2056, participant code
8794188.
“In the third quarter of 2017, we initiated productive
discussions with the FDA to review data emerging from the ongoing
Phase 1/2 clinical trial of our specific E-selectin inhibitor
product candidate, GMI-1271, for the treatment of acute myeloid
leukemia (AML) and to plan a mid-2018 start of the Phase 3 trial.
The discussions reflect the FDA’s granting of Breakthrough Therapy
designation to GMI-1271 for the treatment of relapsed/refractory
AML patients. Our focus is on finalizing the design of the
registrational trial in relapsed/refractory disease. While in the
near term we are preparing to provide an update on the GMI-1271
program via two oral presentations at the ASH meeting, we also
continue to make progress across our clinical pipeline and in the
preclinical arena,” stated Rachel King, Chief Executive
Officer.
Key Operational Highlights for the Third Quarter of
2017:
- GlycoMimetics engaged with the FDA
under the terms of the Breakthrough Therapy designation the Company
received in May. Discussions are focused on the design of a Phase 3
clinical trial protocol, including appropriate endpoints to capture
GMI-1271’s potential benefits and a plan for other aspects of the
program required for registration.
- Data related to GMI-1271 will be
highlighted in two oral presentations at the 59th American Society
of Hematology (ASH) Annual Meeting and Expo. The ASH meeting will
take place in Atlanta, GA, December 9-12, 2017. The oral
presentations at the ASH meeting will include results from the
ongoing Phase 1/2 clinical trial of GMI-1271, as well as a
preclinical study in which the mechanism by which E-selectin
mediates resistance to chemotherapy was observed. In the Phase 1/2
clinical trial, improved clinical outcomes were seen in both
relapsed/refractory and newly diagnosed AML patients following
treatment with GMI-1271. The preclinical data point to E-selectin
dependent upregulation of tumor survival pathways, which are
inhibited by GMI-1271.
- The rivipansel Phase 3 trial, being
conducted by the Company’s collaborator Pfizer, is evaluating
patients hospitalized for vaso-occlusive crisis of sickle cell
disease. Pfizer reports that the study remains on track for
completion in the second half of 2018.
Third Quarter 2017 Financial Results:
- Cash position: As of September 30,
2017, GlycoMimetics had cash and cash equivalents of $112.9 million
as compared to $40.0 million as of December 31, 2016. The Company
raised $86.8 million in net proceeds from a public offering of
common stock completed in May 2017. Subsequent to September 30, the
Company raised an additional $19.2 million in net proceeds under an
at-the-market equity facility, resulting in a pro forma cash
balance of $132.1 million as of September 30.
- R&D Expenses: The Company’s
research and development expenses decreased slightly to $5.8
million for the quarter ended September 30, 2017 as compared to
$5.9 million for the third quarter of 2016. The decrease was
primarily caused by lower clinical trial expenses related to the
Phase 1/2 clinical trial of GMI-1271 for the treatment of AML due
to patient enrollment completion in May 2017 and a decrease in
costs for non-clinical toxicology studies and clinical studies for
GMI-1359. These decreases were offset in part by additional costs
related to the manufacturing of Phase 3 clinical supplies of
GMI-1271.
- G&A Expenses: The Company’s general
and administrative expenses increased to $2.4 million for the
quarter ended September 30, 2017 as compared to $2.0 million for
the third quarter of 2016. These increases were primarily
attributable to annual salary adjustments and stock-based
compensation expense from 2017 equity awards to employees and
directors.
- Shares Outstanding: Shares of common
stock outstanding as of September 30, 2017 were 32,737,799.
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.
In a Phase 1/2 clinical trial that has now completed enrollment,
GMI-1271 is being evaluated in both newly diagnosed elderly and
relapsed/refractory patients with acute myeloid leukemia (AML). In
both populations in this trial, patients treated with GMI-1271
together with standard chemotherapy have achieved higher than
expected remission rates based on historical controls, as well as
lower than expected induction-related mortality rates. Importantly,
treatment in these patient populations has been well tolerated with
minimal adverse effects.
About GMI-1359
GMI-1359 is designed to simultaneously inhibit both E-selectin
and CXCR4. Since E-selectin and CXCR4 are both adhesion molecules
that keep cancer cells in the bone marrow, the Company believes
that targeting both E-selectin and CXCR4 with a single compound
could improve efficacy in the treatment of both liquid and solid
tumors that affect the bone marrow, as compared to targeting CXCR4
alone. GMI-1359 is currently being evaluated in a Phase 1 clinical
trial.
About Rivipansel
Rivipansel, a pan-selectin antagonist, is being developed for
the treatment of vaso-occlusive crisis (VOC) in sickle cell disease
and is being evaluated in a Phase 3 clinical trial being conducted
by GlycoMimetics’ strategic collaborator, Pfizer. Sickle cell
disease is a genetic disease that, according to the U.S. Centers
for Disease Control and Prevention, affects millions of people
throughout the world, including an estimated 90,000 to 100,000
people in the United States. VOC is one of the most severe
complications of sickle cell disease.
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' 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 for the treatment of multiple myeloma. The FDA
has granted GMI-1271 Breakthrough Therapy designation for the
treatment of adult AML patients with relapsed/refractory disease.
GlycoMimetics has also initiated 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 completion of clinical trials 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) 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 September 30,
Nine months ended September 30, (Unaudited) (Unaudited) 2017
2016 2017 2016 Revenue $ - $ 18 $ - $
18 Cost and expenses: Research and development expense 5,780
5,921 17,380 17,221 General and administrative expense 2,402
1,984 7,016 6,352
Total costs and expenses 8,182 7,905
24,396 23,573 Loss from
operations (8,182 ) (7,887 ) (24,396 ) (23,555 ) Other
income 232 32 373
74 Net loss and comprehensive loss $ (7,950 ) $
(7,855 ) $ (24,023 ) $ (23,481 ) Net loss per
share - basic and diluted $ (0.24 ) $ (0.34 ) $ (0.86 ) $ (1.14 )
Weighted average shares - basic and diluted 32,724,010 23,049,347
27,814,781 20,638,129 GlycoMimetics, Inc. Balance
Sheet Data (In thousands)
September 30, December 31, 2017 2016
(unaudited) Cash and cash equivalents $ 112,873 $ 40,042
Working capital 107,357 34,187 Total assets 115,822
42,388 Total liabilities 7,258 7,087 Stockholders'
equity 108,564 35,301
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version on businesswire.com: http://www.businesswire.com/news/home/20171108005448/en/
GlycoMimetics, Inc.Investor Contact:Shari Annes,
650-888-0902sannes@annesassociates.comorMedia Contact:Jamie
Lacey-Moreira, 410-299-3310jamielacey@presscommpr.com
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