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GlycoMimetics Presents New AML Data with Uproleselan at 60th ASH Annual Meeting

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  • Data in relapsed/refractory and newly diagnosed acute myeloid
    leukemia (AML) patients underscore clinical opportunities across
    multiple outcomes measures and subgroups
  • Selective disruption of bone marrow microenvironment with
    uproleselan resulting in high remission rates; majority of evaluable
    patients achieving stringent level of measurable residual disease
    (MRD) negativity; promising survival outcomes across all AML subgroups
    assessed
  • Correlative studies further strengthen scientific rationale for
    inhibiting E-selectin in patients with AML, particularly those
    individuals with high-risk disease

GlycoMimetics, Inc. (NASDAQ:GLYC) announced today that new data on
uproleselan-treated high risk patients with both relapsed/refractory and
newly diagnosed AML were presented at an oral session during the
60th American Society of Hematology (ASH) Annual Meeting and Exposition.
An analysis of clinical outcomes from the Phase 1/2 clinical study
showed that uproleselan (GMI-1271) resulted in the majority of evaluable
patients achieving a stringent level of measurable residual disease
(MRD) negativity, an effect which translated into extended overall
survival relative to matched, historical controls.1-4

Additionally, an analysis of E-selectin ligand expression on leukemic
cells demonstrated that detectable levels are present in every patient
tested, providing strong clinical evidence of biological relevance in
this disease setting. In bone marrow blasts, leukemic stem cell
expression of E-selectin ligand correlated with leukemic blast
E-selectin ligand expression (p<0.0001), consistent with the hypothesis
that E-selectin-mediated interactions are a mechanism of
chemoresistance. Additionally, investigators assessed the association
between baseline E-selectin ligand expression and clinical outcomes
using a log-rank test. In the R/R cohort of patients (n=22), this
analysis demonstrated that ≥10% E-selectin ligand expression at baseline
is correlated with prolonged survival (p<0.01) for patients treated with
uproleselan. This observation is important since separately Chien et al.
(Abstract 1513) report that high levels of E-selectin ligand in patients
not treated with uproleselan correlate with worse clinical prognosis.

"The new MRD and correlative efficacy data in difficult-to-treat
patients, when combined with the already encouraging response rate and
survival results from this trial, further demonstrate the potential of
uproleselan to be an important new treatment option in AML," said Daniel
J. DeAngelo, M.D., Ph.D., Chief of the Division of Leukemia at the
Dana-Farber Cancer Institute and Brigham and Women's Hospital, and the
trial's lead investigator. "The fact that more than half of the
evaluable patients achieved a stringent level of MRD negativity is
particularly noteworthy as uproleselan's mechanism of action is to
selectively disrupt the relationship between leukemic cells and the bone
marrow microenvironment."

"It is now clearly established that patients with AML who express
E-selectin ligands on their leukemic cells have more infiltrative,
aggressive disease and significantly worse clinical outcomes when not
treated with uproleselan," said Helen Thackray, M.D., FAAP,
GlycoMimetics Senior Vice President, Clinical Development and Chief
Medical Officer. "While we would expect patients with R/R AML and >10%
E-selectin ligand expression on their leukemic blasts to do very poorly,
it is extremely exciting to see that the addition of uproleselan is
resulting in statistically significant improvements in clinical outcomes
in these high-risk patients. This is completely counterintuitive to what
you would expect and provides robust scientific evidence suggesting that
uproleselan is exerting biologic activity."

The ASH presentations referenced above include:

Publication Number: 331
TITLE: Uproleselan (GMI-1271), an
E-Selectin Antagonist, Improves the Efficacy and Safety of Chemotherapy
in Relapsed/Refractory (R/R) and Newly Diagnosed Older Patients with
Acute Myeloid Leukemia: Final, Correlative and Subgroup Analyses

Publication Number: 1513
TITLE: E-Selectin Ligand Expression by
Leukemic Blasts Is Associated with Prognosis in Patients with AML

References
1 Feldman et al, J Clin
Oncol. 2005 Jun 20;23(18):4110-6.

2 Greenberg
et al, J Clin Oncol. 2004 Mar 15;22(6):1078-86.

3 Lowenberg
et al, N Engl J Med. 2009 Sep 24;361(13).

4 Lancet
et al, Blood. 2014 May 22;123(21):3239-46.

About Uproleselan (GMI-1271)

Uproleselan (yoo' pro le'sel an) 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, uproleselan was
evaluated in both newly diagnosed elderly and relapsed/refractory
patients with AML. In both populations, patients treated with
uproleselan together with standard chemotherapy achieved better than
expected remission rates and overall survival compared to historical
controls, which have been derived from results from third party clinical
trials evaluating standard chemotherapy, as well as lower than expected
induction-related mortality rates. Treatment in these patient
populations was generally well tolerated, with fewer than expected
adverse effects. The U.S. Food and Drug Administration (FDA) has granted
uproleselan Breakthrough Therapy Designation for the treatment of adult
AML patients with relapsed/refractory (R/R) disease. GlycoMimetics is
currently implementing a comprehensive development program across the
clinical spectrum of AML. This includes a company sponsored Phase 3
trial in R/R AML and two consortia-sponsored trials in newly diagnosed
patients. One consortium trial is being sponsored by the NCI and will
enroll newly diagnosed patients fit for intensive chemotherapy. The
other trial is sponsored by the HOVON group in Europe and will enroll
newly diagnosed patients unfit for intensive chemotherapy.

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,
uproleselan, an E-selectin antagonist, was evaluated in a Phase 1/2
clinical trial as a potential treatment for AML and is currently being
evaluated in a company-sponsored Phase 3 trial in relapsed/refractory
AML. The U.S. Food and Drug Administration granted uproleselan
Breakthrough Therapy designation for the treatment of adult AML patients
with relapsed/refractory disease. GlycoMimetics has also completed 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.

Forward-Looking Statements

This press release contains forward-looking statements, including
statements regarding the clinical development and potential utility of
the company's drug candidates. 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 filed with the U.S. Securities and
Exchange Commission (SEC) on March 6, 2018, 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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