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GlycoMimetics Reports Third Quarter 2018 Results and Highlights Recent Company Achievements

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  • Continued to select new clinical sites and ready previously-selected
    sites in the U.S., Europe, Canada and Australia for the
    company-sponsored Phase 3 pivotal trial in relapsed/refractory AML;
    study now open for enrollment
  • Received notice of Japanese patent issuance in August for uproleselan
    (GMI-1271) composition of matter as well as pharmaceutical
    formulations, expiring in December 2032
  • On November 1, announced that six abstracts have been accepted for
    oral and poster presentations at the Annual Meeting of the American
    Society of Hematology (ASH) in December
  • An oral presentation at the Annual ASH meeting provides new and
    updated clinical outcomes data and subgroup analyses which continue to
    demonstrate potential benefit of treatment with uproleselan when added
    to chemotherapy

GlycoMimetics, Inc. (NASDAQ:GLYC) today reported its financial results
for the third quarter ended September 30, 2018 and highlighted recent
company achievements. Quarter-end cash and cash equivalents at September
30, 2018 were $219.8 million.

"During the third quarter, we focused our activity on planning and
initiating GlycoMimetics' comprehensive clinical program to evaluate
uproleselan across the spectrum of AML. We expect to announce enrollment
of the first patient in our own Phase 3 pivotal study of "upro" in
relapsed/refractory patients within a very short period of time, as
initiation activity is well underway at many sites, and enrollment is
now open. Support among investigators for this trial as well as for our
two consortia-led trials is strong. We believe that the data contained
in the abstracts selected for oral and poster presentations at the ASH
meeting reinforce the benefits already shared at prior medical meetings
and bolster our confidence in upro's potential to change the treatment
paradigm in AML, whether patients have AML that is relapsed, refractory,
or newly diagnosed," said Rachel King, GlycoMimetics Chief Executive
Officer.

Key Operational Highlights for the Third Quarter of 2018:

  • The company's strategic partner Pfizer continued to enroll individuals
    with sickle cell disease (SCD) in its Phase 3 clinical study of
    rivipansel for the treatment of vaso-occlusive crisis (VOC). Pfizer
    advised GlycoMimetics in August that enrollment was approximately 75%
    complete and is estimated to be completed in early 2019, with top-line
    data expected to be available in the second quarter of 2019.
  • The GMI-sponsored pivotal Phase 3 trial of uproleselan in
    relapsed/refractory AML is being initiated across multiple
    investigative sites in the US, and work continues to expand to
    clinical sites across Europe, Canada and Australia.
  • Planning advanced for the National Cancer Institute (NCI)
    collaborative study of uproleselan in newly diagnosed patients fit for
    chemotherapy; a protocol including an interim analysis of event-free
    survival was finalized and posted on clinicaltrials.gov.
  • Planning continued for the collaborative Haemato Oncology Foundation
    for Adults in the Netherlands (HOVON) European study of uproleselan in
    newly diagnosed patients unfit for chemo with a goal of trial
    initiation in 2019.

Third Quarter 2018 Financial Results:

  • Cash position: As of September 30, 2018, GlycoMimetics had cash and
    cash equivalents of $219.8 million as compared to $123.9 million as of
    December 31, 2017. In March 2018, GlycoMimetics completed a public
    offering of 8,050,000 shares of common stock, yielding net proceeds of
    $128.4 million.
  • R&D Expenses: The Company's research and development expenses
    increased to $9.7 million for the quarter ended September 30, 2018 as
    compared to $5.8 million for the prior year quarter. The increase was
    primarily due to an increase in clinical trial expenses related to the
    start-up of the Phase 3 clinical trial of uproleselan and higher
    manufacturing expenditures for uproleselan clinical supplies for our
    planned Phase 3 clinical trial and to meet our supply obligations for
    clinical trials of uproleselan conducted by or in collaboration with
    third parties.
  • G&A Expenses: The Company's general and administrative expenses
    increased to $2.8 million for the quarter ended September 30, 2018 as
    compared to $2.4 million for the prior year quarter. The increase was
    primarily due to higher patent and other legal expenses.
  • Shares Outstanding: Shares outstanding as of September 30, 2018 were
    43,137,227.

The company will host a conference call and webcast today at 8:30 a.m.
ET. The dial-in number for the conference call is (844) 413-7154
(U.S. and Canada) or (216) 562-0466 (international) with passcode
9176334. 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.

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 Rivipansel

Rivipansel, the most advanced drug candidate in the GlycoMimetics
pipeline, is a glycomimetic drug candidate that acts as a pan-selectin
antagonist, meaning it binds to all three members of the selectin family
– E-, P- and L-selectin. The first potential indication for rivipansel
is VOC of SCD, one of the most severe complications of SCD which can
result in acute ischemic organ injury at one or more sites. By reducing
cell adhesion, activation and inflammation that are believed to
contribute to reduced blood flow through the microvasculature during
VOC, GlycoMimetics believes that rivipansel could be the first drug to
interrupt the underlying cause of VOC, thereby potentially enabling
patients to leave the hospital more quickly. Pfizer is conducting a
Phase 3 clinical trial for rivipansel in SCD.

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
multiple myeloma (MM) or in solid tumors that metastasize to the bone,
such as prostate cancer and breast cancer. GlycoMimetics has completed a
Phase 1 clinical trial of GMI-1359 in healthy volunteers.

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, as well in two consortia sponsored trials in newly diagnosed
AML. The FDA granted uproleselan Breakthrough Therapy Designation
for the treatment of adult acute myeloid leukemia (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.

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 enrollment in and conduct of clinical trials, the presentation
of clinical data, and expiration of issued patents. 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.

       
GlycoMimetics, Inc.
Condensed Statements of Operations
(In thousands, except share and per share data)
 
 
Three months ended September 30,   Nine months ended September 30,
2018 2017 2018 2017
(Unaudited) (Unaudited)
 
Revenue $ - $ - $ - $ -
 
Cost and expenses:
Research and development expense 9,729 5,780 28,053 17,380
General and administrative expense   2,790     2,402     8,492     7,016  
Total costs and expenses   12,519     8,182     36,545     24,396  
 
Loss from operations (12,519 ) (8,182 ) (36,545 ) (24,396 )
 
Other income   944     232     2,178     373  
 
Net loss and comprehensive loss $ (11,575 ) $ (7,950 ) $ (34,367 ) $ (24,023 )
 
 
 
Net loss per share - basic and diluted $ (0.27 ) $ (0.24 ) $ (0.85 ) $ (0.86 )
Weighted average shares - basic and diluted 43,069,282 32,724,010 40,345,071 27,814,781
 
   
GlycoMimetics, Inc.
Balance Sheet Data
(In thousands)
 
 
 
September 30, December 31,
2018 2017
(unaudited)
 
Cash and cash equivalents $ 219,829 $ 123,925
 
Working capital 216,000 119,045
 
Total assets 225,170 128,583
 
Total liabilities 7,074 8,882
 
Stockholders' equity 218,096 119,701
 

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