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GlycoMimetics Reports Second Quarter 2018 Results and Highlights Recent Company Achievements

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  • Announced a Cooperative Research and Development Agreement (CRADA) to
    collaborate with the National Cancer Institute (NCI) and the Alliance
    for Clinical Trials in Oncology to fund a planned pivotal Phase 3
    trial to evaluate uproleselan (GMI-1271) in older, newly diagnosed
    acute myeloid leukemia (AML) patients eligible for intensive
    chemotherapy
  • Continued to select new clinical sites and ready previously-selected
    sites for the company's sponsored Phase 3 pivotal trial
  • Presented preclinical research at the American Association for Cancer
    Research (AACR) Annual Meeting 2018 in Chicago suggesting the
    potential anti-cancer activity of two of GlycoMimetics' drug
    candidates, uproleselan and GMI-1359, as treatments for AML,
    metastasis in osteosarcoma and other cancers

GlycoMimetics, Inc. (NASDAQ:GLYC) today reported its financial results
for the second quarter ended June 30, 2018 and highlighted recent
company achievements. Quarter-end cash at June 30, 2018 was $229.4
million.

"Our second-quarter 2018 accomplishments reflect significant progress as
we finalized our plans to conduct a comprehensive Phase 3 development
program for uproleselan across the spectrum of AML. With our
announcement in May of an NCI CRADA, in addition to the previously
announced trial in Europe sponsored by the prestigious HOVON consortium
and our own sponsored registration trial, we are now planning three
separate randomized, controlled trials, which we believe should provide
clear efficacy and safety outcome measures in each of settings being
evaluated," said Rachel King, GlycoMimetics Chief Executive Officer.
"The unique mechanism of action of uproleselan allows for the potential
treatment of not only relapsed/refractory AML patients, but also older,
newly diagnosed AML patients who are considered to be either fit or
unfit for intensive chemotherapy. If successful, we believe that the
combination of these trials could position us to offer a new standard
treatment across the continuum of care in AML."

Key Operational Highlights for the Second Quarter of 2018:

  • The company's agreement with the NCI, part of the National Institutes
    of Health (NIH), provides for GlycoMimetics to collaborate with both
    the NCI and the Alliance for Clinical Trials in Oncology to conduct a
    randomized, controlled clinical trial testing the addition of
    uproleselan to a standard cytarabine/daunorubicin regimen (7&3) in
    older adults with previously untreated AML who are eligible for
    intensive chemotherapy. The trial will be funded by the NCI.
    GlycoMimetics will provide uproleselan as well as financial support to
    augment data analysis and monitoring. Geoffrey Uy, M.D., Associate
    Professor of Medicine, Bone Marrow Transplantation and
    Leukemia, Washington University School of Medicine in St. Louis, will
    lead this Phase 3 trial. The primary endpoint will be overall
    survival, with a planned interim analysis based on event-free survival
    (EFS) after the first 250 patients have been enrolled in the study.
  • At the AACR annual meeting, the company highlighted data from
    preclinical models of selected cancers in which uproleselan and
    GMI-1359, a dual antagonist of E-selectin and CXCR4, exhibited
    anti-cancer activity. Key findings from the preclinical research
    include:
    • Uproleselan could potentially be used with a hypomethylating
      agent, such as 5-azacitidine, to treat AML patients not healthy
      enough for intensive chemotherapy.
    • GMI-1359 mobilized tumor-reactive T-cells from bone marrow, which
      could enhance effectiveness of treatments despite tumor resistance.
    • Both tumor growth and metastasis of osteosarcoma to lung tissue
      were reduced with GMI-1359 treatment.
  • The company's strategic partner Pfizer continues 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
    has advised GlycoMimetics that enrollment is 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.

Second Quarter 2018 Financial Results:

  • Cash position: As of June 30, 2018, GlycoMimetics had cash and cash
    equivalents of $229.4 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 $9.3 million for the quarter ended June 30, 2018 as
    compared to $5.7 million for the prior year quarter. The increase was
    primarily due to higher manufacturing costs for uproleselan clinical
    supplies as the Company prepares 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. This
    increase was offset in part by a decrease in clinical trial expenses
    as patient enrollment for our Phase 1/2 clinical trial of uproleselan
    was completed in May 2017.
  • G&A Expenses: The Company's general and administrative expenses
    increased to $2.8 million for the quarter ended June 30, 2018 as
    compared to $2.5 million for the prior year quarter. The increase was
    primarily due to higher patent and other legal expenses.
  • Shares Outstanding: Shares outstanding as of June 30, 2018 were
    43,055,424.

The company will host a conference call and webcast tomorrow, Friday,
August 10, 2018, 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 3876308. 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 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 FDA has granted uproleselan
Breakthrough Therapy designation for the treatment of adult AML patients
with relapsed/refractory (R/R) disease. GlycoMimetics plans to implement
a comprehensive development program across the clinical spectrum of AML.
This will include a company sponsored Phase 3 trial in R/R AML and two
consortia-sponsored trials in newly diagnosed patients. One consortium
trial will be sponsored by the NCI and will enroll newly diagnosed
patients fit for intensive chemotherapy. The other trial will be
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. GMI-1359 is currently in
Phase 1 testing 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 has three clinical-stage programs:
rivipansel, uproleselan and GMI-1359. In addition, the company is
researching additional pre-clinical stage compounds based on its
specialized chemistry expertise. 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 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 June 30, Six months ended June 30,
2018 2017 2018 2017
(Unaudited) (Unaudited)
 
Revenue $ - $ - $ - $ -
 
Cost and expenses:
Research and development expense 9,302 5,722 18,324 11,601
General and administrative expense   2,847     2,522     5,702     4,614  
Total costs and expenses   12,149     8,244     24,026     16,215  
 
Loss from operations (12,149 ) (8,244 ) (24,026 ) (16,215 )
 
Other income   870     102     1,234     142  
 
Net loss and comprehensive loss $ (11,279 ) $ (8,142 ) $ (22,792 ) $ (16,073 )
 
 
 
Net loss per share - basic and diluted $ (0.26 ) $ (0.30 ) $ (0.58 ) $ (0.63 )
Weighted average shares - basic and diluted 42,809,840 27,239,902 38,982,965 25,360,167
 
 
 
 
 
GlycoMimetics, Inc.
Balance Sheet Data
(In thousands)
 
 
 
June 30, December 31,
2018 2017
(unaudited)
 
Cash and cash equivalents $ 229,435 $ 123,925
 
Working capital 225,881 119,045
 
Total assets 235,696 128,583
 
Total liabilities 7,701 8,882
 
Stockholders' equity 227,995 119,701

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