GlycoMimetics ends first quarter 2019 with $195.6 million cash

GlycoMimetics ends first quarter 2019 with $195.6 million cash

May 2, 2019 Off By BusinessWire
    • Enrolled first patient in National Cancer Institute (NCI)-sponsored
      Phase 3 trial of uproleselan in older adults with previously untreated
      acute myeloid leukemia (AML)
    • Announced plans to initiate a trial of GMI-1359 in individuals with
      breast cancer in collaboration with the Duke Cancer Institute
    • Established transition plan to new Chairman of Board of Directors

ROCKVILLE, Md.–(BUSINESS WIRE)–GlycoMimetics, Inc. (Nasdaq: GLYC) today reported its financial results
for the quarter ended March 31, 2019 and highlighted recent company
achievements. Quarter-end cash was $195.6 million.

“The first quarter of 2019 was one of focused activity in the clinical
development arena. We continued to identify and initiate new sites and
enroll participants in our Company-sponsored Phase 3 trial in relapsed
or refractory AML patients. We also worked closely with our two
consortia partners to expand our late-stage uproleselan program,
culminating in our announcement that the NCI consortium dosed its first
patient in its trial in late April. During the same period, we worked
with clinical collaborators at Duke Cancer Institute to plan our next
trial for GMI-1359, a dual antagonist of E-selectin and CXCR-4, and
defined individuals with breast cancer and bone metastases as our
initial target study population,” said Rachel King, GlycoMimetics Chief
Executive Officer.

Key First-Quarter 2019 and Recent Operational Highlights:

    • The GlycoMimetics-sponsored pivotal Phase 3 trial of uproleselan in
      relapsed/refractory AML continues to enroll patients in the US and
      Australia. Clinical sites across the US, Europe, Canada and Australia
      continue to be identified and activated.
    • The NCI-sponsored clinical trial evaluating uproleselan in newly
      diagnosed older adults with AML who are fit for chemotherapy has
      initiated enrollment.
    • Study start-up activities continued for the collaborative Haemato
      Oncology Foundation for Adults in the Netherlands (HOVON) European
      study of uproleselan in newly diagnosed patients unfit for
      chemotherapy.
    • The Company announced plans to initiate a proof-of-concept clinical
      trial of GMI-1359 in individuals with breast cancer whose tumors have
      spread to bone. The trial will evaluate safety and biomarkers of
      cancer cell mobilization in individuals with hormone receptor positive
      metastatic breast cancer.
    • Data was published in Nature Cell Biology that strongly
      suggests that E-selectin is key to tumor growth and metastasis to bone
      and provides further support for the upcoming clinical trial of
      GMI-1359 in individuals with metastatic breast cancer.
    • Dr. Eric Feldman has joined the GlycoMimetics executive team as Vice
      President, Clinical Development, and Christian Dinneen-Long has joined
      as Vice President, Corporate Counsel.
    • A planned transition is taking place within the Company’s Board of
      Directors. Current Board Chair Jim Barrett, who has held the role
      since the Company’s inception, will not seek re-election as he retires
      from the Board of Directors and scales back participation in several
      organizations. Current GlycoMimetics Board Member Tim Pearson will
      become Board Chair as of the close of the Company’s annual meeting on
      May 17, 2019.

First Quarter 2019 Financial Results:

    • Cash position: As of March 31, 2019, GlycoMimetics had cash and cash
      equivalents of $195.6 million as compared to $209.9 million as of
      December 31, 2018.
    • R&D Expenses: The Company’s research and development expenses
      increased to $11.8 million for the quarter ended March 31, 2019 as
      compared to $9.0 million for the first quarter of 2018. These
      increases were primarily the result of the Company’s Phase 3 clinical
      trial in relapsed or refractory AML patients.
    • G&A Expenses: The Company’s general and administrative expenses
      increased to $3.4 million for the quarter ended March 31, 2019 as
      compared to $2.9 million for the quarter ended March 31, 2018. The
      increase was due to higher patent, legal and non-cash stock-based
      compensation expenses.
    • Shares Outstanding: Shares outstanding as of March 31, 2019 were
      43,180,169.

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) and entering
passcode 6537429. 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 or 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 or refractory disease. GlycoMimetics is
progressing a comprehensive development program across the clinical
spectrum of AML.

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 vaso-occlusive crisis (VOC) of sickle cell disease
(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 Inc., the exclusive
licensee of rivipansel for clinical development and worldwide
commercialization, is conducting a Phase 3 clinical trial for rivipansel
in SCD.