GlycoMimetics Announces Strategic Review and Corporate Restructuring Plan
25 Luglio 2024 - 3:00PM
Business Wire
- After meeting with the U.S. Food and Drug Administration (FDA),
it has been determined that the regulatory path forward for
uproleselan in relapsed and refractory (R/R) Acute Myeloid Leukemia
(AML) would require an additional clinical trial
- The Company will conduct a strategic review of the business
seeking to maximize shareholder value, including the evaluation of
potential business development opportunities for uproleselan and
GMI-1687 to ensure their continued advancement
- The Company is advancing discussions with the National Cancer
Institute (NCI) and Alliance for Clinical Trials in Oncology for
the ongoing Phase 2/3 study of uproleselan in newly diagnosed AML
patients
- The Company will reduce its workforce by approximately 80%;
cash and cash equivalents are expected to fund the company into the
second quarter of 2025
GlycoMimetics, Inc. (Nasdaq: GLYC), a late clinical-stage
biotechnology company discovering and developing glycobiology-based
therapies for cancers and inflammatory diseases, today announced
the initiation of a strategic review and corporate restructuring
plan. GlycoMimetics has engaged Lucid Capital Markets to act as a
strategic advisor in the process.
“We are committed to acting in the best interests of patients,
employees and shareholders. Given our organization’s cash
resources, we plan to explore a range of potential strategic
alternatives and seek to deliver value to our shareholders and find
avenues that allow uproleselan and GMI-1687 to build upon their
clinical promise, including in the ongoing NCI Phase 2/3 study of
uproleselan in newly diagnosed AML patients,” said Harout
Semerjian, Chief Executive Officer of GlycoMimetics. “We believe
both drug candidates have the potential to address significant
unmet needs in their respective therapeutic areas and we are
focused on finding organizations to advance these programs. We are
proud of our team’s dedication to improving the lives of patients
and are thankful for their hard work progressing uproleselan and
GMI-1687.”
The Company will evaluate strategic alternatives and no
timetable has been set for the conclusion of the strategic review
or the consummation of any such strategic transaction.
GlycoMimetics had cash and cash equivalents of approximately
$31.3 million as of March 31, 2024. Based on the corporate
restructuring and streamlining of operations, the Company expects
to significantly reduce future operating expenses and extend its
cash runway into the second quarter of 2025.
NCI Phase 2/3 Study of Uproleselan in Frontline AML
The National Cancer Institute (NCI) and the Alliance for
Clinical Trials in Oncology are conducting an adaptive Phase 2/3
study of uproleselan in adults with newly diagnosed AML who are 60
years or older and fit for intensive chemotherapy. Their
randomized, controlled study is evaluating the addition of
uproleselan to a standard cytarabine / daunorubicin regimen (7+3)
versus chemotherapy alone. The Phase 2 portion of the study
completed enrollment of 267 patients in December 2021.
About AML
AML is the most common acute leukemia in adults. A cancer of the
bone marrow, nearly 21,000 people in the United States are
diagnosed with AML each year. Despite the availability of multiple
treatments, disease prognosis is poor, and new treatment options
are needed to improve outcomes. Newly diagnosed AML has the lowest
5-year survival rate of all leukemias at 31.7%. The five-year
survival rate for people with relapsed/refractory disease is only
10%.
About Uproleselan
Discovered and developed by GlycoMimetics, uproleselan (yoo’ pro
le’se lan) is an investigational, first-in-class E-selectin
antagonist. GlycoMimetics has received Breakthrough Therapy and
Fast Track designations from the U.S. Food and Drug Administration
(FDA) and Breakthrough Therapy designation from the Chinese
National Medical Products Administration for uproleselan as a
potential treatment for adult AML patients with relapsed or
refractory disease. E-selectin is a leukocyte adhesion molecule
constitutively expressed on endothelial cells of the vasculature
and bone marrow. In AML, there is evidence that E-selectin–ligand
interaction between endothelial cells in the protective niche of
the Bone Marrow microEnvironment (BME) and leukemic stem cells and
blasts promotes leukemic cell survival and hides them from AML
therapies. Uproleselan is designed to disrupt E-selectin binding
and prevent leukemic myeloid cells using the protective niche of
the BME.
About GMI-1687
Discovered and developed by GlycoMimetics, GMI-1687 is a highly
potent E-selectin antagonist that is bioavailable after
subcutaneous administration. This second-generation compound has
potential application in oncology and inflammatory diseases, and
the company’s initial clinical development has focused on
sickle-cell disease (SCD). E-selectin is believed to play a major
role in vaso-occlusive events (VOEs), a group of acute
complications that are associated with SCD and include
vaso-occlusive pain crises, acute chest syndrome (ACS), stroke, and
splenic sequestration. Administration of GMI-1687 by subcutaneous
injection, if successfully developed in the clinic, may enable this
study drug to be approved as a patient-controlled, point-of-care
treatment option.
About GlycoMimetics, Inc.
GlycoMimetics is a late clinical-stage biotechnology company
discovering and developing glycobiology-based therapies for
cancers, including AML, and for inflammatory diseases. The
company’s scientific approach is based on an understanding of the
role that carbohydrates play in cell recognition. Its specialized
chemistry platform can be used to discover small molecule drugs,
known as glycomimetics, that alter carbohydrate-mediated
recognition in diverse disease states, including cancers and
inflammation. The company’s goal is to develop transformative
therapies for diseases with high unmet medical need. GlycoMimetics
is headquartered in Rockville, MD in the BioHealth Capital Region.
Learn more at www.glycomimetics.com.
Forward-Looking Statements
This press release contains forward-looking statements. These
forward-looking statements may include, but are not limited to,
statements regarding the conduct of a strategic review of its
business, the implementation of a corporate restructuring plan, the
extension of its cash resources, and the potential benefits and
impact of its product candidates. Actual results may differ
materially from those described 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 27, 2024, the company’s Quarterly Report
on Form 10-Q filed with the SEC on May 9, 2024, 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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version on businesswire.com: https://www.businesswire.com/news/home/20240725473857/en/
Investor Contact: Argot Partners Leo Vartorella
212-600-1902 Glycomimetics@argotpartners.com
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