GlycoMimetics Reports Highlights and Financial Results for Second Quarter 2023
02 Agosto 2023 - 8:00AM
Business Wire
- Topline results from pivotal Phase 3 study of uproleselan in
relapsed/refractory (R/R) Acute Myeloid Leukemia (AML) expected by
end of Q2 2024 after addition of time-based analysis option
- U.S. Food and Drug Administration (FDA) agrees to initial
Pediatric Study Plan (iPSP) for uproleselan, and National Cancer
Institute (NCI) agrees to sponsor pediatric Phase 1/2 study in
acute AML
- First pediatric patient dosed in separate
investigator-initiated Phase 1/2 study of uproleselan combined with
pre-stem cell transplant conditioning regimen for
chemotherapy-resistant AML
- Clinical pipeline expanding with planned initiation of
first-in-human Phase 1a study for GMI-1687 in Q3 2023
- Conference call and webcast today at 8:30 a.m. ET
GlycoMimetics, Inc. (Nasdaq: GLYC), a late clinical-stage
biotechnology company discovering and developing glycobiology-based
therapies for cancers and inflammatory diseases, today reported its
financial results and highlights for the second quarter ended June
30, 2023. Cash and cash equivalents as of June 30, 2023 were $58.0
million.
“With the addition of a time-based analysis option to our
pivotal Phase 3 study, we look forward to reporting topline
uproleselan results in R/R AML by the end of Q2 2024. This readout
will draw from a clinically mature dataset with more than three
years of median follow-up and can potentially bring us closer to
delivering this therapy to patients in need of new treatment
options,” said Harout Semerjian, Chief Executive Officer of
GlycoMimetics. “We continue to execute our broad development
strategy for uproleselan while we explore potential benefit in AML
patients of all ages as evidenced by the FDA agreement on the
pediatric study plan as well as the NCI sponsored, and investigator
initiated pediatric studies. In addition to these advances, we are
excited to expand our clinical pipeline and move GMI-1687, a novel,
highly potent E-selectin antagonist into first-in-human studies. We
look forward to initiating our Phase 1a study in the coming
weeks.”
Operational Highlights
- In June 2023, GlycoMimetics announced FDA clearance of a
protocol amendment to the company’s pivotal Phase 3 study of
uproleselan for R/R AML. This amendment will allow conduct of a
time-based analysis of the primary endpoint of overall survival
after a defined cutoff date, if the 295 survival events of the
originally planned event-driven analysis have not been observed by
that date. With the addition of a time-based analysis, the company
now expects to report topline results by the end of Q2 2024.
- The NCI Alliance for Clinical Trials in Oncology will conduct a
planned interim analysis of event-free survival in 267 patients
randomized to its Phase 2/3 clinical trial (NCI protocol A041701)
evaluating uproleselan in newly diagnosed older adults with AML who
are fit for chemotherapy. Enrollment of the Phase 2 portion of the
study was completed in December of 2021. When available, the
company will share these results.
- In May 2023, FDA agreed to the initial Pediatric Study Plan
(iPSP) submitted by GlycoMimetics. As part of the iPSP, NCI has
agreed to sponsor a Phase 1/2 dose escalation study (NCI protocol
PEPN2113) to explore safety and preliminary activity of uproleselan
plus fludarabine and high dose cytarabine (FLA) in pediatric AML
patients after 2 or more prior therapies. The Children’s Oncology
Group will conduct this study. Enrollment in the Phase 1 portion is
open and expected to be up to 18 patients.
- In June, the first pediatric patient was treated with
uproleselan in an investigator-initiated single arm, multi-center
Phase 1/2 study to assess safety and tolerability, as well as
determine a recommended phase 2 dose (RP2D) of uproleselan plus
myeloablative, busulfan-based, pre-transplant conditioning for
treatment of AML. This study, led by John Horan, MD, MPH, of the
Boston Children’s Hospital and Dana Farber Cancer Institute, will
enroll up to 28 patients (Age ≥12 months and ≤ 30 years) and will
also assess preliminary uproleselan efficacy at the RP2D.
- GlycoMimetics plans to initiate in Q3 2023 a Phase 1a study for
GMI-1687 in healthy volunteers. GMI-1687 is a highly potent
E-selectin antagonist that has potential application in
inflammatory diseases with initial focus on sickle cell
disease.
Second Quarter 2023 Financial
Results:
- Cash position: As of June 30, 2023, GlycoMimetics had cash and
cash equivalents of $58.0 million as compared to $47.9 million as
of December 31, 2022.
- R&D Expenses: The Company’s research and development
expenses decreased to $4.1 million for the quarter ended June 30,
2023, as compared to $8.0 million for the same period in 2022. The
decreased expenses were primarily due to lower clinical trial and
development costs related to our global Phase 3 clinical trial of
uproleselan in individuals with R/R AML, which completed enrollment
November 2021.
- G&A Expenses: The Company’s general and administrative
expenses decreased to $4.9 million for the quarter ended June 30,
2023, as compared to $5.5 million for the same period in 2022,
primarily due to lower outside consulting and professional
expenses.
- Shares Outstanding: Shares of common stock outstanding as of
June 30, 2023, were 64,313,333.
The company will host a conference call and webcast today at
8:30 a.m. ET. To access the call by phone, please go to this
registration link, and you will be provided with dial in details.
Participants are encouraged to connect 15 minutes in advance of the
scheduled start time.
A live webcast of the call will be available on the “Investors”
tab on the GlycoMimetics website. A webcast replay will be
available for 30 days following the call.
About Uproleselan
Discovered and developed by GlycoMimetics, uproleselan is an
investigational first-in-class, E-selectin antagonist. Uproleselan
(yoo’ pro le’se lan), currently in a broad Phase 3 development
program in acute myeloid leukemia (AML), has received Breakthrough
Therapy and Fast Track designations from the U.S. FDA and
Breakthrough Therapy designation from the Chinese National Medical
Products Administration for the treatment of adult AML patients
with relapsed or refractory disease. Uproleselan is designed to
block E-selectin binding and stimulation of myeloid cells.
E-selectin is expressed on the surface of blood vessels, and its
binding to myeloid cells confers a pro-survival effect. Uproleselan
is intended to enable a novel approach to disrupting established
mechanisms of leukemic cell resistance.
About GMI-1687
Discovered and developed by GlycoMimetics, GMI-1687 is a highly
potent E-selectin antagonist that has been shown in animal models
to be fully bioavailable following subcutaneous administration. It
is a second-generation compound that has potential application in
inflammatory diseases with initial focus on sickle cell disease
(SCD). E-selectin is believed to play a major role in
vaso-occlusive crisis (VOC), the vascular clots and blockages that
cause pain crises in people living with SCD. The administration of
GMI-1687 via subcutaneous injection, if this treatment method is
successfully developed in the clinic, may enable the drug to
address certain challenges of IV therapies for SCD as well as offer
a potential point-of-care treatment option at the onset of VOC.
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 science is based on an understanding of the role that
carbohydrates play in cell recognition. Its specialized chemistry
platform is being deployed to discover small molecule drugs--known
as glycomimetics--that alter carbohydrate-mediated recognition in
diverse disease states, including cancers and inflammation. As a
leader in this science, GlycoMimetics leverages this unique
approach to advance its pipeline of wholly-owned drug candidates,
with the goal of developing 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 and data from clinical trials,
planned or potential clinical development, regulatory plans and
submissions, and the potential benefits and impact of the company’s
drug 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 29,
2023, 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,
2023
2022
2023
2022
(Unaudited)
(Unaudited)
Revenue from collaboration and
license agreements
$
-
$
75
$
-
$
75
Cost and expenses:
Research and development expense
4,073
7,973
9,491
17,577
General and administrative expense
4,857
5,455
10,380
10,511
Total costs and expenses
8,930
13,428
19,871
28,088
Loss from operations
(8,930
)
(13,353
)
(19,871
)
(28,013
)
Other income
671
86
1,253
93
Net loss and comprehensive loss
$
(8,259
)
$
(13,267
)
$
(18,618
)
$
(27,920
)
Net loss per share - basic and diluted
$
(0.13
)
$
(0.25
)
$
(0.30
)
$
(0.53
)
Weighted-average common shares outstanding – basic and diluted
64,276,184
52,407,347
62,313,155
52,369,369
GlycoMimetics, Inc.
Balance Sheet Data
(In thousands)
June 30,
December 31,
2023
2022
(unaudited)
Cash and cash equivalents
$
58,037
$
47,871
Working capital
53,797
41,834
Total assets
61,822
51,811
Total liabilities
7,021
8,881
Stockholders' equity
54,801
42,930
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version on businesswire.com: https://www.businesswire.com/news/home/20230802607094/en/
Investor Contact: Argot
Partners Leo Vartorella 212-600-1902
Glycomimetics@argotpartners.com
Public Relations Contact:
Geoff Cook 973-652-7929
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