- GlycoMimetics continues to target year-end 2021 for completing
enrollment of the Company-sponsored pivotal trial evaluating
uproleselan in patients with relapsed/refractory acute myeloid
leukemia (AML)
- Enrollment in the Phase 2 portion of the NCI-sponsored Phase
2/3 registration trial evaluating uproleselan in newly diagnosed
AML patients fit for chemotherapy is expected to complete by
year-end 2021 and to support a subsequent interim analysis based on
event-free survival
- The Chinese heath agency granted a Breakthrough Therapy
Designation for uproleselan as a treatment for relapsed or
refractory AML; Apollomics, GlycoMimetics’ exclusive collaborator
for uproleselan in Greater China, announced dosing of the first
patient in its registration program
- Company pipeline continued to advance with presentations of
preclinical data at the 2021 annual meeting of the American
Association for Cancer Research (AACR) as well progress in
IND-enabling studies of GMI-1687
- Hosting a conference call and webcast today at 8:30 a.m.
ET
GlycoMimetics, Inc. (Nasdaq: GLYC) today reported its financial
results for the quarter ended March 31, 2021 and highlighted recent
company events. Cash and cash equivalents at March 31, 2021 were
$132.5 million.
“Our recent achievements, both in our collaboration with
Apollomics and in data presentations at AACR, underscore the
productivity of our pipeline. Working closely with investigators,
regulators and collaborators, we are seeing great enthusiasm for
our lead program, uproleselan, globally. The Chinese health
agency’s granting of a Breakthrough Therapy Designation as well as
Apollomics’ announcement of dosing of the first patient in Greater
China support our outlook for this drug candidate. Complementing
that achievement is our work with uproleselan in the U.S., namely,
continued progress on our own Phase 3 AML trial and that of the
National Cancer Institute, or NCI. Finally, with a focus on the
early results from our GMI-1359 proof-of-concept trial and our
preclinical work in the galectin-3 space, the AACR meeting added
visibility for our pipeline opportunities that have the potential
to address key unmet needs in hematology and beyond,” commented
Rachel King, Chief Executive Officer.
Operational Highlights
Uproleselan
- Enrollment of GlycoMimetics’ pivotal Phase 3 trial in
relapsed/refractory AML continued in the U.S., Australia and Europe
at a steady pace throughout the first quarter of 2021. The Company
continues to be confident that enrollment will be completed by
year-end 2021.
- The pace of enrollment in the NCI-sponsored Phase 2/3
registration trial, designed to evaluate uproleselan in newly
diagnosed older adults with AML who are fit for chemotherapy,
continues to support our expectation that the Phase 2 portion will
complete in 2021, and allow for a subsequent interim Event-Free
Survival analysis of 262 patients.
- Apollomics, our exclusive collaborator for development and
commercialization of uproleselan in Greater China, received
Breakthrough Therapy Designation from the Center for Drug
Evaluation of the China National Medical Products Administration in
early January. In March, Apollomics reported the dosing of its
first patient in a Phase 1 clinical trial that will bridge to a
Phase 3 study in China.
GMI-1359
- In April 2021 at the AACR meeting, Duke University clinicians
reported biologic activity, cell mobilization and immune activation
in the first two patients treated in a proof-of-concept Phase 1b
study to evaluate GMI-1359 in patients with advanced breast cancer
with bone metastases. The ongoing study’s data support the dual
functionality of the compound.
GMI-1687
- The Company announced it would focus on advancing GMI-1687,
designed for subcutaneous dosing, towards an Investigational New
Drug Application and further development in sickle cell disease.
Published preclinical data support the compound’s profile as a
fast-acting, subcutaneously-dosed, E-selectin inhibitor that could
potentially be self-administered at the onset of a vaso-occlusive
crisis to obviate the need for opioids, acute care visits and
inpatient hospitalization.
Executive Management Team
- The Company announced the promotion of Eric Feldman, M.D., to
Senior Vice President and Chief Medical Officer. Dr. Feldman, who
joined the Company two years ago as Vice President, Global Clinical
Development, is internationally recognized for his work in the
development of new therapies for the treatment of leukemias and
related bone marrow disorders.
First Quarter 2021 Financial Results
- Cash position: As of March 31, 2021, GlycoMimetics had cash and
cash equivalents of $132.5 million as compared to $137.0 million as
of December 31, 2020.
- R&D Expenses: The Company’s research and development
expenses decreased to $11.2 million for the quarter ended March 31,
2021 as compared to $12.7 million for the same period in 2020
primarily due to lower clinical assay development and manufacturing
expenses related to uproleselan.
- G&A Expenses: The Company’s general and administrative
expenses decreased to $4.2 million for the quarter ended March 31,
2021 as compared to $4.4 million for the same period in 2020,
primarily due to lower stock-based compensation expense.
- Shares Outstanding: Shares of common stock outstanding as of
March 31, 2021 were 51,539,010.
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 for domestic participants or (216) 562-0466 for
international participants, with participant code 9891637.
Participants are encouraged to connect 15 minutes in advance of the
call to ensure that all callers are able to connect. A webcast
replay will be available via the “Investors” tab on the
GlycoMimetics website for 30 days following the call. A dial-in
phone replay will be available for 24 hours after the close of the
call by dialing (855) 859-2056 for domestic participants and (404)
537-3406 for international participants, participant code
9891637.
About Uproleselan
Discovered and developed by GlycoMimetics, uproleselan is an
investigational, first-in-class, targeted inhibitor of E-selectin.
Uproleselan (yoo’ pro le’ sel an), currently in a comprehensive
Phase 3 development program in AML, has received Breakthrough
Therapy Designation from the U.S. FDA and 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 (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.
About GMI-1687
Discovered and developed by GlycoMimetics, GMI-1687 is a
highly-targeted, highly-potent E-selectin antagonist. It has been
shown in preclinical studies to be bioavailable via subcutaneous
administration. During 2020, data from oral presentations at major
scientific conferences pointed to the potential for a
self-administered drug to treat VOC of sickle cell disease.
Previously, GlycoMimetics demonstrated in preclinical models that
GMI-1687 could be a potentially self-administered drug to be used
in treatment of AML. The investigational drug also represents a
potential life cycle extension opportunity for uproleselan.
About GMI-1359
GMI-1359 is designed to simultaneously inhibit both E-selectin
and CXCR4, which are adhesion molecules involved in tumor
trafficking and metastatic spread. 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, or in solid tumors
that metastasize to the bone, such as prostate cancer and breast
cancer, as well as in osteosarcoma, a rare pediatric tumor
affecting about 900 adolescents a year in the United States.
GMI-1359 completed a Phase 1 clinical trial in healthy volunteers,
and a Phase 1b clinical study designed to enable investigators to
study dose ranging and to generate initial biomarker data around
the drug’s activity in breast cancer patients is in progress. In
the first two patients evaluated, the study showed evidence of
on-target effects, immune-activation and cell mobilization.
GMI-1359 has received Orphan Drug Designation and Rare Pediatric
Disease Designation from the FDA for the treatment of
osteosarcoma.
About GlycoMimetics, Inc.
GlycoMimetics is a biotechnology company with a focus in
hematology-oncology and a pipeline of novel glycomimetic drugs, all
designed to address unmet medical needs resulting from diseases in
which carbohydrate biology plays a key role. GlycoMimetics' drug
candidate, uproleselan, an E-selectin antagonist, was evaluated in
a Phase 1/2 clinical trial as a potential treatment for AML and is
being evaluated across a range of patient populations including in
a Company-sponsored Phase 3 trial in relapsed/refractory AML.
GlycoMimetics has an ongoing Phase 1b clinical trial evaluating its
wholly-owned 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.
Forward-Looking Statements
This press release contains forward-looking statements. These
forward-looking statements include those relating to the planned or
potential clinical development of the Company’s product candidates,
as well as the presentation of data from preclinical studies and
clinical trials, 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 2,
2021, 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 March
31,
2021
2020
(Unaudited)
Revenue
$
1,055
$
9,000
Costs and expenses:
Research and development expense
11,147
12,668
General and administrative expense
4,188
4,440
Total costs and expenses
15,335
17,108
Loss from operations
(14,280
)
(8,108
)
Interest income
6
445
Net loss and comprehensive loss
$
(14,274
)
$
(7,663
)
Net loss per common share – basic and
diluted
$
(0.28
)
$
(0.18
)
Weighted-average common shares – basic and
diluted
50,697,183
43,575,590
GlycoMimetics, Inc. Balance Sheet
Data (In thousands)
March 31, 2021
December 31,
2020
(unaudited)
Cash and cash equivalents
$
132,471
$
137,035
Working capital
122,867
125,845
Total assets
138,020
142,832
Total liabilities
12,896
14,613
Total stockholders' equity
125,124
128,219
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version on businesswire.com: https://www.businesswire.com/news/home/20210503005270/en/
Investor Contact: Shari Annes Phone: 650-888-0902
Email: sannes@annesassociates.com
Media Contact: Jamie Lacey-Moreira Phone: 410-299-3310
Email: jamielacey@presscommpr.com
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