- Second half of 2021 remains the target for completion of
enrollment of the GlycoMimetics-sponsored pivotal Phase 3 trial
evaluating uproleselan in patients with relapsed/refractory acute
myeloid leukemia (AML)
- Enrollment in 2021 is expected to support a planned interim
analysis based on event-free survival in the National Cancer
Institute’s (NCI) registration trial evaluating uproleselan in
newly diagnosed AML patients over the age of 60 years and fit for
chemotherapy
- The Company announces plans to take GMI-1687 forward toward an
investigational new drug (IND) filing, with acute treatment of
acute vaso-occlusive crisis (VOC) in outpatient settings as one
possible use. The Company discontinues development of
rivipansel
- Evidence of biologic activity in first patients treated in
Phase 1b study of GMI-1359 in advanced breast cancer has been
submitted to a scientific meeting for presentation
- Hosting a conference call and webcast today at 8:30 a.m.
ET
GlycoMimetics, Inc. (Nasdaq: GLYC) today reported its financial
results for the fourth quarter and year ended December 31, 2020,
and highlighted recent Company events, including several
accomplishments reported to date in 2021. Cash and cash equivalents
at December 31, 2020 were $137.0 million.
“During 2020, we remained on track to complete enrollment of our
uproleselan pivotal trial in the second half of 2021. Uproleselan
continues to have strong support from collaborators working with us
in the clinical and preclinical arenas. We believe this broad-based
support for uproleselan reflects confidence in our approach to
establish this product candidate as a potential foundational
therapy across the spectrum of AML. In addition, the Chinese
regulatory authority granted Breakthrough Therapy designation for
uproleselan for the treatment of relapsed/refractory AML,
complementing a prior designation by the FDA. We will seek to
demonstrate in both ongoing and new clinical trials that
uproleselan in combination with standard treatments may both extend
survival and ameliorate the severe side effects experienced by
cancer patients,” commented Rachel King, Chief Executive
Officer.
“December’s ASH meeting gave us an opportunity to share an
in-depth understanding of the rivipansel Phase 3 and subsequent
Open Label Extension (OLE) data demonstrating the key role of
E-selectin and importance of early treatment in VOC. Nevertheless,
based on input from the FDA with respect to rivipansel as well as
input from key opinion leaders in sickle cell disease, we intend to
focus development in this setting on our GMI-1687 product
candidate,” she added. “We believe that development of GMI-1687
will be a better option than additional clinical work on
rivipansel. This is particularly important since the care of
individuals with sickle cell disease has continued to shift to the
outpatient setting, a trend which has accelerated during the
pandemic. As a potentially subcutaneously available compound,
GMI-1687 may be ideally suited to this changing landscape, and we
have, therefore, initiated IND-enabling work with the compound. Our
current cash position provides a runway into the fourth quarter of
2022 and through several key milestones in the uproleselan program,
based on our current plan.”
Operational Highlights
Uproleselan
- GlycoMimetics’ pivotal Phase 3 trial in relapsed/refractory AML
continued to enroll patients in the U.S., Australia and in Europe
at a steady pace in the fourth quarter of 2020. With momentum
carrying into 2021 and building further with newly added sites, the
Company reiterates its projection that enrollment will be completed
in the second half of 2021.
- In parallel, the NCI-sponsored Phase 3 clinical trial, which is
designed to evaluate uproleselan in newly diagnosed older adults
with AML who are fit for chemotherapy, has continued to enroll
patients. Based on the NCI’s public disclosures, the Company
anticipates the trial will achieve enrollment of the initial 262
patients necessary for the interim event-free survival assessment
before the 2021 year-end.
- Apollomics, our exclusive collaborator for development and
commercialization of uproleselan in Greater China, received
Breakthrough Therapy designation from the China National Medical
Products Administration (NMPA) in early 2021.
- Uproleselan was featured in December 2020 at the Annual Meeting
of the American Society of Hematology (ASH), in a presentation by
the MD Anderson Cancer Center Department of Leukemia. Specifically,
new preclinical data were presented elucidating how inhibiting
E-selectin with uproleselan overcomes microenvironment-mediated
resistance to venetoclax/HMA therapy, resulting in prolonged
survival. We are now working actively toward exploring this
combination through an investigator-sponsored clinical trial.
GMI-1687
- At the Annual Scientific Conference on Sickle Cell and
Thalassemia (ASCAT) meeting in October and at the ASH meeting in
December, GlycoMimetics gave oral presentations on the effects of
GMI-1687 in two separate preclinical models of VOC. These
presentations highlighted the drug candidate’s ability to prevent
sickle red blood cell adherence to inflamed vasculature, inhibit
vessel occlusion and restore normal blood flow within 90 minutes of
administration. Suitable for subcutaneous dosing, the data support
the development of GMI-1687 as a fast-acting, E-selectin inhibitor
that could potentially be self-administered at the time of VOC
onset to obviate the need for opioids, acute care visits and
inpatient hospitalization.
- In 2020, the Company initiated an IND-enabling program with
sickle cell disease VOC as a potential lead indication.
Rivipansel
- GlycoMimetics completed and presented at the December ASH
meeting a comprehensive review of the Phase 3 RESET data and for
the first time, results of the OLE study. The analyses demonstrated
that administration of rivipansel early during the cascade of VOC
(within approximately 26-30 hours of the onset of VOC) resulted in
statistically significant improvement on key clinical outcomes,
particularly in the pediatric subgroup.
- Today, GlycoMimetics announced that rather than continuing to
focus on rivipansel, it plans to take GMI-1687 forward toward an
IND, with treatment of acute VOC as one possible use.
GMI-1359
- The Company has observed evidence of biologic activity in the
initial patients treated in a Phase 1b proof-of-concept trial. The
analyses are based on pharmacodynamic biomarkers, and have been
submitted for presentation at a major medical meeting.
Executive Management
Team
- The Company announced the promotion of Eric Feldman, M.D., to
Senior Vice President and Chief Medical Officer in February
2021.
Fourth Quarter and Year-end 2020
Financial Results:
- Cash position: As of December 31, 2020, GlycoMimetics had cash
and cash equivalents of $137.0 million as compared to $158.2
million as of December 31, 2019.
- Revenue: During the year ended December 31, 2020, the Company
recognized revenue of $10.2 million, all of which was the result of
payments received under our agreements with Apollomics for the
development and commercialization of uproleselan and GMI-1687 in
Greater China. There was no revenue recognized during the year
ended December 31, 2019.
- R&D Expenses: The Company’s research and development
expenses increased to $11.7 million for the quarter ended December
31, 2020 as compared to $11.5 million for the fourth quarter of
2019 due to higher clinical development expenses. Clinical expenses
were higher as a result of increased number of sites and enrollment
in the Company’s ongoing global Phase 3 clinical trial of
uproleselan in individuals with relapsed/refractory AML. Research
and development expenses for the year ended December 31, 2020
decreased to $44.9 million as compared to $47.0 million in the
prior year. The decrease in expenses was due to lower raw material
purchases in the year ended December 31, 2020 offset by the higher
clinical development expenses resulting from the increased number
of sites and enrollment in the Company’s ongoing global Phase 3
clinical trial of uproleselan in individuals with
relapsed/refractory AML.
- G&A Expenses: The Company’s general and administrative
expenses increased to $4.0 million for the quarter ended December
31, 2020 as compared to $3.9 million for the fourth quarter of
2019. General and administrative expenses for the year ended
December 31, 2020 increased to $16.7 million as compared to $14.4
million in the prior year. These increases were due to a
significant increase in the cost of directors and officers
liability insurance in 2020 as compared to 2019. In addition,
personnel-related and stock-based compensation expenses increased
due to additional headcount, annual salary adjustments and
retention bonuses. Other expenses decreased as compared to the
prior year due to lower travel, meals and conference registration
expenses as a result of travel restrictions due to the COVID-19
pandemic.
- Shares Outstanding: Shares of common stock outstanding as of
December 31, 2020 were 49,017,622.
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 1034166.
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
1034166.
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 NMPA 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 has also 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 Rivipansel
Rivipansel, the Company’s wholly-owned glycomimetic drug
candidate that binds to all three members of the selectin family
(E-, P- and L-selectin), was GlycoMimetics’ first drug candidate to
enter clinical development. Rivipansel has been granted a Rare
Pediatric Disease designation for treatment of sickle cell disease
in patients 18 years old and younger, and has also received Orphan
Drug and Fast Track designations from the FDA. GlycoMimetics is
discontinuing development of rivipansel as a treatment for VOC of
sickle cell disease.
About GMI-1359
GMI-1359 is designed to simultaneously inhibit both E-selectin
and CXCR4. E-selectin and CXCR4 are both 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 has completed a Phase 1 clinical trial in healthy
volunteers. A Phase 1b clinical study is underway in breast cancer
patients and is designed to enable investigators to identify an
effective dose of the drug candidate and to generate initial
biomarker data around the drug’s activity. 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
GMI-1359, a combined CXCR4 and E-selectin antagonist, also a
wholly-owned drug candidate,. 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, the potential benefits and impact of the Company’s
drug candidates and the Company’s expectations regarding its cash
runway. 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 December
31,
Year ended December 31,
2020
2019
2020
2019
(Unaudited)
Revenue
$
163
$
-
$
10,163
$
-
Costs and expenses: Research and
development expense
11,720
11,467
44,929
47,029
General and administrative expense
4,011
3,868
16,743
14,360
Total costs and expenses
15,731
15,335
61,672
61,389
Loss from operations
(15,568
)
(15,335
)
(51,509
)
(61,389
)
Interest income
5
609
482
3,497
Net loss and net comprehensive loss
$
(15,563
)
$
(14,726
)
$
(51,027
)
$
(57,892
)
Net loss per common share
– basic and diluted
$
(0.32
)
$
(0.34
)
$
(1.12
)
$
(1.34
)
Weighted average common shares – basic and diluted
47,995,898
43,373,753
45,721,139
43,254,782
GlycoMimetics,
Inc.Balance Sheet Data(In thousands)
December 31,2020 December 31,2019
Cash and cash equivalents
$
137,035
$
158,201
Working capital
125,845
151,577
Total assets
142,832
167,970
Total liabilities
14,613
13,769
Total stockholders' equity
128,219
154,201
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210302005336/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
GlycoMimetics (NASDAQ:GLYC)
Historical Stock Chart
From Apr 2024 to May 2024
GlycoMimetics (NASDAQ:GLYC)
Historical Stock Chart
From May 2023 to May 2024