- Enrollment in the Company-sponsored pivotal Phase 3 trial
evaluating uproleselan in patients with relapsed/refractory acute
myeloid leukemia (AML) continues on track, and the Company
reiterates its prior guidance that completion of enrollment for the
Company-sponsored Phase 3 trial is expected in the second half of
2021
- Enrollment also continues in the National Cancer Institute
(NCI)-sponsored Phase 3 trial to evaluate uproleselan for
newly-diagnosed AML patients fit for chemotherapy
- Three oral presentations and two additional poster
presentations at the upcoming American Society of Hematology (ASH)
Annual Meeting will highlight the GlycoMimetics pipeline; multiple
medical meetings in the second half of 2020 feature uproleselan and
rivipansel
- U.S. Food and Drug Administration (FDA) grants Company a Rare
Pediatric Disease designation for rivipansel for treatment of
sickle cell disease
- Company hosting webcast and conference call this morning at
8:30 a.m. ET
GlycoMimetics, Inc. (Nasdaq: GLYC) today reported its financial
results for the third quarter ended September 30, 2020, and
highlighted recent company events. Cash and cash equivalents at
September 30, 2020 were $142.9 million.
“During the third quarter, both late-stage trials of uproleselan
– the Company-sponsored Phase 3 trial in relapsed/refractory AML
patients as well as the NCI’s study in newly-diagnosed AML patients
fit for chemotherapy – progressed in the face of the COVID-19
pandemic, thanks in significant part to the dedicated efforts of
clinicians, statisticians and sites. We continue to project
completion of enrollment in our own Phase 3 trial in the second
half of 2021,” said Rachel King, Chief Executive Officer. “In
sickle cell disease, new post hoc analyses of the rivipansel Phase
3 study provide additional perspective on the potential of our
targeted E-selectin product candidates in early vaso-occlusive
crisis. We have presented findings at multiple sickle cell
congresses, and at the upcoming ASH meeting, we plan to share key
secondary endpoint, subgroup and subset data. We believe these data
provide a foundation for our ongoing evaluation of potential
opportunities in our pipeline for the treatment of acute
vaso-occlusive crisis, or VOC.”
Operational Highlights
Uproleselan
- GlycoMimetics’ ongoing pivotal Phase 3 trial in
relapsed/refractory AML continued to activate clinical sites and
enroll patients in North America, Australia and Europe. While
individual sites were affected earlier in the year by the COVID-19
pandemic, in this quarter patient enrollment returned to forecasted
rates.
- GlycoMimetics reiterated its guidance that completion of
enrollment for its trial was expected in the second half of
2021.
- New preclinical studies support the use of uproleselan with
venetoclax and a hypomethylating agent (HMA) in AML:
- At the upcoming ASH meeting in December 2020, GlycoMimetics
will make an oral presentation of preclinical data from a study in
an AML mouse model that shows the potential benefit of a
combination therapy of uproleselan with venetoclax and HMA.
- At the virtual meeting of the Society of Hematologic Oncology
(SOHO) in September 2020, GlycoMimetics presented preclinical data
showing a statistically significant prolongation of survival in a
patient-derived xenograft (PDX) model.
Rivipansel
- At the Foundation for Sickle Cell Disease Research (FSCDR)
virtual meeting held in September 2020, GlycoMimetics presented for
the first time new efficacy and biomarker data from the post hoc
analysis of the Phase 3 RESET trial that showed statistically
significant improvements for patients treated early in crisis
(within 26.4 hours of onset of pain) in the primary efficacy
endpoint of time to readiness for discharge compared to placebo.
This primary endpoint analysis demonstrated p=0.03, and median
improvement of 56.3 hours compared to placebo.
- At the Annual Scientific Conference on Sickle Cell and
Thalassaemia (ASCAT) in October 2020, a GlycoMimetics’ poster
highlighted new pediatric and other key secondary endpoint
subset/subgroup efficacy and biomarker data from the Phase 3 RESET
trial.
- Accepted for oral presentation at the ASH meeting is an
abstract also presenting pediatric and secondary endpoint data from
the post hoc analysis of the Phase 3 RESET trial. These data as
well as biomarker data show the potential benefits conferred when
rivipansel is used to treat patients early in the VOC pain
crisis.
- FDA granted GlycoMimetics a Rare Pediatric Disease designation
for rivipansel for treatment of sickle cell disease.
- Based upon its review of the emerging Phase 3 rivipansel data
set, GlycoMimetics is engaging with the FDA to identify what, if
any, next steps to take, with a focus on determining if there is a
potential streamlined path forward for this product candidate in
sickle cell disease.
GMI-1687
- Building on clinical data for rivipansel disclosed at the FSCDR
meeting in September and at ASCAT in October, GlycoMimetics also
gave oral presentations at the FSCDR and ASCAT meetings reporting
on preclinical data highlighting GMI-1687 in animal models of VOC.
The data demonstrated its potential efficacy as a subcutaneously
administered treatment for VOC to prevent sickle red blood cell
adherence to inflamed vasculature, inhibit vessel occlusion and
restore normal blood flow.
- An abstract was accepted for oral presentation at the ASH
meeting in December 2020 on the product candidate’s potential for
intravenous and subcutaneous administration to restore blood flow.
A mouse model of VOC sickle cell disease will be highlighted.
Third Quarter 2020 Financial Results:
- Cash position: As of September 30, 2020, GlycoMimetics had cash
and cash equivalents of $142.9 million as compared to $158.2
million as of December 31, 2019. During the quarter, the Company
received a $1 million clinical development milestone from
Apollomics pursuant to the Company’s collaboration and license
agreement for the development and commercialization of uproleselan
and GMI-1687 in Mainland China, Hong Kong, Macau and Taiwan.
- R&D Expenses: The Company’s research and development
expenses were $10.7 million for each of the quarters ended
September 30, 2020 and 2019. The Company’s research and development
expenses decreased to $33.2 million for the nine months ended
September 30, 2020 as compared to $35.6 million for the same period
in 2019. Manufacturing and formulation expenses decreased in the
three and nine months ended September 30, 2020 as compared to the
same periods in 2019 as a result of lower raw material costs
purchased in 2020. These decreases were offset by higher clinical
expenses due to the increased enrollment in the ongoing global
Phase 3 clinical trial of uproleselan in individuals with
relapsed/refractory AML and the Phase 2/3 clinical trial being
conducted by the National Cancer Institute in 2020 as compared to
2019. Contract research services, consulting and other costs were
lower in the three and nine months ended September 30, 2020 as
research activities were affected at outside universities and
travel by research and development personnel was largely eliminated
due to the COVID-19 pandemic.
- G&A Expenses: The Company’s general and administrative
expenses increased to $4.1 million for the third quarter ended
September 30, 2020 as compared to $3.4 million for the third
quarter of 2019. General and administrative expenses for the nine
months ended September 30, 2020 increased to $12.7 million as
compared to $10.5 million in the same period in 2019.
Personnel-related expenses increased due to additional general and
administrative headcount, annual salary adjustments awarded in the
first quarter of 2020 and retention bonuses. Patent, legal fees,
consulting and other professional expenses, including director and
officer’s insurance premiums, increased as compared to 2019. Other
general and administrative expenses decreased for the three and
nine months ended September 30, 2020, as compared to the same
periods in 2019, due to lower travel, meals and conference
registration expenses as a result of travel restrictions imposed
during the COVID-19 pandemic.
- Shares Outstanding: Shares of common stock outstanding as of
September 30, 2020 were 47,828,831
The Company will host a conference call and webcast today at
8:30 a.m. ET. The conference call will be broadcast live in
listen-only mode on the “Investors” tab of the Company’s website at
https://ir.glycomimetics.com/investor-relations. For those who wish
to ask questions, 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 3073766.
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
3073766.
About Uproleselan (GMI-1271)
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 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 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. After the Phase 3 RESET trial conducted
by Pfizer, GlycoMimetics’ former collaborator, did not meet its
primary or key secondary efficacy endpoints in 2019, new efficacy
data from a post hoc analysis of rivipansel were published in June
2020 and subsequently presented at the Foundation for Sickle Cell
Disease Research Meeting in September 2020. GlycoMimetics is
engaging with the FDA to identify what, if any, next steps to take,
with a focus on determining if there is a potential streamlined
path forward for this asset in sickle cell disease.
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. At the 2018 Annual Meeting of the American Society
of Hematology, data presented in a poster about GMI-1687 pointed to
the potential for a life-cycle extension for GlycoMimetics’
uproleselan. The investigational drug has also been shown to
represent a more highly-potent and subcutaneously bioavailable
potential life-cycle extension for rivipansel.
About GlycoMimetics, Inc.
GlycoMimetics is a biotechnology company with two late-stage
clinical development programs 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 a Company-sponsored Phase 3 trial
in relapsed/refractory AML under Breakthrough Therapy designation.
Rivipansel, a pan-selectin antagonist, is being explored for use in
treatment of acute VOC in sickle cell disease. GlycoMimetics has
also completed a Phase 1 clinical trial with another 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,
including expectations with regard to the enrollment of patients in
its ongoing Phase 3 clinical trial of uproleselan and the Company’s
engagement with regulatory authorities, 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 February 28, 2020, 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 September
30,
Nine months ended September
30,
2020
2019
2020
2019
(Unaudited)
(Unaudited)
Revenue
$
1,000
$
-
$
10,000
$
-
Cost and expenses: Research and development
expense
10,670
10,724
33,209
35,562
General and administrative expense
4,058
3,381
12,732
10,492
Total costs and expenses
14,728
14,105
45,941
46,054
Loss from operations
(13,728)
(14,105)
(35,941)
(46,054)
Other income
5
853
477
2,888
Net loss and comprehensive loss
$
(13,723)
$
(13,252)
$
(35,464)
$
(43,166)
Net loss per share - basic and diluted
$
(0.29)
$
(0.31)
$
(0.79)
$
(1.00)
Weighted average shares - basic and diluted
47,511,818
43,295,397
44,962,886
43,215,125
GlycoMimetics, Inc.
Balance Sheet Data
(In thousands)
September 30, December 31,
2020
2019
(unaudited) Cash and cash equivalents
$
142,870
$
158,201
Working capital
135,825
151,577
Total assets
150,419
167,970
Total liabilities
12,153
13,769
Total stockholders' equity
138,266
154,201
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version on businesswire.com: https://www.businesswire.com/news/home/20201106005216/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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