- Enrollment in the Company-sponsored pivotal Phase 3 trial
evaluating uproleselan in patients with relapsed/refractory acute
myeloid leukemia (AML) continued, and the company affirmed second
half of 2021 as target for completion of enrollment
- A post hoc analysis of the Phase 3 RESET study evaluating the
efficacy of rivipansel in acute vaso-occlusive crisis (VOC) in
sickle cell disease (SCD) produced new efficacy data showing
statistically significant improvements for patients treated early
in crisis in the primary efficacy endpoint of time to readiness for
discharge compared to placebo
- Pfizer completed the transfer to GlycoMimetics of all
commercial and development rights and the Investigational New Drug
Application (IND) for rivipansel
GlycoMimetics, Inc. (Nasdaq: GLYC) today reported its financial
results for the second quarter ended June 30, 2020, and highlighted
recent company events. Cash and cash equivalents at June 30, 2020
were $149.8 million.
“The second quarter was quite productive as we noted strong
enrollment in our company-sponsored pivotal trial of uproleselan in
relapsed/refractory AML. Though we did see a slow down early in the
COVID crisis, we were pleased to see enrollment pick back up later
in the quarter. This was an important achievement in the face of
the COVID-19 pandemic, and we are able to maintain prior guidance
that we expect to complete enrollment in the second half of 2021.
Also important were new data from a post hoc analysis of the
rivipansel Phase 3 study that showed that patients treated with
rivipansel within approximately 26 hours of the onset of pain in
their crisis experienced statistically significant improvements in
the primary efficacy endpoint of time to readiness for discharge
compared to placebo. These data provide a foundation, we believe,
for us to discuss with the U.S. Food and Drug Administration (FDA)
whether there may be a path forward for rivipansel in acute VOC,”
commented Rachel King, Chief Executive Officer.
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 by COVID-19, overall clinicians
continued to enroll patients well this quarter.
- At the American Association for Cancer Research (AACR) Annual
Meeting 2020, held June 22-24, preclinical research for both
uproleselan and GMI-1359 was shared in a virtual format.
Preclinical data supporting the potential use of uproleselan in the
treatment of AML as well as in the setting of stem cell
transplantation were presented. Additionally, new information
demonstrated the ability of transcriptome profiling to identify
those tumor types most likely to benefit from targeted E-selectin
inhibition, a key mechanism of GlycoMimetics drug candidates.
- Important new preclinical data on the mechanism of action for
uproleselan were published in the April 27, 2020, issue of Nature
Communications. The paper outlined how uproleselan, a
first-in-class, targeted inhibitor of E-selectin, can reduce
chemoresistance in AML through the key mechanism of targeted
E-selectin inhibition.
GMI-1687
- An abstract that was accepted for oral presentation at the
Foundation for Sickle Cell Disease (FSCDR) meeting and published
online in June, disclosed data from a preclinical model of the
Company’s E-selectin antagonist, GMI-1687, which is more potent
than rivipansel and is being formulated for subcutaneous dosing.
The data support development of GMI-1687 as a possible follow-on to
rivipansel, which has the potential for subcutaneous
self-administration as would be used in an outpatient setting.
Rivipansel
- The FSCDR also published online an abstract including data from
a post hoc analysis of the Phase 3 RESET trial of 345 patients
(ranging in age from six years to adults, with a mean age of 22
years) who were experiencing acute VOC requiring hospitalization
for treatment. The organization selected the abstract for poster
presentation at its September meeting. The analysis showed that
patients treated with rivipansel early in their acute episode
experienced a statistically significant improvement on the primary
efficacy endpoint, time to readiness for discharge (p=0.03, median
improvement at 56.3 hours compared to placebo).
- Based upon its review of the Phase 3 rivipansel data set,
GlycoMimetics is committed to an assessment of what, if any, next
steps to take, with a focus on determining if there is a potential
path forward for this asset in sickle cell disease.
- GlycoMimetics completed in April a transfer back from Pfizer of
the commercial and development rights and licenses for rivipansel,
the IND for the clinical development program, and the entire data
set for the Phase 3 RESET trial.
Executive Management
Team
- The Company announced that veteran regulatory expert Myra
Rosario Herrle, PhD, RPh, RAC, joined the executive management team
as Vice President, Regulatory Affairs.
Second Quarter 2020 Financial Results:
- Cash position: As of June 30, 2020, GlycoMimetics had cash and
cash equivalents of $149.8 million as compared to $158.2 million as
of December 31, 2019. During the quarter, the Company sold common
stock under its at-the-market facility with Cowen for aggregate net
proceeds of $9.6 million.
- R&D Expenses: The Company’s research and development
expenses decreased to $9.9 million for the quarter ended June 30,
2020 as compared to $13.1 million for the second quarter of 2019.
The Company’s research and development expenses decreased to $22.5
million for the six months ended June 30, 2020 as compared to $24.8
million for the same period in 2019. These decreases were due
primarily to a decrease in manufacturing and formulation expenses
resulting from lower raw material costs as the validation
manufacturing batches were purchased in the prior year. The
decreases were offset in part by higher clinical expenses as a
result of 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. Contract research
services, consulting and other costs were lower in 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 $4.2 million for the second quarter ended
June 30, 2020 as compared to $3.8 million for the second quarter of
2019. General and administrative expenses for the six months ended
June 30, 2020 increased to $8.7 million as compared to $7.1 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 both the three and six months
ended June 30, 2020, as compared to the same periods in 2019, due
to lower travel, meals and conference registration expenses as a
result of the travel restrictions due to the COVID-19
pandemic.
- Shares Outstanding: Shares of common stock outstanding as of
June 30, 2020 were 46,714,698.
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 1677593.
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
1677593.
About Uproleselan (GMI-1271)
Discovered and developed by GlycoMimetics, uproleselan and
GMI-1687 are investigational, first-in-class, targeted inhibitors
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 GMI-1687
GMI-1687 is a rationally designed, innovative antagonist of
E-selectin that is potentially suitable for subcutaneous (SC)
administration. When given by SC injection in preclinical models,
GMI-1687 has been observed to have equivalent activity to
uproleselan, but at an approximately 1,000-fold lower dose.
GlycoMimetics believes that GMI-1687 could be developed as a
potential life-cycle expansion to broaden the clinical usefulness
of an E-selectin antagonist to conditions, such as sickle cell
disease crisis, where outpatient treatment may be preferred or
required. GMI-1687 is currently undergoing IND-enabling
studies.
About Rivipansel
Rivipansel, a 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 in advance of a
presentation to occur at the Foundation for Sickle Cell Disease
Research Meeting in September 2020. GlycoMimetics is committed to
exploring a path forward for the use of rivipansel in treating
acute VOC in SCD.
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. GMI-1359 has completed a Phase 1 clinical trial in healthy
volunteers. The Duke University Phase 1b clinical study in breast
cancer patients 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, a rare cancer affecting
about 900 adolescents a year in the United States.
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 as a
potential treatment for acute VOC in SCD. 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 regarding
the Company’s strategy and the clinical development and potential
utility, benefits and impact of its drug candidates. These
forward-looking statements include those relating to the planned
preclinical research and 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 potential impact of the ongoing global COVID-19
pandemic on the Company’s operations, and the Company’s plans for
discussing data from the Phase 3 clinical trial of rivipansel with
the FDA. Actual results may differ materially from those expressed
in or implied by 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, the updated risk factors described in the Company’s quarterly
report on Form 10-Q filed with the SEC on July 31, 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 June 30,
Six months ended June 30,
2020
2019
2020
2019
(Unaudited)
(Unaudited)
Revenue
$
-
$
-
$
9,000
$
-
Cost and expenses: Research and development expense
9,871
13,065
22,539
24,838
General and administrative expense
4,235
3,751
8,675
7,111
Total costs and expenses
14,106
16,816
31,214
31,949
Loss from operations
(14,106
)
(16,816
)
(22,214
)
(31,949
)
Other income
27
986
472
2,035
Net loss and comprehensive loss
$
(14,079
)
$
(15,830
)
$
(21,742
)
$
(29,914
)
Net loss per share - basic and diluted
$
(0.32
)
$
(0.37
)
$
(0.50
)
$
(0.69
)
Weighted average shares - basic and diluted
43,801,251
43,183,010
43,688,420
43,174,989
GlycoMimetics, Inc.
Balance Sheet Data
(In thousands)
June 30,
December 31,
2020
2019
(unaudited)
Cash and cash equivalents
$
149,845
$
158,201
Working capital
143,657
151,577
Total assets
158,353
167,970
Total liabilities
12,600
13,769
Total stockholders' equity
145,752
154,201
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200731005215/en/
GlycoMimetics Contacts 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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